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The External Fixation Bone Distractor is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
The External Fixation Bone Distractor is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

The Paragon 28 External fixation Bone Distractor is a transverse bone transport system designed to assist in the controlled movement of a bone segment across a defect. The device can be used independently or in conjunction with the Monkey Rings External Fixation System (K232838) or Monkey Bars Pin to Bar External Fixation System (K242452) to form hybrid frames.

The provided FDA 510(k) clearance letter for the "External Fixation Bone Distractor" does NOT include information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, especially not in the context of an AI/ML-driven medical device.

This document describes a traditional medical device (an external fixation system) and its clearance is based on substantial equivalence to existing predicate devices, rather than on meeting specific performance metrics derived from a study like an MRMC or standalone AI performance evaluation. The "Performance Testing" section explicitly states: "No additional bench testing was performed for the subject device. Instead, a worst-case analysis was conducted using existing data from other components within the device system." This means the clearance is based on engineering design analysis and comparison to mechanically similar, already cleared components, not on a study with clinical performance acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The questions posed relate to the evaluation of AI/ML-driven medical devices, which operate under different regulatory and performance evaluation paradigms.

To answer your request thoroughly, I will indicate that the information is not present in the provided document for each point.

Here's the breakdown, indicating the information is not present based on the provided FDA 510(k) letter:

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

• Information Not Present: The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) nor does it report performance metrics from a clinical study. The clearance is based on substantial equivalence and mechanical properties derived from "worst-case analysis" using existing data, not a specific performance study against defined clinical criteria.

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

• Information Not Present: No test set is mentioned, as there was no clinical performance study conducted or reported for this 510(k) submission. The document relies on existing data from other components and worst-case analysis for mechanical performance.

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)

• Information Not Present: This is not applicable. There was no test set with clinical ground truth established by experts.

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

• Information Not Present: This is not applicable. No test set involving human expert adjudication was used.

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

• Information Not Present: An MRMC study was not done. The device is a mechanical medical device, not an AI/ML-driven diagnostic or assistive tool.

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

• Information Not Present: A standalone performance study was not done. The device is a mechanical bone distractor, not an algorithm.

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

• Information Not Present: Ground truth, in the context of clinical performance evaluation for AI/ML devices, is not relevant here as it's a mechanical device. The "ground truth" for this device's clearance relates to its mechanical integrity and biocompatibility, established through engineering standards (ASTM F1541-17) and material properties.

8. The sample size for the training set

• Information Not Present: A training set is not applicable. This is a mechanical device, not an AI/ML system.

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

• Information Not Present: This is not applicable. No training set or associated ground truth establishment method is mentioned.

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The Parkell Pit and Fissure Sealant is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations.

The Device is a light-cured, flowable, resin-based sealant for prophylactic sealing of pits and fissures as well as for micro-restorative procedures. The Device is light-curable under standard power (600 mW/cm²) and contains filling agents which cause the Device to release and recharge beneficial ions (fluoride and calcium).

The provided text describes the 510(k) clearance for the "Parkell Pit and Fissure Sealant." However, the clearance letter and accompanying 510(k) summary pertain to a physical dental device (a sealant), not an AI/software medical device.

Therefore, many of the requested criteria regarding AI/software performance studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable and are not mentioned in this document.

The document focuses on the physical and chemical properties of the sealant and compares them to a predicate device. The performance data is based on non-clinical, in-vitro testing of these physical properties.

Below is the information that can be extracted from the provided text, adapted as best as possible to the requested format, with clear indications where information is not applicable (N/A) due to the nature of the device.

Acceptance Criteria and Device Performance for Parkell Pit and Fissure Sealant

This device is a physical dental sealant, not an AI/software medical device. Therefore, the performance evaluation focuses on physical and chemical properties and biocompatibility, not algorithmic performance on image data.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The testing was non-clinical (in-vitro).
• Data Provenance: Non-clinical physical property testing. Not applicable for geographical or retrospective/prospective distinctions.

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

• N/A. This is a physical dental material. "Ground truth" in this context typically refers to objective measurements from laboratory testing equipment (e.g., universal testing machines for strength, viscometers for viscosity, etc.), not expert interpretation of data like in AI/imaging studies.

