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The LZI Fentanyl III Enzyme Immunoassay is intended for the qualitative determination of fentanyl in human urine at the cutoff value of 1 ng/mL when calibrated against fentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Fentanyl III Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between the drug in the sample and the drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. The drug-labeled G6PDH conjugate is traceable to a commercially available fentanyl standard and referred to as fentanyl-labeled G6PDH conjugate. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of a drug in the sample, fentanyl-labeled G6PDH conjugate is bound to the antibody, and the enzyme activity is inhibited. On the other hand, when the free drug is present in the sample, the antibody would bind to the free drug; the unbound fentanyl-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

The LZI Fentanyl III Enzyme Immunoassay is a kit comprised of two reagents, R1 and R2, which are bottled separately but sold together within the kit.

The R1 solution contains mouse monoclonal anti-fentanyl antibody, glucose-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with fentanyl in buffer with sodium azide (0.09%) as a preservative.

The provided FDA 510(k) Clearance Letter for the LZI Fentanyl III Enzyme Immunoassay details the device's acceptance criteria (in terms of performance characteristics) and the study results that demonstrate the device meets these criteria.

Here's a breakdown of the requested information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the satisfactory performance demonstrated in the various studies, aiming to prove substantial equivalence to the predicate device. The performance characteristics sections show the device meets the expected qualitative and quantitative accuracy, precision, and specificity.

• Negative by LC/MS analysis: 35 negatives, 0 positives by EIA.
• ** 50% above cutoff) by LC/MS:** 0 negatives, 61 positives by EIA.

Overall, 35/35 true negatives, 83/83 true positives (excluding near-cutoff positives and positives above cutoff). The remaining 32 discrepant samples (20 + 12) were positive by EIA but negative by LC/MS for fentanyl, indicating cross-reactivity with norfentanyl as a contributing factor. |
| Precision | Consistent and reliable qualitative results (positive/negative) across multiple runs and days, especially around the cutoff concentration. | Precision: 1 ng/mL Cutoff (N=88 total replicates over 22 days):

• 0 ng/mL, 0.25 ng/mL, 0.5 ng/mL, 0.75 ng/mL: 88/88 Negative (100% agreement).
• 1 ng/mL (Cutoff): 4 Neg / 84 Pos (95.5% Positive, 4.5% Negative - demonstrating near-cutoff variability, which is expected for qualitative assays at the cutoff).
• 1.25 ng/mL, 1.5 ng/mL, 1.75 ng/mL, 2 ng/mL: 88/88 Positive (100% agreement). |
  | Cross-Reactivity (Specificity) | Minimal or no false positives from structurally unrelated compounds. Acceptable cross-reactivity with fentanyl metabolites and structurally related compounds as defined by the assay's intended specificity. | Fentanyl and Metabolites: Fentanyl (100%), Norfentanyl (40%).
  Structurally Related Compounds: Varying levels of cross-reactivity (e.g., Acetyl fentanyl 25%, Acryl fentanyl 100%, Thiofentanyl 200%). Many substances showed "ND" (Not Detected) at high concentrations (e.g., 100,000 ng/mL).
  Structurally Unrelated Pharmacological Compounds: No interference (all Neg/Neg/Pos results for 0 ng/mL Fentanyl, -50% Cutoff, +50% Cutoff respectively) at 100,000 ng/mL for almost all listed compounds, except Dextromethorphan, which showed interference at 20,000 ng/mL (Neg/Pos/Pos) but was acceptable at 15,000 ng/mL (Neg/Neg/Pos). This demonstrates good specificity against common drugs. |
  | Interference | Test performance (positive/negative results) should not be significantly affected by common endogenous substances or preservatives found in urine, or by varying specific gravity and pH within physiological ranges. | Endogenous and Preservative Compound Interference: No interference observed for most compounds (e.g., Acetone, Ascorbic acid, Bilirubin, Glucose, Hemoglobin) at high concentrations (e.g., 100,000 mg/dL), showing Neg/Neg/Pos results for 0 ng/mL, -50% Cutoff, +50% Cutoff respectively. Boric acid showed interference at 1,000 mg/dL (Neg/Neg/Neg), indicating a potential issue if present at high concentrations. This is a known interference for certain urine assays.
  Specific Gravity Interference: No interference observed across the range of 1.000 to 1.030 (all Neg/Neg/Pos).
  pH Interference: No major interference observed between pH 3 to pH 11 (all Neg/Neg/Pos). |

