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

This document is a 510(k) Summary for a medical device called the EMS KERMIT®, an ultrasonic scaler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics as one might find in a Premarket Approval (PMA) application or a clinical trial report.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present within this 510(k) Summary for the EMS KERMIT®.

Here's why and what can be inferred:

510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. This often relies on comparing technical specifications, materials, performance claims, and intended use rather than requiring new, extensive clinical trials to establish safety and effectiveness from scratch.
"Acceptance Criteria" in 510(k): For a 510(k), "acceptance criteria" generally refer to the criteria used to determine if the new device performs as safely and effectively as the predicate device for its intended use. This might involve bench testing, engineering comparisons, or limited performance testing, but not typically the kind of detailed clinical study data often associated with AI/software devices.
"Study that proves the device meets the acceptance criteria": In a 510(k), this is typically a "substantial equivalence" comparison, where the new device's features and performance are shown to be comparable to the predicate. The document lists predicate devices (EMS miniPiezon, Piezon Master 400, etc.) which means the applicant likely presented data or arguments showing the EMS KERMIT® performs similarly to these devices.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details because the information is not provided in this 510(k) Summary.

However, I can extract the relevant information about the device and its intended use, and explain the absence of the other requested data.

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

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance (Inferred from 510(k) process)
Safety and Effectiveness: Demonstrate that the EMS KERMIT® is as safe and effective as its predicate devices for its stated intended uses.	The FDA determined the device is "substantially equivalent" to predicate devices, implying it meets comparable safety and effectiveness standards.
Performance for Intended Use: Perform consistently for tasks such as removing calculus, scaling, root planing, etc., without introducing new risks compared to predicates.	The device's intended uses are listed (removing calculus, scaling, root planing, etc.). The FDA's clearance indicates that the applicant successfully demonstrated it performs these functions comparably to predicates.
Technical Characteristics: Physical and operational characteristics (e.g., ultrasonic vibration, power output, tip design) should be comparable to predicate devices or have justified differences.	Not explicitly detailed in this summary, but a 510(k) submission would include such comparisons. The FDA's clearance implies these characteristics were found acceptable.

2. Sample sized used for the test set and the data provenance

Not provided in the 510(k) Summary. 510(k)s for mechanical devices like ultrasonic scalers often rely on bench testing, materials testing, and comparisons to predicate devices rather than clinical studies with large "test sets" in the context of AI. If any testing was done, the details are not in this summary.

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

Not applicable/Not provided. This level of detail is typically associated with clinical studies for AI/software devices where ground truth needs to be established by multiple expert reviewers. For an ultrasonic scaler, performance verification would likely rely on engineering/bench testing and comparison to predicate device specifications.

4. Adjudication method for the test set

Not applicable/Not provided. See the explanation for point 3.

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. The EMS KERMIT® is a physical medical device (ultrasonic scaler), not an AI or software-as-a-medical-device (SaMD) that assists human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

Not applicable. The EMS KERMIT® is a physical medical device, not an algorithm.

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

Not applicable/Not provided in this summary. For a physical device, "ground truth" often relates to measured physical properties, successful removal of calculus in in-vitro models, or comparison against established predicate device performance. Specific "ground truth" in the clinical AI sense is not relevant here.

8. The sample size for the training set

Not applicable. The EMS KERMIT® is a physical device, not an AI model that requires a training set.

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

Not applicable. See the explanation for point 8.

Summary

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.