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The DePuy Interference Screw Systems are intended to be used to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction and of soft tissue grafts in ACL reconstruction.

The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws available in three diameters (7, 8, and 9mm) in three lengths (20, 25,and 30mm), and manufactured from titanium alloy (DePuy Profile Round Head Interference Screw) and from Poly-L-lactic acid (DePuy Phantom Absorbable Interference Screw).

The provided text does not contain any acceptance criteria or a study that proves the device meets specific criteria in the way a typical medical device study would be presented with performance metrics.

Instead, the document is a 510(k) premarket notification summary for a medical device (DePuy Profile™ Round Head Interference Screw and DePuy Phantom™ Resorbable Interference Screw). This means the manufacturer is seeking to demonstrate that their new device is "substantially equivalent" to an already legally marketed predicate device, rather than proving its safety and effectiveness through a new clinical trial with specific acceptance criteria.

The "Basis of Substantial Equivalence" section describes the rationale for this claim:

• Materials and Design Similarity: The screws are similar in design and materials to previously cleared DePuy Advantage and Hyloc Interference screws.
• Minor Differences: There are only minor design changes and fewer screw length options compared to previously cleared devices.
• Additional Indication: The key difference is an additional indication for interference fixation of soft tissue grafts in ACL reconstruction.
• Mechanical Testing: To support this additional indication, mechanical testing in cadaver bone was performed.

Here's how to address your specific points based on the provided text, while noting the limitations:

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

The document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a table format as you would expect from a performance study.

Instead, it states:
"Mechanical testing in cadaver bone has shown that the average insertion torque and pull-out strength of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those of the previously cleared DePuy SofThread Soft Tissue Interference Screw and Linvatec BioScrew indicated for interference fixation of soft tissue grafts in ACL reconstruction."

• Acceptance Criteria (Implied): "Comparable" average insertion torque and pull-out strength to predicate devices.
• Reported Device Performance: "Comparable" average insertion torque and pull-out strength.

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. The text only mentions "cadaver bone" but does not give the number of samples or tests performed.
• Data Provenance: The study appears to be a bench/mechanical study using "cadaver bone." The country of origin of this data is not specified, but the firm is located in Warsaw, Indiana, USA, suggesting the testing likely occurred in the US or a related facility. This would be considered prospective testing for the purpose of demonstrating substantial equivalence, although not a clinical trial.

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 question is not applicable to the provided document. The study was a mechanical/bench test on cadaver bone, not a diagnostic or clinical study requiring expert review to establish ground truth.

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

This question is not applicable. There was no clinical or diagnostic test set requiring adjudication. The comparison was based on quantitative mechanical properties (insertion torque and pull-out strength).

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 question is not applicable. The device is a bone screw, not an AI or imaging diagnostic device.

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

This question is not applicable. The device is a bone screw, not an algorithm.

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

For the mechanical testing, the "ground truth" (or reference) was the established mechanical performance (insertion torque and pull-out strength) of the predicate devices (DePuy SofThread Soft Tissue Interference Screw and Linvatec BioScrew). The goal was to show comparability, not to establish a new clinical ground truth.

8. The sample size for the training set

This question is not applicable. There was no "training set" in the context of an AI/algorithm. If interpreted loosely as the historical data from which the "comparable" predicate devices were developed, that information is not provided.

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

This question is not applicable as there was no training set in the context of an AI/algorithm.

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