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Precision Study: 88 replicates for each concentration level (0 ng/mL to 2 ng/mL fentanyl).
  • Method Comparison (Clinical Samples): 150 unaltered clinical samples.
  • Cross-Reactivity: Duplicates for each compound and concentration tested.
  • Interference (Endogenous/Preservative): Duplicates for each compound and concentration tested.
  • Specific Gravity/pH Interference: Duplicates for each specific gravity/pH level and fentanyl concentration.
• Data Provenance:
  • The clinical samples for the Method Comparison study were obtained by LZI and "through collaboration with various clinical laboratories across the United States and Canada." This indicates a prospective and/or retrospective collection of real-world clinical samples from diverse geographical regions. The nature (retrospective/prospective) of the collection for these specific 150 samples isn't explicitly stated but "clinical samples" usually implies samples collected from patients.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish ground truth.
• Qualifications of Experts: Not explicitly stated. However, for LC/MS confirmation, it implicitly relies on the expertise of the laboratory personnel performing and interpreting the LC/MS (Liquid Chromatography-Mass Spectrometry) analysis, which is a gold standard for chemical identification and quantification. These would typically be trained analytical chemists or lab technicians with experience in mass spectrometry.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the test set in the typical sense of multiple human readers or reviewers resolving discrepancies.
• For the Method Comparison study, the "ground truth" was established independently by LC/MS. Discrepancies between the EIA result and the LC/MS result were reported and attributed to norfentanyl cross-reactivity. This is a comparison against a reference method, not a subjective adjudication by experts.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI algorithms where human interpretation is a primary component and AI aims to augment or replace it. This document describes an in vitro diagnostic (IVD) assay, an enzyme immunoassay, which is an automated lab test. Its performance is evaluated against a reference standard (LC/MS), not against human reader performance.

6. Standalone Performance

• Yes, standalone performance was done. The entire submission details the performance of the LZI Fentanyl III Enzyme Immunoassay as a standalone device. The qualitative accuracy, precision, cross-reactivity, and interference studies all evaluate the algorithm/device's performance independently in generating a preliminary analytical result from a urine sample. It does not involve human-in-the-loop performance; rather, it provides a result that a clinician then interprets in conjunction with other clinical data.

7. Type of Ground Truth Used

• The primary type of ground truth used for the quantitative confirmation of fentanyl concentration in the clinical samples (Method Comparison study) was LC/MS (Liquid Chromatography-Mass Spectrometry) analysis. This is considered a highly specific and sensitive reference method for drug quantification.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set. The described studies are verification and validation activities for a modified assay (Special 510(k) for an existing predicate device, LZI Fentanyl II). For IVD assays, "training" often refers to the internal development and optimization of the assay performed by the manufacturer, which precedes the formal V&V studies presented for regulatory submission. The reported studies are the test set performance.

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

• Since the training set size is not explicitly stated, the method for establishing ground truth for it is also not explicitly described. However, it is highly probable that internal development and optimization of the assay would have utilized similar rigorous analytical methods, likely LC/MS or other established analytical techniques, to calibrate and refine the assay's performance against known concentrations of fentanyl and its metabolites. This would be part of the manufacturer's design control and development process.

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General Indications:
The MobileLink Acetabular Cup System is indicated for mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• Primary and secondary osteoarthritis
• Rheumatoid arthritis
• Correction of functional deformities
• Avascular necrosis
• Femoral neck fractures
• Revision after implant loosening dependent on bone mass and quality

Dual Mobility Insert (in addition to the indications and general indications):

• Dislocation risk

The MobileLink Acetabular Shells are intended for cementless fixation.

The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

Additional indications specific to the TrabecuLink Augments:

• Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system.