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

• N/A. As above, this is laboratory-based physical property testing, not subjective assessment 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

• N/A. This is not an AI-assisted device. No MRMC study was performed.

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

• N/A. This is not an algorithm. Standalone performance is not applicable.

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

• Laboratory Standard Measurements / In-vitro physical property testing. The performance criteria (e.g., strength in MPa, shrinkage in %, viscosity in Pa.s) are based on standardized tests for dental materials.

8. The sample size for the training set

• N/A. This is not an AI/machine learning device. No training set was used.

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

• N/A. As above, no training set was used.

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The MycoMEIA® Aspergillus Assay (MycoMEIA) is an enzyme immunoassay (EIA) for the in vitro qualitative detection of Aspergillus antigens in human urine from adults (>/= 18 years old) with suspected invasive aspergillosis (IA). The assay is not intended for use in lung transplant recipients. The results should be interpreted by trained healthcare professionals, incorporating other diagnostic procedures such as microbiological culture, histological examination of biopsy samples, and radiographic evidence to support the diagnosis of IA.

The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. The assay uses two mouse monoclonal antibodies that recognize galactofuranose (galf) epitopes. Both monoclonal antibodies are used to coat the wells of the microplate to bind the antigen, and to detect the antigen bound to the sensitized microplate as horseradish-peroxidase conjugates.

The design of the assay is in 96-well plates to enable large-volume testing in clinical laboratories.

Urine is first processed through Sample Processing Columns to eliminate an inhibitor of antibody-antigen recognition. The processed urine samples are added to the plate wells coated with the antibodies, incubated, and washed to remove unbound material. The bound antigen is incubated with antibodies linked to horseradish peroxidase and washed to remove the unbound material.

Next, the peroxidase substrate solution is added, which reacts with the complexes bound to the well to form a blue color reaction. The enzyme reaction is stopped by the addition of acid, which changes the blue color to yellow. The absorbance (optical density) of specimens and controls is determined with a spectrophotometer set at 450 and 620 nm wavelengths.

The amount of antigen in the clinical sample is determined by optical density (OD) using a spectrophotometer and interpreted as an OD index relative to the mean OD of a threshold control provided in the kit.

The MycoMEIA-ASP kit contains the following components:

• Microwell Plate
• Negative Control (NC) Sample (green)
• Threshold Control (TC) Sample (blue)
• Positive Control (PC) Sample (red)
• Conjugate (100X) (white)
• Conjugate Diluent (white)
• Chromogen Solution (yellow)
• Stop Solution (blue)
• Column Rinse
• Plate sealers

25X Concentrated Wash Solution and Sample Processing columns are required to perform the assay and are provided separately from the kit.

If a partial plate is used, empty ELISA plates to fill in the ELISA frame are available to customers as a separate product.

Each laboratory will be required to test positive and negative controls provided in the kit to confirm or authenticate the assay results and to determine the sample index factor that is calculated using the assay ODs. Calculations can be performed manually or using the WS001 MycoMEIA Calculation Worksheet, which is available separately.

The provided FDA 510(k) clearance letter and summary for the MycoMEIA Aspergillus Assay details the device's analytical and clinical performance. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for clinical performance in a pass/fail manner. Instead, it presents the determined performance characteristics. For several analytical aspects, the criteria are implicitly defined by standard guidelines (e.g., CLSI EP17-A2 for LoD, CLSI EP05-A3 for precision and reproducibility).

