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The Medacta® Endo Head is intended for use in combination with Medacta® Hip Prosthesis System for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

· Femoral neck and trochanteric fractures of the proximal femur;

· Osteonecrosis of the femoral head;

· Revision procedures where other devices or treatments for these indications have failed.

The Medacta Endo Head is a unipolar prosthesis that consists of a monobloc prosthetic femoral head made of Cobalt Chromium Molybdenum (CoCrMo ISO 5832-12) designed to articulate directly in the patient's acetabulum. It is designed to be assembled with all the Medacta stems. Three sizes (S, M and L) are available for a 12/14 Morse taper with an outer diameter varying from 40 to 56 mm with 1 mm increments between sizes.

The provided text is a 510(k) Summary for a medical device called "Endo Head" by Medacta International. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria for device performance. Therefore, the information required to populate the fields of your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the document.

The document primarily provides:

• Device Information: Trade name, common name, classification, product codes.
• Predicate Devices: A list of previously cleared devices to which the Endo Head is compared.
• Product Description: Material (CoCrMo), design (unipolar prosthesis, monobloc), and sizes.
• Indications for Use: Conditions for which the device is intended (femoral neck/trochanteric fractures, osteonecrosis, revision procedures).
• Comparison to Predicate Devices: Claims of substantial equivalence based on intended use, material, neck lengths, external diameter, sterilization, biocompatibility, and coupling with Medacta stems.
• Regulatory Conclusion: Affirmation of substantial equivalence by the FDA.

No study proving the device meets acceptance criteria, as per your request, is described in this 510(k) summary. The 510(k) process for this type of device (a hip prosthes is component) typically relies on demonstrating equivalence to existing legally marketed devices, often through mechanical testing (e.g., fatigue, wear) and material characterization, rather than clinical efficacy studies with human subjects that would involve ground truth establishment and expert adjudication in the manner you described.

Therefore, I cannot fill out the requested table and details based on the provided text.

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The New Bio-Moore Endo Heads is indicated for use in:

• a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
• b.) rheumatoid arthritis
• c.) revisions procedures where other devices or treatments have failed
• d.) correction of functional deformities
• e.) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement.

The Bio-Moore Endo Heads are intended for impaction on either a press-fit or cemented femoral component and are for single use implantation.

The New Bio-Moore Endo Heads are used as a hemi device and only replaces the head and not the acetubulum. The purpose is to preserve as much bone as possible. The heads allows for the use of taper inserts to vary the lengths of the neck which allows the surgeon greater flexibility in the OR. The taper inserts are assembled during surgery to insure an accurate fit.

The provided text is a 510(k) summary for a medical device (New Bio-Moore Endo Heads), which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a dedicated study.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

A 510(k) submission typically relies on a comparison to an already legally marketed device (predicate device) and demonstrates that the new device is as safe and effective as the predicate. It doesn't usually include a standalone study that establishes and then meets specific performance acceptance criteria in the way a PMA (Premarket Approval) submission would.

Here's a breakdown of why the requested information is absent:

1. Table of acceptance criteria and reported device performance: Not present. The document focuses on intended use and device description, and then lists predicate devices.
2. Sample size used for the test set and data provenance: No test set is described. The filing is a regulatory submission for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such study is detailed.
4. Adjudication method for the test set: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory filing for substantial equivalence and does not detail a study proving specific performance against defined acceptance criteria.

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The Prime Modular Endo Heads, with the Prime Cemented Femoral Stems, are intended to replace the femoral head in cases of femoral head and neck fracture, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed hip fracture treatment.

The Prime Modular Endo Heads feature a one piece spherical endo head and a Morse-type taper. This Morse-type taper provides for modular component selection, allowing the head to attach to the Prime Cemented Calcar Femoral Stems. The Prime Modular Endo Heads are provided in diameters from 36mm to 70mm in 1 mm (one millimeter) increments. It is constructed from Cobalt-Chrome Alloy, per ASTM F-1537. Sold Presterile.

This document is a 510(k) summary for a medical device (hip joint femoral prosthesis). It describes the device, its intended use, and compares it to substantially equivalent products. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical or performance validation study report for an AI/algorithm-based device.

The provided text is from a regulatory submission (510(k)) for a physical medical device (orthopaedic implant). The questions in your prompt are geared towards the validation of a software or AI-based medical device, which is a different type of submission and validation process.

Therefore, I cannot extract the requested information from the provided text because it does not exist within this document.

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