(13 days)
The ASC-12 is an ultrasonic scaler that is intended for the following procedures:
Scaling:
Interdentium treatment
Tooth neck and subgingival treatment
Treatment of large dental calculi
Treatment of coatings and tobacco stains
Treatment of periodontal pockets
Interproximal treatment
Loosening of crowns and posts
Endodontics:
Pulp Chamber Cleaning
Canal filling by ultrasonic gutta-percha condensation
The ASC-12 is an AC mains-powered piezoelectric ultrasonic scaler intended for scaling and endodontic procedures. The device consists of a console, a footswitch and an autoclavable handpiece with interchangeable and autoclavable scaling tips.
The provided document K0708166 describes the Aseptico ASC-12 Piezoelectric Scaler. The submission is a 510(k) for substantial equivalence, not a study presenting novel performance data against acceptance criteria. Therefore, much of the requested information regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not applicable to this type of document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (Satelec Suprasson P5 Booster - K961158 and NSK Varios 350 - K031421) by comparing intended use, design, construction, sterility assurance, and performance specifications.
Here's the breakdown of the information provided in the document concerning "acceptance criteria" which, in this context, are the specified performance characteristics for substantial equivalence validation:
1. Table of "Acceptance Criteria" (Performance Specifications) and Reported Device Performance
The acceptance criteria here are derived from the performance specifications of the predicate devices, which the ASC-12 aims to meet or be equivalent to.
| Acceptance Criteria (Performance Characteristic) | Reported Device Performance (ASC-12) |
|---|---|
| Vibration frequency | Between 27 and 32 kHz |
| Scaler coolant flow at the tip | Between 12 ml and 82 ml |
| Water pressure rating | Between 14.5 to 73 psi (1 to 5 bar) |
| Electrical Safety Specifications | Class II equipment with Type BF applied part |
| Equivalence of scaler tip amplitudes and power settings | Established equivalent scaler tip amplitudes and power settings between ASC-12 and predicate device using prescribed power settings for exact same scaler tips. (See tip movement compatibility data - Table not provided in this extract, but referenced in the document) |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the document is a 510(k) summary for substantial equivalence. It does not describe a clinical study with a "test set" in the traditional sense of evaluating diagnostic or treatment efficacy on patients. The "test" mentioned refers to engineering verification of performance specifications against predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. Ground truth, expert consensus, or clinical outcome data as part of a "test set" is not detailed in this 510(k) summary. The "ground truth" for the engineering performance validation would be the measured physical parameters against the specified ranges.
4. Adjudication Method for the Test Set
This is not applicable. There is no mention of an adjudication method as there's no clinical "test set" with subjective interpretations requiring expert consensus.
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
This is not applicable. The device is an ultrasonic scaler, a physical medical device, not an AI-powered diagnostic or decision support tool. Therefore, MRMC studies are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical instrument, not an algorithm. Standalone performance as typically described for AI devices does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the claims in this submission is based on:
- Engineering Specifications and Measurements: The physical properties and performance parameters (e.g., vibration frequency, coolant flow, water pressure, electrical safety) are measured and compared against established benchmarks or the predicate devices' specifications.
- Comparison to Predicate Devices: The primary "ground truth" for substantial equivalence is the documented characteristics and performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not a machine learning or AI device that requires training data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. See point 8.
Study Proving Acceptance Criteria (Substantial Equivalence)
The entire 510(k) submission itself serves as the "study" proving the device meets the "acceptance criteria" (i.e., demonstrating substantial equivalence to predicate devices). The document states:
- "The following intended [uses] were validated by establishing equivalent scaler tip amplitudes and power settings between a predicate device using their prescribed power settings for the exact same scaler tips to be used with the ASC-12. See tip movement compatibility data."
This indicates that internal engineering verification and comparison testing was conducted. While the detailed "tip movement compatibility data" is not provided in this excerpt, it would constitute the direct evidence of the device's performance against the predicate. The performance claims (frequency, flow, pressure, electrical safety) are typically verified through bench testing and measurements and compared to industry standards or the predicate device's known specifications. The overall conclusion of the FDA (as shown in the subsequent pages granting 510(k) clearance) is that the device is "substantially equivalent" for its intended uses and performance characteristics.
§ 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.