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The DOLORCLAST Focused Shock Waves System is intended to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The DOLORCLAST Focused Shock Waves system is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The DOLORCLAST Focused Shock Waves system is composed of the DolorClast console, a handpiece, interchangeable gel pads (3 different sizes) and optional cart. EMS DolorClast Gel, previously approved under P050004 and K220538, is also provided for transmitting shock waves between the piezoceramic elements to the gel pad and coupling the treatment gel pad to the patient's skin.

The DOLORCLAST Focused Shock Waves system generates acoustic pressure waves generated using piezoelectric technology. A high-voltage impulse, controlled by the console, is used to stimulate the piezoceramic elements arranged across a concave surface in the emission source (the handpiece), causing the elements to expand simultaneously and briefly by a few micrometers, thus generating a focused shock wave. The shock waves are delivered to the patient's body via the handpiece, through a gel pad in a focused manner, and the treatment depth varies in line with the gel pad used.

The provided 510(k) clearance letter and summary for the DOLORCLAST Focused Shock Waves device do not describe a study involving acceptance criteria for an AI/ML-based medical device performance benchmark (e.g., accuracy, sensitivity, specificity). Instead, the document focuses on demonstrating substantial equivalence to a predicate device through physical and electrical performance testing, and biocompatibility, as well as characterization of its acoustic properties and software validation.

The acceptance criteria mentioned in the document are related to:

• Acoustic Pulse Characterization: Comparing the pressure field output to publicly available information on the predicate device.
• System Functional Performance Testing: Confirming correct operation of the console and handpiece at all treatment settings.
• Lifetime Testing: Confirming the console and handpiece function and meet performance specifications for their claimed useful lifetimes.
• Software Validation: Compliance with IEC 62304.
• Electrical Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2.
• Biocompatibility Testing: Compliance with various ISO 10993 standards.

Since the request asks for information relevant to AI/ML device performance (like acceptance criteria related to accuracy, sample size for test sets, expert ground truth, MRMC studies, etc.), and the provided text does not contain this information for the DOLORCLAST Focused Shock Waves device, I cannot fulfill the request as written.

The DOLORCLAST Focused Shock Waves device is a physical therapeutic device, not an AI/ML diagnostic or assistive device. Therefore, the types of studies and acceptance criteria typically associated with AI/ML devices (like sensitivity, specificity, MRMC studies, and expert adjudication of ground truth) are not applicable or described in this 510(k) submission.

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PGDx elio plasma focus Dx is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of single nucleotide variants (SNVs), insertions and deletions (indels), copy number amplifications (CNAs), and translocations in human genomic circulating cell-free DNA (cfDNA) on the Illumina NextSeq 550Dx instrument. PGDx elio plasma focus Dx utilizes cfDNA from plasma of peripheral whole blood collected in Streek Cell-Free DNA blood collection tubes (BCTs). PGDx elio plasma focus Dx is a tumor mutation profiling test intended to provide information on mutations to be used by qualified health care professionals in accordance with professional. guidelines in oncology for cancer patients with solid malignant neoplasms. The test is for use with patients previously diagnosed with cancer and in conjunction with other laboratory and clinical findings. A negative result from a plasma specimen does not assure that the patient's tumor is negative for genomic findings. Genomic findings are not prescriptive or conclusive for use of any specific therapeutic product.

The PGDx elio plasma focus Dx assay is a hybrid-capture, next generation sequencing (NGS)based in vitro diagnostic assay (IVD) for the qualitative reporting of sequence mutations (SNVs and indels) in 33 genes, translocations in 3 genes, and amplifications in 5 genes. The assay consists of library preparation and sample indexing reagents. PGDx elio platform software, and a server inclusive of all essential data analysis software. The input of the test is cfDNA extracted from blood collected in the Streck Cell-Free DNA BCT using the OIAGEN OIAamp DSP Circulating NA Kit. The blood collection and DNA extraction materials are required but not supplied with the PGDx elio plasma focus Dx assay. Extracted cfDNA is used to prepare an indexed, targeted DNA library suitable for NGS on an Illumina NextSeq 550Dx instrument qualified by PGDx. Data analysis occurs on a dedicated server running the PGDx elio plasma focus Dx software that performs demultiplexing, alignment, variant calling, and filtering to generate reports containing detected and reportable alterations.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to orthogonal methods, as well as satisfactory performance in areas like Limit of Detection (LoD), Limit of Blank (LoB), and reproducibility.

