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The Phantom Sof-Thread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.

The Phantom Sof-Thread Screw is a resorbable, cannulated, interference screw with widely spaced, rounded threads and a conical tip, designed for use with soft tissue grafts. The Sof-Thread Screw is available in 4 diameters, 7. 8, 9 and 10mm, and one length, 25mm.

This is a 510(k) premarket notification for a medical device (Phantom Sof-Thread Soft Tissue Interference Screw), not an AI/ML software device. Therefore, the information requested regarding acceptance criteria, study details, ground truth, and training sets for AI/ML performance evaluation is not applicable and cannot be extracted from this document.

The document describes the device, its intended use, and establishes substantial equivalence to predicate devices based on design and mechanical testing in cadaver bone.

Here's a breakdown of the relevant information provided in the document, which pertains to traditional medical device clearance, not AI/ML:

1. Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is "substantial equivalence" to legally marketed predicate devices. This is demonstrated by comparing design, materials, and mechanical performance.
   • Reported Device Performance:
     • Mechanical Testing: "Mechanical testing in cadaver bone has shown that the average insertion torque and pull-out strength of the Phantom Sof-Thread Screw are comparable to those of the Linvatec BioScrew."
     • Comparison to Predicate: The Phantom Sof-Thread Screw has comparable insertion torque and pull-out strength to the Linvatec BioScrew, which is a legally marketed device.

2. Sample Size for Test Set and Data Provenance:

   • Sample Size: Not explicitly stated as a number of cases or subjects in a traditional clinical trial sense. The "mechanical testing in cadaver bone" implies a sample of cadaver bones and screws, but the specific number (e.g., how many screws, how many bones) is not provided.
   • Data Provenance: The testing was conducted "in cadaver bone," indicating an ex vivo setting. Country of origin is not specified.

3. Number of experts used to establish ground truth & qualifications: N/A for this type of device and study. Ground truth in this context is based on direct physical measurements of mechanical properties.

4. Adjudication Method: N/A. No human interpretation requiring adjudication is involved.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML device, nor is it a diagnostic device where human reader performance would be the primary endpoint.

6. Standalone (algorithm-only) performance: Not applicable. There is no algorithm.

7. Type of ground truth used: For the mechanical testing, the ground truth is the direct physical measurement of "average insertion torque" and "pull-out strength" in cadaver bone.

8. Sample size for the training set: Not applicable. There is no AI/ML model, hence no training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional surgical implant, not an AI/ML device. Therefore, most of the requested information regarding AI/ML performance evaluation is not present. The device demonstrated substantial equivalence through mechanical testing in cadaver bone comparing its performance (insertion torque and pull-out strength) to a legally marketed predicate device.

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• The BioScrew is used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament reconstruction.
• The BioScrew is used to provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
• The BioScrew is used to provide interference fixation during posterior cruciate ligament reconstruction.
  Implantation of the interference screw is accomplished through arthroscopy or arthrotomy. This device is a single-use device.

The BioScrew Absorbable Interference Screw is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body.

The provided text focuses on the 510(k) premarket notification for the BioScrew® Absorbable Interference Screw. It establishes substantial equivalence to predicate devices and describes the device's intended use and characteristics. However, it does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics (e.g., accuracy, sensitivity, specificity) typically associated with diagnostic or AI-driven medical devices.

Instead, the "acceptance criteria" for this device, as implied by the FDA 510(k) process, are met through demonstrating:

1. Substantial Equivalence: The new device is as safe and effective as a legally marketed predicate device. This is the primary "acceptance criterion" for a 510(k) submission.
2. Compliance with General Controls: Meeting requirements for annual registration, device listing, good manufacturing practices (GMP), labeling, and prohibitions against misbranding and adulteration.

The "study" that proves the device meets these generalized acceptance criteria for a 510(k) is the comparison to legally marketed predicate devices.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an interference screw, the "performance" is primarily defined by its physical characteristics and intended use being substantially equivalent to existing devices. There are no quantitative performance metrics like accuracy, sensitivity, or specificity that would typically be reported for a diagnostic device.

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

The document does not describe a traditional "test set" with a sample size for performance evaluation in the way one might for an AI algorithm or a diagnostic assay. The "test" here is the comparison of the new device's features and intended use against predicate devices based on existing regulatory clearances.

• Sample Size for Test Set: Not applicable in the context of device performance testing for this 510(k). The "test" is a qualitative comparison to existing devices.
• Data Provenance: Not applicable. The "data" primarily consists of the specifications of the new device and the predicate devices, as described in their respective 510(k) submissions.

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

Not applicable. The assessment of substantial equivalence is conducted by FDA reviewers (e.g., in the Division of General and Restorative Devices) based on submitted documentation, not by external experts establishing "ground truth" for a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" and thus no adjudication method for establishing ground truth in the way described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes a 510(k) submission for an absorbable interference screw, which is a physical implant. MRMC studies are typically used for evaluating diagnostic imaging systems or AI algorithms with human readers.

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

No. This device is not an algorithm or a diagnostic tool.

7. The Type of Ground Truth Used

The "ground truth" for a 510(k) is implicitly the regulatory clearance and established safety and effectiveness of the predicate devices. The new device is deemed "safe and effective enough" if it is substantially equivalent to these already-cleared devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm.

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

Not applicable. This is not an AI algorithm.

In summary, the provided document is a 510(k) premarket notification. The "acceptance criteria" and "study" for this type of submission revolve around demonstrating substantial equivalence to predicate devices, rather than meeting quantitative performance metrics derived from a specific test set, as would be the case for a new diagnostic or AI-powered solution. The document explicitly states: "Strength and degradation tests are planned to compare the BioScrew to the Arthrex and/or BioMet screws," indicating that future comparative testing was intended, but the 510(k) clearance itself was based on the substantial equivalence argument, not necessarily the results of those planned tests at the time of submission.

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