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

• Analytical Sensitivity (LoD): 60 determinations with low target analyte level replicates.
• Precision (Repeatability and Within-Laboratory): 80 replicates per sample (run twice daily for 20 days, by two operators, in duplicate). Samples included kit controls, contrived samples, and clinical sample pools.
• Reproducibility: 90 replicates per sample (run twice daily for 5 days, by two operators, in triplicate) across three sites. Samples included kit controls, contrived samples, and clinical sample pools.
• Interfering Substances: Endogenous and exogenous substances spiked into pooled healthy urine, and clinical samples from patients with known endogenous conditions.
• Cross-Reactivity (Microorganisms): Tested in duplicate (n=2) for each microorganism listed.
• Cross-Reactivity (Clinical Samples): Urine samples from people with various medical conditions, including fungal, viral, and bacterial infections.
  • Specific numbers for each condition are listed in the summary (e.g., 1 with histoplasmosis, 2 with streptococcus, etc.).
  • Additional cross-reactivity testing involved 21 subjects with documented bacterial pneumonia, 1 with mixed bacterial infection, 2 with mixed GI complications, 2 with histoplasmosis, 1 with blastomycosis, 1 with candidemia, and 1 with disseminated fusariosis.
• Clinical Performance:
  • Archived, Retrospective Study: 475 samples collected from 290 subjects. 226 samples from 50 subjects with proven (n=3) or probable (n=47) IA.
  • Prospective Study:
    • Initiated with 210 consented subjects providing 254 urine samples during 213 suspected infection episodes.
    • Excluded 34 lung transplant recipients, 2 pediatric subjects, 1 contaminated sample, 3 subjects without CT scans, and 4 subjects who received mold-active antifungal therapy.
    • Final analysis: 166 subjects and 169 infectious episodes for specificity.
    • "Possible" IA cases (n=106) were excluded from the analysis for specificity.
    • 38 subjects were adjudicated as having no invasive fungal infection.
    • 26 subjects were adjudicated as having mixed or other (non-IA) infections.

Data Provenance:

• Clinical Performance: Comprised of both archived, retrospective samples and prospectively collected samples.
• Cross-Reactivity, Interfering Substances, Analytical Sensitivity, Precision, Reproducibility: Laboratory-based studies using spiked samples, controls, and some clinical samples (origin of clinical samples not explicitly stated beyond "healthy urine" or "clinical samples from patients with known endogenous conditions" or "urine samples obtained from people with different medical conditions").

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

• Clinical Performance (Prospective Study): Clinical diagnoses were adjudicated by "a reviewer who was blinded to MycoMEIA test results."
• Qualifications: The specific qualifications of this reviewer (e.g., specialty, years of experience) are not specified in the provided text.

4. Adjudication Method for the Test Set

• Clinical Performance (Prospective Study): The adjudication method involved "a reviewer who was blinded to MycoMEIA test results." The reviewer applied the 2020 EORTC/MSG diagnostic criteria to establish diagnoses of proven IA, probable IA, and possible IA.
• No specific multi-expert adjudication method (e.g., 2+1, 3+1) is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance

• The MycoMEIA Aspergillus Assay is an enzyme immunoassay (EIA), an in vitro diagnostic (IVD) device for detecting antigens.
• This is not an AI-powered device or imaging-based device that would involve human readers interpreting images with or without AI assistance.
• Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted, and such data is not applicable here.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This is an in vitro diagnostic assay, which intrinsically provides a standalone (assay-only) result (an index value). The device itself is the algorithm/assay.
• The clinical performance section (sensitivity and specificity tables) represents the standalone performance of the MycoMEIA assay in detecting Aspergillus antigens in urine.
• While results are "interpreted by trained healthcare professionals, incorporating other diagnostic procedures," the reported sensitivity and specificity values reflect the assay's direct performance against the established ground truth.

7. The Type of Ground Truth Used

• Clinical Performance: The ground truth for Invasive Aspergillosis (IA) was established using 2020 EORTC/MSG diagnostic criteria for proven and probable IA. This is a consensus-based diagnostic standard.
• Analytical Studies (LoD, Precision, Reproducibility, Interfering Substances, Cross-Reactivity): Ground truth was based on known concentrations of Aspergillus antigen, specific microorganisms, or specific interfering substances as used in controlled spiking experiments.

8. The Sample Size for the Training Set

• The provided document describes a 510(k) submission for a clinical assay. It details analytical and clinical performance studies, which serve as validation.
• Unlike machine learning or AI-based devices, traditional IVDs typically do not involve a distinct "training set" in the same sense. The assay's design and optimization (analogous to training) would have occurred during its development phase, but specific "training set" sample sizes are not applicable or provided in this context. The study data presented are for validation/testing.

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

• As explained above, a distinct "training set" with established ground truth in the context of machine learning is not relevant for this traditional immunoassay device. The ground truth for validation data was established as per point 7.

