Search Results

The MARGRON™ Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: Osteoarthritis, Rheumatoid arthritis, Tumor conditions involving the upper third of the femur or the acetablym, Ankylosing spondylitis, Psoriatic arthritis, Old osteomyelitis - with a long infection-free period and a normal WBC. ESR and C-reactive protein, Non union of femoral neck fracture or avascular necrosis of the femoral head, Post-traumatic fracture/dislocation of the hip, Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling, Revision of an unsuccessful cemented or un-cemented hip replacement stem, providing sufficient bone stock is present, Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The MARGRON 100 hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly. The MARGRON TM Femoral Stem is a modular prosthesis consisting of - A tapering stem cone with two different speed external threads and longitudinal . derotation columns. - A neck component which allows the optimum angle of anteversion to be selected ● after stem insertion. - . Precision milling and tapping is used to prepare the femur and stem insertion is by "screw home" rotation. - . A unique set of instruments have been designed to insert and extract the prosthesis.

The provided document is limited to a Special 510(k) Notification for the MARGRON™ Hip Replacement System, asserting substantial equivalence to an existing predicate device (K992158). This type of submission generally relies on demonstrating that changes to a previously cleared device do not introduce new questions of safety or effectiveness.

Therefore, the document does not contain the detailed information typically found in a study demonstrating performance against specific acceptance criteria for a novel device. It refers to the testing of the original design of the predicate device.

Based on the provided text, here's what can be extracted and what cannot:

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

This information is not provided in the document. The document states: "All materials used in the fabrication of this MARGRON™ Hip Replacement System were evaluated with the original design through physical testing (fatigue, torque and corrosion testing) and biocompatibility testing. It has been shown to be substantially equivalent to the predicate device."

This implies that the original device underwent testing, and the current device's materials are equivalent to those used in the original. However, specific acceptance criteria for these tests and the detailed results are not presented.

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

This information is not provided. The document makes generic statements about "physical testing" and "biocompatibility testing" of the "original design," but no details about sample sizes or data provenance are given.

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)

This information is not applicable/provided. Since this is a physical medical device (hip replacement system) and not a diagnostic AI/software, the concept of "ground truth" established by human experts in the context of a test set (e.g., for image interpretation) does not apply. The testing mentioned (fatigue, torque, corrosion, biocompatibility) are laboratory-based physical and chemical tests, not clinical evaluations requiring expert interpretation of results in the same way.

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

This information is not applicable/provided for the same reasons as point 3.

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

This information is not applicable/provided. This is a physical hip replacement implant, not an AI or diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this device.

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

This information is not applicable/provided. This is a physical hip replacement implant, not an algorithm or software.

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

This information is not applicable/provided. As explained in point 3, the testing involves physical and chemical property assessments, not diagnostic evaluations requiring a "ground truth" derived from expert consensus, pathology, or outcomes data. The "ground truth" for material properties would be established by validated scientific methodologies and standards.

8. The sample size for the training set

This information is not applicable/provided. The concept of a "training set" applies to machine learning and AI, which is not relevant to this physical implant device.

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

This information is not applicable/provided for the same reasons as point 8.

In summary:

The provided document is a regulatory submission for a hip replacement system, focusing on demonstrating substantial equivalence to a predicate device based on similar design and materials. It does not provide details about specific acceptance criteria or performance studies in the format requested, as these are typically part of a full Premarket Approval (PMA) application or a more extensive 510(k) for a novel device, especially for AI/software products. The testing mentioned pertains to the physical and biocompatible properties of the materials used in the original design of the predicate device.

Ask a specific question about this device

The Margron™ Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present.

The patient should be skeletally mature. The patient's condition should be due to one or more of the following:

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Psoriatic arthritis
• Old osteomyelitis with a long infection free period and a normal WBC, C- Reactive protein and ESR
• Non union of femoral neck fracture or avascular necrosis of the femoral head
• Post-traumatic fracture/dislocation of the hip
• Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling
• Revision of an unsuccessful uncemented or cemented hip replacement stem, providing sufficient bone stock is present
• Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The Margron™ hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly.

The Margron™ Femoral Stem is a modular prosthesis consisting of:

• A tapering stem cone with two different speed external threads and longitudinal derotation columns.
• A neck component which allows the optimum angle of anteversion to be selected after stem insertion.
• Precision milling and tapping is used to prepare the femur, and stem insertion is by 'screw home' rotation.
• A unique set of instruments have been designed to insert and extract the prosthesis.

The provided document is a 510(k) summary for the Margron™ Hip Replacement System. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, rather than novel devices requiring extensive clinical trials to demonstrate safety and effectiveness.

Therefore, the document does not contain information about a study designed to prove the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel medical device would. Instead, it focuses on demonstrating substantial equivalence to existing, legally marketed devices.

Because of this, I cannot extract the following information about acceptance criteria and a study proving their fulfillment:

1. A table of acceptance criteria and the reported device performance: This document doesn't define quantitative clinical "acceptance criteria" for the Margron system or report clinical performance against such criteria. The "Mechanical Characteristics" section mentions fatigue, torque, and corrosion tests were performed, and the results showed "substantial equivalence to the predicate devices," but no specific numerical criteria or performance data are provided.
2. Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" in the context of a comparative effectiveness study mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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 device is a hip replacement system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a clinical performance study. The "ground truth" for substantial equivalence is defined by comparison to predicate devices, which involves design, materials, and intended use, not clinical outcomes from a specific study outlined here.
8. The sample size for the training set: Not applicable, as there's no 'training set' in the context of a clinical performance study for this type of device submission.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "acceptance criteria" and "proof":

The "acceptance criteria" for marketing approval of the Margron™ Hip Replacement System under a 510(k) pathway are based on demonstrating substantial equivalence to predicate devices already on the market.

Study/Evidence for Substantial Equivalence:

The document states:

• "The Margron Hip is similar in design, materials and intended use to" a list of predicate devices (Metagen Modular Femoral Hip System, Biomet Impact, Mallory-Head, S-ROM, Infinity, Modular Hip System).
• Mechanical Characteristics: "The Margron Hip System has been evaluated by use of the fatigue, torque and corrosion tests. It has been shown to be substantially equivalent to the predicate devices." (Page 3)
• Materials: The material composition (Chrome Cobalt, Calcium Phosphate Coating) is specified and stated to be "implant grade materials." (Page 3)
• Intended Use/Indications: The stated indications for use are similar to those typically found for hip replacement systems and are implied to be consistent with the predicate devices. (Page 2, Page 5)

In summary, for a 510(k) submission like this, the "study" is a comparison to predicate devices, and the "acceptance criteria" revolve around proving substantial equivalence in terms of design, materials, manufacturing processes, and performance (often assessed through non-clinical testing like mechanical tests). This is distinct from a clinical trial that evaluates specific performance metrics in human subjects against predefined clinical acceptance criteria.

Ask a specific question about this device