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The drive unit is an electrically controlled screwdriver with adjustable torques to tighten and unscrew prosthodontic screws. Consisting of: - Cordless drive unit - Mechanical transmission instrument 80:1

The cordless Prosthodontic Screwdriver IA-400 consists of the cordless drive IA-40H, the contra-angle attachment IA-80 and a key pad (finger switch). The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-charged using the provided charging station. The drive and the contra-angle attachment are connected via a special coupling, based on ISO 3964. By means of the different buttons on the drive the user controls the various settings, such as ON, forward/reverse and the torque. The attached key pad (finger switch) allows starting and stopping the screwdriver's rotation. The handpiece's application is intended in dentistry.

The provided 510(k) summary for the "Prosthodontic Screwdriver IA-400" does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way a clinical or performance study for an AI/CADe device would.

This submission is for a physical medical device (a dental handpiece), not a software-based or AI-powered diagnostic device. Therefore, the questions related to AI/CADe studies, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this 510(k) document.

The "Performance Testing" section states: "W&H's Prosthodontic Screwdriver IA-400 was developed and is produced under consideration of all applicable technical standards and quality management directives. The product's conformance with the applicable technical standards was verified in the course of type testing. Bench testing results demonstrated substantially equivalence. Perfect functionality and accuracy of all serial devices are controlled in the final step of production."

This implies that performance was assessed against relevant technical standards and internal quality controls through bench testing. The acceptance criteria would likely be derived from these technical standards for dental handpieces, focusing on aspects like torque accuracy, power output, durability, and safety, as well as demonstrating substantial equivalence to predicate devices.

Here's a breakdown based on the provided document, acknowledging the non-AI nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the performance testing at a high level. Specific, quantifiable acceptance criteria and detailed reported performance values are not provided in this 510(k) summary. Instead, it broadly states:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated. For bench testing of a physical device like this, the 'sample' would refer to the units tested during type testing and then controls during production.
• Data Provenance: Not specified, but implied to be from W&H Dentalwerk Buermoos GmbH's internal testing facilities in Austria ("A - 5111 Buermoos Austria").
• Retrospective/Prospective: Not applicable in the context of clinical studies for this device.Bench testing is generally part of a prospective product development and verification process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a physical device undergoing bench testing against technical standards, not a diagnostic device requiring expert interpretation of results for ground truth.

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

• Not applicable. The assessment would involve direct measurement and comparison against technical specifications.

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 not an AI/CADe device.

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

• Not applicable. This is not an AI/CADe device.

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

• For bench testing of a physical medical device, the "ground truth" or reference standard would be the engineering specifications, established technical standards (e.g., ISO standards relevant to dental handpieces), and performance characteristics of the predicate device. Measurements taken during testing would be compared against these predefined standards.

8. The sample size for the training set:

• Not applicable. This is not a machine learning/AI device that requires a training set.

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

• Not applicable. This is not a machine learning/AI device that requires a training set.

In summary: The 510(k) for the Prosthodontic Screwdriver IA-400 relies on bench testing against applicable technical standards and comparison to predicate devices to demonstrate substantial equivalence, rather than clinical trials or AI performance studies.

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