(211 days)
The MSA Hip System is indicated for cementless use and is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fracture of the femur. patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion patients with acute femoral neck fractures
The MSA Hip System is a modular hip system consisting of a short stem which mates with a modular neck. The proximal portion of the stem has a plasma spray coating and a hydroxyapatite coating. The MSA Hip System can be mated with a number of previously cleared femoral heads and acetabular components. The hip system is intended for cementless implantation. The hip stems are made of Ti-6AI-4V (ASTM F136) with a commercially pure titanium plasma spray coating (ASTM F1580) and the modular necks are made of CoCr alloy (ASTM F1537).
The provided text describes a 510(k) submission for the "MSA Hip System" and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting specific performance metrics against such criteria in the traditional sense of a clinical or standalone study.
Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, and specific performance outcomes cannot be extracted from the provided text as it does not contain this type of information.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Neck endurance testing results were satisfactory. |
| Not specified in document | Stem fatigue testing results were satisfactory. |
| Not specified in document | Interconnection strength of modular connections testing results were satisfactory. |
| Not specified in document | ROM (Range of Motion) testing results were satisfactory. |
| Not specified in document | Overall, non-clinical tests demonstrate substantial equivalence to legally marketed predicate devices. |
Explanation: The document states that "The test results demonstrate that the MSA Hip System is substantially equivalent to legally marketed predicate devices." This implies that the tests performed (neck endurance, stem fatigue, interconnection strength, and ROM testing) met the necessary internal criteria to support substantial equivalence. However, the specific numerical acceptance criteria (e.g., minimum endurance cycles, maximum fatigue crack propagation) and quantifiable performance results for each test are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. (The document mentions "non-clinical tests" but does not detail the number of units tested for each specific test like neck endurance or stem fatigue).
- Data Provenance: Not specified. (As these are non-clinical tests, data provenance in terms of country of origin or retrospective/prospective status typically applies to clinical data, which is not discussed here.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes non-clinical engineering tests (mechanical performance), not clinical studies where expert-established ground truth is typically assessed for diagnostic accuracy or similar endpoints.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See explanation above.
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. This document does not mention any MRMC study or AI components. It pertains to a physical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This document does not describe an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For mechanical testing, the "ground truth" would be established by the physical testing methodology and predefined engineering standards for material properties and mechanical performance rather than clinical ground truth types.
8. The sample size for the training set:
- Not Applicable. There is no mention of machine learning or an "algorithm" with a training set.
9. How the ground truth for the training set was established:
- Not Applicable. There is no mention of machine learning or an "algorithm" with a training set.
§ 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.