• SNVs/indels with Clinical Significance in Plasma: 97.6% - 100% PPA, 99.9% NPA
• SNVs/indels with Clinical Significance in Tissue: 95.7% PPA, 99.99% NPA
• SNVs/indels with Potential Clinical Significance: 94.3% PPA, 99.99% NPA
  All Variants (Primary Analysis):
• SNVs/indels with Clinical Significance in Plasma: 63.8% - 100% PPA, 99.6% - 100% NPA
• SNVs/indels with Clinical Significance in Tissue: 60.5% PPA, 99.99% NPA
• SNVs/indels with Potential Clinical Significance: 53.4% PPA, 99.99% NPA | Device meets and often exceeds these criteria for variants at or above LoD. Lower PPA for "all variants" is acknowledged and attributed to variants below LoD. |
  | Accuracy (PCCPTerms) | Accuracy point estimates of ≥ 80% PPA and ≥ 95% NPA for copy number amplifications and translocations when considering variants at or above LoD of the PGDx elio plasma focus Dx only. Accuracy point estimates of > 60% PPA and > 95% NPA for all copy number amplifications and translocations irrespective of variant level. | Variants ≥ LoD of Orthogonal Method:
• Amplifications (CCND1, CD274, ERBB2, FGFR2, MET): 65.6% - 100% PPA, 99.4% - 99.8% NPA
• Translocations (ALK, NTRK1, RET): 75% - 92.3% PPA, 99.63% - 100% NPA
  All Variants (Primary Analysis):
• Amplifications: 57.9% - 100% PPA, 99.3% - 99.8% NPA
• Translocations: 50% - 92.9% PPA, 99.63% - 100% NPA | Device meets and often exceeds these criteria for variants at or above LoD of the orthogonal method. |
  | False Positive Rate (FPR) | 95% PPA for mutation positive samples with alteration at 1-1.5x LoD and > 95% NPA for mutation negative samples for precision evaluation (PCCP terms) | Interlaboratory Reproducibility (at 1-1.5x LoD):
• Clinical Blends (Plasma): 97.2% PPA
• Cell Line Blends: 90.3% PPA
  End-to-end Precision (at >1x LoD):
• SNVs: 97.4% APA
• Indels: 100.0% APA
• Aggregate variants: 97.8% APA
• All structural variants: 100% APA
  Lot-to-Lot Precision:
• SNVs: 90.5% PPA
• Deletions: 86.6% PPA
• Amplifications & Translocations: 100% PPA | PPA for 1-1.5x LoD is generally >95% for clinical samples but slightly lower for cell-line blends in interlaboratory. End-to-end and lot-to-lot also demonstrate high agreement. |
  | Interfering Substances | Assay results robust in presence of interfering substances. | Across 11 potential interferents (16 conditions), concordance of variant calls was ≥92.6% PPA and ≥99.9% NPA. Overall success rate ≥ 85.7%, with 2 failures attributed to operator error. | Performance demonstrated as robust. |
  | Hybrid Capture Probe Specificity | Probes uniquely map to intended targets, with off-target hits showing low mapping quality. Minimal risk of false positives from mis-mapping. | 97.1% of probes uniquely mapped. Zero of simulated off-target reads mapped to on-target positions. | Demonstrated high specificity. |
  | DNA Input Robustness | Performance maintained across reasonable DNA input variations. | PPAs >96% and NPAs ≥99.9% across input levels for clinical plasma samples (5ng - 50ng LP, 150ng - 600ng CAP). Overall success rate >47.5%, with failures at very low input (5ng LP) impacting cell lines. | Robust performance around the recommended 25ng input. Acknowledged reduced performance at very low inputs. |
  | Assay Guard Banding | Robustness to variations in assay protocol (volume/time for reagents). | PPAs >94% and NPAs >99.9% for all test conditions, except -25% ligation master mix (PPA 88.6%). Supplemental study improved -15% ligation to 93.2% PPA. | Generally robust, with one identified sensitivity point (Ligation Master Mix volume) leading to a precaution in labeling. |
  | Whole Blood Stability | Performance maintained after storage in BCTs under varying conditions. | PPAs 100% and NPAs ≥99.9% across storage conditions (Room Temp, Summer, Winter for 8 days). Overall success rates >86.7%, with failures attributed to low cfDNA yield from patient. | Blood stable for 7 days in Streck cfDNA BCTs. |
  | Plasma Stability | Performance maintained after storage of isolated plasma. | PPAs 95.0% - 100% and NPAs ≥99.9% across storage conditions (25 hours at 2-8°C, 46 days at -80°C, 1 year at -80°C). Overall success rates >92%. | Plasma stable for up to 1 year at -80°C. |
  | cfDNA Stability | Performance maintained after storage of isolated cfDNA. | Modal PPA ≥ 93% and modal NPA ≥ 99% for 3.5 months at -20°C. PPAs 93.1% - 97.1% for up to >250 days. | cfDNA stable for extended periods at -20°C. |
  | Sample Carryover and Cross-Contamination | No evidence of carryover or cross-contamination. | No evidence of contamination in 100% of mutation-negative samples within and between sequencing runs. | Demonstrated to be contamination-free. |
  | Lot Interchangeability | Performance maintained after exchanging reagents between unique lots. | PPA > 91% and NPA ≥ 99.9% across all aggregated variant types. | Reagents from different lots are interchangeable. |
  | Lane Combination | Performance maintained when using filling material for partial batches. | 100% PPA and ≥ 99.99% NPA for all variants at all lane ratio test conditions. | Device performs consistently even with partial batch filling. |
  | BCT Incomplete Mixing & Underfilled Tube | Performance maintained with variations in mixing and filling of BCTs. | PPAs 100% and NPAs >99% for all conditions except 5mL underfilled tube (73.3% success rate). | Performance maintained for proper usage, but a limitation for underfilled tubes is noted. |
  | BCT Lot-to-Lot Reproducibility | Consistent performance across different BCT lots. | APA between and within lots >93% and ANA ≥99%. | Consistent performance across BCT lots. |
  | BCT Concordance | Concordance between Streck cfDNA BCTs and BD Vacutainer K2 EDTA BCTs. | PPA 95.8% and NPA 99.9% for aggregated variant types. | High concordance between BCT types. |