MobileLink PlasmaLink and TiCaP Shells: The MobileLink System consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either titanium plasma sprayed (TPS) coating (brand name: PlasmaLink) or a double coating consisting of titanium plasma spray coating plus calcium phosphate (CaP) coating (brand name: TiCaP). The MobileLink PlasmaLink and TiCaP Shells are compatible with polyethylene liners (K182321, K241636), acetabular bone screws (K192559), Dual Mobility Inserts (K200607) with BiMobile Dual Mobility Liners (K171273, K190535), Shell/Insert Adapters ("Face Changers", K200607), and TrabecuLink Augments (K241636).

This FDA 510(k) clearance letter is for a medical device called the "MobileLink Acetabular Cup System - inhouse coatings." It does not involve AI software and therefore does not have the acceptance criteria and study information typically associated with AI/ML-based devices.

The submission is specifically for a change in the coating supplier for an existing device from an external vendor to an in-house process. This means the core design and function of the acetabular cup system are already established and cleared.

Therefore, the requested information elements (acceptance criteria table, sample size for test set, experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, how training ground truth was established) are not applicable to this specific 510(k) submission.

Here's why and what information is provided:

• Device Type: This is a physical orthopedic implant (hip replacement component), not an AI/ML software device.
• Reason for Submission: The primary reason for this 510(k) is to notify the FDA of a change in the manufacturing process (in-house coating application instead of external). This is a manufacturing/materials change, not a new device with new performance claims requiring extensive clinical or AI performance studies.
• Performance Testing: The document states:
  • "Non-clinical performance testing and analysis were provided, including: Characterization of the TPS and TiCaP inhouse coatings."
  • "Biocompatibility evaluation."
  • "The results of non-clinical performance testing demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent."
  • "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

This means the acceptance criteria and supporting studies were focused on material characterization and biocompatibility to ensure the new in-house coating process yields a product that is equivalent to the predicate device in terms of safety and performance (e.g., adhesion, wear resistance, biological response), rather than diagnostic accuracy or human-AI interaction.

In summary, there is no information in this document to answer the questions about acceptance criteria related to AI/ML performance studies, as this is not an AI/ML device submission.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate and Other Select Drugs using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL, Gloves meet the specification of ASTM D6319 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and Select Other Drugs as per ASTM D6978. The gloves are single use, disposable, and non-sterile.

Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for length, width, thickness, etc.). However, the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such evaluations.

• Provenance: This information is not directly stated. The tests were conducted according to international standards (ASTM and ISO). The manufacturing company is Lingshi Hongruida Health Protection Technology Co., Ltd. located in Jinzhong, Shanxi, China. It is highly probable that the testing was performed in a laboratory either in China or an accredited facility capable of performing these international standard test methods. The study appears to be retrospective as it involves the testing of a finished device against established performance criteria.

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

This information is not applicable. The device is a physical product (nitrile gloves), and its performance is evaluated against objective, measurable criteria defined by established engineering and biological safety standards (ASTM and ISO), not subjective expert interpretation of medical images or patient data. The "ground truth" is derived from direct measurements and laboratory analyses, not expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable. As the testing involved objective physical and chemical performance standards, there was no need for expert adjudication. The results were quantifiable measurements against pre-defined acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices involving human interpretation of medical data (e.g., radiologists reading images). This product is a medical glove, and its effectiveness is determined through standardized physical, chemical, and biological testing.

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

Yes, the studies conducted are standalone performance evaluations of the physical glove itself, without any human-in-the-loop component in the evaluation of its core performance characteristics (e.g., tensile strength, resistance to chemical permeation, cytotoxicity). The testing directly measured the attributes of the glove.

7. The Type of Ground Truth Used:

The ground truth for this device's performance evaluation is based on established objective technical standards and laboratory measurements. Specifically:

• Physical properties (length, width, thickness, tensile strength, elongation) are measured directly according to ASTM D6319-19 and ASTM D412-16(2021).
• Chemical resistance (chemotherapy drug permeation) is measured according to ASTM D6978-05 (Reapproved 2019).
• Biocompatibility (skin sensitization, irritation, cytotoxicity, systemic toxicity) is evaluated through laboratory tests following ISO 10993 series standards.
• Freedom from holes is evaluated by ASTM D5151-19.
• Powder residue is evaluated by ASTM D6124-06 (Reapproved 2022).

