(175 days)
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The Wagner Revision Stem incorporates a circular cross-section with eight equally spaced conical anchorage ribs (or flutes) which run the entire length of the stem. This device is intended for cementless application where primary fixation occurs predominantly in the distal region and is primarily used in clinical situations where there are deficiencies in the proximal femur due to extensive bone resorption and/or damage in the prosthetic bed.
Currently, the Wagner Revision Stem is offered in four stem lengths (190, 225, 265 and 305mm) with distal diameters ranging from 14-20mm, and 14-25mm (in 1mm increments) for the 190, 225, and 265/305mm lengths respectively. The number of size offerings is being increased to include a stem length of 345mm with distal diameters of 14-25mm (1mm increments) and a stem length of 385mm with distal diameters of 14-25mm (1mm increments).
The additional sizes are identical in configuration to the original Wagner Stems, but have been designed in proportion to the sizes already available. Static and dynamic testing were performed, verifying that the additional sizes exhibit sufficient strength for clinical use.
This document describes a medical device, the Wagner Revision Stem, and its proposed modifications (additional sizes). It focuses on demonstrating substantial equivalence to predicate devices for 510(k) clearance, not on providing performance criteria or a clinical study proving its effectiveness in terms of diagnostic accuracy or treatment outcomes.
Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or expert agreement) cannot be extracted from this document because it is not relevant to the type of submission described (a 510(k) for a modified implant).
Here's a breakdown of what can be extracted or inferred, and why other sections cannot be addressed:
1. A table of acceptance criteria and the reported device performance
This document does not specify performance acceptance criteria in terms of diagnostic accuracy or clinical outcomes, as it’s for a surgical implant modification. The "performance" reported is related to mechanical strength.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sufficient strength for clinical use | Static and dynamic testing performed, verifying sufficient strength. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document refers to mechanical testing of the implant, not a clinical study involving patients or a diagnostic test.
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)
Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant to the mechanical testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be the engineering specifications and material properties verified by the testing. This isn't clinical "ground truth."
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for the mechanical testing of an orthopedic implant in this context.
9. How the ground truth for the training set was established
Not applicable.
Summary of what the document does convey:
- Device Type: Orthopedic implant (hip stem).
- Purpose of Submission: 510(k) for additional sizes of an existing device.
- Basis for Clearance: Substantial equivalence to predicate devices (Müller Type Proximal Femur, Proximal Third Femoral Prosthesis).
- Justification for Substantial Equivalence (for new sizes): The additional sizes are identical in configuration to the original Wägner Stems but proportioned differently. Static and dynamic mechanical testing was performed to verify that the new sizes exhibit sufficient strength for clinical use.
The document is a regulatory summary for a physical medical device, not a diagnostic algorithm or a device requiring clinical performance data in the way you've outlined for AI or diagnostic studies.
§ 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.