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Accuracy Study):
  • Clinical Plasma Specimens: 931 samples across 35 solid tumor types (e.g., NSCLC, Colorectal, Breast, etc.).
  • Contrived Samples: 48 samples (34 spiked cell lines, 13 spiked cell line blends, 1 clinical plasma blend).
  • Total Samples Assessed: 979 (785 passed QC for both PGDx elio plasma focus Dx and at least one orthogonal method).
  • Data Provenance: The text does not explicitly state the country of origin for the clinical samples. It mentions "clinical plasma specimens," implying human-derived samples. It appears to be retrospective as samples were compared to "orthogonal methods" which are likely established assays already used for patient variant detection. The "Orthogonal Method" results served as the reference standard.
  • LoB Study (Test Set):
    • Cohort 1: 29 normal plasma specimens (tested in duplicate)
    • Cohort 2: 38 normal plasma specimens (tested singularly)
    • Total unique donors: 67
    • Data Provenance: Healthy donors (no cancer diagnosis). Retrospective.
  • LoD Study (Test Set):
    • 11 cell line blends (dilution series, 10 replicates at 5 levels)
    • Clinical plasma blends (20 unique pools, 10 replicates, 2 reagent lots)
    • Data Provenance: Contrived and clinical plasma samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the test set (accuracy study) was established by orthogonal methods, not directly by human experts reviewing the PGDx elio plasma focus Dx results. The orthogonal methods themselves would have undergone their own validation processes, which may or may not have involved expert review for their initial validation. The text does not specify the number of experts or their qualifications who established the ground truth for these orthogonal methods.

4. Adjudication Method for the Test Set

The primary method for establishing ground truth was comparison to orthogonal methods.

• Concordance Assessment: Reference status was assigned to each variant based on the orthogonal method.
• The comparisons were made between the PGDx elio plasma focus Dx output and the orthogonal methods. There is no mention of an "adjudication panel" or specific adjudication method (e.g., 2+1, 3+1) being used to resolve discrepancies between the PGDx elio plasma focus Dx and the orthogonal methods, or between multiple orthogonal methods (though one instance mentions a second orthogonal method was used when a discrepancy occurred for NTRKI translocation).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The performance evaluation focuses on the analytical performance of the device itself (standalone) against orthogonal methods, not on how human readers' performance might improve with or without AI assistance from this specific device.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The entire "Analytical Performance" section (VI.A) describes the performance of the PGDx elio plasma focus Dx assay, which is a "next generation sequencing based tumor profiling assay" with automated data analysis software. The evaluation metrics (PPA, NPA, LoD, LoB, reproducibility) are all measures of the assay's ability to detect genetic variants autonomously. There is no mention of human-in-the-loop performance in any of the analytical or clinical validation sections.

7. The Type of Ground Truth Used

The primary type of ground truth used was:

• Orthogonal Methods: For the accuracy study, variants detected by established and validated independent assays served as the reference.
• Known Mutations in Cell Lines/Blends: For LoD and reproducibility studies, where contrived samples (cell line DNA spiked into plasma) were used, the "expected variants" in these materials were the ground truth.
• Absence of Mutations in Healthy Donors: For LoB studies, a "mutation negative" status based on pre-screening with an externally validated orthogonal method or sequencing of matched buffy coat (to exclude CHIP and germline variants) was used as ground truth.
• Modal Status: For precision/reproducibility studies across replicates, the majority call (modal status) served as a form of internal reference to assess consistency.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" for the PGDx elio plasma focus Dx algorithm. Phrases like "Metrics were first established and optimized using well-characterized cell lines with known variants. Once initial thresholds were established, clinical samples were run through the assay to measure device performance prior to assay lock and the commencement of analytical performance testing" imply an internal development and optimization phase. However, a distinct, quantified "training set" with specific sample sizes for algorithm development (in the machine learning sense) is not provided. The study design focuses on the analytical validation (test set) of the final locked assay.

9. How the Ground Truth for the Training Set was Established

As noted above, a formal "training set" is not explicitly defined. However, the initial establishment and optimization of metrics involved:

• Well-characterized cell lines with known variants: This implies that for initial parameter tuning and threshold setting, variants in these cell lines were used as ground truth, likely established through extensive prior characterization (e.g., Sanger sequencing, other NGS methods, etc.).
• Clinical samples for initial performance measurement: These samples would have had ground truth established by orthogonal methods, similar to the main accuracy study.

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The Ki Mobility Focus CR manual wheelchair is a manually operated device with wheels that is intended to provide mobility to adults restricted to a sitting position.

The Ki Mobility Focus CR manual wheelchair is intended to provide mobility to adults limited to a sitting position. The primary use is by adult users in need of manual wheeled mobility offering an operator adjustable body support system. The Focus CR offers both seat tilt and an optional reclining backrest, with both adjustable by the attendant.

The Focus CR manual wheelchair can be propelled by the occupant with access to hand-rims on the rear wheels or moved by an attendant with access to push handles are used by the attendant to control the seat tilt function and recline of the backrest. Hand control levers on the push handles or a foot-operated pedal on the frame are used to release a slide-locking mechanism for changing the seat tilt angle. The backrest recline is controlled through hand control levers on the push handles which release sliding mechanical wrapped spring rod locks to change the backrest angle.

The Focus CR wheelbase is of a welded high-strength aluminum frame, upon which an inner high-strength forged aluminum frame can rotate on four rollers (two on each side) fixed to the base frame. The use of two control paths rolling on the fixed rollers is designed to create a complex rotation (CR) with a neutral resting angle of 20° tilt and minimizes the translation of the user-loaded system weight for safely controlling the change in seat tilt angle. The high-strength tubular aluminum seat frame assembles to the inner rotating frame and can be adjusted for seat depth and to adjust the user loaded center of gravity (CG) relative to the frame. Seat adjustment is optimal when the user-loaded and unlocked seating system will rest without force applied at 20°. CG adjustment is made with two easily accessed bolts are align to a series of holes through the seat frame and connected to the inner rotating frame.