8. The Sample Size for the Training Set:

This information is not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and quality control would involve statistical sampling typical for medical device production.

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

This information is not applicable, as there is no training set for this type of device.

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The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy.

The CORE Shoulder System is designed for use with the following LINK Implant systems:

• · LINK Embrace Shoulder System Reverse Configuration (K200368, K212992, K231445)
• · LINK Embrace Shoulder System Anatomic Configuration (K210899)

The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. CORE Shoulder assists the surgeon in placing the K-wire according to the preoperatively planned location. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy.

It allows the surgeon to visually compare the planned and placed position/trajectory of the guide pin (K-wire) by referencing a virtual 3D model of the pre-operative plan and the measured location of the K-wire. The system components include the Workstation (tablet, AC adapter, stand), the handheld COREmote (single-use Power Unit and reusable Sensor Unit), and reusable stainless-steel probes of different sizes.

The provided text is a 510(k) summary for the CORE Shoulder System, a surgical instrument with computer-assisted instrument tracking. It does not describe an AI/ML-based medical device. Therefore, it does not contain the specific information required to answer the prompt regarding AI/ML device performance.

The document focuses on the substantial equivalence of the CORE Shoulder System to a predicate device, based on non-clinical performance testing. It explicitly states that "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." This implies that there was no study proving the device meets acceptance criteria in terms of clinical outcomes or human reader performance with AI assistance, as would be expected for an AI/ML device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, the study proving it meets those criteria, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for the training set, as these details are not present in the provided 510(k) summary.

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The MobileLink Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• 1. Primary and secondary osteoarthritis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformities
• 4. Avascular necrosis
• 5. Femoral neck fractures
• 6. Revision after implant loosening dependent on bone mass and quality

The MobileLink Dual Mobility Insert is additionally indicated for:
7) Dislocation risks

Additional indications specific to the TrabecuLink Augments:
Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Shells are intended for cementless fixation. The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. This 510k adds several system components to the MobileLink Acetabular Cup System previously cleared in K182321, K192559, K200607, and K222066.

X-LINKed Inserts: The X-LINKed Inserts are manufactured from highly crosslinked polyethylene material. The inserts are available in the same sizes and designs as the previously cleared E-Dur inserts (K182321). The design variants include a neutral variant with or without offset, a shouldered variant with or without offset and 10° and 20° inclining variants with an offset. The inserts are fixed using a clamping system consisting of a combination of snap mechanism and conical clamping. Notches (tabs/recesses) at the rim further contribute to the rotational stability of the PE inserts.

TrabecuLink Augments: The TrabecuLink Metal Acetabular Augments are wedgeshaped components that conform to the shape of the acetabular shell. They are additively manufactured Ti6A14V alloy per ISO 5832-3 (chemistry and mechanical properties) and feature a porous structure (TrabecuLink) on the bone interfacing surface. They mate with the same MobileLink (TrabecuLink) Shells as previously cleared in K182321 and K222066 and they can be used with the same 6.5mm diameter bone screws cleared in K192559, or with new smaller diameter (4.5mm) bone screws introduced in this submission.

Bone Screws: The MobileLink Bone Screws are Ø 4.5mm in lengths from 15 -60mm (by 5mm increments). They feature the same head size/design as the previously cleared Ø 6.5mm screws and are made of the same wrought Ti6A14V alloy per ISO 5832-3 and ASTM F136 as the previously cleared Ø 6.5mm screws.

This document is a 510(k) Premarket Notification from Waldemar Link GmbH & Co. KG for their MobileLink Acetabular Cup System - Line Extension (Multiple). It's a submission to the FDA regarding new components for an existing hip replacement system.

The document does not describe a study involving acceptance criteria for a device's performance in a diagnostic or AI context. Instead, it is a regulatory filing for a medical device (hip replacement components). The "performance testing" section refers to non-clinical tests to ensure the mechanical and material integrity of the new components are comparable to existing, cleared devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as it is not relevant to the type of device or study described.

