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Auxilock GFS Mini, GFS II Large, GFS Ultimate Mini and GFS Ultimate Large are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The Auxilock GFS Mini, GFS II Large & GFS Ultimate are a range of devices design for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. Each device is made from a medical grade titanium alloy, Ti-6Al-4V ELI, grade 5 as per ASTM F136 and also includes an UHMWPE polyblend suture component as per ASTM F2848-17. These implants are sold in sterile conditions (Ethylene Oxide Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.

I am sorry, but the provided text does not contain detailed information about acceptance criteria and study proving device meets the acceptance criteria. The document is a 510(k) Premarket Notification for a medical device (Auxilock Graft Fixation System) and primarily focuses on establishing substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical bench testing.

Specifically, the text does not include:

• A table of acceptance criteria and reported device performance. While a comparison table between the subject and predicate devices is present, it focuses on general parameters like product code, regulation number, and material standards, rather than specific performance metrics with acceptance thresholds.
• Sample size used for a test set, data provenance, or details about patient data.
• Information about experts used to establish ground truth, their qualifications, or adjudication methods.
• Any mention of a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Standalone algorithm performance or human-in-the-loop performance details, as this is not an AI/ML medical device.
• The type of ground truth used (e.g., pathology, outcomes data) for clinical validation, as clinical studies involving such ground truth are not detailed.
• Training set sample size or how ground truth for a training set was established.

The document primarily states that "Bench tests were conducted to verify that the subject device met all design specifications" and that "The results of this testing indicate that the Auxilock Graft Fixation System is equivalent to a predicate device." The "performance tests" mentioned are "Tensile Static and Pull out following cyclic loading test." However, the specific acceptance criteria for these tests (e.g., minimum tensile strength, maximum pull-out force) and the detailed results showing the device met these criteria are not provided in this summary.

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The Parcus GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The Parcus GFS Naked devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The GFS Ultimate devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The GFS BTB devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The Parcus ATLAS is indicated for adjunct fixation of the 1st and 2nd metacarpals in CMC arthroplasty.

The Parcus Actiflip Naked, Actiflip Cinch, and Actiflip Whip are used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, pectoralis repair (minor), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.

The Parcus Synd-EZ Ti are intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. The Parcus Synd-EZ Ti are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

The Parcus GFS II, GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip are a range of devices design for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. Each device is made from a medical grade titanium alloy, Ti-6AI4V ELI, and may also include an UHMWPE polyblend suture component. Each device is provided sterile.

This document is a 510(k) Premarket Notification from Parcus Medical, LLC for several orthopedic fixation devices. It is a submission to the FDA for market clearance, asserting substantial equivalence to previously cleared predicate devices. The primary focus of the performance data in this submission is related to MR Conditional safety, as the devices themselves are largely unchanged from their predicates.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states that "worst-case devices were selected for testing" for the MR environment evaluation. It does not provide a specific number for the sample size.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It implies the testing was conducted by or for Parcus Medical, LLC, which is based in Sarasota, Florida, USA. The testing was likely prospective for the specific purpose of this submission (determining MR Conditional status).

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

This type of information is not applicable to this submission. The "ground truth" here is based on objective physical measurements of the devices' interaction with an MR environment and chemical testing (LAL), not on expert subjective interpretation or clinical outcomes. The evaluation against standards like the "FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards" serves as the "ground truth" criteria.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective physical and chemical testing against established standards, not on expert consensus or adjudication of subjective data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms, not for the safety assessment of orthopedic implants.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This submission is for medical devices (implants), not for an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this submission is based on:

• Physical measurements and compliance with established standards: For MR Conditional safety, this refers to measurements of magnetic force, torque, and heating in MR environments, assessed against the "FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards."
• Chemical testing results: For LAL (Limulus Amebocyte Lysate) testing, the ground truth is the measured endotoxin level against a defined acceptable limit.
• Predicate device characteristics: For biocompatibility, packaging, shelf-life, and sterilization, the "ground truth" is that these aspects remain unchanged and were previously deemed acceptable based on predicate devices.

8. The Sample Size for the Training Set

This is not applicable. This submission is for medical devices (implants) and does not involve an AI algorithm that requires a training set.

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

This is not applicable for the reason stated above.

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The Parcus AcTiFlip is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.

The Parcus AcTiFlip and GFS Ultimate Hip devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and UHMWPE suture and are provided sterile.

This FDA 510(k) summary provides limited information regarding the acceptance criteria and study data for the Parcus Medical AcTiFlip and GFS Ultimate Hip devices.

Here's an analysis based on the provided text, highlighting where information is available and where it's missing for your specific requests:

Summary of Acceptance Criteria and Device Performance (Limited Information):

Detailed Responses to Specific Questions:

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

   • See the table above. The document primarily states that the devices demonstrate "substantial equivalency" to predicate devices for mechanical properties (strength and elongation) and meet endotoxin specifications. Specific numerical acceptance criteria for strength and elongation are not
     provided in this summary, nor are the precise numerical results of the testing.

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 states that "testing was conducted on the worst case configurations," but does not specify the sample size (N) for these tests.
   • Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective. It describes laboratory testing, not clinical studies.

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 is not applicable as the summary describes mechanical and biocompatibility laboratory testing of a medical device (fixation fasteners), not a diagnostic or AI-driven device requiring expert-established ground truth.

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

   • This is not applicable for mechanical and biocompatibility testing. Adjudication methods are typically used in clinical studies or studies involving human assessment of data.

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 is not applicable. The device (fixation fasteners) is not an AI/diagnostic 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. The device is a physical medical implant, not an algorithm.

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

   • For the mechanical tests, the "ground truth" (or more accurately, the reference standard for comparison) was the performance of the predicate device. The testing aimed to show that the new device's performance was "substantially equivalent" to this established predicate.
   • For pyrogenicity, the "ground truth" was established based on endotoxin limit specifications, which are regulatory standards.

8. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is not an AI/machine learning device. The testing described is for physical properties and biocompatibility.

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

   • This is not applicable for the reasons stated above.

In summary, the provided FDA 510(k) letter and summary focus on demonstrating substantial equivalence of a physical medical device (bone/soft tissue fixation fasteners) to already cleared predicate devices through mechanical testing and biocompatibility assessments. It does not involve AI, diagnostic algorithms, or human interpretation studies.

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The GFS Ultimate are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The GFS Ultimate devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and UHMWPE suture. The GFS Ultimate devices are provided sterile.

The provided text is a 510(k) Substantial Equivalence Determination for the GFS Ultimate device. This type of document is for medical device regulation and focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not typically contain information about AI-based CADe/CADx systems or studies with acceptance criteria as commonly understood in that context.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details, as these are not present in the given document.

The document does include "Summary Performance Data" which states:

Summary Performance Data:

• The GFS Ultimate were evaluated and testing was conducted on the worst case configurations.
• Devices were assembled per the DFU and placed in a test fixture.
• Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions.
• Results were compared with test data for the predicate device and demonstrated substantial equivalency.

However, this summary does not provide specific acceptance criteria or quantitative performance metrics for the GFS Ultimate, nor does it detail the study design, sample sizes, or ground truth establishment that would be relevant for an AI-powered diagnostic/CADe device. Instead, it confirms that mechanical testing was performed and the results supported substantial equivalence to the predicate device.

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