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EPIQ Series Diagnostic Ultrasound System: The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.
The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Affiniti Series Diagnostic Ultrasound Systems: The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

The purpose of this 510(k) Pre-market Notification is to introduce the SVS v2 Contrast software application with the EPIQ and Affiniti Series Diagnostic Ultrasound Systems as part of the VM13.0 program.
SVS v2 Contrast is an automated software feature that assists in the selection of images for analysis with the new Philips license options 2D Auto EF Advanced (Adv) developed by DiA Imaging Analysis (K243235), now part of Philips Ultrasound LLC, and existing Philips license options AutoStrain LV; or 2D Auto LV (both K240850) license application in Adult Echo Transthoracic (TTE) examinations.
As described in 510(k) K240850, this feature automatically classifies each acquired image by view and selects an appropriate set of images for Left ventricle (LV) analysis. The classification is based on a Deep Learning AI inference engine; the selection is a non-AI algorithm that considers the view classification and image depth to select the optimal set of images. The difference in SVS v2 Contrast from the predicate SVS v1 (K240850) is that the algorithm is revised to include the selection of optimal images for analysis when contrast is used in routine TTE exams.
Users can launch existing 2D Auto EF; 2D Auto EF Adv; AutoStrain LV; or 2D Auto LV with the set of images that have been automatically selected without the need to review the acquired images and manually select the views. Users may select 2D Auto EF Adv, to process the selected views by SVS v2 Contrast. SVS v2 Contrast prioritizes the contrast image pair; however, if an appropriate pair of contrast images is not found, then Auto EF Adv may select non-contrast images. The manual approach to select views is still available and the user can override automatically selected images from SVS v2 Contrast.
No hardware changes to the EPIQ or Affiniti Series Diagnostic Ultrasound Systems are required when using SVS v2 Contrast, and existing, cleared Philips TTE transducers.
The SVS v2 Contrast feature is supported by all EPIQ models running software version 13.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5. The SVS v2 Contrast feature is supported by the Affiniti models running software version VM13.0 or higher, including Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The SVS v2 Contrast feature is associated with the cardiac adult indication.

Acceptance Criteria and Study Details for SVS v2 Contrast Software

This document outlines the acceptance criteria and details of the study conducted to demonstrate that the Philips Ultrasound systems (EPIQ and Affiniti Series Diagnostic Ultrasound System) with the SVS v2 Contrast software application meet the established performance benchmarks.

1. Table of Acceptance Criteria and Reported Device Performance

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Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.

Granudacyn® Wound Wash Solution is composed of water (H2O), hypochlorous acid (HOCl), sodium hypochlorite (NaOCl) and sodium chloride (NaCl). Pure water and pure sodium chloride are subjected to an electrolysis process to create the final solution.

The provided FDA 510(k) clearance letter for Granudacyn® Wound Irrigation Solution (K243415) does not contain information about acceptance criteria or a study that uses a device to meet acceptance criteria in the context of AI/ML or diagnostic performance.

This document pertains to a medical device that is a wound wash solution, not an AI-powered diagnostic device. The clearance is based on demonstrating substantial equivalence to a predicate device (Vashe® Wound Solution) through non-clinical testing of its physical and chemical properties and general effectiveness as a wound care product.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the type of device and regulatory submission presented.

The "Clinical Data Summary – Subject Device" section explicitly states: "Clinical Testing: Clinical data is not required." and "No clinical data was required to support substantial equivalence." This further confirms that no studies proving diagnostic accuracy or clinical effectiveness in a human cohort were conducted or needed for this clearance.

In summary, the provided text does not contain the information required to answer your specific questions related to AI/ML device performance and acceptance criteria.

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The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in both adult and pediatric patients. Specific examples include:

Forefoot:

• Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
• Metatarsal or phalangeal fractures and osteotomies
• Lesser metatarsal shortening osteotomies (e.g. Weil)
• Fifth metatarsal fractures (e.g. Jones Fracture)

Mid/Hindfoot:

• LisFranc Arthrodesis and/or Stabilization
• 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• Intercuneiform Fusions
• Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion
• Subtalar Fusion
• Medial Column Fusion
• Cuneiform Fracture
• Cuboid Fracture
• Navicular Fracture

Ankle:

• Lateral Malleolar Fractures
• Syndesmosis Injuries
• Medial Malleolar Fractures and Osteotomies
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• Vertical Shear Fractures of the Medial Malleolus
• Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• Medial Malleolar Avulsion Fractures
• Lateral Malleolar Avulsion Fractures
• Tibiotalocalcaneal Joint Arthrodesis
• Tibiotalar Joint Arthrodesis
• Tibiocalcaneal Arthrodesis
• Supramalleolar Osteotomy
• Fibular Osteotomy

