(224 days)
This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement. This device may be used for the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli and painful hip dysplasia.
- Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
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- Correction of function deformity.
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- Revision procedures where other treatments or devices have failed.
- Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
U2 Bipolar Implant is intraoperatively assembled to any appropriately size UNITED femoral stem with compatible head size. This device is offered in 38-56 mm outer diameters and with 22mm, 26mm and 28mm inner diameter. It is comprised of an outer shell (ASTM F75-12/ ISO 5832-4:2014 casting Co-Cr-Mo allov, raw materials ASTM F1537-11/ISO 5832-12:2007) into a permanently assembled bearing insert (ASTM F648-14/ISO 5834-1:2005 and ISO 5834-2:2011). The minimum thickness of the polyethylene at the load bearing area is 5 mm. The assembled prosthesis provides for primary articulation at the femoral head/inner polyethylene bearing interface and secondary articulation at the outer shell/acetabulum interface. The internal aspect of the shell is designed to lock the polyethylene liner. The outer metal surface of the bipolar hip prosthesis is highly polished for articulation with the patient's acetabulum.
Femoral head for size 22mm is designed for use with U2 Bipolar Implant. It is made of Co-Cr-Mo alloy (ASTM F1537-11). The material and process method of 22 mm femoral head are identical to the previous cleared "United" femoral head (K994078).
The provided document describes a 510(k) premarket notification for a medical device, the "U2 Bipolar Implant and 22mm Femoral Head." This particular type of document from the FDA is a regulatory submission for medical devices that are substantially equivalent to legally marketed predicate devices, and it generally does not include detailed clinical study reports or acceptance criteria/performance results in the same format as a novel device approval.
Based on the content, here's an analysis of what can and cannot be answered regarding acceptance criteria and device study:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with corresponding device performance values. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and then proving the device meets them through clinical or extensive non-clinical studies for novel products.
The "Performance Data" section lists non-clinical tests performed:
- a. Locking Mechanism of U2 Bipolar Implant
- b. Range of Motion of U2 Bipolar Implant
- c. Disassembly Force for Femoral Head and Stem
However, specific acceptance criteria for these tests (e.g., minimum disassembly force in Newtons, minimum range of motion in degrees) and the numerical results of these tests are not provided in this document extract. The document simply states that these tests were "conducted to evaluate the safety and effectiveness of the subjected device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions non-clinical performance tests but does not detail the sample sizes used for these mechanical tests or the provenance of any data beyond indicating "Taiwan" as the submitter's location.
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)
This information is not applicable/provided. Since the document refers to non-clinical (mechanical) tests and no clinical data, there is no mention of experts establishing a ground truth as would be relevant for diagnostic imaging or similar devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically associated with human-read clinical studies, which are not detailed here.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices, which is not the nature of this hip implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a passive hip implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be the engineering specifications and performance expectations derived from predicate devices and relevant ISO/ASTM standards. However, the specific "type of ground truth" (e.g., a specific standard section referencing a required force or range) is not explicitly stated in this document. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission, as no clinical studies are presented.
8. The sample size for the training set
This information is not applicable/provided. This device is a mechanical implant, not an AI/algorithm-based device that would require training data.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reason as point 8.
Summary of what is known from the document regarding acceptance criteria and study:
- Device Type: U2 Bipolar Implant and 22mm Femoral Head (hip joint femoral prosthesis).
- Submission Type: 510(k) Premarket Notification based on substantial equivalence to predicate devices.
- Study Focus: Primarily non-clinical performance tests.
- Non-clinical Tests Conducted:
- Locking Mechanism of U2 Bipolar Implant
- Range of Motion of U2 Bipolar Implant
- Disassembly Force for Femoral Head and Stem
- Clinical Performance Data: "None provided as a basis for substantial equivalence."
- Acceptance Criteria & Performance Values: Not explicitly detailed in the document. The statement "the performance evaluation for stopper ring of subject device was also conducted" implies successful evaluation without providing specific results or criteria.
- Sample Sizes / Provenance / Ground Truth for Experts: Not provided or not applicable given the nature of the device and submission.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.