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Mallory-Head® Modular Calcar Stems with Interlocking Slots are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.

The Mallory-Head® Modular Calcar System consists of a variety of proximal metaphyseal segments and distal stems. This 510(k) was for a distal stem that has three medial/lateral slots located in the distal half of the device designed for cross screw placement. The proximal bodies and distal stems of the Mallory-Head® Modular Calcar System are joined by means of a Morse looking taper similar to that used to attach the modular head components to most hip stems. The cross-screws are available in lengths of 25mm to 60mm and 5mm diameters.

The provided text indicates that no clinical testing was performed to prove the device met acceptance criteria. Only non-clinical mechanical testing was conducted.

Therefore, the following information cannot be extracted:

• Table of acceptance criteria and reported device performance (as no clinical performance data is reported)
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

Non-Clinical Testing Summary:

• Acceptance Criteria/Testing Performed: Mechanical testing has been conducted to demonstrate the ability of the screws to survive physiological loading.
• Device Performance: The summary states "Mechanical testing has been conducted to demonstrate the ability of the screws to survive physiological loading," implying successful demonstration. However, specific performance metrics or acceptance thresholds for this mechanical testing are not provided in the document.

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Cemented and non-cemented total joint replacement in cases of:

1. Noninflamatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision of previously failed total hip arthroplasty

Each stem consists of two separate parts, a proximal metaphyseal segment and a distal stem. A variety of stem lengths and proximal segment sizes allow the surgeon to "construct" the proper sized implant while in surgery. All pieces are interchangeable. The device utilizes a modular femoral head taper fit on to the stem at the time of surgery. The proximal segment is designed to replace the proximal portion of the femur in cases of severe bone loss. The device is porous coated. The proximal components are available in 5 resection levels and 7 widths. A hole through the proximal component gives the surgeon the option of using a trochanter plate and trochanter bolt or a trochanter claw. This assembly will allow the greater trochanter to be compressed against the prosthesis for enhanced fixation and proximal stability. Distal stems are available in six lengths, 165mm, 200mm, 240mm, 250mm and 300mm. Stems are available with 40%, 80% or 100% of the stem porous coated, as well as a non-coated, splined configuration. Since the stems are modular, left and right components are not necessary. The proximal and distal segments are joined by means of a Morse locking taper similar to that used to attach the modular head components to most hip stems. Additional fixation is achieved through a locking screw inserted through the driving platform on the metaphyseal component and engaging with the stem taper.

The provided document is a 510(k) premarket notification for a medical device (Mallory-Head® Modular Calcar Femoral Component). It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it explicitly states:

• Clinical Testing: None provided.

Therefore, there is no information in this document regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. This type of submission relies on demonstrating substantial equivalence to predicates through non-clinical testing (engineering analysis, finite element analysis, and mechanical testing) rather than new clinical data.

In summary, as per the provided document:

There is no information available regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; 5) revision of previously failed total hip arthroplasty due to recurrent dislocations.

The predicate Mallory-Head Modular Calcar was originally Device Deseription. The presented use. The distal stem has been modified by encared in 10-15-15 110 read/machined process to the male portion of the Morse applying a ron nardened massimal and distal portions of the stem. The prodicate locking taper that joins are pade of the same and have the same surface finishes and indications for use as well as the same lengths and configurations. These and indications for ass are interchangeable with all of Biomet's modular hip modified distal blems are liters. the proximal body and the distal stem are joined by means of a Morse locking taper.

The provided document, K000335, is a 510(k) premarket notification for the "Mallory-Head Modular Calcar Total Hip" system. It describes the device, its indications for use, and potential risks. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) submission process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting performance data against predefined acceptance criteria from a specific clinical or performance study.

Therefore, I cannot provide the requested information from this document. The document primarily confirms that the FDA has determined the device is substantially equivalent to existing devices and can be marketed. It does not include:

1. A table of acceptance criteria and reported device performance: This type of information would be found in a performance study report, which is not present here.
2. Sample size used for the test set and data provenance: Not applicable as a performance study against acceptance criteria is not detailed.
3. Number of experts used to establish ground truth and their qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

For medical device approvals, performance data and acceptance criteria are typically found in more detailed technical reports, clinical study summaries, or test reports that would be referenced or summarized in a comprehensive premarket application (like a PMA) or potentially in supporting documentation for a 510(k) that is not included in this high-level summary.

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