(47 days)
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."
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.