Search Results
Found 1 results
510(k) Data Aggregation
(28 days)
The DePuy RECLAIM Monobloc Revision Femoral Stem 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 subject devices in this line extension to the RECLAIM Monobloc Revision Femoral Stem (previously cleared through Primary Predicate 510(k) K221462 and with MRI Conditional status cleared through 510(k) K231873) include four new Standard length RECLAIM Monobloc Revision Femoral Stems and twenty-three new Short length RECLAIM Monobloc Revision Femoral Stems.
The line extension will extend the DePuy RECLAIM Monobloc Revision Femoral Stems portfolio by twenty-seven product codes.
The Subject Device RECLAIM Monobloc Revision Femoral Stems are revision implants that are intended to treat patients with prior failed hip replacement devices. They are made of Ti6Al4V alloy and present a grit-blasted tapered fluted intramedullary region with splines that are intended to be in interference of the previously reamed femoral cavity and in contact with the cortical bone in the canal in an uncemented use.
The provided text describes a 510(k) clearance letter for the RECLAIM Monobloc Revision Femoral Stem. This is a medical device, specifically a hip joint prosthesis, not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to AI/SaMD performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone algorithm-only performance," "number of experts for ground truth," and "training set size," are not applicable to this submission.
The clearance is for an expansion of the existing RECLAIM Monobloc Revision Femoral Stem (K221462 and K231873) to include additional sizes. The regulatory review focuses on mechanical performance and substantial equivalence to the predicate devices.
Here's the information extracted from the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Neck Fatigue | No new worst-case was identified. (This implies it met existing neck fatigue criteria, likely established for the predicate devices). |
| MRI Safety | No new worst-case was identified. (This implies it met existing MRI safety criteria, likely established for the predicate devices). |
| Range of Motion | Tested to demonstrate substantial equivalence to identified predicate devices. (Results are not detailed but concluded as equivalent). |
| Stem Fatigue | Tested to demonstrate substantial equivalence to identified predicate devices. (Results are not detailed but concluded as equivalent). |
| Substantial Equivalence: | The RECLAIM Monobloc Revision Femoral Stem is substantially equivalent to the identified predicate with respect to intended use, indications, materials, geometry, range of sizes, and method of fixation. Results of performance testing and analyses demonstrate that the RECLAIM Monobloc Revision Femoral Stem performs as well as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the mechanical tests (Neck Fatigue, MRI Safety, Range of Motion, Stem Fatigue). However, for medical device mechanical testing, typically a representative number of samples (e.g., 3-6 or more) for each configuration are tested according to relevant ISO or ASTM standards.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. As these are physical device tests, they would be conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is a physical device, not an AI/SaMD for which expert-established ground truth would be required. The "truth" is determined by mechanical testing against established engineering standards.
4. Adjudication Method for the Test Set
Not applicable. This is a physical device, not an AI/SaMD where adjudications of expert interpretations are relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is a physical medical device (hip implant), not an AI/SaMD that assists human readers.
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 AI/SaMD.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" is established by:
- Engineering Standards: Bench testing against industry-accepted standards (e.g., ISO, ASTM) for fatigue, range of motion, and other mechanical properties.
- Predicate Device Performance: Demonstrating that the subject device performs "as well as" or equivalently to the legally marketed predicate devices, which have already established safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/SaMD, therefore a "training set" in the context of machine learning is not relevant.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no "training set" for this type of device.
Ask a specific question about this device
Page 1 of 1