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The Stainless Steel Soft Suture Wire is intended for general orthopedic surgery such as Sternulli Closure, nature bones and patella fracture fixation. The device is also intended for soft tissue approximation such as abdominal wound closure and hernia repair.

Suture Wire (87 LRN)

This document is a 510(k) clearance letter from the FDA for a medical device called "Stainless Steel Soft Suture Wire." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, or details regarding ground truth, expert opinions, or sample sizes.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the input document. The document is a regulatory approval, not a technical report detailing performance studies.

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The J-Fx Cerclage System is indicated for use in general orthopaedic repairs. This includes such procedures as reinforcement of bone, reattachment of the greater trochanter, fixation of long bone fracture with grafting, fixation of patellar fractures, and closure of sternum following open heart surgery.

The J-Fx Cerclage System consists of implants and instruments. The implants are cables and sleeves in both stainless steel and cobalt chromium alloy. The cables are available in two diameters, 1.6 mm and 2.0 mm. Instrumentation is also part of the system to assist in the placement of the implants.

This document is a 510(k) summary for the J-Fx Cerclage System, a medical device. It does not include information about performance evaluations based on AI, image analysis, or expert-based ground truth. Therefore, many of the requested sections about AI-specific criteria cannot be fulfilled from this document.

The document describes the device, its intended use, and compares its technological characteristics to predicate devices for substantial equivalence. It does not provide details of a study that establishes acceptance criteria in the way one would for a diagnostic or AI-driven device (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on similarities in design, materials, and intended use with previously approved devices.

Here's an attempt to answer the questions based only on the provided text, noting where the information is not applicable or unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, or accuracy) for the J-Fx Cerclage System, nor does it report device performance against such criteria. The "performance standards" section explicitly states, "No performance standards have been developed for this device."

The approval is based on "substantial equivalence" to predicate devices, meaning its technological characteristics are deemed sufficiently similar so that it can be marketed without new, extensive clinical trials to prove efficacy and safety from scratch.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This device is a physical medical implant system, not a diagnostic or AI-powered device that would typically use a "test set" of data for performance evaluation in the context of sensitivity/specificity. The evaluation for substantial equivalence is based on a comparison of device characteristics and intended use. There is no mention of a "test set" of patient data in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the context of expert consensus, is not established for this type of device in this document. The assessment for substantial equivalence is performed by the FDA based on the provided technical characteristics and comparison to predicate devices, not on human expert reads of data.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" or human reader adjudication process described in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a surgical implant 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. This device is a surgical implant system, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for this submission is essentially the established safety and efficacy of the predicate devices based on their prior marketing approval and clinical experience. The J-Fx Cerclage System is deemed substantially equivalent because its design, materials, and intended uses are so similar to these already approved devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or data analysis.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set" for this device.

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