(316 days)
The Taperloc® Complete Hip Stems are intended for hip joint arthroplasty.
- Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union. Femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures where other treatment or devices have failed
Porous coated components are intended for uncemented biological fixation.
Taperloc® Complete Hip Stems are an implant device, a porous coated femoral stem intended for uncemented biological fixation. The Taperloc® Complete is a series of hip stems with a bi-planar wedge design, titanium substrate, and proximally circumferential titanium porous plasma sprayed design.
The document provided is a 510(k) premarket notification for the Taperloc® Complete Hip Stems. It describes the device, its intended use, and provides a summary of performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a formal table with pass/fail thresholds for the tests conducted. Instead, it states that "All testing passed and met the specifications or comparison testing (as applicable) to the predicate devices." This implies that the acceptance criteria were either established by the referenced ASTM standards or through direct comparison to the performance of the predicate device.
| Test Performed | Standard / Comparison Basis | Reported Device Performance |
|---|---|---|
| Porous Plasma Spray Coating Testing: | ||
| Tensile | ASTM 1147 | Passed and met specifications or comparison to predicate |
| Fatigue | ASTM F1160 | Passed and met specifications or comparison to predicate |
| Porosity | ASTM F1854 | Passed and met specifications or comparison to predicate |
| Pore Size | ASTM F1854 | Passed and met specifications or comparison to predicate |
| Thickness | ASTM F1854 | Passed and met specifications or comparison to predicate |
| Tabor Abrasion | ASTM F1978 | Passed and met specifications or comparison to predicate |
| Shear Fatigue | ASTM F1160 | Passed and met specifications or comparison to predicate |
| Shear Static | ASTM F1044 | Passed and met specifications or comparison to predicate |
| Roughness | Comparison to predicate | Passed and met specifications or comparison to predicate |
| One-Step Forging Distal Pot Up/Down Fatigue Testing: | ||
| Rotating Beam Fatigue | ASTM STP 731 | Passed and met specifications and comparison to predicate device |
2. Sample sizes 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 mentions "samples" for the porous plasma spray coating testing and "samples" for the one-step forging distal pot up/down fatigue testing. However, specific numerical sample sizes are not provided for any of these non-clinical tests.
- Data Provenance: The document states these are "Non-Clinical Tests" performed to support the 510(k) submission. It does not specify the country of origin where the testing was conducted. It is inherently prospective in the sense that the tests were performed specifically for this regulatory submission to evaluate the cumulative changes to the device.
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 a medical device, specifically an orthopedic implant (hip stem), and the performance data is entirely non-clinical (mechanical and material testing). Therefore, there were no human experts involved in establishing ground truth in the traditional sense of clinical or diagnostic studies. The "ground truth" for these engineering tests would be established by the testing protocols and the objective measurements themselves, adhering to the specified ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As stated above, these are non-clinical, objective engineering tests, not clinical evaluations requiring expert adjudication.
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 document describes a medical device (hip implant), not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a physical medical device, not an algorithm or AI.
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 objective measurements obtained through adherence to the specified ASTM standards and direct comparison to the predicate device's performance. There is no expert consensus, pathology, or outcomes data used as ground truth for these non-clinical mechanical tests.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a physical medical device and the studies refer to non-clinical material and manufacturing process changes, not machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set mentioned or implied.
§ 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.