The Focus CR manual wheelchair has a folding backrest frame for ease of storage for transport. A non-folding backrest and a reclining backrest are options. The adjustable tubular aluminum seat and backrest frame assembly is made to adapt to planar seating systems which have hardware adapted to mount to tubes. A solid mounted and depth adjustable aluminum seat pan is available for use with wheelchair seat cushions and the backrest frame accepts contoured wheelchair backrests. The seating system is a separate medical device adapted for use to the Focus CR and is the primary contact surface to the occupant. Focus CR components such as armrests and footrests will also have contact to the occupant.

The Focus CR wheelchair is custom configured to the user requirements by order form selection of components and accessories. The standard weight capacity for all models is 300 pounds, with an option for configuration as a heavy-duty weight capacity of 400 lbs. The seat tilt range is -5° to 50° with an accessory tilt stop available to limit the range. The backrest recline option range is available from 0 to 65°, 10° to 75° or 20° to 85°. The Focus CR, CRe & TTL are the same product with order form variations to meet different market configuration requirements only for pricing.

This document is a 510(k) Summary for a medical device called the "Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL," which is a mechanical wheelchair. The purpose of this summary is to demonstrate substantial equivalence to previously marketed predicate devices (Ki Mobility Focus CR to Invacare (K181090) and Sunrise Medical, Quickie IRIS (K123975)).

The acceptance criteria and study that proves the device meets these criteria are primarily based on non-clinical performance testing against recognized international standards for wheelchairs. There are no clinical studies mentioned or required for this submission. Therefore, for a device like a mechanical wheelchair, the "performance" is demonstrated through adherence to engineering and safety standards, rather than clinical efficacy or diagnostic accuracy.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally "Pass/Fail Limits" as defined by the recognized standards, or "Informative" for comparison data. The reported device performance is "PASS" for tests with pass/fail limits and "Comparison Data" for informative tests.

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify a numerical sample size for the mechanical wheelchairs tested. It implies that "the Focus CR" (singular, referring to the model) was tested according to the standards. For non-clinical, bench testing of physical devices, "sample size" typically refers to the number of units tested. However, the standards themselves often dictate the number of test pieces required (e.g., prototypes, production units). It's reasonable to assume standard engineering practices were followed, which usually involve testing a small number of representative units to destruction or for endurance.
• Data Provenance: The tests were conducted by a "Third party lab testing." The country of origin is not explicitly stated, but the standards cited (ANSI/RESNA, ISO) are international. The nature of the testing is retrospective in the context of the 510(k) submission, as these tests were completed before the submission to demonstrate compliance. They are not prospective clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the context of this device. The "ground truth" for a mechanical wheelchair's performance is established by objective engineering measurements and adherence to predefined specifications within recognized international standards. There are no human experts "establishing ground truth" in the way radiologists interpret images for an AI study. The "experts" here would be the engineers and technicians at the third-party lab who conduct the tests and ensure they conform to the standard's methodology. Their qualifications would be expertise in mechanical testing and adherence to quality systems.

4. Adjudication method for the test set

Not applicable. There is no subjective interpretation that requires adjudication. The tests involve quantifiable measurements (e.g., angles, forces, dimensions) and observations (e.g., breakage, slippage) against pass/fail criteria defined by the standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical wheelchair, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical wheelchair. There is no "algorithm only" performance separate from the physical device itself.

7. The type of ground truth used

The "ground truth" for the performance evaluation of this mechanical wheelchair is:

• Established engineering standards and specifications: Compliance with objective, quantifiable metrics defined by ANSI/RESNA WC-1:2009, WC-4:2012, and the ISO 7176 series (e.g., static stability angles, brake effectiveness, fatigue strength limits).
• Physical performance measurements and observations: Direct measurements and observations during bench testing conducted by a third-party laboratory.

8. The sample size for the training set

Not applicable. This is a physical mechanical device, not a machine learning model. Therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a mechanical wheelchair. For this specific device, the closest analog to "ground truth establishment" would be the initial design specifications, engineering calculations, and component testing, long before full product integration and final performance testing against standards.

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The FOCUS Interbody System is intended to be used as a lumbar intervertebral fusion device at one or two adjacent levels from L2 to S1. This system should be limited to skeletally mature patients who have had six months of non-operative care for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. In addition, the FOCUS Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The FOCUS Interbody System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures such as the OrthoCircle Spine Pedicle Screw System.

The FOCUS Interbody System includes interbody fusion devices for lumbar implantation. The FOCUS-T and FOCUS-TO implants are designed as structural columns to provide surgical stabilization of the lumbar spine. Each interbody has a central cavity to be packed with bone graft material and inferior/superior teeth to resist expulsion. Lateral windows provide for radiographic visualization on most implant sizes. The implants are available with and without the XCELLerate surface coating and in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. The implants are supplied sterile.

The provided text describes the 510(k) premarket notification for the "FOCUS Interbody System," a lumbar intervertebral fusion device. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical testing rather than performance in a study involving human subjects or AI-assisted interpretation of medical images. As such, many of the requested elements for an AI/device study (such as MRMC studies, ground truth establishment for image data, or AI-specific acceptance criteria) are not applicable to this specific device submission.

