(193 days)
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia.
- Inflammatory degenerative joint disease such as rheumatoid arthritis.
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed.
- Patients suffering from disability due to previous fusion.
- Patients with acute femoral neck fractures.
This device is a single use implant and intended for cemented use only.
UCP (United Cement Polished) stem is a triple tapered, polished, collarless stem. It is available for three series: Standards offset, High offset and Long stem to accommodate various surgical requirements. UCP Stem is intended to be fixed only with the use of PMMA bone cement and should be used with centralizer and cement restrictor. UCP stem, centralizer and cement restrictor are made of Co-Cr-Mo alloy (ASTM F799-11), PMMA and UHMWPE (ASTM F648-14/ISO5834), respectively. UCP Stem is intended to use for primary or revision hip arthroplasty. For total hip arthroplasty, UCP Stem can be used with UNITED acetabular liner, cup and femoral head. For bipolar hip replacement, UCP Stem can be used with UNITED bipolar prosthesis.
The provided document is a 510(k) premarket notification from the FDA for a medical device called the "UCP Stem," which is a hip joint prosthesis. The document describes the device, its indications for use, and a comparison to predicate devices, along with performance data.
However, the document does not contain information regarding acceptance criteria or a study proving the device meets specific acceptance criteria in the way envisioned by the request. Instead, the performance data section focuses on non-clinical mechanical tests to demonstrate safety and effectiveness for a hip stem, in comparison to predicate devices for substantial equivalence. There is no mention of a study involving human subjects or expert assessment of performance data in relation to specific acceptance criteria.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's a breakdown of what can be extracted or inferred, and what cannot:
1. Table of acceptance criteria and reported device performance:
The document does not specify quantitative acceptance criteria with corresponding performance metrics for the device. It states that "the test results comply with the recommendations according to the FDA guidance 'Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Protheses'." This implies a qualitative acceptance of meeting guidance recommendations rather than predefined numerical thresholds.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Stem Fatigue Test | Complies with recommendations per FDA guidance "Non-clinical Information for Femoral Stem Protheses" |
| Neck Fatigue Test | Complies with recommendations per FDA guidance "Non-clinical Information for Femoral Stem Protheses" |
| Range of Motion | Complies with recommendations per FDA guidance "Non-clinical Information for Femoral Stem Protheses" |
| Mechanical Testing for Ceramic Femoral Head while Collocating with UCP Stem | Complies with recommendations per FDA guidance "Non-clinical Information for Femoral Stem Protheses" |
| Clinical Performance | None provided as a basis for substantial equivalence. |
The document does not specify the quantitative outcomes of these tests, only that they "comply with the recommendations."
2. Sample size used for the test set and the data provenance:
- Sample size for non-clinical tests: Not specified in the document.
- Data provenance: Non-clinical (laboratory tests) conducted by United Orthopedic Corporation. Country of origin for the testing itself is not explicitly stated, but the company is based in Taiwan. The data is non-clinical performance data, not retrospective or prospective human clinical data.
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 non-clinical mechanical tests, not clinical studies requiring expert ground truth for interpretation of outcomes.
4. Adjudication method for the test set:
Not applicable, as there is no mention of a test set requiring adjudication in the context of human interpretation or clinical endpoints.
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. The UCP Stem is a physical medical device (hip prosthesis), not an AI diagnostic or assistance tool. Therefore, an MRMC study and AI-related effect size are outside the scope of this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The UCP Stem is a physical medical device, not an algorithm.
7. The type of ground truth used:
For the non-clinical mechanical tests, the "ground truth" would be the engineering specifications, material properties, and performance benchmarks outlined in relevant ASTM/ISO standards and FDA guidance documents (e.g., ASTM F799-11, ASTM F648-14/ISO5834, and FDA Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Protheses).
8. The sample size for the training set:
Not applicable. This is for a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.