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The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty. 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: - Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. - Avascular necrosis of the femoral head. 2. - Acute traumatic facture of the femoral head or 3. neck. - Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. - Certain cases of ankylosis. 5.

The DePuy C-Stem System hip stem is a collarless, triple-tapered polished stem slim-profiled, manufactured from stainless steel. The C-Stem system also includes an end cap made from either gelatin or PMMA and PMMA centralizers.

The provided text is a 510(k) summary for the DePuy C-Stem™ System, a total hip joint replacement prosthesis. It does not contain acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes for test/training sets, expert qualifications, etc.).

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared device (K982918 DePuy C-Stem System), rather than providing detailed performance studies against specific acceptance criteria.

The key points from the provided text are:

• Device: DePuy C-Stem™ System
• Classification: Class II Device (21 CFR 888.3350)
• Intended Use: Total hip arthroplasty to increase patient mobility and reduce pain.
• Indications for Use: Severely painful/disabled joint from various conditions (osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia), avascular necrosis, acute traumatic fracture, failed previous hip surgery, and certain cases of ankylosis.
• Substantial Equivalence Claim: The document states that "The fundamental scientific technology of the C-Stem System has not changed from the FDA cleared DePuy C-Stem System described in K982918. The intended use and indications for use have not changed. The material from which the additional end cap is manufactured has been changed to PMMA, the same material used to manufacture other legally marketed end cap devices."
• Approval Basis: Conformance with design control procedures and similarities in design, intended use, and indications for use to the predicate device.

Therefore, I cannot fill out the requested table or answer most of the questions because the provided text does not contain the necessary information regarding acceptance criteria or a performance study.

The document is a regulatory filing focused on demonstrating equivalence for market clearance, not on providing a study with specific performance metrics against pre-defined acceptance criteria for a new or significantly modified device requiring such studies.

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The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient with a severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and certain cases of ankylosis.

The subject DePuy C-Stem System includes stainless steel femoral stems, a gelatin end cap and PMMA centralizers. The C-Stern is a collarless, slim profiled, triple-tapered, and overall polished stem that is available in four stem designs. The four stem designs are: a CDH stem available in one size; a primary stem available in eight sizes (1, 2, 3, 4, 5, 6, 7; an d 8); a high offset stem available in three sizes (3, 4, and 5); and a revision stem available in three sizes (4, 6, and 8) each of which is available in two lengths (200mm and 240mm).

This document is a 510(k) summary for the DePuy C-Stem™ System, a hip prosthesis. It is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Critical Note: This 510(k) summary does not contain acceptance criteria for device performance, nor details of a study that proves the device meets such criteria. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through comparisons of design, materials, and intended use, rather than presenting clinical trial data or performance against acceptance thresholds.

Therefore, many of the requested information points cannot be provided from the given text.

Here's a breakdown of what can be extracted or inferred based on the document's nature:

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

• Not applicable. This document does not define explicit acceptance criteria for device performance (e.g., mechanical strength, wear rates, clinical outcomes) for the DePuy C-Stem™ System itself. Instead, it argues that the device's design, materials, and intended use are similar to already approved devices. There is no "reported device performance" against specific acceptance criteria presented here.

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. The document does not describe performance testing or clinical studies with test sets in the way implied by this question. It relies on a comparison with predicate devices.

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 expert-established ground truth for a test set is described.

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

• Not applicable. No adjudication method 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 device is a physical hip prosthesis, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable. No ground truth for performance testing is discussed. The "ground truth" for the submission is the regulatory acceptance of the predicate devices.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an algorithm that uses training data.

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

• Not applicable. This is a physical medical device, not an algorithm that uses training data.

Summary of available information from the document (relevant to substantial equivalence, not performance criteria):

The basis of substantial equivalence is a comparison of the DePuy C-Stem™ System to several FDA-cleared predicate devices: CPT Hip Prosthesis (K960658), Exeter Total Hip System (K974054, K980843), Ortron 90* Hip Prosthesis (Charnley) (K802627), DePuy Elite Hip (K871867), BIOSTOP® G Bone Cement Restrictor (K943727), and DePuy Distal Stem Centralizers (K951930).

The argument for substantial equivalence is based on:

• Material: Ortron Stainless Steel (similar to Elite and Charnley), or stainless steel (similar to Exeter).
• Intended Use: Cemented use as the femoral component in total hip arthroplasty (identical to all predicates mentioned).
• Design: Collarless, slim profiled, polished, use of femoral canal centering devices (similar to CPT and Exeter). The C-Stem has three tapers, while CPT and Exeter have two; Elite and Charnley are textured rather than polished, but are otherwise similar.
• Component usage: Modular heads, end caps/centralizers/cement restrictors (present in C-Stem and most predicates).

The document explicitly states: "Based on similarities of design, materials and intended use, DePuy believes that the subject C-Stem System is substantially equivalent to the FDA cleared CPT, Exeter, Elite and Charnley Hip Systems."

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