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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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The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip and disability due to rheumatoid arthritis, 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 previous fusion Patients with acute femoral neck fractures. 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, 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. Indications for use of the CONSENSUS® HIP SYSTEM-PRIMARY HIP: A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis. B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C) Proximal femoral fractures. D) Avascular necrosis of the femoral head. E) Non-union of proximal femoral neck fractures. F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities. Acetabular components are indicated for cemented and cementless use.

The Consensus Acetabular Cup from Hayes Medical is a Titanium alloy shell with a highly cross linked polyethylene insert. The Consensus acetabular cups are available in 28mm, 32mm, and 36mm ID's, a variety of sizes, and in either standard or hooded versions. The shells are available with or without screws. The Aesculap Excia hip systems also comes in 28mm - 36 mm ID's, it is available in both cemented and uncemented variants, and a wide range of sizes. Aesculap's Metha hip system also comes in 28 - 36 mm ID's but is for uncemented use, and also comes in a variety of sizes. The PlasmaCup acetabular cup from Aesculap is cleared for use with both the Excia and Metha systems.

This document describes the 510(k) summary for the Consensus Acetabular Cups for use with Aesculap Excia and Metha Hip Systems. It outlines the substantial equivalence to previously cleared devices based on technological characteristics and engineering evaluation, rather than new performance data from a specific study.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity for diagnostic devices; or mechanical test results for orthopedic implants) are listed in the document. The filing is based on the substantial equivalence of the device's design to existing cleared devices.

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

No specific test set or clinical study yielding performance data was conducted or described in this 510(k) submission for the Consensus Acetabular Cups. The submission relies on the engineering evaluation of dimensions and the equivalence to previously cleared devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable, as no new performance data requiring ground truth establishment from experts was generated or presented in this submission.

4. Adjudication Method

Not applicable, as no new performance data requiring adjudication was generated or presented.

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

No MRMC study was conducted or described. This K081978 submission is for an orthopedic implant and does not involve AI or human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is an orthopedic implant, not an algorithm.

7. Type of Ground Truth Used

Not applicable, as no primary performance study needing ground truth was performed for this submission. The basis for clearance is technological equivalence and previous clearances.

8. Sample Size for the Training Set

Not applicable. This device is an orthopedic implant, and there is no mention of a training set as would be relevant for an AI/algorithm-based device.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set or ground truth for such a set is mentioned.

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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 .

Metha® is a femoral short stem intended to replace the hip joint in total hip arthroplasty. The femoral stem is collarless, conical shaped and is intended for cementless, press-fit application. The femoral stem is manufactured from titanium alloy and is available in various sizes. The proximal area of the femoral stem is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate(u-CaP®). It is designed for use with currently available Aescular Implant Systems femoral heads, acetabular components and Bipolar cups.

This is a 510(k) premarket notification for a medical device (hip implant), which typically relies on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria in the way an AI/software device would. Therefore, most of the requested fields are not applicable or cannot be extracted from the provided text.

Here is what can be inferred and stated based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The concept of "acceptance criteria" for a 510(k) clearance of a mechanical implant like this is not about meeting specific numerical performance targets in a clinical study with a predefined sample size and ground truth, as it would be for a diagnostic AI. Instead, it's about demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through engineering performance testing (e.g., mechanical, material, biocompatibility) and comparison of technological characteristics. 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," along with several other specific guidance documents. This implies that the device successfully met the benchmarks or standards outlined in those guidances.

2. Sample size used for the test set and the data provenance
Not applicable. The clearance is based on mechanical and material testing, not a clinical test set with human data that would have provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/diagnostic studies is not relevant here.

4. Adjudication method for the test set
Not applicable.

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 implant, not an AI/diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an AI/diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical "ground truth" for diagnostic performance. For mechanical implants, the "ground truth" for safety and effectiveness is established through adherence to national/international standards and FDA guidance documents for material properties, mechanical integrity, and biocompatibility, as well as comparison to predicate devices.

8. The sample size for the training set
Not applicable. This is a medical implant, not an AI/machine learning model.

9. How the ground truth for the training set was established
Not applicable.

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