(284 days)
Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
The Revision Femoral Stem consists of a femoral stem and a modular neck, assembled together through a taper coupling stabilized by means of a safety screw. When used in total hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with modular femoral heads and compatible acetabular cups. When used in partial hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with a Lock Bipolar Head.
The stem is made of Ti6Al4V (ASTM F1472 – ISO 5832-3). The stem is straight, with a tapered profile, round finned section and a rounded tip to facilitate insertion. The external surface of the stem features a macro-roughened finishing obtained by sandblasting. Diameters ranging from 14 to 26 mm, with increases of 1 mm, for a total of 13 diameters are available. Two lengths (140 or 200 mm) for each diameter of the stem are available.
The neck is made of Ti6A14V (ASTM F1472 – ISO 5832-3). The same material is also used for the safety screw, which also has a small pin made of UHMWPE (ISO 5834-2, ASTM F648) to help prevent loosening of the safety screw. Two (2) versions of the neck are available , one with a CCD angle of 131° and another with a CCD angle of 135°. Both the neck versions are available in 7 different heights. Distally, the external surface of the neck component features a macro-roughened finishing obtained by sandblasting; proximally, the surface of the neck component is polished to reduce the chance of polyethylene wear particles if the neck accidentally rubs against the polyethylene of the acetabular component.
This document is a 510(k) premarket notification for a medical device called "Revision Femoral Stem." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria. Therefore, the information requested may not be fully available in this document.
Based on the provided text, here's what can be extracted and what is explicitly stated as not applicable or not provided:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical testing designed to demonstrate substantial equivalence, not to meet specific performance acceptance criteria for a new clinical indication. The tests performed are those commonly used for implantable orthopedic devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fatigue testing (ISO 7206-4) performance comparable to predicate | Device's ability to perform substantially equivalent to the predicate devices |
| Fatigue testing (ISO 7206-6) performance comparable to predicate | Device's ability to perform substantially equivalent to the predicate devices |
| Fretting evaluation performance comparable to predicate | Device's ability to perform substantially equivalent to the predicate devices |
| Analysis of disassembly torque of safety screw comparable to predicate | Device's ability to perform substantially equivalent to the predicate devices |
| Range of motion (ISO 21535) comparable to predicate | Device's ability to perform substantially equivalent to the predicate devices |
| LAL (Endotoxin) limit of 20EU/device | Subject device meet the specified 20EU/device limit |
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: The document refers to "non-clinical testing" (mechanical and LAL testing), which typically involves a number of physical samples rather than biological test sets. The specific number of mechanical test samples for each test (e.g., how many stems were fatigued) is not provided.
- Data provenance: As this is non-clinical testing, there isn't a "country of origin of the data" in the sense of patient data. The manufacturer is Limacorporate S.p.A. in Italy, suggesting the testing likely occurred in a facility associated with the manufacturer or a contract testing laboratory.
- Retrospective or prospective: This concept is not applicable to non-clinical mechanical or LAL testing.
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 is not applicable as the document describes non-clinical mechanical and LAL testing, not studies requiring expert interpretation of clinical data to establish a ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable as the document describes non-clinical mechanical and LAL testing.
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:
This is not applicable. The device is an orthopedic implant (femoral stem), not an AI algorithm or an imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is an orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" is defined by the standards themselves (e.g., ISO 7206-4, ISO 7206-6, ISO 21535) and the physical properties and performance characteristics measured against those standards. For LAL testing, the ground truth is the specified endotoxin limit (20EU/device).
8. The sample size for the training set:
This is not applicable as the document describes non-clinical mechanical and LAL testing for an orthopedic implant, not an AI algorithm or a clinical study that would have a "training set."
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above.
§ 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.