Search Results

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, . pationity banoming fromatic arthritis, polyarthritis, collagen disorders, avascular ostcountinties, tradmise 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 Systems are a short stem design with either a single piece stem or a The Metha Thip Systems are a short seem beag. These hip systems share common heads in either modular Stemmeck Option: Doll of the Step titanium alloy. The proximal area of Cool of Geranic. The stem to manufacturers with a secondary coating of the lemoral stem is plasma oplaysu (r lasinopolised for cementless use only. Galcium i nosphate (p Oal o). "This etsin a sestems is referred to as The acetabiliar Jup that is VIPE insert with a Titanium plasmaspray shell.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Metha Hip System, structured to address your specific points:

The provided text is a 510(k) summary for the Metha Hip System, focusing on demonstrating substantial equivalence to predicate devices. This type of submission relies heavily on non-clinical performance data (mechanical testing) rather than clinical studies with human subjects or AI-driven evaluation. Therefore, many of your requested fields related to AI, clinical trials, ground truth, and expert consensus are not applicable to this document.

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

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

• Sample Size for Test Set: Not explicitly stated in the document for the fatigue testing. It refers to "testing" performed, but not the number of units tested.
• Data Provenance: Not specified, but implied to be from laboratory testing and not human subject data.

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 this context refers to mechanical performance parameters established by industry standards (ISO, ASTM) and evaluated in a laboratory setting, not by clinical experts.

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

Not applicable. Adjudication methods are typically for clinical data and consensus building among human experts, which is not relevant for mechanical testing.

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 medical device (hip implant), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (hip implant), not an algorithm.

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

The "ground truth" for the performance data is established industry standards and predicate device performance. The device's mechanical integrity and durability are compared against the performance requirements outlined in standards like ISO 7206-4 and ASTM F2068-03, and implicit performance of the predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing for a medical implant like this.

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

Not applicable. There is no "training set" or corresponding ground truth establishment process relevant to this type of device submission.

Summary of Acceptance Criteria and Study:

The acceptance criteria for the Metha Hip System are demonstrating that its technological characteristics (design, intended use, material composition, function, and range of sizes) and performance data (specifically fatigue testing) are substantially equivalent to legally marketed predicate devices.

The study that proves the device meets these criteria is fatigue testing per ISO 7206-4 and ASTM F2068-03. This testing, a non-clinical evaluation, aims to show the mechanical durability and safety of the implant under simulated physiological loads, demonstrating that it performs "as safe, as effective, and performs as well as the predicate devices." The specific numerical results of this testing and the comparison points to predicate devices are not detailed in this summary but would have been part of the full 510(k) submission.

Ask a specific question about this device

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

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.

Ask a specific question about this device