(56 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 hip stems are made of Ti-6AI-4V (ASTM F136) with a commercially pure titanium plasma spray coating (ASTM F1580) on the proximal end. The stems are available with and without a hydroxyapatite coating. The modular necks are made of CoCr alloy (ASTM F1537). The MSA Hip System can be mated with metal or ceramic femoral heads and acetabular components.
The provided text describes a Special 510(k) submission for the MSA Hip System, specifically to add ceramic femoral heads to the device. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical study evaluating human or AI performance.
Therefore, many of the requested elements (sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, human-in-the-loop performance, etc.) are not applicable and not present in the provided document, as it is a regulatory submission for a physical medical device (hip implant) and not a software/AI-driven diagnostic or treatment device.
Here's a breakdown of the relevant information from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pre-determined acceptance criteria identified in the Design Control Activities Summary for burst strength testing of ceramic femoral head | The test results demonstrate that the pre-determined acceptance criteria identified in the Design Control Activities Summary were met. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not specified. The document only mentions "burst strength testing of the ceramic femoral head" but does not provide details on the number of samples tested.
- Data provenance: Not specified. The manufacturer, Global Manufacturing Technology, is located in Australia, so it is likely the testing was conducted there or at a supplier's facility. It is a technical test on the device itself, not human clinical data.
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)
- Number of experts: Not applicable. The "ground truth" here is the physical performance of the device (burst strength) against engineering specifications, not a diagnostic assessment requiring expert interpretation of medical images or clinical outcomes. The determination of whether the acceptance criteria were met would be based on objective measurements and comparison to predefined thresholds, typically validated by engineers or quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. See point 3.
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
- MRMC study: No. This is not applicable as the device is a physical hip implant, not an AI or diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: No. This is not applicable as the device is a physical hip implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Engineering specifications/pre-determined acceptance criteria for burst strength of the ceramic femoral head. This is a physical and mechanical performance metric.
8. The sample size for the training set
- Training set sample size: Not applicable. This concept applies to machine learning models, not physical medical devices undergoing mechanical testing.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable. See point 8.
§ 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.