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Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue.

Device Description

The device consists of a small hand held motor, a foot control and a controller. Accessories complete the device. They are designed for use in dental surrery. Optimum irrigation of the treatment site is an important factor for successful treatment. An integrated pump is used to supply the treatment fluid / oooolant from its reservoir via a pump to the motor / handpiece.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "Private Label Versions of implantMED SI-915/923" (K060287). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria through performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from the provided text in the manner typically expected for a performance study of an AI/imaging device.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" for this 510(k) submission are primarily focused on demonstrating substantial equivalence to existing predicate devices (implantMED SI-95 (K002469) and implantMED SI 915/923 (K052741)). The performance is not reported in terms of specific quantitative metrics, but rather in terms of similarity to the predicate.

Acceptance Criteria (based on substantial equivalence)	Reported Device Performance (based on this 510(k))
Same Intended Use as Predicate Device	The private label versions share the same indication for use as implantMED SI-95. The intended use is: "Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue."
Similar Technological Characteristics to Predicate Devices	"The technological characteristics of the private label versions are very similar to the previous implantMED versions."
"The comparison of the subject and the predicate device 'implantMED SI-915/923' shows very similar technological characteristics."
Same Performance Properties as Predicate Devices	"Performance properties... are the same [as the subject and predicate device 'implantMED SI-915/923']."
Same Biocompatibility as Predicate Devices	"Biocompatibility are the same [as the subject and predicate device 'implantMED SI-915/923']."
Minor Differences from Predicate Devices	Differences "result from the modification of the Intended Use and become manifest in programs and factory settings." Also, "an alternative foot control" is offered. These differences are deemed not to raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. This document does not describe a performance study with a test set of data. It's a regulatory submission demonstrating substantial equivalence based on comparing device specifications and intended use.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. No ground truth establishment activity for a test set is described.

4. Adjudication Method for the Test Set:

Not Applicable. No test set or adjudication method is described.

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 mechanical dental surgical unit, not an AI or imaging device with human readers.

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

Not Applicable. This device contains a mechanical motor and control unit, not an algorithm in the sense of AI or image processing.

7. The type of ground truth used:

Not Applicable. No explicit "ground truth" in the context of diagnostic accuracy or AI performance is used or described. The "ground truth," in a regulatory sense for this submission, is the established safety and effectiveness of the predicate devices to which this device is compared.

8. The sample size for the training set:

Not Applicable. This document does not describe the development of an algorithm or model that would require a training set.

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

Not Applicable. As no training set is described, no ground truth for it was established in this context.

Summary of what the document does provide:

Predicate Devices: implantMED SI-95 (K002469) and implantMED SI 915/923 (K052741).
Basis for Substantial Equivalence: The new private label versions share the same indication for use, very similar technological characteristics, and the same performance properties and biocompatibility as the predicate devices. Differences are minor (modification of intended use interpretation and factory settings, alternative foot control).
Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls.

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