(34 days)
The Large Screws range is indicated for the fixation of bone fractures, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
The Large Screws range consists of screws and washers designed for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults. The implants of the Large Screws Range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Large Screws Range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial S) containing implants and/or instruments will be provided sterile by gamma sterilization. Additional sterile instruments will also be provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Large Screws range are indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
The provided document is a 510(k) premarket notification letter and summary for the "Large Screws Range" by Newclip Technics. It details the device's substantial equivalence to predicate devices and provides information on non-clinical testing. However, it explicitly states that no clinical studies were performed.
Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria, as no such study is presented in this document.
Here's a breakdown of what can be extracted or inferred, and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided based on this document. The document does not define specific acceptance criteria for performance endpoints, nor does it report device performance from a clinical study.
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 based on this document. Since no clinical studies were performed, there is no test set, sample size, or data provenance to report.
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 based on this document. As no clinical studies were performed, there was no test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided based on this document. No clinical studies, no adjudication method.
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 based on this document. This device is a bone fixation screw, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided based on this document. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided based on this document. No clinical studies were conducted, so no ground truth for performance evaluation was established using these methods.
8. The sample size for the training set:
- Cannot be provided based on this document. No clinical studies were performed, and this is not an AI/algorithm-based device that would typically have a "training set" in that context.
9. How the ground truth for the training set was established:
- Cannot be provided based on this document. (See #8).
What was reported in terms of testing:
The document explicitly states:
- "No clinical studies were performed." (Page 5)
- "Engineering analyses have been conducted in comparison with Large Screws Range of Newclip Technics (K160617)." (Page 5) - This refers to non-clinical, mechanical testing to show equivalence to a predicate device. The specifics of these analyses (e.g., sample size for mechanical tests, specific criteria) are not detailed in this summary.
- **"LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of
§ 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.