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510(k) Data Aggregation
(126 days)
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
The Zimmer M/L Taper Hip Prostheses are flat, collarless, modular femoral stems with a proximal to distal taper in the mediolateral plane. The prostheses are circumferentially coated with titanium alloy plasma spray over the proximal body region and are available in standard and extended offset options, with or without Calcicoat Ceramic Coating. An additional size option and an additional neck length option are being added to the previously cleared Zimmer M/L Taper Hip Prosthesis system.
Here's an analysis of the provided text regarding the Zimmer® M/L Taper Hip Prosthesis, focusing on acceptance criteria and study information:
Based on the provided document, the device described (Zimmer® M/L Taper Hip Prosthesis) is a medical implant in the orthopedic category, specifically for hip replacement. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously cleared devices, rather than prove safety and effectiveness through extensive clinical trials for novel devices.
Therefore, the "acceptance criteria" and "study" described in the document are primarily focused on demonstrating substantial equivalence to predicate devices, rather than performance against a set of quantitative metrics for a new, innovative device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Material Equivalence | The device (Zimmer® M/L Taper Hip Prosthesis) is described as "flat, collarless, modular femoral stems with a proximal to distal taper in the mediolateral plane. The prostheses are circumferentially coated with titanium alloy plasma spray over the proximal body region and are available in standard and extended offset options, with or without Calcicoat Ceramic Coating." This description is compared to the predicate devices. | The document doesn't explicitly list materials, but relies on the descriptor being substantially equivalent to the predicates. The mention of "titanium alloy plasma spray" and "Calcicoat Ceramic Coating" suggests material components that are likely consistent with predicate devices for hip prostheses. |
| Design/Function Equivalence | "An additional size option and an additional neck length option are being added to the previously cleared Zimmer M/L Taper Hip Prosthesis system." | The core design (M/L Taper) is equivalent to its own previous versions (K032726, K042337) and other Zimmer products (K030265, K973714). The changes are incremental (additional sizes/neck lengths). |
| Intended Use/Indications Equivalence | The stated "Indications for Use" for both Total Hip Replacement and Hemi-hip Replacement are comprehensive and are implicitly accepted as equivalent to the predicate devices. | The FDA reviewed and accepted these indications as substantially equivalent. Examples include severe hip pain due to various arthritic conditions, avascular necrosis, fractures, failed endoprostheses, etc. |
| Non-Clinical Performance | "Analysis of the modified devices indicates that they are substantially equivalent to the predicates." | This statement confirms that non-clinical testing (which would typically involve mechanical, biocompatibility, and sterilization testing, etc., though not explicitly detailed here) was sufficient to demonstrate equivalence. No specific numerical performance criteria are provided in this summary. |
| Clinical Performance | "Clinical data and conclusions were not needed for this device." | This explicitly states that clinical trials demonstrating specific performance metrics were not required for this 510(k) submission due to substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. There was no specific "test set" of patients or data evaluated for a de novo performance study. The assessment was based on comparing the device's design, materials, and intended use against existing predicate devices.
- Data Provenance: Not applicable for a clinical test set. The "data" used for demonstrating equivalence would be design specifications, material characterizations, and existing regulatory information from the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Given that "Clinical data and conclusions were not needed for this device," there was no "ground truth" to be established by panels of experts in the traditional sense of a clinical trial. The "experts" involved were likely internal Zimmer engineers and regulatory specialists, and subsequently, FDA reviewers who assessed the substantial equivalence claim.
- Qualifications of Experts: FDA reviewers are typically well-versed in engineering, medical device regulations, and relevant clinical fields, but their role here was not to establish clinical ground truth for a novel device.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set to adjudicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical data and conclusions were not needed for this device." This type of study is typically performed to compare the diagnostic performance of a new medical imaging device or AI algorithm with human readers, and it is not relevant for a hip prosthesis 510(k) submission focused on substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a passive hip prosthesis, not an active device, diagnostic tool, or an AI algorithm. Therefore, "standalone performance" in the context of an algorithm or diagnostic device is irrelevant.
7. The Type of Ground Truth Used
- Type of Ground Truth: In this 510(k) context, the "ground truth" is established by the legally marketed predicate devices. The new device's design, materials, and intended use are considered "true" in so far as they are substantially equivalent to these already-cleared devices, meaning they are considered safe and effective for their intended purpose. There is no external clinical ground truth (e.g., pathology, outcomes data) generated specifically for this submission.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of a hip prosthesis 510(k) submission. This concept applies primarily to machine learning algorithms or devices requiring iterative development based on data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there was no training set.
Summary of the Study and Acceptance Criteria for K060040:
The "study" supporting the Zimmer® M/L Taper Hip Prosthesis (K060040) was a non-clinical analysis to demonstrate substantial equivalence to already legally marketed predicate devices. The acceptance criteria were met by demonstrating that the modified device (an additional size and neck length option for an existing line) shares the same technological characteristics, intended use, and performs comparably in non-clinical assessments (as implied by the "Analysis of the modified devices indicates that they are substantially equivalent to the predicates") such that it raises no new questions of safety or effectiveness. No new clinical data or human-in-the-loop studies were required or conducted for this particular submission.
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