The "study" in this context refers to the performance data obtained from mechanical testing of the device itself, proving its structural integrity and functional characteristics are substantially equivalent to predicates.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that "The mechanical test results demonstrate that the FOCUS Interbody System performance is substantially equivalent to the predicate devices." Specific numerical thresholds for acceptance criteria and the exact numerical results for the device are not provided in this summary, but are implicitly deemed acceptable by the FDA's clearance.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document refers to "worst case FOCUS Interbody System implant" undergoing testing. This implies a limited, focused sample size for mechanical testing. The exact number of units tested is not specified but is typical for benchtop mechanical validation rather than clinical study sample sizes.
• Data Provenance: The data is generated from laboratory mechanical testing of the device prototypes. This is not patient data; therefore, concepts like country of origin or retrospective/prospective do not apply.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

• Not Applicable. For mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F2077, ASTM F2267) and the physical properties of the materials and design. There are no "experts" establishing ground truth in the sense of medical image interpretation. Engineers and test technicians perform the testing and interpret results against the standards.

4. Adjudication Method for the Test Set:

• Not Applicable. This is mechanical engineering testing against defined standards, not an observational study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This device is a physical medical implant. MRMC studies are relevant for devices that assist in diagnostic interpretation (e.g., AI for radiology). This is not such a device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

• Engineering Standards and Material Properties: The "ground truth" for the performance of the FOCUS Interbody System is established by recognized ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices (F2077 for static/dynamic axial compression and F2267 for subsidence), as well as the known properties of the materials used (Ti6Al4V ELI titanium alloy, titanium powder, calcium phosphate).

8. The Sample Size for the Training Set:

• Not Applicable. This device did not involve machine learning or a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there was no training set, this question is irrelevant to this device.

In summary, the provided document details the regulatory clearance of a physical medical device based on its mechanical performance demonstrating substantial equivalence to existing devices, adhering to established engineering standards. It does not involve AI, image analysis, or clinical performance studies with human subjects in the contexts typically associated with the acceptance criteria questions.

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The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

The CARTO® 3 EP Navigation System with AFM, software V7.3, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheters location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTO® 3 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO® 3 System with AFM consists of the following hardware components:

• Patient Interface Unit (PIU)
• Workstation with Graphic User Interface (GUI)
• Wide-Screen monitors, keyboard, and mouse
• Intracardiac In Port
• Intracardiac Out Port
• Power Supply
• Patches Connection Box and Cables (PU)
• Pedals
• Location Pad (LP)
• Signal Processing Unit (SPU)

All hardware components of the CARTO® 3 system with AFM are identical to those described for the predicate device.

The provided text describes a 510(k) premarket notification for the CARTO® 3 EP Navigation System with Advanced Focus Mapping (AFM). While the document outlines performance testing, it does not provide detailed acceptance criteria or the specifics of a study proving the device meets those criteria in the format requested.

The document discusses:

• Bench Testing:
  • Proof of Design – "CARTO® 3 System AFM algorithms were verified to meet specifications." "All testing performed met the acceptance criteria."
  • Functional verification – "All system features were found to perform according to specifications and met the tests acceptance criteria."
  • Unit Test – "performed to verify isolated software components that were modified."
• Animal Testing: "conducted to evaluate the CARTO® 3 System with AFM functionality under simulated clinical workflow and conditions." "All test protocol steps were successfully completed and expected results were achieved."

However, the specific quantitative acceptance criteria (e.g., "accuracy must be > 95%") and the detailed results against these criteria are not disclosed in this regulatory summary. Similarly, the study design elements like sample size, data provenance, expert qualifications, or detailed ground truth establishment methods for these specific validation tests are not provided. The document focuses on demonstrating substantial equivalence to a predicate device based on identical intended use, fundamental scientific technology, hardware platform, and core mapping technology, with software modifications undergoing verification and validation.

Therefore, based on the provided text, I cannot fill out the requested table or answer most of the detailed questions regarding acceptance criteria and study specifics. The document confirms that testing was done and acceptance criteria were met, but it does not describe those criteria or the exact study details.

Limitations based on the provided text:

• Acceptance Criteria Table: No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) are provided in the text. It only states that "All testing performed met the acceptance criteria" and "All system features were found to perform according to specifications and met the tests acceptance criteria."
• Sample Size and Data Provenance: Not specified for the bench or animal testing. The animal testing implies prospective data collection in a controlled setting.
• Number/Qualifications of Experts: Not mentioned.
• Adjudication Method: Not mentioned.
• MRMC Comparative Effectiveness Study: Not mentioned. The focus is on a "human-in-the-loop" system, but a comparative effectiveness study with/without AI assistance is not described.
• Standalone Performance: Not explicitly detailed as a separate study. Performance is likely intertwined with the system's overall function during bench and animal testing.
• Type of Ground Truth: For the bench testing, ground truth would be the known, expected outputs based on specifications. For animal testing, it would be the direct physiological measurements and observations during the procedures. No mention of expert consensus, pathology, or outcomes data for validation.
• Training Set Sample Size/Ground Truth Establishment: No information about a training set for machine learning models is provided. The new features appear to be software-driven calculations and displays (CLM, PDM, Ripple Frequency, PASO™ Module Improvement) rather than AI models requiring extensive training data and ground truth labeling in the traditional sense of deep learning. The testing described is verification and validation of these new features and regression testing for existing ones.

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Focus HD 43 Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.

Focus HD 43 Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 42.67cm×42.67cm. The sensor plate of Focus HD 43 Detector is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus HD 43 Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software. SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.

