(30 days)
The Corin Optimom Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.
The device is intended for prescription use only.
The Corin Optimom Modular Head is a polished, truncated sphere with a high tolerance internal female taper. It is a device modification of the internal female taper of the Corin Unipolar Modular Heads (K063791) to provide for compatibility with an additional range of Corin femoral hip stem designs with a 12/14 male taper. The materials and dimensions of the internal female taper are substantially equivalent to the CoCr Modular Heads cleared in K003666 and K010243 and the Trinity Modular Heads cleared in K110087. The Optimom Modular Head is manufactured from Cobalt-Chrome alloy conforming to ASTM F75 and is available in diameters ranging from 40-56mm with a variety of offsets.
The provided text describes a 510(k) premarket notification for the "Corin Optimom Modular Head," a hip joint femoral prosthesis component. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving performance against specific acceptance criteria for a new type of device or AI algorithm.
Therefore, many of the requested categories regarding acceptance criteria, study design, and ground truth are not applicable to this type of submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document is a 510(k) submission for substantial equivalence. It does not present specific quantitative acceptance criteria or performance metrics for a novel technology that would typically be evaluated against such criteria. Instead, it argues that the device's design, materials, and intended use are similar enough to existing devices that no new performance testing to specific criteria is needed for market clearance beyond demonstrating equivalent physical properties.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical test set data is presented as clinical testing was not deemed necessary for this submission. The "test set" in this context would refer to physical device samples undergoing engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This submission does not involve expert review or ground truth establishment in the way an AI/CADe device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No expert adjudication of a test set is described.
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 a study involving human readers or AI assistance.
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 (expert concensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth in the sense of a medical diagnosis or outcome is established for a study. The "ground truth" for this submission is based on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device.
Summary of the Study/Evidence Presented in the Document:
The "study" in this context is a non-clinical engineering assessment and comparison to legally marketed predicate devices, rather than a clinical trial or performance evaluation against new, pre-defined acceptance criteria.
Key Information from the Document:
- Device: Corin Optimom Modular Head
- Purpose: To demonstrate substantial equivalence to predicate devices (Corin Unipolar Modular Head, Corin Taperfit Total Hip System, Corin Tri-Fit Femoral Stem, Trinity Modular Heads).
- Methodology (Non-Clinical Testing):
- Comparison of designs.
- Comparison of materials.
- Comparison of intended use and indications.
- Comparison of dimensions.
- Specific engineering tests conducted: Fatigue, rotational torque, axial pull-off, and fretting corrosion. The results of these tests are not provided in the summary but were conducted to support the substantial equivalence claim.
- Conclusion: Based on these comparisons and non-clinical tests, the Optimom Modular Heads are believed to be substantially equivalent to the predicate devices.
- Clinical Testing: "Clinical testing was not necessary to determine substantial equivalence between the Corin Optimom Modular Heads and the predicate devices." (Page 1)
In essence, the document states that specific engineering tests were performed (fatigue, rotational torque, axial pull-off, fretting corrosion) to show that the new device performs comparably to the predicate devices in these critical aspects. The "acceptance criteria" implicitly would be that the new device meets or exceeds the performance of the predicate device for these tests, demonstrating equivalent safety and efficacy. However, the specific quantitative results or acceptance thresholds are not detailed in this 510(k) summary.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.