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The Revelation™ Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nomunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

The Revelation™ Porous Hip Stem is fabricated from wrought/forged or cast Ti-6A1-4V that conforms to ASTM F136 or F1108. respectively. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads to provide a porous surface for enhanced fixation. The Revelation™ Porous Hip Stem is collarless and has a Morse type taper to receive modular heads.

This document is a 510(k) premarket notification for a medical device (Revelation™ Porous Hip Stem). It indicates that the device has been found substantially equivalent to a predicate device already on the market.

Crucially, this document does not describe acceptance criteria or a study that proves the device meets those criteria, in the way one would typically expect for an AI/software device submission.

Instead, it's a notification about a physical orthopedic implant. For such devices, "acceptance criteria" and "studies" usually refer to mechanical testing (fatigue strength, torsional strength, etc.), biocompatibility testing, and potentially limited clinical follow-up for specific features if new. However, the provided text does not contain any of this information.

Therefore, I cannot fulfill your request as the information regarding acceptance criteria and performance studies for the Revelation™ Porous Hip Stem is not present in the provided text. The document is primarily an FDA clearance letter and a summary of the device's characteristics and intended use, asserting substantial equivalence to existing devices rather than detailing specific performance studies against acceptance criteria.

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The Revelation™ Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

The Revelation™ Porous Hip Stem is fabricated from wrought/forged or cast Ti-6A1-4V that conforms to ASTM F136 or F1108, respectively. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads to provide a porous surface for enhanced fixation. The Revelation™ Porous Hip Stem is collarless and has a Morse type taper to receive modular heads.

This document is a 510(k) summary for the K973685 Revelation™ Porous Hip Stem.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary for K973685 does not specify a separate "test set" in the context of clinical data for performance evaluation. The device is a hip stem, and the testing mentioned is mechanical fatigue testing. Therefore, details about data provenance (country of origin, retrospective/prospective) are not applicable as there's no clinical trial data discussed.

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

This is not applicable as the summary discusses mechanical testing, not a study involving human experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

This is not applicable as the summary discusses mechanical testing, not a study involving adjudication of clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is a hip stem, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI performance improvement are irrelevant.

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

This is not applicable. The device is a hip stem, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing would be the physical properties and failure points observed during the fatigue testing. For a hip stem, this would likely involve reaching a specified number of cycles without failure or exceeding a certain strain/deflection. The summary does not detail the specific ground truth metrics or methodology beyond stating "fatigue testing" was performed.

8. The Sample Size for the Training Set

This is not applicable. The device is a hip stem undergoing mechanical testing, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

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