The provided text is a 510(k) summary for the iRay Technology Taicang Ltd. Focus HD 43 Detector. It states that the device is substantially equivalent to a predicate device (Mars1717X Wireless Digital Flat Panel Detector, K210314).

Crucially, the document does NOT contain information about a study proving the device meets acceptance criteria derived from a performance study with human readers or AI algorithms. Instead, it focuses on demonstrating substantial equivalence through non-clinical testing and comparison of technical specifications with a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as typically seen in performance claims for AI/CADe devices or new clinical functionalities. The information given indicates a different pathway to market clearance for this type of device (a digital X-ray detector).

However, I can extract the information provided about the device's technical specifications and the comparison to its predicate, which implicitly serves as the "acceptance criteria" for demonstrating substantial equivalence for this type of hardware device.

Here's an attempt to structure the available information relevant to the prompt, acknowledging the absence of a "study" in the typical sense of AI/clinical performance, and focusing on the technical equivalence:

Acceptance Criteria and Study for Focus HD 43 Detector (Based on Substantial Equivalence to Predicate Device)

The "acceptance criteria" for the Focus HD 43 Detector are primarily its substantial equivalence in performance characteristics to the legally marketed predicate device, the Mars1717X Wireless Digital Flat Panel Detector (K210314). The "study" proving this equivalence is a series of non-clinical tests and direct comparison of specifications.

1. Table of Acceptance Criteria and Reported Device Performance

For a device like an X-ray detector, acceptance criteria are generally based on meeting or exceeding the technical specifications of a predicate device, along with demonstrating safety and electromagnetic compatibility. The following table showcases the comparison provided in the 510(k) summary:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the context of a clinical test set with patient data for performance evaluation. The "tests" were non-clinical engineering and safety tests.
• Data Provenance: The 510(k) summary explicitly states that "Non-clinical studies have been performed," and "All test results are meet the standard requirements." The testing was conducted by the manufacturer, iRay Technology Taicang Ltd. (China). The data refers to engineering and safety performance data, not patient-specific clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not applicable. Ground truth as typically defined for clinical/AI performance studies (e.g., expert radiological reads, pathology) was not established for this device's premarket clearance, as it's a hardware device demonstrating substantial equivalence through non-clinical testing.

4. Adjudication Method for the Test Set

• Not applicable. There was no human "adjudication" of images for clinical ground truth. Non-clinical tests typically adhere to defined protocols and measurement standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is relevant for assessing human reader performance, often with and without AI assistance, or comparing different imaging modalities/interpretations. This 510(k) is for a digital X-ray detector hardware, not an AI or CADe device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This is not an algorithmic device in the sense of AI/CADe. Its performance is demonstrated through its physical characteristics and image acquisition capabilities, which are then used by human readers and integrated into existing DR systems.

7. Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on engineering specifications, safety standards compliance (e.g., IEC/ES 60601-1, IEC 60601-1-2, ISO 10993-1), and direct comparison to the technical characteristics of a legally marketed predicate device. There is no clinical or pathological "ground truth" derived from patient outcomes involved in this specific premarket notification.

8. Sample Size for the Training Set

• Not applicable. This device is a hardware component (digital flat panel detector) and does not involve AI or machine learning that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this device.

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Focus HD 35 Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.

Focus HD 35 Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35cm×43cm.

The sensor plate of Focus HD 35 Detector is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus HD 35 Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.

SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.

The provided text is a 510(k) summary for the iRay Technology Taicang Ltd. Focus HD 35 Detector. This document primarily focuses on establishing substantial equivalence to a predicate device (Mars1417X Wireless Digital Flat Panel Detector, K210316) rather than directly presenting a study proving that the device meets specific acceptance criteria related to a diagnostic task or clinical performance.

Medical device 510(k) clearances typically rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering and performance testing. They do not usually involve clinical trials or studies like those required for novel AI/diagnostic devices that predict diagnoses or outcomes.

Therefore, many of the requested points regarding acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth, and training set information are not applicable or not explicitly detailed in this type of submission.

Here's a breakdown of what can be gleaned from the text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the technical specifications and safety standards required for substantial equivalence, rather than diagnostic performance metrics (e.g., sensitivity, specificity for disease detection). The comparison is primarily against the predicate device's specifications.

2. Sample size used for the test set and the data provenance

• Sample size used for the test set: Not applicable for a typical 510(k) submission based on technical equivalence. The "test set" here refers to the actual physical device and its components undergoing engineering and safety tests, not a dataset for diagnostic performance evaluation.
• Data provenance: Not applicable. The data is from engineering and safety tests conducted on the physical device and from a comparison of specifications with the predicate. There is no mention of country of origin for clinical or image data, as such data is not the primary basis for this type of submission. The tests were likely conducted by the manufacturer or accredited labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This device is an X-ray detector, a hardware component. Its clearance is based on technical specifications, safety, and performance as an imaging capture device, not on its ability to produce a specific diagnosis from images or generate ground truth. There is no "ground truth" in the diagnostic sense being established for a test set of images within this submission.

4. Adjudication method for the test set

• Not Applicable. As no clinical diagnostic performance study with images and ground truth is described, there's no adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI-powered diagnostic device. It's a digital X-ray detector. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a hardware device (X-ray detector), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. For this hardware device submission, "ground truth" relates to physical measurements and compliance with engineering standards (e.g., spatial resolution, DQE, electrical safety standards). There is no clinical ground truth (pathology, expert consensus on images, etc.) associated with this submission.

