TWISTCUT ENDOSORB SCREWS by MERETE MEDICAL GMBH

The TwistCut™ EndoSorb™ Bone Screws are made out of the absorbable EndoSorb™ material. EndoSorb™ is a polyester derivative of L-Lactic and glycolic acids.
Poly(L-lactide-co-dlycolide) material (PLGA) degrades and absorbs in vivo by hydrolysis into L-lactic and glycolic acids, which are then metabolized by the screw head provides a hexagonal twist off portion to enable screw head to be flush with the bone.

AI/ML Overview

The provided text describes a 510(k) submission for the TwistCut™ EndoSorb™ Bone Screws. It details the device, its intended use, and claims substantial equivalence to predicate devices. However, the submission does not contain information regarding direct acceptance criteria for device performance based on a study with a test set of data, nor does it include a study that proves the device meets such criteria.

The "studies" mentioned are bench tests primarily focused on material properties, degradation, mechanical strength, and packaging stability to demonstrate similarity to legally marketed devices. These are not performance studies in the context of diagnostic accuracy, which would typically involve human-in-the-loop or standalone algorithm performance against a ground truth.

Here's an breakdown of why the requested information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance

Not Available: The document lists bench tests performed (e.g., in vitro degradation, determination of inherent viscosity, breakage strength, insertion torque, stability tests) and states that a "geometrical and a material comparison" was provided. However, it does not specify quantitative acceptance criteria or specific numerical performance results for these tests that would typically be reported for a "device performance" section in the context of diagnostic or AI-enabled systems. The purpose of these tests was to support the claim of substantial equivalence, not to demonstrate performance against predefined clinical accuracy metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable/Available: The device is a bone screw, not a diagnostic or AI algorithm that processes data. Therefore, there is no "test set" of patient data or images to evaluate. The "samples" for the bench tests would refer to the physical screws or material samples. The document does not specify the number of samples used for each bench test, nor is there any mention of data provenance (country of origin, retrospective/prospective).

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/Available: As there is no "test set" of patient data that requires ground truth establishment (e.g., image interpretation), there were no experts used for this purpose. The evaluation was based on engineering and material science bench tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable/Available: Since there is no test set requiring expert interpretation, no adjudication method was used.

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 is a physical orthopedic implant. It does not involve AI, human readers, or image interpretation. Therefore, an MRMC study is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This is a physical bone screw, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable/Available: For the bench tests, the "ground truth" would be the established material science and engineering principles, and the measurements taken against those principles (e.g., a specific breakage strength being within an acceptable range). There is no "ground truth" in the clinical sense (e.g., pathology, outcomes data) relevant to the data provided for this type of device.

8. The sample size for the training set

Not Applicable: As this is not an AI/ML device, there is no concept of a "training set."

9. How the ground truth for the training set was established

Not Applicable: Since there is no training set, there is no ground truth for it.

In summary, the provided document is a 510(k) submission for a medical device (bone screw) that relies on demonstrating substantial equivalence through bench testing of its physical and material properties. It does not involve AI or diagnostic image analysis, and therefore, the structured questions regarding acceptance criteria and studies for AI/diagnostic devices are not applicable to this submission.

Summary

Regulation Number and Section

§ 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.