FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Eisertech, LLC Temporary Fixation Pins are indicated for the fixation of bone fractures, fusion of joints or bone reconstructions, or as guide pins for insertion of other implants. The Temporary Fixation Pins are offered in a variety of lengths, diameters, tip styles, and threading. The devices are made of either 17-4 stainless steel per ASTM F138 or titanium alloy (Ti-6Al-4V-ELI) per ASTM F136. The devices are delivered non-sterile and have to be sterilized before use. After fracture healing the implants have to be removed.

AI/ML Overview

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device performance:

The provided document is a 510(k) summary for a medical device (Temporary Fixation Pins), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the way you've described.

Therefore, most of the information you've requested regarding acceptance criteria, study design, sample sizes, ground truth, experts, and comparative effectiveness studies is not present in this type of document because such studies are generally not required for 510(k) clearances.

However, I can extract the relevant information and explain why other parts are missing based on the nature of a 510(k) submission.

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

Acceptance Criteria	Reported Device Performance
Not Available	Not Available
(Specific performance metrics and their acceptance thresholds are not provided as a separate study was not conducted.)	The document states: "The subject Temporary Fixation pins are manufactured from the same materials, fall within the geometry and dimensions, and share the same intended use as previously cleared for the predicate device. Therefore, it is expected that they would perform equivalent to the predicate devices."

Explanation: In a 510(k) submission like this, the "acceptance criteria" for the device's performance are implicitly met by demonstrating substantial equivalence to a predicate device that has already established safety and effectiveness. No new, specific performance acceptance criteria are defined for this particular submission.

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

Sample Size for Test Set: Not applicable. No performance study was conducted.
Data Provenance: Not applicable. No performance study was conducted.

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)

Number of Experts: Not applicable. No performance study was conducted.
Qualifications of Experts: Not applicable. No performance study was conducted.

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

Adjudication Method: Not applicable. No performance study was conducted.

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

MRMC Study: No. This is a physical medical device (fixation pins), not an AI/software device that would involve human readers or AI assistance.
Effect Size: Not applicable.

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

Standalone Study: No. This is not an algorithm or AI device.

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

Type of Ground Truth: Not applicable. No performance study was conducted in this 510(k) submission. The "ground truth" here is the prior FDA clearance of the predicate device, which established its safety and effectiveness.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. No AI/software device or training data set is involved.

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

Ground Truth Establishment for Training Set: Not applicable. No AI/software device or training data set is involved.

Summary of Device and Rationale from the Document:

Device: Eisertech, LLC Temporary Fixation Pins
Indications for Use: Guide wire for osteosynthesis implants, accessories for external fixation (Steinmann Pin), application as implant according to the principles of fracture management.
Predicate Device: aap Implantate AG aap Wire Bone / K-Wire; Cerciage Wire, Steinmann Pin (K131459)
Primary Argument for Substantial Equivalence: The subject device is substantially equivalent because it uses the "same materials, fall within the geometry and dimensions, and share the same intended use as previously cleared for the predicate device." It also notes that the surface treatment is identical to a reference device (K190565).
Performance Testing: "Performance testing is not necessary and was not performed on the subject device" due to the substantial equivalence argument based on materials, geometry, dimensions, and intended use to the predicate.

In essence, this 510(k) submission is a regulatory filing arguing that the new device is sufficiently similar to an already-approved device that it does not raise new questions of safety or effectiveness, therefore eliminating the need for extensive new performance studies as would be required for a novel device or a PMA.

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.