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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

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The Large Screws range is intended 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 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 Large Screws range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136-12a and/or 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 text describes a medical device (Large Screws range) and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a study, nor does it present the results of a study designed to meet specific acceptance criteria.

The document is a 510(k) summary, which is a premarket notification to the FDA demonstrating that a device is substantially equivalent to a legally marketed predicate device. This process typically relies on demonstrating equivalence through comparison of technological characteristics, materials, and non-clinical testing, rather than a study against specific performance acceptance criteria as one might see for a novel AI/software medical device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document lists "Non-clinical Test Summary" items (Comparative torsional tests, Comparative pullout engineering analysis, Driving torque tests) but does not provide specific acceptance criteria or performance data for these tests. It also explicitly states "No clinical studies were performed."
2. Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" described. The non-clinical tests would have involved samples of the screws, but details on sample size, other than implied through "comparative", are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant here as no clinical studies were performed.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical bone fixation fastener, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is for a physical medical device (bone screws) and focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing predicate devices, not on a study with specific acceptance criteria as would be typical for an AI/software medical device.

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