(155 days)
The DePuy RECLAIM Monobloc Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
The Subject Devices DePuy Reclaim Monobloc 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 design of the Subject Device extramedullary region is based on that of the Predicate Reclaim Modular stem implants which were cleared by the FDA via K102080 in 2010. The extramedullary region has standard and high offset options on a polished neck, with a 12/14 AMT trunnion. The Subject Devices are intended to be inserted into the femoral canal using the Reclaim Monobloc Inserter Instruments.
With the exception of the Subject Device being a one-piece implant versus the Predicate two-piece modular implant, resulting in fewer theoretically possible construct lengths, and the addition of the secondary splines, the Subject and Predicate Devices are identical in intended use, indications for use, materials, sterilization method, and fixation method. The non-modular design, and the addition of the secondary splines do not impact the safety or effectiveness of the Subject Device as compared to the Predicate.
This 510(k) also includes sterilization instrument trays, that, according to FDA guidance document "Medical Device Accessories – Describing Accessories and Classification Pathways, Guidance for Industry and Food and Drug Administration Staff," issued on December 20, 2017, requires clearance under the same product codes as the Subject Device.
The provided document is a 510(k) summary for the DePuy Reclaim Monobloc Revision Femoral Stem. It describes the device, its indications for use, and how it demonstrates substantial equivalence to a predicate device.
Crucially, this document is for a medical device (hip stem prosthesis), not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of a "test set" for AI models, "ground truth" established by experts, "multi-reader multi-case (MRMC) studies," "training set," or "adjudication methods" are not applicable to the information presented in this document.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility testing for a physical implant, not the performance of an AI algorithm.
Here's a breakdown of the requested information based on what is relevant and present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes non-clinical performance benchmarks and biocompatibility tests. The "acceptance criteria" are implied to be "Pass" for each test, indicating the device met the pre-defined standards for that specific test.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Stem Fatigue Design Verification (ISO 7206-4) | Pass | Pass |
| Neck Fatigue Design Verification (ISO 7206-6) | Pass | Pass |
| Range of Motion (ISO 21535:2007 Annex A) | Pass | Pass |
| Trays Drop and Mating Part Test | Pass | Pass |
| Monobloc Stem Biocompatibility Testing | Pass | Pass |
| Instrument Trays Biocompatibility Evaluation | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of stems tested) for each non-clinical performance test. It simply states that "All testing was performed on final sterile devices."
- Data Provenance: The tests are laboratory-based, non-clinical tests performed on the physical device. There's no "country of origin of the data" or "retrospective/prospective" distinction in the way it applies to clinical data or AI
studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a physical device, and its performance is evaluated through engineering and material science tests, not by expert interpretation of images or other data for ground truth establishment.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication is relevant for consensus-based ground truth establishment in AI/clinical studies, not for objective engineering tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is designed for evaluating human performance, often with and without AI assistance, in interpreting medical images or data. This document describes a physical medical implant. No such study was performed or is relevant here.
- Effect Size of Human Improvement with AI: Not Applicable.
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
- Engineering/Physical Test Standards. The "ground truth" here is the adherence of the device's physical properties and performance to established, industry-recognized standards (e.g., ISO standards for fatigue, biocompatibility testing protocols).
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set.
In summary: The provided document is a regulatory submission for a physical medical device. The concepts and terminology surrounding AI/SaMD performance evaluation do not apply to this context. The "acceptance criteria" were met through a series of non-clinical, bench-top engineering and biocompatibility tests designed to demonstrate the physical and material safety and effectiveness of the hip stem prosthesis.
§ 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.