Here's an attempt to fill in the table and address the relevant points based on the provided text, while noting where information is not applicable or available:

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance:
See the table above. The acceptance criteria essentially boil down to demonstrating "substantial equivalence" to predicate devices through various non-clinical performance tests. The reported performance for each test is that "The results... demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent." Specific numerical thresholds for acceptance are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The tests are non-clinical, likely bench testing on prototypes or manufactured samples, not 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):
Not applicable. This is a non-clinical device performance study, not a diagnostic study requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a non-clinical device performance study, not a diagnostic 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:
Not applicable. This is not an AI/Software device, nor is it a diagnostic device where MRMC studies would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/Software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical performance tests, the "ground truth" would be the established engineering standards, material specifications (e.g., ISO 5832-3, ASTM F136, ASTM F543), and the performance characteristics of the predicate devices. The new components are tested to meet these established benchmarks.

8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device.

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Linshom Continuous Predictive Respiratory Monitor System (CPRMS) is indicated for use by healthcare professionals in healthcare facilities, such as procedural areas and recovery rooms, to monitor breathing in adult, (at least 22 years of age) patients.

The CPRMS is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rate and seconds since last breath, along with a trend of tidal volume.

CPRMS measurements are used as an adjunct to other clinical information sources.

The Linshom CPRMS (Continuous Predictive Respiratory Monitoring System) is portable, reliable and an inexpensive system for precise detection of spontaneous respiration. It is non-invasive and is not corrupted by motion artifacts. The system autonomously adapts to the local thermal environment to deliver a usable signal without complicated hardware and firmware processing.

The provided text details the FDA 510(k) clearance for the Linshom Continuous Predictive Respiratory Monitoring System (CPRMS), demonstrating its substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, reported device performance metrics in a table, or details regarding the study designs (sample sizes, data provenance, expert qualifications, ground truth establishment, or clinical study effect sizes) that directly prove the device meets pre-defined quantitative acceptance criteria.

The document primarily focuses on:

• Regulatory Clearance: The FDA's determination of substantial equivalence for the CPRMS to its predicate device (Linshom Respiratory Monitoring Device - LRMD).
• Technological Comparison: A table comparing the characteristics of the subject device (CPRMS) and the predicate device (LRMD), highlighting their similarities.
• Non-Clinical Testing Summary: A general statement about the types of non-clinical tests performed (e.g., Lifetime Test, Movement Test, Respiration Rate Test, Tidal Volume Trend Test) and conformance to various medical device standards. It mentions "Statistical analysis, including correlation methods, showed strong alignment with reference data, indicating that the device functions accurately and reliably within its intended use parameters," but does not provide the specific numerical results of these analyses or the acceptance thresholds.

Therefore, based solely on the provided text, I cannot complete many of the requested sections.

Here's a breakdown of what can be inferred from the text and what cannot:

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

The document mentions specific accuracy for respiration rate and tidal volume trend for both the subject and predicate devices:

Note: These are presented as specifications that are "Same" for both devices, implying the CPRMS met these already established performance levels of the predicate device. The text does not explicitly state them as "acceptance criteria" for a new study, but rather as inherent accuracy specifications of the device's mechanism.

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

• Sample Size for Test Set: Not specified. The document states "The subject device [K240271] underwent testing across the full range of physiological parameters, including respiratory rates from 0-60 breaths per minute (BPM)." This implies a test set was used, but its size or specific characteristics (e.g., number of subjects, number of data points) are not provided.
• Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data. The testing mentioned appears to be laboratory/non-clinical.

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

• Not specified. The document outlines non-clinical testing focused on device performance against reference data, not human expert interpretation of clinical data for ground truth.

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

• Not applicable/Not specified for this type of non-clinical device performance testing. Adjudication methods are typically used in studies involving human interpretation (e.g., image reading).

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 or human-in-the-loop study is mentioned. The device provides measurements (respiratory rate, seconds since last breath, tidal volume trend) as an adjunct to other clinical information sources, but the text does not describe a study where human readers/clinicians used the device and their performance was evaluated comparatively.

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

• Yes, implicitly. The "Non-Clinical and/or Clinical Tests Summary" describes tests where the device's measurements (respiration rate, tidal volume trend) were compared against "reference data," indicating a standalone evaluation of the algorithm's performance against a known standard.

