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510(k) Data Aggregation
(90 days)
Relief of pain and restoration of hip function following the effects of osteo, rheumatoid and Netier of pain and restoration of mip state effects, avascular necrosis, and total hip revision.
The C-Fit and DC-Fit plasma sprayed acetabular components are intended for use ONLY with bone cement.
Acetabular Cup System for use with previously cleared femoral stems and modular heads.
The acetabular cups are available in a range of diameters and are plasma sprayed.
The devices are used to resurface the acetabulum and are used in combination with UHMWPE inserts, femoral stems and modular heads to reinstate function following the degenerative effects of osteo and rheumatoid arthritis, post-trauma disease effects, avascular necrosis and septic or aseptic total hip revision.
The acetabular cups are manufactured from cobalt chrome alloy. The cobalt chrome plasma spray coating provides an increased surface roughness to act as a key for mechanical interlock with PMMA bone cement.
The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a 510(k) summary and an FDA clearance letter for a medical device called the "C-Fit and DC-Fit Acetabular Cup System."
The document primarily focuses on establishing substantial equivalence to a predicate device (Mallory Head Acetabular Cup range) based on design, material, and intended use, rather than detailing specific performance acceptance criteria or a study designed to meet them.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.
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(99 days)
The devices are used to resurface the femoral hip joint and reconstitute function following the degenerative effects of osteo and rheumatoid arthritis. post trauma disease effects, avascular necrosis and septic total hip revision.
A femoral hip system consisting of standard and long stem options with or without calcar collars, plasma sprayed either proximally or five eighths of stem and for use with or without a PMMA cement centralizer. The devices are used to resurface the femoral hip joint and reconstitute function following the degenerative effects of osteo and rheumatoid arthritis. post trauma disease effects, avascular necrosis and septic total hip revision. The femoral stems are manufactured from cobalt chrome alloy. The cobalt chrome plasma spray coating provides an increased surface roughness to act as key for mechanical interlock with PMMA bone cement. The stem devices may be used with any one of a range of previously cleared Corin cobalt chrome modular heads, bipolar or uni-polar modular devices. The C-Fit plasma sprayed femoral components are intended for use with bone cement only.
This document is a 510(k) summary for a medical device (C-Fit Femoral Hip System) and describes its equivalence to existing devices and mechanical testing data. It does not present acceptance criteria or a study proving the device meets specific performance criteria in the way a modern AI/ML device submission would.
Therefore, I cannot populate most of the requested fields as they pertain to a type of study that is not described in the provided text.
Here's how this 1997 submission differs from what your prompt is expecting for a modern diagnostic or AI/ML device:
- No "Acceptance Criteria" in the AI/ML sense: The document focuses on "substantial equivalence" to predicate devices, meaning it performs similarly to devices already on the market. It doesn't define quantitative performance metrics (like sensitivity, specificity, AUC) and corresponding acceptance thresholds for a diagnostic task.
- No "Reported Device Performance" in the AI/ML sense: Instead of performance metrics, it states the device has been in "clinical use outside the U.S. for approximately ten years and no significant post-operative problems have been reported." This is qualitative experience, not quantitative performance data against specific criteria.
- No "Ground Truth" as in diagnostic accuracy: The "ground truth" for a hip implant is its long-term clinical success and safety, not a diagnostic label derived from expert consensus or pathology on a dataset.
- No "Training Set" or "Test Set": These concepts are relevant to AI/ML model development and validation, which is not applicable to this purely mechanical device submission.
- No "Experts," "Adjudication," or "MRMC Studies": These are all related to evaluating diagnostic performance, which is not the focus here.
Based on the provided text, here's what can be extracted, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: | The C-Fit Femoral Hip system is a modification of the previously cleared V.S.P. Hip system (Corin Medical Ltd.) and claims substantial equivalence to the Mallory/head system from Biomet, specifically for plasma sprayed long femoral stems. The C-Fit cobalt chrome stem without coating is previously cleared. |
| Safety and Effectiveness (Demonstrated by Mechanical Testing): | "Extensive mechanical test data confirming the device's safety and effectiveness." (Specific criteria not detailed in the summary). |
| Absence of Significant Post-Operative Problems in Clinical Use: | "The device has been in clinical use outside the U.S. for approximately ten years and no significant post-operative problems have been reported." |
Due to the nature of the provided document (a 1997 510(k) summary for a mechanical implant), the following sections cannot be fully populated as they pertain to AI/ML or diagnostic performance studies not described herein.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The submission refers to mechanical test data and clinical experience, not a "test set" for diagnostic performance.
- Data Provenance: "Clinical use outside the U.S. for approximately ten years." The mechanical test data would be lab-generated, not from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no diagnostic "ground truth" for a test set described.
4. Adjudication method for the test set
- Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used
- For Substantial Equivalence: Comparison to the design, materials, and intended use of predicate devices, supported by mechanical testing results.
- For Clinical Efficacy/Safety: The absence of "significant post-operative problems" over ten years of clinical use represents a form of real-world outcome data, though not formally structured as a clinical trial with specific ground truth endpoints.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
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