The OSspray Cleaning Compound is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. The OSspray Cleaning Compound is also intended to provide relief from tooth sensitivity during the prophylaxis treatment.

Device Description

The OSspray Cleaning Compound is a biocompatible calcium sodium phosphosilicate compound in powder form intended for cleaning and polishing procedures as part of a dental prophylaxis treatment to remove debris from tooth surfaces. The OSspray Cleaning Compound is also intended to physically occlude dentin tubules to provide relief from tooth sensitivity during the prophylaxis treatment. The process of cleaning the tooth surface with the OSspray Cleaning Compound physically occludes dentin tubules for the management of sensitive teeth. The OSspray Cleaning Compound is a dry inorganic particulate (calcium sodium phosphosilicate) composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). When exposed to an aqueous environment, the OSspray Cleaning Compound undergoes a rapid surface reaction, allowing it to physically adhere to exposed root dentin and to physically occlude tubules. Within a short period of time, essentially all of the particles of the compound react to form hydroxycarbonate apatite (HCA), which is chemically similar to natural tooth mineral.

AI/ML Overview

The provided text describes the OSspray Cleaning Compound, a product intended for dental cleaning, polishing, and relief from tooth sensitivity. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, AUC).

The document focuses on:

Device description and intended use.
Comparison to predicate devices (Prophy Powder and BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN) for substantial equivalence based on technological characteristics.
Biocompatibility testing (cytotoxicity, intracutaneous irritation, maximization sensitization tests) according to ISO 10993.
Tubule occlusion efficacy evaluation using an in vitro dentin block model.
The device's performance is discussed in terms of biocompatibility and in vitro efficacy for tubule occlusion, not in terms of traditional statistical performance metrics like sensitivity, specificity, or reader studies which are typically associated with diagnostic or AI/ML-driven devices.

Therefore, I cannot populate the requested table and answer many of the specific questions as the information is not present in the provided text.

Here's an attempt to answer what can be inferred from the text, with clear indications where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from study types)	Reported Device Performance
Biocompatibility:
- Cytotoxicity (L-929)	Met ─ device is biocompatible and safe.
- Intracutaneous Irritation	Met ─ device is biocompatible and safe.
- Maximization Sensitization	Met ─ device is biocompatible and safe.
Tubule Occlusion Efficacy:
- Statistically significant tubule occlusion compared to controls	Achieved ─ statistically significant tubule occlusion compared to both positive and negative controls.

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

Biocompatibility tests: Sample sizes are not specified for L-929 cytotoxicity, intracutaneous irritation, or maximization sensitization tests.
Tubule occlusion study: The sample size for the in vitro dentin block model is not specified.
Data provenance: Not explicitly stated, but assumed to be from internal lab studies by OSspray Ltd. given the context of a 510(k) submission. No mention of country of origin for data; studies are likely conducted by or for the manufacturer. The studies are in vitro in nature, not retrospective or prospective patient data.

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

Not applicable. The tests described are laboratory-based (biocompatibility, in vitro tubule occlusion) and do not involve human expert interpretation for establishing ground truth in the way a diagnostic imaging study would. The ground truth for biocompatibility is determined by standardized protocols (ISO 10993) and for tubule occlusion by quantitative microscopic analysis.

4. Adjudication method for the test set:

Not applicable. This concept pertains to resolving discrepancies among multiple readers or experts in studies involving human interpretation. The described studies are laboratory-based.

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:

No. An MRMC study was not done. This device is not an AI/ML diagnostic tool, and its performance is not assessed in terms of human reader improvement.

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

Partially applicable, but for a different context. The tubule occlusion efficacy study and biocompatibility tests can be considered "standalone" in the sense that they assess the device's inherent physical/chemical performance, not its interaction or assistance with a human operator's diagnostic capabilities. However, this is not in the context of an "algorithm" or AI.

7. The type of ground truth used:

Biocompatibility: Standardized test protocols (ISO 10993) where "ground truth" is defined by the absence of toxicity, irritation, or sensitization.
Tubule occlusion: Quantitative measurement of occluded tubules using microscopy in an in vitro dentin block model. The "ground truth" is the objective measurement itself.