7. The type of ground truth used

• Reference Data: The document states "Statistical analysis, including correlation methods, showed strong alignment with reference data." This implies that the ground truth was derived from established, accurate measurement methods or simulated physiological parameters (e.g., a ventilator for tidal volume, a controlled breathing simulator for respiration rate). It's not explicitly stated as expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not specified. The document mentions "Proprietary Algorithm" for both subject and predicate devices but provides no details on how these algorithms were developed or trained, nor the size of any training datasets.

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

• Not specified. As no training set details are provided, the method for establishing its ground truth is also absent.

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The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRV™ is intended for use with electronic IV pumps in IV catheter applications where tension may act on the IV tubing. The Orchid SRV™ is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent infusion and continuous infusion.

The Orchid SRV™ is intended to aid in reduction of IV mechanical complications requiring IV replacement.

The Orchid SRVTM is for use with patients two (2) weeks of age and older.

The Orchid Safety Release Valve™ or Orchid SRV™ connects via standard luer-locking connection, allowing flow during IV therapy. The Orchid SRV™ is designed to allow the device to separate into two halves when longitudinal tension exceeds the SRV tension window, automatically closing the flow path to both IV extension set and IV administration set. Following separation, a component of the Orchid SRV™ is left attached to each side of the infusion system to protect the intraluminal pathway. Upon separation, replacement of the SRV™ is necessary. Follow institutional policy to replace the SRV™, or at least every seven (7) days.

The document provided is a 510(k) summary for the Orchid Safety Release Valve™ (K241415), which is being submitted for substantial equivalence to a previously cleared device (K232094). The primary difference between the two devices lies in a change to the contraindications, allowing for use with blood, which required additional hemocompatibility testing.

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

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in numerical terms for the hemocompatibility testing. Instead, it states that "additional testing performed to support limited blood contact did not raise new questions for safety or effectiveness." This implies that the device met internal acceptance criteria for these tests.

However, the "Table 1: General Technological Characteristics Comparison" provides a comparison of features, and for "Contraindications," it implicitly describes the change and how it was supported:

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

The document does not specify the sample size for the hemocompatibility tests or the provenance of the data (e.g., in vitro, animal, human). It only states that these tests were conducted.

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. The hemocompatibility tests are typically laboratory-based and follow established international standards (ISO 10993-4: 2017), which define parameters for assessing blood interactions, rather than relying on expert consensus for ground truth.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies with human assessors, not for bench or laboratory testing.

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

An MRMC study was not done. This device is a mechanical medical device, not an AI or imaging device that would involve human readers or AI assistance.

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

This is not applicable and not provided. The device is a mechanical safety release valve, not an algorithm, so there is no "standalone" algorithm performance to evaluate.

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

For the hemocompatibility testing, the ground truth is established by the accepted scientific principles and thresholds defined within the ISO 10993-4: 2017 standard for biological evaluation of medical devices. The test results are compared against these established criteria to determine safety.

8. The sample size for the training set

This information is not applicable and not provided. The device is a mechanical product, not a machine learning model, so there is no "training set."

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

This information is not applicable and not provided, as there is no training set for this type of device.

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The LiNA CystoVu HD is intended for use in visualization via LiNA displaying unit of adult male and female urethra and bladder cavity during diagnostic and therapeutic cystoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.

The LiNA ScopeVu is intended for visualization from compatible LiNA endoscopes for female and male patients of all ages during diagnostic and therapeutic endoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.

The LiNA CystoVu™ HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. Visualization will be achieved by LiNA Scope Vu™ full HD display and light source. The LiNA Cysto Vu™ HD is intended to be used with a reusable LiNA ScopeVu™ to visualize the urethra and the bladder. The LiNA CystoVu™ HD can be operated by the left or right hand. The optical module in the distal tip consists of a camera housing containing camera and LED light sources.

The provided text describes the LiNA CystoVu HD and LiNA ScopeVu, single-use flexible cystoscopes, and their substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study that proves the device meets those criteria with detailed device performance metrics, MRMC comparative effectiveness studies, standalone algorithm performance, or training set details as requested in your prompt.

The document focuses on demonstrating substantial equivalence to a predicate device (Ambu aScope 4 Cysto) through non-clinical performance testing.

