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The Phantom™ Interference Screw, M. Kurosaka Interference Screw and the BioScrew® are intended to provide bone-tendon-bone patellar graft fixation, employing the same principles of graft fixation. These fixation screws provide an interference fit engaging both the drill tunnel and the bone plug of the graft.

The Phantom PLLA Interference Screw is an absorbable interference fixation screw. The DePuy DuPont Phantom™ Interference Screw is a fully threaded cancellous bone screw available in 7.0mm, 8.0mm and 9.0mm diameter sizes. Each diameter is available in either 15, 20, 25, and 30mm lengths and is offered in cannulated and non-cannulated versions.

The tip of the 9mm sized screw is tapered to a point which produces the self tapping feature of the screw. The screw is inserted by a square drive which is broached into the minor diameter of the screw body. The headless, low profile design minimizes subcutaneous surface protrusions. The threads are a symmetrical thread form designed to equally match stiffness between bone and thread. The Phantom screw is radiolucent on x-rays, but can be visualized with MRI and CAT scans.

This submission K955733 describes an absorbable interference fixation screw, the "Phantom PLLA Interference Screw." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not present in this type of submission.

Here's an analysis based on the provided text:

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

The document does not explicitly state acceptance criteria or report device performance in the context of a study demonstrating such. The focus is on demonstrating substantial equivalence to predicate devices. The "Basis of Substantial Equivalence" section highlights similarities in:

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

Not applicable. No "test set" in the sense of a clinical or ex-vivo performance study is described. The submission focuses on device characteristics and comparison to predicates.

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. No ground truth establishment for a performance study is described.

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

Not applicable. No adjudication method for a performance study is described.

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 medical device (implant) submission, not an AI/software device.

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

Not applicable. This is a medical device (implant) submission, not an AI/software device.

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

Not applicable. The submission refers to manufacturing specifications, material properties, and design similarities for establishing substantial equivalence.

8. The sample size for the training set

Not applicable. No "training set" in an AI/machine learning context is described.

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

Not applicable.

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