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The Mayo Clinic BC-10 3.0T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific area of the body, which can be imaged.

The Mayo Clinic BC-10 magnetic resonance coil is a transmit/receive, high-pass, quadrature coil using the birdcage circuit design.

The provided text describes a 510(k) submission for a medical device, the Mayo Clinic BC-10 3.0T MR coil. This submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study for a diagnostic algorithm.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable in this context. The document primarily details the device's technical specifications and intended use, comparing it to existing, legally marketed devices.

Here's a breakdown of the available information:

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

The provided summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way one would for a diagnostic algorithm with sensitivity, specificity, etc. Instead, the "acceptance criteria" are implied to be that the device performs "in accordance with predetermined acceptance criteria and that the safety and reliability of the coil meets/exceeds standards." The reported device performance is that it is "substantially equivalent to already approved extremity coils" and is a "proven design with well documented clinical, safety, and reliability data from years of use at the Mayo Clinic."

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 in the document for a formal test set in the context of proving diagnostic performance. The submission refers to "clinical, safety, and reliability data from years of use at the Mayo Clinic in Rochester, MN," which suggests retrospective data from a U.S. institution, but specific sample sizes for particular tests are not detailed.

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 provided as this is not a study evaluating a diagnostic image interpretation algorithm.

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

This information is not provided as this is not a study evaluating a diagnostic image interpretation algorithm.

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 provided nor is it applicable, as the device is an MR coil, not an AI-powered diagnostic tool requiring human reader evaluation.

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

This information is not provided nor is it applicable, as the device is an MR coil, not an algorithm.

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

This information is not provided in the context of a formal study with ground truth for a diagnostic outcome. The "clinical, safety, and reliability data" would likely refer to a combination of clinical observations, imaging characteristics, and potentially patient outcomes over time, but no specific method for establishing "ground truth" for a test set is described.

8. The sample size for the training set

This information is not provided as this refers to an MR coil, not an algorithm that undergoes a training phase.

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

This information is not provided as this refers to an MR coil, not an algorithm that undergoes a training phase.

In summary: The provided document is a 510(k) summary for an MR coil, focusing on demonstrating substantial equivalence to existing devices. It does not contain the detailed information about clinical study design, performance metrics, ground truth establishment, or reader studies that would be expected for a diagnostic algorithm. The "study" mentioned generally refers to engineering tests and the accumulated clinical use data at Mayo Clinic, rather than a specific clinical trial designed to prove diagnostic performance through a test set.

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The MAYO Hip is used in total hip arthroplasty, a surgical procedure restricted to patients with substantial pain or marked functional disabilities in which conservative treatment has not provided acceptable relief and who are not candidates for other less aggressive forms of surgery. This hip is indicated for noncemented use in skeletally mature individuals. Diagnostic indications include severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The MAYO Hip Prosthesis is a short-stemmed, press-fit modular femoral component developed by Bernard F. Morrey, M.D., of the Mayo Clinic and is intended to be implanted into the human femur to replace a hip joint. The MAYO Hip incorporates several technological features of the Zimmer Anatomic Hip Prosthesis (and other predicate devices) such as the Morse-type tapered neck and fiber metal pads for bone ingrowth, and is made from the same materials (titanium alloy and commercially pure titanium) as the predicate devices. The femoral stem is collarless, has a dual taper (double wedge) body, and has a short distal stem (tail). The femoral stem is available in four sizes each of which can be utilized in the left or right hip.

The modular femoral stem is designed to mate with a femoral head through a Morse-type taper. The femoral head in turn articulates upon the UHMWPE liner of an acetabular component. The MAYO Hip Prosthesis meets the criteria of the generic device described in 21 CFR 888.3358.

The MAYO Hip supports a conservative approach to total hip arthroplasty by allowing for minimal femoral neck resection, minimal bone preparation, minimal stress shielding, absence of intramedullary fixation, reduction in blood loss, and potential for ease of revision.

The short distal portion of the stem is used to assist in proper placement of the stem and provides for rotary fixation. Immediate fixation is achieved through three-point (anteroposterior and lateral planes) fixation in the metaphyseal bone of the proximal femur. The stem does not rely upon intramedullary fixation, therefore the source of thigh pain is eliminated. Surgery time is reduced because the femoral medullary canal is not reamed or violated. This results in statistically significant less blood loss than that of a conventional, uncemented primary total hip arthroplasty. Additionally, reduction in the amount of metal (due to the short distal stem and double wedge shape) results in less exposure of a foreign body to the intramedullary canal. The conservative femoral neck resection, which preserves bone stock, will facilitate subsequent procedures should a revision of the hip be required.

This document describes the safety and effectiveness of the MAYO® Hip Prosthesis. However, it does not contain the specific information required to complete the detailed table and answer the study-related questions. The provided text is a summary of safety and effectiveness, likely from a regulatory submission, which discusses the device description, intended use, comparison to predicate devices, and mentions clinical and nonclinical data in a general way, but does not provide the granular details of a specific clinical study with acceptance criteria and performance metrics.

Specifically, the following information is missing from the provided text:

• Explicit Acceptance Criteria: The document mentions "satisfactory clinical outcome" and "statistically significant reduction in blood loss" and "pain," but it does not specify quantitative acceptance criteria (e.g., "95% survival rate at 5 years," "mean blood loss reduction of X ml").
• Reported Device Performance against specific criteria: While general positive outcomes are noted, specific performance metrics against defined acceptance criteria are absent.
• Details of the "eight years of clinical research": This is a key piece of information that is only mentioned generally.
  • Sample size used for the test set: Not specified.
  • Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
  • Number of experts and qualifications for ground truth: Not specified.
  • Adjudication method: Not specified.
  • MRMC comparative effectiveness study details: Not specified. It mentions a comparison of blood loss and pain reduction between MAYO Hip and BIAS Hip, but this isn't framed as an MRMC study with human readers improving with AI.
  • Standalone performance: Not applicable as this is a medical device, not an AI algorithm.
  • Type of ground truth used: Implied clinical outcomes (pain, blood loss, satisfactory outcome), but not explicitly defined in terms of how it was established (e.g., expert consensus, pathology, long-term follow-up).
  • Sample size for the training set: Not applicable, as this is a physical medical device, not an AI model.
  • How ground truth for training set was established: Not applicable.

Therefore, while the document confirms that performance data exists and supports claims of safety and effectiveness, it does not provide the detailed study design, acceptance criteria, and specific performance results that you are requesting in your template.

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