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The SpiraLok Anchor is intended for: Shoulder: Rotor Cuff Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The SpiraLok Anchor is a PLA threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of two strands of suture to bone. Ethibond non-absorbable suture, the Panacryl absorbable suture and the Orthocord composite suture options may include tapered needles to facilitate suture passage through tissue. The attached suture is then used to reattach soft tissue back to bone where it reconnects through the healing process.

This looks like a 510(k) summary for a medical device called the SpiraLok Anchor. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in an AI/ML medical device submission.

The submission document focuses on demonstrating substantial equivalence through a "detailed device description" and "non-clinical laboratory testing" which showed the device is "safe and can be considered substantially equivalent to the predicate Arthrex Bio-Corkscrew Suture Anchor for the proposed new intended uses."

Therefore, it is not possible to provide the requested information based on the provided text. The prompt's specific requirements (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are characteristic of AI/ML software performance studies, which are not relevant to this type of device (a physical suture anchor).

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The Spiralok Anchor is intended for: Shoulder: Rotator cuff repair.

The SpiraLok Anchor, like the current BioFastin RC Anchor, is a PLA threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of two strands of suture to bone. Ethibond non-absorbable suture, the Panacryl absorbable suture and the Orthocord composite suture options may include tapered needles to facilitate suture passage through tissue. The attached suture is then used to reattach soft tissue back to bone where it reconnects through the healing process.

The provided document is a 510(k) summary for a medical device (Spiralok Anchor) and focuses on demonstrating substantial equivalence to a predicate device (BioFastin RC Anchor). It does not contain information about clinical studies with acceptance criteria, device performance metrics, or study design details in the way typically required for AI/software-as-a-medical-device (SaMD) clearances.

Therefore, the requested information cannot be fully provided from the given text. Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Device Performance (Not Applicable/Not Provided for this Type of Device)

This 510(k) pertains to a physical medical device (suture anchor), not an AI/SaMD. The "acceptance criteria" here are based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical laboratory testing and by showing that dimensional and material changes do not affect safety or effectiveness. Specific performance metrics like sensitivity, specificity, or F1-score, which are common for AI/SaMD, are not relevant or provided for this type of device.

Table of Acceptance Criteria and Reported Device Performance:

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

• Information Not Provided: The document mentions "Non-clinical laboratory testing was performed," but does not detail sample sizes, specific test protocols, or data provenance for these non-clinical tests. This is a physical device, and these would likely be engineering or bench tests rather than clinical studies with patient data.

2. 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: For a physical device undergoing non-clinical laboratory testing, "ground truth" and expert consensus in the context of diagnostic interpretation (like for AI/SaMD) are not relevant. Testing would involve engineering measurements and material property assessments against established standards or predicate device performance.

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

• Not Applicable: Adjudication methods are typically associated with human interpretation of data in clinical studies, not non-clinical laboratory testing of a physical implant.

4. 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 implant, not an AI/SaMD. MRMC studies or human reader improvement with AI assistance are not relevant.

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

• Not Applicable: This is a physical medical implant, not an algorithm or SaMD.

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

• Not Applicable in the traditional sense: For non-clinical lab testing of a physical implant, "ground truth" would be established by validated measurement techniques, material specifications, and engineering principles, often by comparison to the established performance of the predicate device under simulated conditions.

7. The sample size for the training set

• Not Applicable: This device is not an AI/SaMD and does not involve "training sets" in the context of machine learning.

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

• Not Applicable: As there is no training set for an AI/SaMD, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria (from the provided text):

The document states that the determination of substantial equivalence was based on a detailed device description and changes made to currently marketed devices. "Non-clinical laboratory testing was performed demonstrating that the device is safe and performs as intended."

The core of the "study" demonstrating the Spiralok Anchor met the criteria for substantial equivalence involved showing that:

• Dimensional changes from the predicate BioFastin RC Anchor were minor and did not affect safety or effectiveness.
• Material changes (specifically the inclusion of the Orthocord suture option) were safe, as Orthocord was previously cleared by the FDA (K040004) for orthopedic surgeries.
• These changes did not alter the intended use, safety, effectiveness, or fundamental scientific technology of the predicate device.

The specific details of the "non-clinical laboratory testing" (e.g., specific tests, precise methodologies, number of units tested, results in terms of strength, degradation, etc.) are not included in this 510(k) summary, but are implicitly assumed to have been robust enough to satisfy the FDA's requirements for substantial equivalence.

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