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Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   Non Porous-coated femoral hip stem prostheses labeled "FOR PRESS-FIT OR CEMENTED USE" are indicated for press-fit uncemented use, or for use with bone cement.

The Response 2000 Hip Stem is manufactured from ASTM F-75 Co-Cr-Mo alloy. It is a smooth, straight-stem design, which will have a glass bead-blasted surface finish, a bullet-shaped distal tip, and is designed with a self-locking taper for use with a DePuy femoral head.

The provided text describes a 510(k) premarket notification for the DePuy Response 2000 Hip Stem, a femoral hip prosthesis. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically understood for AI/ML device submissions.

The information provided pertains to:

• Device Description: The Response 2000 Hip Stem is made from ASTM F-75 Co-Cr-Mo alloy, has a smooth, straight-stem design with a glass bead-blasted surface finish, a bullet-shaped distal tip, and a self-locking taper for use with a DePuy femoral head.
• Intended Use & Indications: For press-fit or cemented use in total hip arthroplasties to increase patient mobility and reduce pain. Specific indications include osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery, and certain cases of ankylosis.
• Basis of Substantial Equivalence: The subject device is stated to be identical to predicate hip stem devices in straight stem geometry, materials, and indications.

To directly answer your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document focuses on substantial equivalence based on design, materials, and indications, not performance metrics.
2. Sample size used for the test set and the data provenance: This information is not present as no performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present as no ground truth establishment for a test set is described.
4. Adjudication method for the test set: This information is not present as no test set or adjudication process 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: This information is not present. This device is a mechanical hip stem, not an AI/ML device, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. This device is a mechanical hip stem, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

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