This document is a 510(k) summary for a prophy paste, which is a dental abrasive used for cleaning teeth. It does not present acceptance criteria or a study proving the device meets said criteria in the way typically found for medical devices that utilize algorithms or AI.

The information provided describes:

Device Name: Prophy paste
Manufacturer: Challenge Products, Inc.
Predicate Device: Challenge Products, Inc. Prophy Paste (K940496)
Device Description: A prophy paste used by dental professionals to help remove resistant stains.
Intended Use: To help remove materia alba, plaque, and resistant stains from teeth.
Technological Characteristics: Minor differences from the predicate, not impacting safety or effectiveness.
Safety Review: A review of 11 MDR records related to FDA product code "EJR" (prophy paste).

Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, algorithm performance, ground truth, or study methodology because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, a different regulatory pathway than showing performance against pre-defined acceptance criteria through a study for a novel device or AI.

Summary

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I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

K962370

1. Name and Address

This Summary of Safety and Effectiveness is being submitted by Challenge Products, Inc., Lake Road 54-22 P.O. Box 468, Osage Beach, Missouri 65065.

2. Name of the Device

The device is generally known as a prophy paste.

3. Identification of Predicate Device(s)

Challenge Products, Inc. Prophy Paste, FDA control number K940496.

4. Description of the Device

The device is a prophy paste which is used by dental professionals to help remove resistant stains from the surface of the teeth.

5. Intended Use of the Device

The intended use of the prophy paste is to help remove materia alba, plaque and resistant stains from the teeth.

6. Comparison of Technological Characteristics

The differences between Challenge's new prophy paste and the predicate device are minor and do not impact the safety and effectiveness of the device in any significant way.

7. Safety

Challenge reviewed the 11 MDR records filed with CDRH relating to FDA's product code,"EJR" which were obtained from a CD-ROM database1. Most of the events occurred as a result from an allergic or adverse reaction to a prophy

1 The Medical Device Library, IHS Regulatory Products, 15 Inverness Way East, Englewood, CO 80150.

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jet powder. 3 of the 11 reports were filed for a prophy paste and 1 report was on a patient with a history of allergies. These reports follow.

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Regulation Number and Section

§ 872.6030 Oral cavity abrasive polishing agent.

(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.