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The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.

The device is intended for:

• skeletally mature individuals undergoing primary surgery for total hip replacement
• patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
• patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
• patients suffering from disability due to previous fusion
• patients with acute femoral neck fractures

The Metha® Hip System is a modular system which consists of two components: the stem and the neck. Each component is available in various sizes. The conical shaped stem is manufactured from titanium alloy. The proximal area of the femoral stem is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate (u-CaP®). This stem is designed for cementless use only.

The modular cone adapter option allows the user to choose a combination of stem, neck, and head component to appropriately fit the individual patient. The modular cone adapter is manufactured from CoCr29MO.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The document is a 510(k) summary for the Metha® Hip System, which is a physical medical device (a hip implant). The "performance data" section refers to physical and mechanical testing conducted according to various guidance documents for orthopedic implants, not a clinical study involving AI or machine learning.

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods, as these concepts are not present in the provided text for this specific device.

The "PERFORMANCE DATA" section explicitly states:
"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the;

• 'Guidance Document for Testing Orthopedic Implants with Modified 事 Metallic Surfaces Apposing Bone or Bone Cement',
• 'Guidance for Industry on the Testing of Metallic Plasma Sprayed 事 Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements'.
• 'Guidance Document for Testing Non-articulating, "Mechanically Locked" . . Modular Implant Components',
• 'Draft Guidance for Femoral Stem Prostheses', 事
• 'Draft Guidance for Calcium Phosphate (Ca-P) Coating' was completed 業 where applicable."

This clearly indicates a focus on physical, mechanical, and material performance testing for a hip implant, not on the performance of a software or AI/ML device.

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The MAYO Conservative Hip Prosthesis is indicated for cementless use in skeletally mature individuals undergoing primary surgery for total hip replacement. Diagnostic indications include severe hip pain and disabilities due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Like its predicate, the modified MAYO Conservative Hip Prosthesis is a modular femoral stem intended to replace the hip joint in total hip arthroplasty. It is identical to its predicate in that it features a 12/14 Morse-type taper and uses the same variety of modular femoral heads. It differs only in overall size where the design is intended to address smaller patient anatomies. As with the predicate, the proposed stem is collarless, wedge-shaped, and is designed for use without bone cement. Fixation is achieved by mechanical press fit into the proximal femoral shaft and by biological ingrowth into the fiber metal pads. As with the predicate, the proposed device is available with and without Calcicoat Ceramic Coating (HA/TCP).

This device, the MAYO® Conservative Hip Prosthesis, is a traditional medical device, not an AI/ML-driven device. As such, the concept of "acceptance criteria" and performance metrics typical for AI/ML devices (like accuracy, precision, etc.) do not directly apply in the same way.

However, I can extract the relevant information from the provided text regarding the device and its evaluation as requested, adapting the AI/ML framework where possible to the context of a traditional medical device submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device." This statement, coupled with the substantial equivalence finding, indicates that the FDA considered the non-clinical data sufficient to demonstrate safety and effectiveness without requiring new human trials. |

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not applicable. This submission relies on "engineering evaluations" and comparison to a predicate device, rather than a "test set" of patient data or images in the AI/ML sense.
• Data Provenance: Not applicable for a "test set." The evaluation is based on engineering principles and comparison to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable. Ground truth for a test set is not relevant for this type of device submission based on engineering evaluations and predicate comparison. The "experts" involved would be the Zimmer Inc. engineers performing the evaluations and the FDA reviewers assessing the submission, but they are not establishing "ground truth" for a dataset.

4. Adjudication Method for the Test Set

• Not applicable, as there is no "test set" in the AI/ML sense.

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. This is a traditional hip prosthesis, not an AI-driven medical imaging or diagnostic device. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant.

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

• Not applicable. This is a physical implantable device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the established safety and effectiveness of the predicate device (MAYO Conservative Hip Prosthesis, K030733) and the engineering principles applied to demonstrate that the modified device is equivalent. It's based on engineering evaluations and regulatory precedent, not pathology, expert consensus on patient data, or outcomes data specifically for this modified device.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

• Not applicable, as there is no "training set" for this device.

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