(60 days)
This instrument is a manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments.
The Karl Storz Flipptack is a manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments. The body contact portions of the KSEA Flipptack are composed of titanium, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided text describes a 510(k) submission for a medical device called the KSEA Flipptack, a manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments.
Crucially, the provided document is a 510(k) summary and approval letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria in the manner you've outlined for diagnostic or AI-based devices.
Therefore, most of the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness studies is not present in this type of regulatory submission for this particular device.
Here's an explanation based on the provided text, addressing what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. This document does not establish specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for the KSEA Flipptack in the way one would for a diagnostic or AI device. The core of a 510(k) submission for this type of device is demonstrating substantial equivalence to a legally marketed predicate device based on similar intended use, technology, materials, and safety/effectiveness profiles.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Provided. This document does not describe any specific clinical test set, sample size, or data provenance from a performance study for the KSEA Flipptack itself. Substantial equivalence for this type of surgical instrument is typically established through a comparison of device characteristics (materials, design, intended use) and, if applicable, bench testing rather than a clinical performance study with human subjects validating specific metrics.
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)
- Not Applicable / Not Provided. There is no mention of a test set requiring expert adjudication or ground truth establishment in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. As there's no test set described, there's no adjudication method mentioned.
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 surgical instrument (suture anchor), not an AI-assisted diagnostic or image analysis tool. Therefore, an MRMC study or AI assistance is irrelevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. Ground truth (in the clinical performance sense) is not established or discussed for this type of device in this document.
8. The sample size for the training set
- Not Applicable. As this is not an AI/ML device, there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As this is not an AI/ML device, there is no training set or ground truth establishment relevant to an AI model.
Summary of Device in the provided text:
- Device Name: KSEA Flipptack
- Intended Use: Manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments.
- Device Description: Composed of titanium, used for suture fixation.
- Regulatory Goal: Substantial Equivalence to a predicate device.
- Conclusion of Document: FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976. This allows the device to be marketed.
This 510(k) summary primarily demonstrates that the KSEA Flipptack is similar enough to existing, legally marketed devices that it raises no new questions of safety or effectiveness, therefore it does not require brand new, extensive performance studies typically associated with novel or AI-driven technologies.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.