Here's a breakdown of what can be extracted from the provided text based on your request, and what is missing:

1. Table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The text states: "Non-clinical performance testing was conducted in order to demonstrate that the LiNA CystoVu HD and LiNA ScopeVu perform according to their requirements and specifications." It then lists the types of tests conducted:

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

This information is not provided. The non-clinical performance testing description does not specify sample sizes for individual tests or the provenance of any data used for these tests.

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

This information is not provided. The testing described is primarily non-clinical and technical performance testing, not involving expert interpretation of medical images or diagnoses. Human factors testing included "Test participants representing the intended users," but their qualifications for establishing ground truth (in the diagnostic sense) are not relevant or mentioned.

4. Adjudication method for the test set

This information is not provided. Given the nature of the non-clinical performance tests conducted, an adjudication method as typically understood for clinical or image interpretation studies is not applicable or described.

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

This information is not provided. The document makes no mention of AI or an MRMC study. It describes a medical device (endoscope components) and its direct performance, not an AI-assisted diagnostic tool.

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

This information is not provided. There is no mention of an algorithm or standalone performance testing for AI components.

7. The type of ground truth used

For the technical and performance tests, the "ground truth" would be the engineering specifications, relevant ISO/IEC standards, and expected functional outcomes. For biocompatibility, it's the established safety profiles within ISO 10993. For sterilization, it's the validated SAL (Sterility Assurance Level).
The document explicitly states: "Clinical data was not used to support substantial equivalence of the subject device to the predicate device." This means there was no ground truth derived from pathology, expert consensus on clinical cases, or outcomes data in a clinical setting for substantial equivalence.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of an AI algorithm or a training set.

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

This information is not applicable and not provided. There is no mention of an AI algorithm or a training set.

In summary: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a medical device (endoscope components) to a predicate device through non-clinical performance testing and technological comparison. It does not involve AI, clinical data for determining substantial equivalence, or detailed studies with the specific metrics the prompt is asking for related to AI performance, expert ground truth, or training sets.

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Over-The-Counter Use:

TENS:

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, arm,and leg, due to strain from exercise or normal household and work activities.

EMS/NMES:

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Prescription Use:

TENS:

1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;

EMS/NMES:

1)Relaxation of muscle spasm;

2)Increase of local blood flow circulation;

3)Prevention or retardation of disuse atrophy;

4)Muscle re-education:

5)Maintaining or increasing range of motion;

6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Not Found

The provided text is an FDA 510(k) clearance letter for a Wireless TENS & EMS device. It does not contain information on the acceptance criteria, study details, or performance metrics often found in a clinical study report. Therefore, I cannot generate the requested table and answer the study-related questions based on this document.

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• The indications for use for the device.
• Regulatory information and requirements.

To answer your questions, I would need a clinical study report or a summary of safety and effectiveness data, which typically includes performance testing and results.

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NOxBOXi Nitric Oxide Delivery System is intended for use by healthcare professionals for the delivery and monitoring of a constant (user set) concentration of nitric oxide (NO) and the monitoring of NO2 and O2 in the inspiratory ventilator lines of a patient undergoing nitric oxide therapy (iNO).

The NOxBOXi Nitric Oxide Delivery System includes:

• The NOxBOXi head unit, which delivers NO gas while in the intelligent delivery mode.
• Continuous monitoring and alarms for NO, O2, and NO2.
• The integrated NOxMixer which provides a backup NO delivery capability that is intended to deliver a continuous flow of NO, mixed with O₂, for iNO therapy and provides a continuous treatment option during transit and transfer conditions within hospitals.

The NOxBOXi Nitric Oxide Delivery System must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling (currently neonates). Refer to this material prior to use.

The NOxBOXi Nitric Oxide Delivery System (NOxBOXi) simultaneously delivers Nitric Oxide (NO) medical gas, while monitoring Nitric Oxide, Nitrogen Dioxide (NO2), and Oxygen (O2) levels in the inspiratory limb of a ventilator for patients undergoing inhaled Nitric Oxide Therapy.

The system is designed for use by healthcare professionals to administer treatment to patients undergoing inhaled Nitric Oxide (iNO) therapy. The NOxBOXi will deliver nitric oxide in a synchronous manner to a single patient.

