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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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Kirschner Wire - ankle fracture fixation femoral shaft fracture hand fracture scaphold fracturc skeletal tractlon wrist fracture patellar fracture
Steinman Pin - ankle arthrodesis tiblotibular syndesmosis fixallorı femoral shaft fracture acromloclavicular Jolnt repair skeletal traction

Stainless Stool Fixation Pins

I apologize, but the provided text is a 510(k) clearance letter from the FDA for medical devices (Bone Screws, Kirschner Wire, and Steinman Pin). This document confirms that the devices are substantially equivalent to previously marketed devices. However, this type of regulatory correspondence does NOT contain information about acceptance criteria for device performance or the specifics of a study proving the device meets those criteria.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

To obtain this information, you would typically need to refer to the preclinical and clinical study reports submitted as part of the 510(k) premarket notification, which are not included in this letter.

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Bone screws are used to fix fractured long and short bones. They are also used to fasten bone plates. Bregma International manufactures three kinds of bonc screws, Aach with its own intended use. Cortical bone screws are used to augment compact and hard bones (diaphyseal reglons of the bones). Cancelluus bone screws are used in the epiphyseal and metaphyseal reglons of the bones which are largely soft and spongy. Cannulated bone screws, are used in situations where surgical wire is required to pass through the central axis of the screw, along which a holes has been drilled.

Not Found

The provided text is a 510(k) clearance letter from the FDA for Bone Screws, Kirschner Wire, and Steinman Pins. It states that these devices are substantially equivalent to devices marketed prior to May 28, 1976. This type of clearance does not involve the kind of detailed study data and acceptance criteria that would be found for a novel medical device requiring de novo classification or PMA.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as such studies were not required for this specific 510(k) clearance. The FDA's determination here is based on the devices being "substantially equivalent" to existing, legally marketed predicate devices, not on new performance data demonstrating meeting specific, novel acceptance criteria through a clinical or performance study of the type usually associated with AI/software devices.

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