(29 days)
Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
The X-Series Bi-Metric® femoral components are identical to the predicate Bi-Metric® femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-620. The stem diameters and lengths are identical. An oblong insertion hole replaces the predicate round insertion hole in order to provide the surgeon with more control during insertion. For the new lateralized style, the difference in the two series lies in the horizontal offsets and neck angle. The offset is increased and therefore the distance from the center of the modular head to the center of the stem is also increased. The taper trunion or post is angled at 130° on the modified device whereas the post of the predicate device is at 135°.
This document describes a 510(k) premarket notification for the "X-Series Bi-Metric® Hip Femoral Components." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria based on performance studies. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not applicable or available in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria as it would be understood for a new AI/medical device performance study. Instead, the "acceptance" in this context refers to the FDA's acceptance of the substantial equivalence claim. The performance relies on the device being "identical to or similar to" the predicate device.
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. This is a submission for a hip femoral component, not an AI or diagnostic device that would typically involve a test set of data. The "test" here refers to mechanical testing of the physical device.
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 document is about a physical medical device (hip implant), not a diagnostic algorithm. Therefore, there's no "ground truth" establishment in the context of image interpretation or diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As there's no test set in the conventional sense for an AI/diagnostic device, no adjudication method was used.
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 device is a physical hip implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's safety and effectiveness is largely based on the established safety and performance of its predicate device, as well as mechanical testing.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary derived from the document regarding "acceptance" for this device:
The "acceptance criteria" for the X-Series Bi-Metric® Hip Femoral Components, as evidenced in this 510(k) submission, revolved around demonstrating substantial equivalence to a legally marketed predicate device (Bi-Metric® Hip Femoral Component, K921224).
The "study" or evidence to prove this substantial equivalence included:
- Comparison of Device Description: The X-Series components are described as "identical to the predicate Bi-Metric® femoral components in overall geometry." Both are made from the same titanium alloy (Ti-6Al-4V). Stem diameters and lengths are identical.
- Minor Design Changes Justification: The only noted design changes are an "oblong insertion hole replaces the predicate round insertion hole" (to provide more surgeon control) and for the new lateralized style, differences in horizontal offsets and neck angle (130° vs. 135° taper trunion). The document argues these changes do not affect safety or effectiveness.
- Summary of Technologies: Stating that "The technological characteristics (materials, design, sizing and indications) of the X-Series Bi-Metric femoral components are similar to or identical to the predicate device."
- Non-Clinical Testing (Mechanical Testing): Mechanical testing was conducted "to insure the design changes would not effect the safety of the device." No specific results or acceptance criteria for this testing are provided in the summary, but its completion is noted as part of the submission package to FDA.
- Clinical Testing: "None provided" – indicating that clinical trials were not deemed necessary to demonstrate substantial equivalence for this device under the 510(k) pathway.
The FDA's letter (K020580) confirms that based on this information, the device was found substantially equivalent for its intended use, allowing it to proceed to market.
§ 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.