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The DePuy Low Profile Bone Screw is indicated for use as an ancillary fixation device to be used with tibial and acetabular components in total knee and hip arthroplasty.

The DePuy Low Profile Bone Screws, manufactured in both titanium and cobaltchrome, are manufactured in eleven lengths (15, 20, 25, 40, 45, 50, 55, 60 and 65mm) with a 6.5mm major diameter. The head of the screw is designed with a "low profile" to allow the head to be placed below the surface of the device being fixed. An internal hex fitting in the head is used for instrument (a hex drive) insertion of the screw during surgery. The distal two-thirds of the screw is coarsely threaded while the proximal one-third is smooth with a polished satin finish. The screw has a distal flute to aid in insertion into cancellous bone.

The provided text describes the regulatory clearance for a medical device and does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than clinical performance or specific acceptance criteria for performance metrics.

Therefore, I cannot fulfill the request for:

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

The document states:

• Device Name: DePuy Low Profile Bone Screw
• Intended Use: As an ancillary fixation device to be used with tibial and acetabular components in total knee and hip arthroplasty.
• Basis of Substantial Equivalence: The device is considered substantially equivalent to pre-1976 DePuy stainless steel bone screws, with differences noted in major diameter, manufacturing material, and a restriction of intended use. The document explicitly states, "Based on the information provided in this premarket notfication, DePuy considers the DePuy Low Profile Bone Screws to be substantially equivalent to specified pre-1976 fixation screws."

This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing it has the same technological characteristics or differences that do not raise new questions of safety or effectiveness. It does not typically involve the kind of performance study details requested.

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