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The Metha® Short Stem 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® Short Stem Hip System XL Femoral Head is manufactured CoCrMo and conforms to ISO 5832. The XL femoral head is offered in two diameters (28mm and 32mm). The CoCrMo head allows the surgeon a further option to meet the patient's needs.

The provided text is a 510(k) Pre-market Notification for the "Metha® Short Stem Hip System XL Femoral Head." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria in the manner typical for AI/ML-based medical devices.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of regulatory submission. The document primarily highlights mechanical and material testing to ensure safety and functionality compared to existing devices.

Here's an attempt to address the request based only on the provided information, noting where information is not present:

Acceptance Criteria and Study for Metha® Short Stem Hip System XL Femoral Head

This 510(k) submission primarily demonstrates substantial equivalence to existing predicate devices, K080584 (Metha® Short Stem Hip System) and K040191 (BiContact Hip System and Femoral Head), by showing similar technological characteristics and materials. The performance data presented is focused on meeting existing orthopedic implant testing standards rather than a clinical study with specific performance metrics against a clinical ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of the number of tested devices. The document implies testing was performed on representative samples or prototypes.
• Data Provenance: Not explicitly stated, but testing would typically be performed in a laboratory setting by the manufacturer or a contracted testing facility. No patient data (retrospective or prospective) is mentioned for this type of performance evaluation.

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

• Not Applicable. This submission does not involve expert-established clinical ground truth for a test set in the context of device performance, as it is not an AI/ML device or a device requiring clinical adjudication. The "ground truth" here is adherence to engineering standards and material specifications, which are assessed through standardized laboratory tests.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication method is described. Performance is evaluated against objective engineering standards and material specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not an AI-assisted diagnostic device, and therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

6. Standalone (Algorithm Only) Performance

• No. This is a physical orthopedic implant. The concept of an "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

• The "ground truth" in this context refers to established engineering standards, material specifications (e.g., ISO 5832), and recognized guidance documents for orthopedic implant testing. It is not clinical expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

• Not Applicable. As no training set is relevant, this question does not apply.

Summary of Performance Data (from the document):

The performance data for the Metha® Short Stem Hip System XL Femoral Head relies on demonstrating compliance with various existing guidance documents for orthopedic implant testing:

• "Draft Guidance for the Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements"
• "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"
• "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
• "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components"
• "Draft Guidance Document for Testing Acetabular Cup Prostheses"
• "Points to Consider for Femoral Stem Prostheses"
• "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems"
• "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices" (where applicable)

The statement "All required testing per... were done where applicable" indicates that the device underwent the necessary mechanical and material characterization tests outlined in these documents to support its safety and effectiveness for its intended use, by demonstrating substantial equivalence to predicate devices. Specific quantitative results are not included in this summary but would have been part of the full 510(k) submission.

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