8. The sample size for the training set:

Not applicable. This device is a physical compound, not an AI/ML algorithm that requires a "training set."

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

Not applicable. (See point 8).

Summary

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510(k) SUMMARY

1. SUBMITTER INFORMATION:

DEC 1 5 2006

OSspray Ltd. Name: Address: 61Thorne Street London SW13 OPT

Phone: +44 (0)207 188 4341 Facsimile: +44 (0)207 188 4360

Contact: Ian Thompson, Ph.D.

Preparation Date: August 2006

2. DEVICE NOMENCLATURE:

Trade Name: OSspray Cleaning Compound Common Name: Dental Prophylaxis Powder Classification Name: Oral Cavity Abrasive Polishing Agent

3. LEGALLY MARKETED PREDICATE DEVICES:

Device Name: Prophy Powder 510(k) Number: Exempt Applicant: PAC-Dent INTL. Inc (Owner Number 9029860)

Device Name: BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN 510(k) Number: K041371 Applicant: NOVAMIN TECHNOLOGY, INC., 13709 Progress Blvd., Suite. 23, Alachua, FL 32615

4. DEVICE DESCRIPTION:

The OSspray Cleaning Compound is a dry inorganic particulate (calcium sodium phosphosilicate) composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). When exposed to an aqueous environment, the OSspray Cleaning Compound undergoes a rapid surface reaction, allowing it to physically adhere to exposed root dentin and to physically occlude tubules. Within a short period of time, essentially all of the particles of the compound react to form hydroxycarbonate apatite (HCA), which is chemically similar to natural tooth mineral.

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5. INTENDED USE:

6. TECHNOLOGICAL CHARACTERISTICS:

The technological characteristics of the OSspray Cleaning Compound and the Prophy Powder are substantially equivalent in that they are both abrasive compounds in powder form designed to polish and clean tooth enamel. The OSspray Cleaning Compound supplies calcium and phosphate ions in the form of a bioactive glass, and the Prophy Powder supplies sodium bicarbonate.

The OSspray Cleaning Compound and the BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN are both composed of bioactive glass particles. Both devices are intended to polish and clean the tooth surface during a prophylaxis treatment. The bioglass component of the Butler predicate device is suspended in glycerin and comes in the form of a paste. The bioglass component of the OSspray Cleaning Compound comes in the form of a dry powder to be applied by a compressed air system (i.e., air polishing). Both devices are also intended for use during a prophylaxis treatment to occlude dentinal tubules and block hydrodynamic flow.

7. SAFETY AND PERFORMANCE DATA:

The biocompatibility of the OSspray Cleaning Compound was evaluated by performing cytotoxicity (L-929), intracutaneous irritation, and maximization sensitization tests according to ISO 10993. The results of these tests indicate that this device is biocompatible and safe if used as directed.

The tubule occlusion efficacy of OSspray Cleaning Compound was evaluated using an in vitro dentin block model. The results indicate that the OSspray Cleaning Compound occludes a statistically significant number of tubules when compared with both positive and negative controls.

8. CONCLUSION:

The OSspray Cleaning Compound is substantially equivalent to the Prophy Powder (510(k) exempt) and the BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN (KO41371). The in vitro performance and biocompatibility data demonstrate that the OSspray Cleaning Compound is substantially equivalent to, and as safe and effective as, the legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2006

OSspray, Limited C/O Ms. Carmelina G. Allis, Esq Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street NW, Suite 1200 Washington, DC 20005

Re: K062502

Trade/Device Name: OSspray Cleaning Compound Regulation Number: 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: December 1, 2006 Received: December 4, 2006

Dear Ms. Allis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Allis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runne
Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION C

INDICATIONS FOR USE

06 > 502 510(k) Number (if known):

Device Name: OSspray Cleaning Compound

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 C.F.R. 801 Subpart D) Over-The-Counter Use (21 C.F.R. 801 Subpart C)

Susan Runne

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

062502

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.