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The Global Modular Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFix® HA Coating were found substantially equivalent in premarket notification K022403. These stems are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System (referred to from this point on as the MRS) in total hip arthroplasty. These devices are intended for use in total hip arthroplasty indicated as a result of extensive proximal femoral bone loss (from trauma, failed previous arthroplasty, or tumor resection). Adequate bone stock must be present to allow the use of the GMRS Pre PureFix® HA Coating.

Indications:
Proximal femoral reconstruction secondary to:

• . Trauma
• Failed previous prosthesis .
• Tumor resection .

The 11mm diameter GMRS Press Fit Stems with PureFix® HA will bear a weight limitation on the label. The 11mm stems will be limited to use in patients with a maximum weight of 199 lbs.

GMRS Press Fit Stems with PureFix® HA

I am sorry, but based on the provided document, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification for a labeling change to an existing medical device (11mm GMRS Press Fit Stem with PureFix® HA).

The document primarily focuses on:

• Identification of the device: GMRS Press Fit Stems with PureFix® HA.
• Intended use and indications: For total hip arthroplasty due to extensive proximal femoral bone loss.
• The purpose of the current submission: To add a warning with a weight limitation (199 lbs) to the package label for the 11mm GMRS Press Fit Stems.
• FDA's response: A substantial equivalence determination for the labeling change.

There are no details about:

• Specific performance metrics or acceptance criteria for the device itself.
• Any studies (clinical or non-clinical) conducted to demonstrate performance against such criteria.
• Sample sizes, data provenance, expert qualifications, or ground truth establishment.
• Multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for the table and study details as that information is not present in the provided text.

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The Global Modular Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFix® HA Coating are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System (referred to from this point on as the MRS) in total hip arthroplasty. These devices are intended for use in total hip arthroplasty indicated as a result of extensive proximal femoral bone loss (from trauma, failed previous arthroplasty, or tumor resection). Adequate bone stock must be present to allow the use of the GMRS Press Fit Stems with PureFix® HA Coating.

The GMRS Press Fit Stems with PureFix® HA Coating are machined from titanium alloy (Titanium-6Aluminum-4Vanadium) which meets the requirements of ASTM standard F-136. The stems are coated with commercially pure titanium (CP titanium) plasma spray coating that conforms to ASTM specification F-1580. The proximal portion of the stem is also coated with PureFix® HA coating which meets ASTM specification F-1185.

The proximal portion of the stem incorporates a male taper with a taper angle of 2 degrees 52 minutes. This male taper mates with the female taper portion of the head/neck section or body section of the proximal femoral section of the Modular Replacement System.

The GMRS Press Fit Stems with PureFix® HA Coating are available in four styles:

• I Straight Stems: These stems are available in a 125mm length, and diameters from 11mm to 19mm in one millimeter increments. The seat diameter varies from 22 to 36mm, and the seat radius ranges from 8mm to 9.25mm.
• Straight Fluted Stems: These stems are also available in a 125mm length, and diameters from 11mm to 19mm in one millimeter increments. This stem design has four flutes that extend from the seat down 25mm of the length of the stem. These flutes are located 90 degrees apart on the body of the stem. The seat diameter varies from 22mm to 36mm, and the seat radius ranges from 8mm to 9.25mm.
• Curved Stem (150mm): These stems are available in a 150mm length, and diameters from 11mm to 19mm in one millimeter increments. The seat diameter of this stem ranges from 22mm to 36mm, and the seat radius ranges from 7mm to 10.5mm. The radius of the curvature is 45 inches.
• Curved Stem (200mm): These stems are available in a 200mm length, and diameters from 11mm to 19mm in one millimeter increments. The seat diameter of this stem varies from 22mm to 36mm, and the seat radius ranges from 7mm to 10.5mm. The radius of the curvature is 45 inches.

The provided text describes a 510(k) Premarket Notification for a medical device called "GMRS Press Fit Stems with PureFix® HA". This document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It is crucial to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence, not on providing detailed clinical study results or establishing acceptance criteria in the way a clinical trial for a novel drug or a high-risk device might.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a medical device such as a hip implant is not typically found within a 510(k) summary document. These types of studies and their detailed outcomes are more characteristic of clinical trials or extensive performance testing, which might be referenced but not fully detailed in this type of summary.

The document states: "Finite element analyses and testing were present to support a claim of substantial equivalence." This indicates that some form of engineering analysis and physical testing was performed, but the specific acceptance criteria and detailed results are not elaborated upon.

Based on the provided text, here is what can and cannot be answered:

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

• Cannot be provided: The document does not specify quantified acceptance criteria or detailed performance metrics from a clinical study for this hip implant. Its purpose is to demonstrate substantial equivalence to predicate devices, not to report on specific clinical performance against predetermined acceptance criteria for a novel device. The "performance" mentioned is in the context of supporting the claim of substantial equivalence through "Finite element analyses and testing," but no specific results are given.

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

• Cannot be provided: The document does not describe a "test set" in the context of clinical data or a formal study with human subjects for which a sample size, provenance, or study design (retrospective/prospective) would be relevant. The "testing" mentioned refers to engineering tests and finite element analyses, not patient-based 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)

• Cannot be provided: This information is not applicable as no clinical "test set" requiring expert ground truth establishment is described in the document.

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

• Cannot be provided: This information is not applicable as no clinical "test set" requiring adjudication is described.

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

• Cannot be provided: This document relates to a hip implant (a physical device), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI-related effectiveness is irrelevant and not mentioned.

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

• Cannot be provided: As this device is a physical hip implant, the concept of "standalone algorithm performance" is not applicable.

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

• Cannot be provided: No specific clinical "ground truth" derived from patient data is described as part of the substantial equivalence claim. The "ground truth" in engineering analysis would relate to material properties, mechanical loads, and structural integrity, defined by engineering standards and simulations, not typically categorized as "expert consensus" or "pathology" in the medical sense.

8. The sample size for the training set

• Cannot be provided: This document describes a physical medical device, not an AI algorithm that requires a "training set."

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

• Cannot be provided: This is not applicable to a physical medical device.

In summary, the provided document is a 510(k) summary for a hip implant. Its purpose is to demonstrate substantial equivalence to existing devices through a description of components and manufacturing, along with mentioning supporting engineering analyses and testing. It does not contain the detailed clinical study design, performance metrics, sample sizes, or ground truth establishment methods typically associated with clinical trials or AI performance evaluations.

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