(120 days)
The DePuy RECLAIM Revision Hip System is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
The ReClaim Revision Hip System is a modular tapered hip stem system that is intended for use in revision hip arthroplasty.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DePuy RECLAIM Revision Hip System:
The provided document describes a 510(k) submission for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific clinical acceptance criteria through clinical trials. Therefore, much of the requested information regarding clinical study design, ground truth, expert consensus, and human reader performance is not applicable to this type of submission.
The "acceptance criteria" discussed here are primarily technical and performance-based to show the new device is as safe and effective as existing legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance (Fatigue) | Neck fatigue testing per ISO-7206-6:1992 specification. | "RECLAIM neck fatigue testing meets the ISO-7206-6:1992 specification when tested to 10 million cycles at 1200 lbf in air." |
| Material/Design Performance (Fatigue) | Distal fatigue testing per ISO 7206-4:1989 requirements/benchmarks set by predicate devices. | "Distal fatigue testing per ISO 7206-4:1989 demonstrated that the subject device achieved higher maximum loads prior to failure when compared to the predicate Spectrum and Solution devices." |
| Overall Safety and Effectiveness | Demonstrated substantial equivalence to predicate devices in intended use, indications for use, materials, geometry, design, and performance, with no new issues of safety or effectiveness. | The submission concludes: "The subject DePuy RECLAIM Revision Hip System is substantially equivalent to the predicate devices identified in this premarket notification." The FDA concurred with this determination. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as there was no clinical test set in the traditional sense. The "test set" was generated through non-clinical mechanical testing (fatigue tests).
- Sample Size: Not explicitly stated for the mechanical tests, but implied multiple units would be tested to demonstrate conformance to ISO standards and for comparison against predicate devices.
- Data Provenance: Laboratory testing data, likely conducted by the manufacturer or a contracted lab. No country of origin for clinical data as none was used. The focus is on the device's physical properties.
- Retrospective/Prospective: Not applicable to mechanical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable. For mechanical testing, the "ground truth" is defined by the established ISO standards and the physical properties of the materials and design, measured by engineering specialists. No human experts were used to establish a "ground truth" for diagnostic or clinical outcomes from a patient dataset.
4. Adjudication Method for the Test Set
This is not applicable. Mechanical test results are objective measurements against established engineering standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was required to demonstrate substantial equivalence." Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. The device is a physical hip implant, not an AI algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was based on:
- International Standards: Adherence to ISO-7206-6:1992 for neck fatigue and ISO 7206-4:1989 for distal fatigue.
- Comparative Performance: The mechanical performance (e.g., maximum loads prior to failure) was compared directly to legally marketed predicate devices (DePuy Spectrum Modular System, K033893, and DePuy Solution Hip System, K060581).
8. The Sample Size for the Training Set
This is not applicable. There was no "training set" as this device is a physical implant, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there was no training set.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.