8. The sample size for the training set

• Not Applicable. This is a hardware device; no "training set" in the context of machine learning or AI is mentioned or relevant to its clearance.

9. How the ground truth for the training set was established

• Not Applicable. As no training set is mentioned, no ground truth for it was established.

Summary of the Study (as described in the 510(k) submission):

The "study" referenced in the document is primarily a technical assessment and comparison to establish substantial equivalence with a legally marketed predicate device (K210316, Mars1417X Wireless Digital Flat Panel Detector).

• Methodology:

  • Side-by-side comparison of technical specifications: The document provides tables comparing parameters like intended use, indications for use, physical dimensions, imaging characteristics (spatial resolution, MTF, DQE), environmental operating conditions, and interfaces between the proposed device and the predicate device.
  • Non-clinical testing: This included:
    • Electrical safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC 60601-1-2 standards.
    • Biological Evaluation: Materials contacting operators' or patient's skin evaluated with ISO 10993-1.
    • Functional performance testing: The document implies that areas with minor differences (e.g., power consumption, local load capacity, operating temperature range, atmospheric pressure range) were still considered substantially equivalent following non-clinical studies. The improved spatial resolution (5.0 lp/mm vs. Min. 4.3 lp/mm) was presented as a positive difference.

• Conclusion: The manufacturer concluded that the Focus HD 35 Detector is substantially equivalent to the predicate device regarding safety and effectiveness, based on the non-clinical studies and comparison of technical characteristics. The main identified differences (DC input port, power consumption, local load, operating temperature range, storage/transportation atmospheric pressure) were implicitly determined not to raise new questions of safety or effectiveness.

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HYPER Focus can be used to correct respiratory motion in PET images. Relative to non - corrected images, HYPER Focus can reduce respiratory motion effects and thus improve the measurement accuracy of SUV and lesion volume.

HYPER Focus is a software-only device. It is intended to be implemented on previously cleared PET/CT devices uMI 550 (K193241) and uMI 780 (K172143). HYPER Focus serves as an additional function for uMI 550 and uMI 780 to carry the respiratory correction. It uses the similar respiratory motion correction technique, non-rigid image registration, as the predicate device.

The provided text describes the regulatory clearance of a medical device called "HYPER Focus" (K210418), a software-only device designed to correct respiratory motion in PET images.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state a table of quantifiable acceptance criteria with corresponding performance metrics like a typical clinical study report would. Instead, the acceptance criteria are implicitly tied to the device's ability to achieve "substantial equivalence" to a predicate device (GE Q.Freeze software, K113408) in terms of its ability to reduce respiratory motion effects and improve the accuracy of SUV and lesion volume.

The reported device performance is described qualitatively as:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify a numerical sample size for the test set. It mentions "identical raw datasets obtained from UIH's uMI 780 (K172143) and uMI 550 (K193241)." This suggests that existing datasets were used, but the quantity of these datasets or individual patient cases is not provided.
• Data Provenance: The data was obtained from UIH's uMI 780 and uMI 550 devices. Given that the company, Shanghai United Imaging Healthcare Co., Ltd., is based in China, it is highly probable that the data originated from China. The document does not explicitly state whether the data was retrospective or prospective, but given they are "identical raw datasets obtained" and "existing data" for bench testing, it strongly implies retrospective use of previously acquired patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document describes "engineering bench testing" and "performance verification" using "identical raw datasets," which suggests a technical analysis rather than an expert-read clinical study to establish ground truth for the test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. The study described appears to be a technical bench test comparing reconstructed images with and without motion correction, rather than a reader study requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study involving human readers is not described in this document. The study focuses on the device's quantitative performance (SUV and lesion volume accuracy) and its ability to reduce motion effects in comparison to non-corrected images, and on demonstrating substantial equivalence to a predicate device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done. The "Performance Verification" section states: "Engineering bench testing was performed to support substantial equivalence and product performance claims. The evaluation and analysis used the identical raw datasets obtained from UIH's uMI 780 (K172143) and uMI 550 (K193241), and then respectively performed image reconstruction with/without HYPER Focus." This indicates that the algorithm's performance was assessed independently of human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document primarily refers to "bench testing" and "analysis" of quantitative metrics like SUV (Standardized Uptake Value) and sphere/lesion volume accuracy. The "ground truth" for this type of test is typically based on:

• Known physical properties of phantoms: For sphere volume and potentially SUV accuracy, phantom studies with known dimensions and activity concentrations are commonly used. While not explicitly stated, "bench test" often implies phantom studies.
• Comparison to "ideal" or "reference" motion-corrected images: The document states a comparison "in comparison with no motion correction." This implies an assessment against a baseline reference, where the ground truth is the improved accuracy obtained by the algorithm. For motion correction, perfect motion-free images are the ideal ground truth, which is often approximated or modeled.
• The document implies that the "ground truth" for proving efficacy is the demonstrated improvement in SUV and lesion volume accuracy and reduction of motion effects when HYPER Focus is applied, compared to images without motion correction.

The document does not suggest the use of expert consensus, pathology, or outcomes data as a ground truth for this particular submission, which is focused on validating the technical performance of motion correction software for PET images in the context of substantial equivalence.

8. The sample size for the training set

The document does not provide any information about the sample size used for the training set of the HYPER Focus algorithm.

9. How the ground truth for the training set was established

The document does not provide any information about how the ground truth for the training set was established. It focuses solely on the performance verification (testing) of the final algorithm.

