(148 days)
The device is indicated for use in hip arthroplasty in patients with the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery.
This device is a single use implant and intended for cemented stem which is designed for cemented use only.
In the USA: United U2 femoral head, 22mm delta ceramic head is only indicated for use with the hemi (bipolar) implant.
The Subject device is a size extension to the previously cleared U2 Femoral Head (K162957). The design, manufacturer, materials, manufacturing progress, sterilization of this subject are identical or similar to its primary and additional predicates.
Ceramic femoral head, delta, 22mm (Subject device) is manufactured from zirconia-toughened alumina ceramic is available in +1, +3 and +5 mm of neck length. This device is intended to articulate with U2 Bipolar Implant, 22mm I.D (K152439) and can be used in conjunction with United titanium Hip Stem. Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti porous coated Stem (K003237, K151316), Ti Press-fit Stem (K111546), Revision Hip Stem (K062978), UTS Stem (K172251), UTF Stem (K110245, K163193, K123550, K132207) and Conformity stem (K183312). The size extension does not affect the intended use or alter the fundamental scientific technology of the device.
Surgical procedures with the use of the subject device shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided text is a 510(k) summary for a medical device (United U2 femoral head, 22mm delta ceramic head) seeking substantial equivalence to predicate devices. It does not describe an AI medical device or a study involving human readers or a training/test set for an algorithm.
Therefore, most of the requested information regarding AI device performance, expert consensus, MRMC studies, and training/test set details cannot be extracted directly from this document.
However, I can extract the acceptance criteria and performance analysis conducted for this specific medical implant device.
Analysis of the Provided Document (Non-AI Medical Device)
The document describes the performance analysis for a ceramic femoral head (a medical implant) to demonstrate its substantial equivalence to previously cleared devices. The "acceptance criteria" here refer to the predefined standards for the engineering tests conducted on the physical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Conclusion) |
|---|---|
| ISO 7206-10 and ASTM F2345-03 | Subject components met the pre-determined acceptance criteria identified in the Design Control Activities for Burst strength, fatigue, and post-fatigue burst strength of femoral head from stem. |
| ASTM F2009 | Subject components met the pre-determined acceptance criteria identified in the Design Control Activities for Pull-off strength of femoral head from stem. |
| ISO 7206-13 | Subject components met the pre-determined acceptance criteria identified in the Design Control Activities for Torque-off strength of femoral head from stem. |
| ISO 21535 | Subject components met the pre-determined acceptance criteria identified in the Design Control Activities for Range of motion (ROM). |
| Not explicitly stated standard | Subject components met the pre-determined acceptance criteria identified in the Design Control Activities for Pull-out strength of femoral head from bipolar head and Lever-out strength of femoral head from bipolar head. (The specific standard for these two tests is not explicitly mentioned but implied to be part of engineering analysis). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document refers to "engineering analysis" and testing of "subject components," which typically involves a specific number of physical samples for mechanical tests.
- Data Provenance: Not applicable in the context of an AI device. For this physical implant, the "data" would be the results of the mechanical tests performed in a lab setting. No information about country of origin or retrospective/prospective nature is relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the document describes mechanical testing of a physical implant, not an AI device requiring expert-established ground truth. The "ground truth" here is the physical performance measured against established ISO/ASTM standards.
4. Adjudication method for the test set
- This is not applicable as the document describes mechanical testing of a physical implant, not an AI device for diagnostic or prognostic purposes. The performance is adjudicated against the predefined limits in the engineering standards.
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
- No, an MRMC study was not done. This document is for a medical implant, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a medical implant, not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this physical medical implant, the "ground truth" implicitly refers to the established mechanical and material performance standards (ISO and ASTM). The device's performance is compared against the limits defined in these engineering standards.
8. The sample size for the training set
- Not applicable. This document is for a medical implant, not an AI device which requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This document is for a medical implant, not an AI device which requires a training set.
Summary for the AI context:
The provided document describes the regulatory clearance for a physical medical implant (femoral head), not an AI medical device. Therefore, the specific information requested about AI acceptance criteria, training/test sets, expert adjudication, and MRMC studies is not present in this text. The "acceptance criteria" discussed are engineering specifications for the mechanical performance of the physical implant, and the "study" is the mechanical engineering analysis and testing.
§ 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.