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The Scaletron ™ consists of the main scaler unit (including a peristaltic water pump), a hose, a connector for handpiece and a foot control switch. It is designed to generate regular linear tip movement at nominal 30 KHz.

AI/ML Overview

This 510(k) premarket notification for the "ScaleTron™ Piezo Ultrasonic Scaler" does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

The provided document describes the device, its intended use, and states its substantial equivalence to a predicate device (Delsonic 2000™ Piezo Ultrasonic Scaler). The FDA letter confirms the substantial equivalence determination.

Therefore, I cannot provide the detailed information requested in the prompt, such as:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number and qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This is because the 510(k) pathway for medical device clearance in this instance relies on demonstrating substantial equivalence to an already legally marketed predicate device, rather than requiring extensive new performance studies with specific acceptance criteria that would typically be detailed in a clinical or performance study report. The substantial equivalence argument is often supported by comparisons of technological characteristics, materials, and intended use, and may not involve a direct "study" in the sense of a clinical trial with acceptance criteria for a new AI/software device.

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K Number

K030603

Device Name

PROANGLE DISPOSABLE PROPHY ANGLE

Manufacturer

PAC-DENT INTERNATIONAL (SUZHOU), LTD.

Date Cleared

2003-04-14

(48 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

ProAngle™ disposable prophy angle is a device intended to polish and clean the surface of teeth. It should be attached to a low speed handpiece for operation.

Device Description

ProAngle™ disposable prophy angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.

AI/ML Overview

The provided text is a 510(k) summary for a dental device, the "ProAngle™ disposable prophy angle." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in the way a clinical trial for a diagnostic AI device would.

Therefore, many of the requested categories for a clinical study with acceptance criteria simply do not apply to this type of submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence: The device must be demonstrated to be "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This is the primary "acceptance criterion" for a 510(k) submission.	The document explicitly states: "ProAngle™ disposable prophy angle is substantially equivalent to other legally marketed devices in the United States. ProAngle™ disposable prophy angles function in a same manner and have the same use as the disposable prophy angle designed by AllPro, Inc." The FDA's letter (K030603) confirms this finding: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (...) to legally marketed predicate devices..."

Acceptance Criteria

Reported Device Performance

Substantial Equivalence: The device must be demonstrated to be "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This is the primary "acceptance criterion" for a 510(k) submission.

The document explicitly states: "ProAngle™ disposable prophy angle is substantially equivalent to other legally marketed devices in the United States. ProAngle™ disposable prophy angles function in a same manner and have the same use as the disposable prophy angle designed by AllPro, Inc." The FDA's letter (K030603) confirms this finding: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (...) to legally marketed predicate devices..."

Regarding specific performance, the document describes the device's function: "It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth." The intended use is "for polishing and cleaning teeth." No specific quantitative performance metrics (e.g., polishing efficiency, wear resistance, noise levels) are provided or required for this type of submission focused on substantial equivalence to a well-established device type. |

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

This information is not applicable and not provided in the 510(k) summary. A 510(k) for a Class I device like this typically relies on a comparison to a predicate device and adherence to general controls, not on a new clinical study with a test set of patients or data. The "test set" in this context is the comparison between the new device's design/function and the predicate device's design/function.

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

This information is not applicable. No "ground truth" establishment by experts in a clinical study context is described or required for this 510(k) submission focused on substantial equivalence of a general dental tool. The "ground truth" for the predicate device's safety and effectiveness would have been established historically through its prior marketing and use.

4. Adjudication Method for the Test Set

This information is not applicable. No adjudication method is described as there isn't a "test set" in the context of a clinical performance study.

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 information is not applicable. This device is a manual dental tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related effect sizes are entirely irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical dental tool, not an algorithm, so a standalone algorithm performance evaluation is not relevant.

7. The Type of Ground Truth Used

This information is not applicable in the context of a clinical "ground truth" from pathology or outcomes data. The "ground truth" for this 510(k) is the established safety, effectiveness, and intended use of the predicate device (Allpro, Inc., Disposable prophy angle) as determined by its prior marketing clearance. The new device is simply confirming it matches this established "ground truth."

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" for an algorithm or a clinical study mentioned in this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set mentioned, the method for establishing its ground truth is also not mentioned.

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