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The LARS® AC Band device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The LARS® AC Band device is intended for single use only.

The LARS® AC Band device is a knitted surgical scaffold manufactured from poly(ethylene terephthalate) (PET) which is non-biodegradable. The LARS® AC Band device is available in 1 size which is 6mm wide by 400mm in length with a loop at one end and is secured by sutures. The use of high strength #2, non-resorbable single use sterile sutures is recommended. The construct permits the mesh to be cut into any desired size without unraveling. The device is supplied sterile, for singlepatient use.

Here's an analysis of the provided text regarding the LARS® AC Band Device's acceptance criteria and studies:

Based on the provided FDA 510(k) summary, the device is a medical implant, and the documentation primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics against specific acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested points related to AI/algorithm performance, such as sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone algorithm performance, are not applicable to this submission as it's for a physical medical device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the submission):

Regarding the specific questions:

1. A table of acceptance criteria and the reported device performance: See table above. The acceptance criteria are largely inferred from the substantial equivalence claim and the types of non-clinical and clinical reviews performed. The "reported performance" is that these tests/analyses were conducted, implying acceptable results for the claim of substantial equivalence. Specific quantitative acceptance criteria or performance metrics are not provided in this 510(k) summary for a physical device.

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

   • Test set sample size: Not applicable in the context of an AI/algorithm test set. For the non-clinical mechanical tests (tensile, tear, burst), standard engineering sample sizes would have been used, but these are not specified. For the clinical data review, the "sample size" would refer to the number of patients/cases in the published literature reviewed, which is not provided.
   • Data provenance: Not specified for the clinical data review. It's likely a review of existing global literature, but no details are given.

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, as this is a physical medical device submission, not an AI/algorithm where expert ground truth is typically established for image/data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical medical device.

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 a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical testing, the "ground truth" would be the measured physical properties according to established engineering standards. For the clinical review, the "ground truth" would be the reported clinical outcomes in the published literature and test reports.

8. The sample size for the training set: Not applicable; this device does not involve a "training set" in the machine learning sense.

9. How the ground truth for the training set was established: Not applicable; there is no training set for this physical device.

Summary of the Study for Substantial Equivalence:

The study conducted was primarily a non-clinical testing program combined with a review and analysis of published clinical data and test reports.

• Non-Clinical Testing: Included mechanical tests (tensile strength, tear strength, burst strength) and biocompatibility testing of the LARS® AC Band device itself. The summary implies these tests demonstrated the device's physical properties are suitable and comparable to the predicate/reference devices.
• Clinical Testing/Review: This was not a de novo clinical trial for the LARS® AC Band device. Instead, it involved a "review and analysis of published clinical data and test reports" related to the LARS® AC Band device or similar devices, focusing on aspects like wear, bone fracture, particulates, and inflammatory/biologic response at the surgical site. This review was presumably used to support the safety and effectiveness profile based on existing literature for the claimed indications.

The overall approach was to demonstrate substantial equivalence to existing legally marketed devices (LOCKDOWN™ Acromioclavicular (AC) device (K091207) as predicate, and Surgicraft Surgical Mesh System (K072370) as a reference for material). Substantial equivalence means the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.

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