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Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for the optical correction of refractive ametropia (myperopia and astigmatism) in not-aphakic persons with nondiseased eyes.

Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Focus DAILIES and DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.

The Focus DAILIES and DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.

The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high molecular weight PVA (for Focus DAILIES lenses) and/or ultra-high molecular weight PVA (for Dailies AquaComfort Plus lenses) and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint™) to make the lenses easier to see when handling.

Focus DAILIES and DAILIES AquaComfort Plus soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foilblister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).

The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.

The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml (DAILIES AquaComfort Plus products) and/or 0.85 ml (Focus DAILIES products) phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. For DAILIES AquaComfort Plus lenses the package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.

The provided text does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML powered medical device.

Instead, it is a 510(k) summary for contact lenses (Focus DAILIES and DAILIES AquaComfort Plus) which outlines a modification to an alternate foil lidding material for their primary packaging. The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for traditional medical devices under the 510(k) pathway, not AI/ML performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details relevant to an AI/ML device from this document.

Here's why and what information is missing:

• No AI/ML Component: The device described is a soft contact lens, a physical medical device. There is no mention of any AI or machine learning component, software, or algorithm in its functionality or development.
• No Performance Metrics for AI: Consequently, there are no AI/ML-specific performance metrics like sensitivity, specificity, AUC, F1-score, etc., nor any acceptance criteria for these.
• No Study Design for AI Validation: The "Performance Data" section discusses:
  • Non-clinical Testing: Stability, biocompatibility, and process validation, referencing ISO standards relevant to material safety and manufacturing for contact lenses. These are not AI/ML validation studies.
  • Clinical Testing: States that clinical testing was not required for this specific modification (changing packaging material), which further confirms the absence of AI/ML validation studies.
• No Mention of Ground Truth, Training Data, Experts: Since there's no AI, there's no need for ground truth establishment, training data, or expert adjudication as would be required for an AI/ML device.
• No MRMC Study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable here.

In summary, the provided document is not about an AI/ML medical device and therefore does not contain the information you requested.

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Focus 43C and TRIMAX 43C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications.

Focus 43C Detector and TRIMAX 43C Detector (Hereinafter referred to as Focus 43C and TRIMAX 43C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 427mm x 427mm. Two models TRIMAX 43C and Focus 43C are totally same except for label and trademark. The sensor plate of Focus 43C and TRIMAX 43C detectors are direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus 43C and TRIMAX 43C detectors are to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers.

The provided text describes a 510(k) premarket notification for the "Focus 43C Detector" and "TRIMAX 43C Detector". The submission focuses on demonstrating substantial equivalence to a predicate device, the "Wireless Digital Flat Panel Detector (Mars1717XF-CSI, K183713)".

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it compares the technical characteristics of the proposed device to the predicate device to demonstrate substantial equivalence. The performance metrics are generally presented as improvements or minor changes compared to the predicate.

The overarching "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, safety, and effectiveness. The document asserts that the proposed devices meet this through direct comparison and noting improvements where applicable.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical images or patient data for evaluating the device's diagnostic performance. The evaluation is primarily focused on non-clinical performance testing and comparison of technical specifications to the predicate device.

• No specific sample size for a test set of images or patient data is mentioned.
• Data provenance (country of origin, retrospective/prospective) is not applicable or provided for such a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the provided document. The submission does not describe a study involving expert readers establishing ground truth for a diagnostic test set. The evaluation is based on technical specifications and engineering testing.

4. Adjudication Method for the Test Set

This information is not applicable as no diagnostic test set or adjudication process is described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is mentioned. This device is a digital X-ray detector, not an AI-powered diagnostic tool, so such a study would not typically be performed or described in this type of submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not an AI algorithm. The device is a digital X-ray detector. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" derived from expert consensus, pathology, or outcomes data is not relevant to this submission, as it focuses on the technical performance specifications of the X-ray detector rather than its diagnostic accuracy in interpreting images. The "ground truth" for the device's performance characteristics (e.g., spatial resolution, MTF, DQE) would be established through physical measurements and standardized test phantoms according to industry standards.

8. The Sample Size for the Training Set

No training set is mentioned as this device is an X-ray detector, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned or relevant for this device.

Summary of Device Performance Demonstration:

The submission demonstrates substantial equivalence primarily through:

• Comparison of Technical Specifications: A detailed table comprehensively compares various technical characteristics, showing that the proposed device is either similar to or improved upon the predicate device (e.g., higher image matrix size, smaller pixel pitch, better spatial resolution, MTF, and DQE).
• Non-Clinical Performance Testing:
  • Electrical Safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC 60601-1-2, with results meeting standard requirements.
  • Biological Evaluation: Materials contacting skin evaluated per ISO 10993-1, with results assuring safety "the same as the predicate device."
  • Other Non-Clinical Considerations: These studies showed that non-clinical considerations mentioned in the "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" are substantially equivalent to the predicate. This likely includes aspects like image quality, dose performance, and environmental testing.
• Clinical Consideration: The document explicitly states that "clinical consideration may not necessary for changes in the pixel size and resolution with the same x-ray detection material and may not necessary for changes in the wireless functionality if non-clinical information is sufficient to support the substantial equivalence." It also states, "There was no significant difference between the images of the Focus 43C/TRIMAX 43C and those of the predicate device." This implies that while no formal clinical study is presented, the technical improvements are not expected to negatively impact clinical performance, and the output images are comparable.

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