(233 days)
The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.
Total Hip Arthroplasty with the Mpres stem 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.
- Failure of previous hip surgery:
o Conservative hip surgery,
o Internal fixation,
o Arthrodesis,
o Hip resurfacing replacement.
Partial hip arthroplasty with the Mpres stem is indicated in the following cases:
- · Acute traumatic fracture of the femoral head.
- · Avascular necrosis of the femoral head.
· Primary pathology involving the femoral head but with a non-deformed acetabulum.
The Mpres Neck Preserving Stem is a cementless short femoral stem intended to be used in total or partial hip arthroplasty for primary or revision surgery with minimally invasive hip replacement techniques. The Mpres Neck Preserving Stem is made of titanium alloy (Ti6Al7Nb) according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite in compliance with ASTM F1185. It is available in 12 sizes (sizes 3-14) for each neck variation configuration: a standard 130° CCD angle or an high offset 123° CCD angle.
This document is a 510(k) Premarket Notification from the FDA regarding the "Mpres Neck Preserving Stem" hip prosthesis. This type of document is generally about establishing substantial equivalence to an existing predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel AI diagnostic would.
Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or reader improvement with AI assistance, does not directly apply to this document's content.
The document focuses on demonstrating that the Mpres Neck Preserving Stem is substantially equivalent to legally marketed predicate devices based on technological characteristics and non-clinical performance data. It explicitly states that "No clinical studies were conducted."
However, I can extract information related to the performance data and the types of studies that were conducted to support the substantial equivalence claim.
Here's an adaptation of the requested information based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a mechanical implant, performance is demonstrated through biomechanical testing and material characterization against established standards, rather than clinical performance metrics typically associated with diagnostic devices. The acceptance criteria are implicit in meeting the requirements of the cited ISO/ASTM standards.
| Performance Characteristic | Acceptance Criteria (Implicit from Standards) | Reported Device Performance |
|---|---|---|
| Design Validation | Adequate performance in simulated use (e.g., sawbone, cadaveric evaluation) | Mpres Sawbone Design validation report, Plastic Stem Impactor, cadaveric evaluation completed. |
| Pull-Off Test | Meet requirements of ASTM F2009-00:2005, ISO 5832-9:2007, ISO 5832-12:1996, ISO 7206-10:2003 | Test Report No.: 167.090722.10.1309 (EndoLab) and CeramTec AG Test Reports 3128, 3300. |
| Range of Motion (ROM) | Meet requirements of EN ISO 21535:2009 | Mpres evaluation of the ROM completed. |
| Neck and Shaft Fatigue | Meet requirements of ISO 7206-6:2013, ISO 7206-4:2010, ASTM F2068-15, ASTM F2996-13, ISO 5832-11 | EndoLab Test Report 167 201005 10 3284-part1-rev0, Accentus Test Report OTC357, Straight Cantilever Test Report. |
| Coating Validation | Meet requirements of ISO 5832-11 | Mpres Coating validation rationale completed. |
| Fretting Corrosion | Meet requirements of ISO 5832-11 and ISO 21534 | Mpres femoral stems Fretting Corrosion Rationale completed. |
| Pyrogenicity | Meet requirements of European Pharmacopoeia §2.6.14 (LAL test) and USP chapter | Bacterial endotoxin test (LAL test) and Pyrogen test completed. Devices are not labeled as non-pyrogenic. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in terms of specific numbers of devices tested for each non-clinical study. The reports cited (e.g., "Endolab Test Report," "CeramTec AG Test Reports," "Accentus Test Report") would contain this detail, but it's not present in this summary. For "cadaveric evaluation," the number of cadavers is not given.
- Data Provenance: The testing appears to have been conducted by various external and internal labs (e.g., EndoLab, CeramTec AG, Accentus). The company, Medacta International SA, is based in Switzerland, and Medacta USA is in Tennessee, USA. The standards cited are international (ISO, ASTM, EN) and US (USP, European Pharmacopoeia). This indicates a varied provenance tied to international standards for medical device testing.
- Retrospective or Prospective: These non-clinical performance tests are "prospective" in the sense that they are specifically performed for the purpose of this submission and validate the current design. They are not observational studies on existing 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)
This concept does not apply to this type of device submission. There is no "ground truth" established by experts in the context of diagnosing or interpreting images, as this is a hip implant, not an AI diagnostic device. The "ground truth" for these tests is the adherence to established engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept does not apply. Adjudication methods are relevant for clinical studies or studies involving expert interpretation, which were not performed 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is designed for AI diagnostic aids, not for a hip implant. The document explicitly states: "No clinical studies were conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept does not apply. A hip implant is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is the performance against established engineering and material science standards (e.g., ISO, ASTM, EN, USP). For example, a fatigue test must demonstrate that the device can withstand a certain number of cycles at a specific load without failure, as defined by the standard.
8. The sample size for the training set
This concept does not apply. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This concept does not apply.
§ 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.