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The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip the following procedures:

• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Acetabular Labral Repair and Reconstruction

The fundamental technology of the Arthrex FiberTak Suture Anchors is that the Arthrex FiberTak Anchors are "all-suture" soft-tissue fixation devices with a push-in design. The subject device is FiberTak Anchor with 1.3 mm SutureTape (White/Blue) and is a knotted FiberTak with a Polyester Sheath and a Polyester/UHMWPE repair suture.

The subject device is preloaded on a disposable inserter, which facilities deployment. The subject anchor and connected sutures are impacted into a pilot hole. The suture is then manually tensioned to set the anchor by "bulging/bunching" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around the soft tissue and is fixated via its surgical technique. The device is provided sterile and is intended for single-use.

The provided FDA 510(k) Clearance Letter concerns a physical medical device (suture anchor) and not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to AI acceptance criteria, training sets, ground truth establishment by experts, MRMC studies, and stand-alone algorithm performance are not applicable to this document.

The clearance for the Arthrex FiberTak Suture Anchor is based on substantial equivalence to existing predicate devices, primarily demonstrated through performance testing rather than clinical study data from image analysis or diagnostic tasks.

Here's an analysis of the provided text based on the nature of the device:

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

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: Not specified in the provided text. The document states "Straight Pull testing... was conducted." For mechanical testing, the "sample size" would refer to the number of anchors tested, which is typically outlined in the test report referenced (ASTM F3690).
• Data Provenance: Not specified. It's likely that the testing was performed in a lab setting (in vitro) to regulatory standards (ASTM F3690). This is not retrospective or prospective clinical data.

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

• Not Applicable. This is a physical device clearance based on mechanical testing and substantial equivalence, not on diagnostic accuracy established by expert consensus. There is no "ground truth" established by experts in the context of image interpretation or diagnosis.

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

• Not Applicable. As per point 3, there is no expert panel or image interpretation data that would require 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-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm.

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

• The "ground truth" in this context refers to the objective mechanical performance characteristics of the device (e.g., force at failure, displacement) as measured by standardized engineering tests (e.g., ASTM F3690). The "truth" is derived from these empirical measurements, not expert interpretation of clinical data.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not a machine learning model.

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

• Not Applicable. There is no "training set" or "ground truth" in the context of machine learning for this device.

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The FOOTPRINT® MINI PK, 3.5mm Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications:

Foot and Ankle:

• · Medial or lateral instability repairs/reconstructions
• · Achilles tendon repairs/reconstructions
  Knee:
• · Extra-capsular repairs
• -Medial collateral ligament
• -Lateral collateral ligament
• -Posterior oblique ligament

The Smith & Nephew FOOTPRINT? MINI PK, 3.5mm Suture Anchor is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of a two-piece suture anchor comprised of an anchor body and inner plug, preassembled onto an insertion device. The device is sold with a disposable suture threader.

This response pertains to a medical device submission, specifically a 510(k) for the "FOOTPRINT® MINI PK, 3.5mm Suture Anchor". The provided text describes a physical medical device and not a software algorithm or AI-powered device. Therefore, many of the requested categories related to AI/software performance evaluation (like test set data provenance, expert ground truth, MRMC studies, training set details, etc.) are not applicable to this type of submission.

The provided document details the regulatory clearance of a physical medical device, not a diagnostic AI or imaging analysis software. Thus, the information requested about acceptance criteria for AI algorithms, training sets, ground truth establishment methods typical for AI, multi-reader multi-case studies, and human-in-the-loop performance is not found in the provided text as it pertains to a different type of medical product.

However, I can extract information regarding the device's performance testing and acceptance, which are analogous to "acceptance criteria" for a physical device.

Here's the relevant information based on the provided text:

Acceptance Criteria and Device Performance (for a physical medical device)

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

Note: The document states, "Non-clinical bench testing was completed on the subject device, and the device met all required specifications for each test. ... Results for all tests passed." It implies that specific predefined criteria for each test type were met, but the precise numerical or qualitative thresholds for these criteria are not detailed in this publicly available summary.

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

• Sample Size: The document does not specify the exact sample size (number of devices/implants) used for each non-clinical bench test.
• Data Provenance: Not applicable as this is bench testing of physical devices, not clinical data or imaging. The tests were performed in a lab setting, likely by Smith & Nephew.

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: "Ground truth" in the context of expert review for medical imaging or AI models is not relevant here. The "ground truth" for the performance of a physical medical device is established through its physical and mechanical properties as measured in bench testing against defined engineering specifications.

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

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used for human review of medical images or data, typically in the context of clinical studies or establishing ground truth for AI. For physical device bench testing, engineering standards and protocols dictate the evaluation, not human adjudication in this sense.

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: MRMC studies are specific to the evaluation of diagnostic imaging devices, often involving human readers and potentially AI assistance. This submission is for a physical orthopedic implant.

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

• Not Applicable: This question refers to the performance of an independent AI algorithm. The device is a physical suture anchor, not an algorithm.

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

• Engineering Specifications/Standards: The "ground truth" for this device's performance is based on established engineering specifications and industry standards for mechanical strength, insertion force, and durability under various loading conditions relevant to its intended use in soft tissue to bone reattachment. The document states, "the device met all required specifications for each test."

8. The sample size for the training set

• Not Applicable: There is no "training set" in the context of a physical device. This term is used for machine learning algorithms.

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

• Not Applicable: As there is no training set for a physical device, this question is not relevant.

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The Smith & Nephew HEALICOIL Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:

Shoulder

• Biceps tenodesis

· Rotator cuff tear repair

The HEALICOIL Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer. The anchor consists of the following components: a proximal implant (REGENESORB or PEEK), a non-absorbable distal implant (PEEK or Titanium), and a nonabsorbable PEEK plug. The anchor is preloaded on a stainless steel inserter. This device is to be used with Smith & Nephew ULTRABRAID, ULTRATAPE, and MINITAPE Sutures. This device is provided sterile, for single use only.

The provided text describes the 510(k) premarket notification for the "HEALICOIL Knotless Suture Anchor" device. It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, but it does not contain detailed information about acceptance criteria or specific study results that would typically be found in a comprehensive clinical or performance study report.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• Multi reader multi case (MRMC) comparative effectiveness study information
• Standalone (algorithm only) performance information
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to already cleared predicate devices by comparing their intended use, technological characteristics, and performance data from bench testing (insertion strength, pull-out strength, cyclic loading, sterilization, shelf-life, biocompatibility, bacterial endotoxin testing).

Here's what the document does provide regarding performance data:

Summary Performance Data (as reported in the document):

Study Information (based on the provided text):

The document describes bench testing rather than a "study" in the traditional sense of a clinical trial or a study involving human readers or algorithms. The performance data summarized relates to the physical and biological characteristics of the device and its components, primarily to establish substantial equivalence with existing devices.

• Data Provenance: The studies are described as "performance data" and "bench testing." The specific location or retrospective/prospective nature of the data collection is not detailed, but it's implied to be laboratory-based testing conducted by the manufacturer or a contracted lab.
• Ground Truth / Experts / Adjudication / MRMC / Standalone / Training Set: These concepts are typically associated with studies evaluating diagnostic or AI-driven devices, neither of which applies to this submission for a surgical suture anchor. Therefore, the document does not contain information on these aspects. The "ground truth" for this type of device is usually established by objective engineering specifications, materials science standards (e.g., ISO for biocompatibility), and mechanical testing protocols.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence through comparison of the device's design, materials, and bench-level performance data against predicate devices, rather than a clinical study report with detailed acceptance criteria for diagnostic performance or AI effectiveness.

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