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Wagner Cone Prosthesis:
• Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Wagner SL Revision Stem Lateral:
· Revision of previously failed hip arthroplasty

The Wagner SL Revision Stem Lateral is a straight stem manufactured from forged titanium alloy and is available in four lengths. The neck design of the stem is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper. The Wagner SL Revision Stem Lateral incorporates a circular stem cross-section and equally spaced conical anchorage ribs, which run nearly the full length of the stem.

The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles, 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm.

This document is a 510(k) summary for the Wagner Cone Prosthesis System and Wagner SL Revision Stem Lateral hip prostheses. It details the substantial equivalence determination made by the FDA. It does not contain information about an AI/ML-based device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, or standalone performance of an AI/ML device, as this document is not related to such a device.

The document primarily focuses on:

• Device Description: Provides details about the design and materials of the Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis.
• Indications for Use: Lists the medical conditions for which these devices are intended, such as noninflammatory degenerative joint disease, inflammatory joint disease, failed previous surgery, and revision hip arthroplasty.
• Comparison to Predicate Device: States that the intended use has not changed despite proposed modifications to indications for use (limiting them) and packaging configuration. It also mentions a reclassification of some instruments from Class I to Class II.
• Performance Data (Nonclinical and/or Clinical):
  • Non-Clinical: Mentions packaging performance testing according to ISO standards to verify sterile barrier integrity and product protection during sterilization, handling, distribution, and storage. It also notes an amendment of design controls for mechanical integrity and resistance due to the instrument reclassification.
  • Clinical: Explicitly states that "Clinical data and conclusions were not needed for this device." This signifies that a clinical trial or study in humans was not required for this 510(k) submission, likely because equivalence was established through non-clinical testing and comparison to predicate devices.
• Conclusion: Reiterates that the subject devices have the same intended use and similar indications for use, and a similar operating principle, design, labeling, manufacturing, and sterilization processes as the predicate devices. It concludes that observed differences do not raise new questions of safety and effectiveness, and the devices are at least as safe and effective as the legally marketed predicate devices.

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No changes are made to the intended use of the Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis® implants as a result of this modification. Indications for use include: - Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis; and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - Patients with failed previous surgery where pain, deformity, or dysfunction persists. - Revision of previously failed hip arthroplasty.

The Wagner SL Revision Stem Lateral is a straight stem manufactured from forged titanium alloy and is available in four lengths. The neck design of the stem is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper. The Wagner SL Revision Stem Lateral incorporates a circular stem crosssection and equally spaced conical anchorage ribs, which run nearly the full length of the stem. The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles. 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm. No changes are being made to the Wagner SL Revision Stem Lateral and the Wagner Cone Prosthesis implants, but one change to the Awls is proposed in this submission: An additional energy type for driving the Wagner -SL Awls and Wagner Cone Awls is introduced: from manually powered use only to manually and power driven use. While manually reaming is still possible the proposed modification enables the use of the awls connected to a powered device to ream the femoral medullary canal.

This document is a 510(k) premarket notification for a medical device (Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System) and does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document is for a hip joint prosthesis and the only modification proposed is to the awls used to ream the femoral medullary canal, specifically introducing an additional energy type for driving the awls (from manually powered only to manually and power driven use).

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, as is common for 510(k) submissions for traditional medical devices.

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The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the proximal femur in total hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications include:

• Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis; and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• Patients with failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed hip arthroplasty.

Both the existing Wagner SL Revision Stem and the proposed Wagner SL Revision Stem Lateral are manufactured from forged titanium alloy and are available in three lengths (165mm, 185mm, and 205mm). The neck design of both stems is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper.

The Wagner SL Revision Stem Lateral incorporates a circular stem cross-section and equally spaced conical anchorage ribs, which run nearly the full length of the stem, as do the ribs on the previously cleared Wagner SL Revision Stem. The surface of both stems is rough-blasted.

To achieve the lateralization of the modified device, the CCD (i.e., neck) angle was lengthened. To compensate for the increased bending moments and lateral stresses, which result from the increased offset, the rib structure was modified so that the greatest bending moment would not be at the base of the rib; and the ribs were widened, which led to an increase in the stem strength.

In addition, a threaded coupling was added to the proximal portion of the stem for use with the new impacter/extractor. The stem neck was shortened to increase the range of motion, and two small holes were added to the proximal portion of the stem for securing non-metallic suture material.

This document is a 510(k) summary for a medical device (hip implant) and does not contain detailed information about acceptance criteria or specific study results that would typically be associated with AI/ML device performance. The document focuses on demonstrating substantial equivalence to a predicate device.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for an AI/ML device is not applicable to this document. The document describes a traditional medical device (hip implant) submission, not an AI/powered diagnostic or therapeutic device.

However, I can extract information related to the device description, intended use, and the concept of "substantial equivalence" as the primary "acceptance criterion" in this context.

1. A table of (implied) acceptance criteria and the reported device performance

In the context of a 510(k) submission for a non-AI/ML medical device, the "acceptance criteria" are generally that the new device is substantially equivalent to a legally marketed predicate device. This substantial equivalence is demonstrated through comparisons of:

Note: The modifications in the "Wagner SL Revision Stem Lateral" (lengthened CCD angle, widened ribs for increased stem strength, threaded coupling, shortened stem neck, added holes for sutures) are presented as design changes that do not alter the fundamental safety and effectiveness to the point of requiring a PMA or new classification, thus maintaining substantial equivalence. These changes are improvements or variations within the established scope of the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes a traditional medical device (hip implant) and does not include information on a "test set" in the context of an AI/ML algorithm evaluation. The demonstration of substantial equivalence relies on design comparisons, material specifications, and performance characteristics (like strength considerations due to design changes). There are no data described that would fit the "test set" definition for an AI/ML 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)

Not applicable. As noted above, this 510(k) summary does not involve a "test set" or "ground truth" establishment by experts in the AI/ML sense. The approval is based on comparison to a predicate device and engineering design principles.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no described "test set" or adjudication process for clinical data in this 510(k) summary.

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 a hip implant, not an AI/ML diagnostic device, so MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hip implant, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For a hip implant 510(k), "ground truth" typically relates to established clinical performance of the predicate device, material standards, and biomechanical principles, rather than a diagnostic 'truth' established for an AI algorithm.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm or associated "training set" described in this document.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML algorithm or associated "training set" described in this document.

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