First metatarsal osteotomies for hallux valgus correction including:

• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic Osteotomy
• Proximal Osteotomy (Chevron and Rotational Oblique)
• Distal Osteotomy (Chevron/Austin)

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• Revision MTP Fusion
• Revision of failed first MTP Arthroplasty implant

Flatfoot:

• Lateral Column Lengthening (Evans Osteotomy)
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
• Calcaneal Slide Osteotomy

Charcot:

• Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot)
• Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)

In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

The Baby Gorilla/Gorilla Plating System is comprised of bone plates, threaded bone screws, and washers. Gorilla Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla/Gorilla Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM F138), and titanium alloy (per ASTM F136).

The provided text is an FDA 510(k) clearance letter for the Baby Gorilla®/Gorilla® Plating System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, many of the requested items regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable to this type of document and product (a metallic bone fixation system). This clearance is based on mechanical performance and material equivalence, not diagnostic accuracy or clinical outcomes as would be relevant for an AI/ML device.

Here's a breakdown of the relevant information from the provided document:

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

• Acceptance Criteria: The document implies that the acceptance criteria are met if the modified design does not adversely affect the original testing performance and is "substantially equivalent" to the predicate device. Specific quantitative acceptance criteria are not detailed in this clearance letter. Instead, the focus is on demonstrating that the revised device's characteristics are similar enough to an already approved device to not raise new safety or effectiveness concerns.
• Reported Device Performance:
  • Performance: Shown not to be adversely affected by modifications.
  • Basic Design: Similar to the predicate.
  • Material: Similar to the predicate (medical grade titanium per ASTM F67, stainless steel per ASTM F138, and titanium alloy per ASTM F136).
  • Manufacturing: Similar to the predicate.
  • Sizes (dimensions): Comparable to those offered by the predicate systems.

2. Sample size 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 clearance is based on engineering analysis and comparison to a predicate device, not a clinical study with a patient test set in the traditional sense.

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 applicable and not provided. This is a hardware device (bone plating system), not an AI/ML diagnostic device requiring expert interpretation 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.

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 applicable and not provided. This device is a bone plating system, 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 applicable and not provided. This is a hardware device.

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

• The "ground truth" for this device's substantial equivalence is its physical and mechanical properties and performance, as determined through engineering analysis and comparison to a legally marketed predicate device (K203511). It's not a clinical "ground truth" derived from patient data or expert consensus.

8. The sample size for the training set

• This information is not applicable and not provided. As a physical medical device, there is no "training set" in the context of an AI/ML algorithm.

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

• This information is not applicable and not provided.

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This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals.

This product is not intended to be used on patients with bypassed upper airways.

This product is not intended to be life-sustaining or life-supporting.

This product is not intended for apneic ventilation.

The F&P Optiflow Air/Oxygen Flow Source is a respiratory high flow therapy device designed to generate a flow of air and/or oxygen. The device allows selectable flow rates up to 70L/min with selectable oxygen concentrations ranging from 21% to 100%.

The subject device is a multi-patient use prescription only device, provided in a non-sterile state. It operates at flow ranges between 0 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.

The provided FDA 510(k) clearance letter and summary for the "F&P Optiflow Air/Oxygen Flow Source" is for a hardware device, a breathing gas mixer, not a software or AI-driven diagnostic device. Therefore, the majority of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI/software performance is not applicable based on the provided document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and compliance with general medical device standards. There is no information regarding AI-specific performance metrics, clinical studies involving human readers, or detailed ground truth establishment for diagnostic capabilities.

Below is a table summarizing the general performance data found, where applicable, according to the structure requested, along with an explanation for the absence of AI-specific information.

Acceptance Criteria and Device Performance for F&P Optiflow Air/Oxygen Flow Source

This device is a hardware breathing gas mixer, not an AI or software-driven diagnostic tool. As such, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, human reader improvement, adjudication, ground truth for AI training/testing) are not present in this 510(k) summary. The "performance data" section primarily refers to compliance with safety, electrical, and performance standards for medical electrical equipment and gas mixers.

1. Table of Acceptance Criteria and Reported Device Performance:

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