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510(k) Data Aggregation
(49 days)
OPTEON UNIPOLAR
The OPTEON Unipolar Endoprosthesis is for use with a modular femoral stem when hemiarthroplasty is indicated. The change to a total hip replacement can then be accomplished in the future without removing the femoral stem.
The OPTEON Unipolar is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis. osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture .
The OPTEON Unipolar Endoprosthesis is a polished, truncated sphere made of cast cobalt chrome, ASTM F75. The high tolerance taper connection machined at the base of each unipolar component will mate with all Exactech femoral hip stems.
The external geometry approximates the shape of the normal femoral head and is intended for use in hemiatthroplasty. The modular system allows for future total hip arthroplasty without removal of the femoral stem.
This document is a 510(k) premarket notification for a medical device (Opteon® Unipolar Endoprosthesis), which focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about a formal clinical study with acceptance criteria and device performance as typically seen for novel devices.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, ground truth, training set sample size) cannot be directly extracted as they are not part of this type of submission.
However, I can extract information related to the device's characteristics and its comparison to predicate devices, which serves as the "proof" for its acceptance based on substantial equivalence.
Here's a summary tailored to the provided input, explaining why some sections are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are not explicit performance metrics derived from a new clinical study. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices in terms of material, design, and intended use. The "reported device performance" is essentially that the device shares the characteristics and has the expected performance profile (based on a long history of similar devices) of the predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| Material Composition (ASTM F75-87 Cast Cobalt Chrome) | The OPTEON Unipolar Endoprosthesis is made from cast cobalt chrome meeting ASTM F75-87. This is similar to the Corin Unipolar and consistent with materials used in hip prostheses for over 50 years (e.g., Moore prosthesis). |
| Mechanical Properties (Tensile Strength, Yield Strength, etc.) | The cast cobalt chromium alloy exhibits mechanical properties in excess of: 95,000 psi tensile strength, 65,000 psi yield strength, 8% elongation, and 8% reduction of area. These values demonstrate the material's structural integrity, consistent with established standards for such implants. |
| Design Characteristics (Polished, Truncated Sphere, Taper) | The OPTEON Unipolar is a polished, truncated sphere with a high-tolerance taper connection. This design is similar to the Corin Unipolar (tapered, truncated sphere) and the Howmedica Unitrax® Unipolar System (metal sphere). It approximates the shape of the normal femoral head. The modular system allows for future total hip arthroplasty without removing the femoral stem, a functional characteristic of similar devices. |
| Biocompatibility (Based on ASTM F75-87) | The material (ASTM F75-87) has been evaluated for biocompatibility, and results/clinical history indicate a "well-characterized level of local biological response," implying a safe biological interaction, consistent with predicate devices made of the same material. |
| Sterilization Method (Gamma Irradiation) | The device will be supplied sterile, sterilized by gamma irradiation at a contract facility, following AAMI guidelines for radiation sterilization. This is a standard and accepted sterilization method for medical devices. |
| Intended Use/Indications (Hemiarthroplasty, specific conditions) | Indicated for use with a modular femoral stem when hemiarthroplasty is indicated, allowing for future total hip arthroplasty without removing the femoral stem. Indicated for skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, post-traumatic degenerative problems, and femoral head replacement following femoral neck fracture. These indications align with the historical use and indications of predicate unipolar endoprostheses. |
| Contraindications (Infection, insufficient bone stock, etc.) | Contraindicated in patients with active infection, insufficient bone stock, neuromuscular disorders affecting hip control, and patients whose weight, age, or activity level would cause early failure. Also contraindicated with degenerative changes in the acetabulum and/or pelvic fractures. These contraindications are standard and reflect the clinical understanding of the appropriate use of such devices, similar to predicate devices. |
| Safety and Effectiveness | The submission asserts that the device is "made of similar materials and is of a similar design to prostheses that were on the market before May 28, 1976" and "similar design to other components on the market that have been determined to be equivalent." Clinical results of unipolar devices, generally, have been reported to be effective, and manufacturing advances have led to devices with increased structural strength and polished surfaces, implying improved or maintained safety and effectiveness over predecessors. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This 510(k) submission relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study with a "test set" of patients or data in the way a clinical trial would. The "data provenance" primarily consists of public domain literature (advertisements, brochures, catalogs) from predicate device manufacturers, along with Exactech's own design drawings and material specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No external "ground truth" establishment by experts for a specific test set was conducted or reported in this 510(k) document. The equivalence relies on comparison by the manufacturer and review by the FDA.
4. Adjudication method for the test set:
- Not applicable. No test set or formal adjudication method among experts was described for this 510(k) submission.
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 device is a passive implant (hip endoprosthesis), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or AI comparison is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As above, this is a passive implant, not an algorithm.
7. The type of ground truth used:
- Not applicable in the typical sense of a clinical study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices (Corin® Unipolar Endoprosthesis #K881288, Howmedica Unitrax® Unipolar System #K902365, and generally devices on the market prior to May 28, 1976). The "ground truth" for the device's material properties comes from ASTM standards (e.g., F75-87) and mechanical testing results.
8. The sample size for the training set:
- Not applicable. This 510(k) involves a physical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
Summary of "Study" Proving Acceptance Criteria:
The "study" or justification for acceptance in this 510(k) is a substantial equivalence comparison to legally marketed predicate devices. The manufacturer provided:
- Detailed descriptions and specifications of the Opteon® Unipolar Endoprosthesis (design drawings, material specifications, photos).
- Material certificates/testing results demonstrating compliance with ASTM F75-87 for cast cobalt chrome, including mechanical properties (tensile strength, yield strength, elongation, reduction of area).
- References to predicate devices (Corin® Unipolar, Howmedica Unitrax® Unipolar) and general categories of pre-amendment devices, asserting similarities in materials, design (e.g., spherical geometry, taper connection), and intended use (hemiarthroplasty indications).
- Commercial literature from predicate manufacturers to demonstrate their characteristics.
- Assertions regarding biocompatibility based on ASTM F75-87 and historical clinical use of the material.
- Description of a standard and acceptable sterilization protocol (gamma irradiation per AAMI guidelines).
The conclusion drawn is that because the Opteon® Unipolar Endoprosthesis is of similar design, materials, and intended use as devices already on the market (and those cleared through 510(k)s), it is equally safe and effective. This type of submission does not require a new, prospective clinical trial to establish novel safety or effectiveness data.
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