An integrated component to the NOxBOXi, the NOxMixer is intended to deliver a continuous flow of Nitric Oxide from the NOxBOXi, mixed in line with O₂ for use in iNO therapy. The NOxMixer will be used in conjunction with manually bagging a patient.

The NOxBOXi includes the NOxBOXi Head Unit, a NOxFLOW sample line, two NO feed hoses, two regulators (connector type dependent on the gas supplier), a test circuit, NO, O2, and NO2 monitors, power supply, drainage syringe, Operating Manual & Technical Guide.

This submission is for the introduction of new compatible ventilators including the addition of pediatric categories for existing ventilators, an additional optional software mode which disables the "Vent Flow Idle" alarm to reduce this alarm which may not be necessary and is considered a "nuisance" alarm in certain situations. Alarm initiations are still recorded in the log file. Additionally, language choices other than English have been disabled for this mode. There are no changes to the indications for use of the product, patient population of neonates, and there are no significant design changes.

The provided text is a 510(k) summary for the NOxBOXi Nitric Oxide Delivery System, focusing on changes to compatible ventilators and an optional software mode. It does not present a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-enabled devices, which often involve performance metrics like sensitivity, specificity, or AUC against a defined ground truth.

Instead, this document describes a modification to an already cleared medical device (NOxBOXi Nitric Oxide Delivery System). The "study" here refers to non-clinical performance testing to demonstrate that these changes do not alter the substantial equivalence of the modified device to its predicate. The acceptance criteria are therefore related to the safety and performance parameters of the delivery system itself, rather than diagnostic or analytical accuracy of an AI model.

Therefore, many of the requested points related to AI/ML study design (like sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone performance for an algorithm) are not applicable to this document's content.

However, I can extract information related to the device's technical specifications and the testing performed for this submission.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the existing performance characteristics of the predicate device (K231823) and regulatory standards. The reported "performance" for this submission is that the device, with the new ventilator compatibility and software mode, continues to meet these original performance specifications and does not raise new questions of safety or effectiveness.

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

• Test Set Description: The "test set" here refers to the specific modifications being evaluated: the compatibility with additional ventilators and an optional software mode.
• Sample Size: Not quantified in terms of a "sample size" of patients or images, as this is a hardware/software modification submission. The testing involves specific ventilator models and configurations, and the software mode itself.
• Data Provenance: Not applicable in the context of clinical data or patient-derived data for an AI/ML model. The testing is non-clinical, likely bench testing, and usability testing.

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

• Not applicable in the context of this 510(k) summary. Ground truth as typically understood for AI/ML diagnostic devices (e.g., expert radiological reads) is not established here. The "truth" is based on the engineering specifications and performance of the device under various conditions and its compliance with regulatory standards.

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

• Not applicable. This relates to clinical endpoint adjudication, which is not described.

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-enabled diagnostic device.

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

• No. This is a medical device for gas delivery and monitoring, not a standalone algorithm.

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

• The "ground truth" for this device's performance, as demonstrated in this submission, is based on:
  • Engineering specifications and design requirements.
  • Validated test methods conforming to international standards (e.g., ISO, IEC).
  • Compliance with FDA guidance documents related to nitric oxide delivery apparatus and software.
  • Bench testing results for parameters like accuracy, flow rates, alarm functionality, and gas purity.

8. The sample size for the training set:

• Not applicable. This document does not describe an AI/ML model with a training set.

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

• Not applicable. This document does not describe an AI/ML model with a training set.

Summary of the study conducted:

The "study" or testing performed for this 510(k) submission was non-clinical performance testing and usability testing. The purpose was to demonstrate that adding compatibility with new ventilators (including pediatric categories for existing ones) and an optional software mode does not adversely impact the safety or effectiveness of the NOxBOXi Nitric Oxide Delivery System, and that it remains substantially equivalent to its predicate device (K231823). The testing focused on validating that the changes did not introduce new safety concerns or alter the specified performance characteristics of the device. This involved testing against international standards and FDA guidance relevant to medical devices, particularly those for nitric oxide delivery systems. No clinical testing was required for this specific submission given the nature of the changes.

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