(30 days)
The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip replacement is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia
· Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty
AMIStem-C is a straight triple tapered cemented femoral stem of rectangular cross-section, for use in total or partial hip arthroplasty for primary or revision surgery. The material is High Nitrogen Stainless steel in accordance with ISO 5832-9. Its superficial feature is a mirror polishing on the neck and the body: the whole body is mirror polished in order to minimize the wear due to the occasional contact between neck and cup, particularly in case of double-mobility cups, and to optimize the load transfer from stem to cement avoiding the stress shielding. The AMIStem-C femoral stem size 00 is a line extension to the stems to the currently marketed Amistem-C product line.
This document is a 510(k) premarket notification for a medical device, specifically a femoral stem for hip replacement. It generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and detailed performance metrics as one might find in an AI/ML device submission.
Therefore, many of the requested elements (e.g., sample sizes for training/test sets, ground truth establishment methods, expert qualifications, MRMC studies, effect sizes of AI assistance) are not applicable as this submission is for a physical orthopedic implant, not an AI/ML-based diagnostic or treatment device.
However, I can extract the relevant information regarding performance testing that was leveraged from the predicate device to support the substantial equivalence claim.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" and "reported device performance" in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it states that the performance testing from the predicate device was leveraged because the new size does not create a new worst-case scenario. The acceptance is implicitly that the device performs equivalently to the predicate and passes the specified ISO standards.
| Acceptance Criteria (Implicit) | Reported (Leveraged) Device Performance |
|---|---|
| Pass neck fatigue testing per ISO 7206-4:2010 | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to pass neck fatigue testing per ISO 7206-4:2010 based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Pass shaft fatigue testing per ISO 7206-6:2013 | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to pass shaft fatigue testing per ISO 7206-6:2013 based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Demonstrate acceptable Range of Motion (ROM) | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to have acceptable Range of Motion (ROM) evaluation based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Demonstrate acceptable Bacterial Endotoxin levels (LAL test and USP ) | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to have acceptable Bacterial Endotoxin Testing (LAL test and USP ) based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Sterilization validated | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to have undergone sterilization validation based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Shelf-life validated | The subject AMIStem-C size 00 standard femoral stem does not create a new worst case, hence it is assumed to have undergone shelf-life testing based on predicate device performance. The specific quantitative results are not provided in this summary. |
| Substantial equivalence to predicate device (K103189, Medacta Total Hip Prosthesis System AMIStem C & QUADRA C Short Neck) in terms of materials, surface finish, biocompatibility, device usage, sterility, shelf-life, and packaging, and biomechanical performance. | The AMIStem C size 00 standard femoral stem is considered as safe and effective and substantially equivalent to the predicate device. The subject device's smaller stem length and neck offset do not introduce a new worst case. |
2. Sample size used for the test set and the data provenance
These concepts (test set, data provenance, country of origin, retrospective/prospective) are mostly associated with clinical studies or AI/ML evaluations. For this submission, which relies on engineering performance testing of a physical implant and leveraging predicate data:
- Sample Size: Not explicitly stated for each test (e.g., how many stems were tested for fatigue). The "test set" here refers to the physical samples used for the engineering tests.
- Data Provenance: The data is from engineering performance testing based on predicate device data, conducted to international standards (ISO). The specific country of origin for the testing or whether it's retrospective/prospective in a clinical sense is not directly relevant or stated, as it's mechanical testing data leveraged from an already cleared device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is an orthopedic implant being cleared based on mechanical performance and substantial equivalence to a predicate, not an AI/ML diagnostic requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for expert consensus on ground truth in clinical or image-based studies. This submission relies on objective engineering measurements against ISO 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
Not Applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device's performance is objective compliance with international engineering standards (ISO 7206-4:2010, ISO 7206-6:2013) and established biocompatibility/sterility standards (LAL test, USP ). The performance of the new design (size 00) is considered equivalent if it does not create a "new worst case" compared to the predicate device that has already demonstrated compliance with these standards.
8. The sample size for the training set
Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not Applicable. This is not an AI/ML device.
§ 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.