(65 days)
The 130° Modified Integral Femoral Components are intended for use in cases with a diagnosis of:
- a) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b) rheumatoid arthritis
- c) non-union, femoral neck, and trochanteric fractures of the proximal femur with head involvement.
- d) correction of functional deformities
- e) revisions of previously failed surgeries and treatments
The 130° Modified Integral Femoral Component is intended for press-fit or cemented application. The device is a single use implant.
The device is composed of a forged titanium stem, which is designed to articulate with any commercially available acetabular component. The device is a modification of Biomet's standard Integral femoral component in that the trunion has been moved inferiorly, medially and rotated 10°, This results in a 130° neck angle as opposed to the standard 140° neck angle. Advantages of a reduced neck angle include potential increased joint stablity by improving soft tissue tension. The remainder of the stem is identical to that of the Biomet's standard Integral stems. The device features a duck-bill collar to provide implant stablity. The modified device has a reduced proximal profile. The device utilizes a modular head that is taper-fit on to the stem at the time of surgery.
This document (K984408) is a 510(k) premarket notification for a medical device called the "130° Modified Integral Femoral Component." It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical trial or AI algorithm validation would.
Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of regulatory submission. This document describes a modification to an existing orthopedic implant, and its clearance is based on comparison to legally marketed predicate devices, not on a performance study against specific acceptance criteria for a new clinical endpoint.
However, I can extract and present the aspects that are relevant from the document:
Acceptance Criteria and Device Performance for Biomet 130° Modified Integral Femoral Component (K984408)
The regulatory submission for the Biomet 130° Modified Integral Femoral Component is a 510(k) premarket notification. For such submissions, the "acceptance criteria" are primarily established through the demonstration of substantial equivalence to existing, legally marketed predicate devices. The "study" proving this generally involves engineering analysis, material testing, and comparison of design features and intended use, rather than clinical efficacy trials with quantitative performance metrics against predefined thresholds.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance/Comparison to Predicate |
|---|---|---|
| Intended Use | Identical or very similar intended use to predicate devices. | The device's intended use is for non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, certain proximal femur fractures, correction of functional deformities, and revisions of failed surgeries. This is consistent with predicate hip prostheses. |
| Technological Characteristics (Materials) | Made of similar materials to predicate devices. | Composed of a forged titanium stem. This is a common material for femoral components and is consistent with predicate devices. |
| Technological Characteristics (Design) | Similar design principles, with minor modifications that do not raise new questions of safety or effectiveness. | The device is a modification of Biomet's standard Integral femoral component. The trunion is moved inferiorly, medially, and rotated 10°, resulting in a 130° neck angle (vs. standard 140°). This modification aims to increase joint stability by improving soft tissue tension without fundamentally altering the implant's function. The remainder of the stem is identical to standard Integral stems, features a duck-bill collar, and a reduced proximal profile. It uses a modular head taper-fit onto the stem. |
| Performance (Bench Testing/Analysis, if applicable) | Demonstration that mechanical properties meet standards and are equivalent to predicate devices, or that modifications do not compromise established performance. | While specific test results are not detailed in this summary, the substantial equivalence assertion implies that any necessary bench testing (e.g., fatigue, static strength) would have demonstrated comparable performance to predicate devices and relevant standards. The document states it is "substantially equivalent to most femoral devices on the market in overall design and intended function." |
| Potential Risks | Similar risk profile to predicate devices. | Potential risks are identified as the same as any joint replacement device, including fracture, loosening, infection, nerve damage, metal sensitivity, etc. This is consistent with the known risks of predicate hip implants. |
2. Sample Size used for the test set and the data provenance:
- Sample Size: Not applicable. This is not a clinical trial evaluating performance against a ground truth dataset in the traditional sense. Substantial equivalence is determined by comparing design, materials, and intended use.
- Data Provenance: Not applicable for a traditional "test set." The "data" involves engineering specifications, material properties, and comparison to existing device designs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of clinical endpoints or diagnostic accuracy is not established for this type of submission. Regulatory experts at the FDA (e.g., engineers, medical officers) review the submission against regulatory requirements and predicate device information.
4. Adjudication method for the test set:
- Not applicable. There is no "test set" and no "adjudication" in the sense of expert consensus on outcomes for a patient cohort.
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 device, nor is it a diagnostic device where reader performance is evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used:
- Not applicable. For a 510(k) device, the "ground truth" for clearance is essentially demonstration of substantial equivalence to a predicate device and compliance with general controls, indicating that the new device is as safe and effective as existing legally marketed devices. This is established through comparative analysis of technical characteristics, intended use, and materials.
8. The sample size for the training set:
- Not applicable. There is no "training set" for this type of regulatory submission.
9. How the ground truth for the training set was established:
- Not applicable.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.