Search Results

The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip ioint. 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 - 0 patients suffering from disability due to previous fusion - t patients with acute femoral neck fractures

The Metha® BIOLOX® forte and delta ceramic femoral head are available in head diameters of 28, 32, and 36 mm with a range of neck lengths. The BIOLOX® forte ceramic heads are manufactured from ceramic (Al2O3) and conforms to ISO 6474. The BIOLOX® delta ceramic heads are manufactured from an alumina matrix composite. The Metha® cementless femoral stem will be offered in an additional size. The Metha® femoral stem has a Plasmapore® u-Cap coating on the proximal two thirds of the stem and is manufactured from Ti which conforms to ISO 5832.

The provided text describes the Metha® Hip System, a hip implant device. It details its components, indications for use, and a claim of substantial equivalence to predicate devices based on technological characteristics and performance data. However, the document does not contain information about specific acceptance criteria or a study that quantitatively proves the device meets such criteria.

The section titled "PERFORMANCE DATA" lists various guidance documents that were followed for testing the device. These guidances typically outline the types of tests required for orthopedic implants, such as mechanical testing, material characterization, and wear testing. However, the document does not report the specific results of these tests, nor does it define numerical acceptance criteria against which these results are measured. It simply states that "All required testing...was done where applicable." and lists the relevant guidance documents.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study demonstrating the device meets these criteria, as this information is not present in the provided text.

Based on the provided information, I can only state the following:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: Not specified in the document.
* Reported Device Performance: Not reported in the document in a quantitative manner. The document states that "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" and lists other relevant guidance documents for testing orthopedic implants. This implies that the device underwent necessary tests, but the specific performance results or the criteria they had to meet are not disclosed.

Regarding the other requested information, the document does not provide any of the following details:

• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical medical device (hip implant), not a diagnostic or AI algorithm requiring expert ground truth for performance evaluation in the described context. The "performance data" refers to physical and mechanical testing of the implant.
• Adjudication method for the test set: Not applicable for the type of testing implied (mechanical, material, etc.).
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI/diagnostic device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for the type of device and testing. Ground truth for physical device testing would relate to established engineering standards and material properties.
• The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

The document is a 510(k) summary for a hip implant system, focusing on demonstrating substantial equivalence to previously cleared predicate devices through similar technological characteristics and adherence to established testing guidelines for orthopedic implants. It does not elaborate on specific performance metrics or detailed study results beyond stating that the required testing was completed.

Ask a specific question about this device