OSspray Sylc CR compound is a single-phase calcium phosphosilicate ceramic product intended for the removal of weakened or decayed small enamel lesions, in addition to the cleaning of enamel surfaces and providing relief of hypersensitivity associated with exposed dentin and open dentinal tubules.

Device Description

OSspray Sylc CR is a biologically-compatible device designed to selectively remove weakened or decayed carious enamel without damaging underlying healthy enamel in addition to cleaning tooth surfaces and closing exposed dentine tubules. The device when applied as a dry powder via an air polishing or air abrasion delivery system to a decayed enamel surface will abrade away the decayed tissue. The process of cleaning the tooth surface physically occludes exposed dentin tubules for the management of sensitive teeth. OSspray cares removal powder is a dry inorganic particulate, (calcium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). To aid powder flow less than 2% by weight of silicon dioxide (Aerosil R972 Pharma) is added to the calcium phosphosilicate.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the OSspray Sylc CR device. It focuses on demonstrating substantial equivalence to a predicate device (OSspray Cleaning Compound) rather than establishing specific quantitative acceptance criteria or a comprehensive study proving performance against such criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Generally, for a 510(k) submission, the "acceptance criteria" are often implicit: demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Specific numerical performance targets (e.g., % reduction in pain, % tooth surface cleaned) are less explicitly stated as "acceptance criteria" in this type of submission, but rather as performance data supporting equivalency.

Acceptance Criterion (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance (OSspray Sylc CR)
Intended Use Equivalence: Same intended uses as predicate (cleaning, desensitization).	Intended for removal of weakened/decayed small enamel lesions, cleaning enamel surfaces, relief of hypersensitivity. (Adds selective removal of weakened/decayed enamel as a specific target.)
Technological Characteristics Equivalence: Similar materials, design, mechanism of action.	Single-phase calcium phosphosilicate ceramic product, dry power, applied via air polishing/abrasion system. Differences: smaller particle size (5-50 microns vs. 55-75 microns for predicate) and addition of up to 2 wt% silicon dioxide flow aid.
Biocompatibility: No hazardous effects to patient.	Evaluated for cytotoxicity (L-929), intracutaneous irritation, sensitization. Results indicate "no evidence of any hazardous effects to the patient if the product is used as directed."
Tubule Occlusion Efficacy (for hypersensitivity relief mechanism): Statistically equivalent tubule occlusion to predicate.	Evaluated using an in vitro dentin block model. Results indicate "statistically equivalent number of tubules occludes when compared with OSspray Cleaning Compound."
Selective Enamel Removal (new primary claim): Ability to selectively remove weakened/decayed enamel without damaging healthy enamel.	"Designed to selectively remove weakened or decayed carious enamel without damaging underlying healthy enamel." "Kinetic energy of the particles is such that it is able to selectively remove any weakened or infected enamel and leave healthy or affected enamel intact."
Not suitable for bulk healthy enamel removal: Safe for healthy enamel.	"Neither OSspray Cleaning Compound nor Sylc CR is suitable for the removal of bulk healthy enamel."

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

Biocompatibility: Not explicitly stated as a "test set" in terms of subject or case count. Standard in vitro tests (cytotoxicity, irritation, sensitization) typically involve cell cultures or animal models. The document does not specify the number of samples or subjects used for these in vitro tests.
Tubule Occlusion Efficacy: In vitro dentin block model. The sample size for dentin blocks used is not specified in the document.
Selective Enamel Removal/Cleaning: The document mentions "Bench testing has shown that Sylc CR is a more accurate method for selectively removing decayed dental tissue than traditional dental burs and aluminum oxide air abrasion." However, no sample size, specific study design, or provenance data are provided for this bench testing.

Data Provenance:

All studies mentioned (biocompatibility, tubule occlusion) appear to be laboratory-based (in vitro or bench testing).
The manufacturer is OSspray Ltd, based in London, UK. It's reasonable to assume the studies were conducted by or on behalf of the manufacturer, potentially in the UK or an affiliated lab. No specific country of origin for the data is explicitly stated, but the company's location suggests non-US origin.
All data are retrospective in the sense that they were generated prior to this submission.

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

There is no mention of expert involvement or ground truth establishment in the context of human expert consensus for image review or clinical assessment. The studies described are in vitro bench tests (biocompatibility, tubule occlusion, general cleaning/abrasion). Therefore, this question is not applicable based on the provided text.

4. Adjudication Method for the Test Set

Not applicable. The studies described are not clinical trials or diagnostic accuracy studies requiring adjudication of human reader findings.

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. This device is an abrasive compound, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is not an algorithm. Its performance is inherent to its physical properties and mechanical action. The in vitro tests described assess the device's inherent performance.

7. The Type of Ground Truth Used

Biocompatibility: Standardized in vitro assay results (cytotoxicity, irritation, sensitization).
Tubule Occlusion Efficacy: Quantitative measures of tubule occlusion observed under microscopy in the in vitro dentin block model ("statistically equivalent number of tubules occluded").
Selective Enamel Removal/Cleaning: The "bench testing" likely involved quantitative measurement of material removal and assessment of surrounding healthy tissue integrity, often by profilometry, microscopy, or other analytical techniques. The document refers to it being "a more accurate method," implying a measurable outcome.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set."

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

Not applicable. As above, this device does not utilize a training set.

Summary

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510(k) Premarket Notification
CONFIDENTIAL
OSSpray Ltd
OSSpray Sylc-CR

SECTION E 510(k) SUMMARY

103114 MAR 1 4 2011

1. SUBMITTER INFORMATION:

Name: Address: OSspray Ltd. Hodgkin Building King's College London Guys Hospital Campus London SEI IUL

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

Contact: Ian Thompson, Ph.D.

Preparation Date: September 2010

2. DEVICE NOMENCLATURE:

Trade Name: OSspray Sylc CR Common Name: Calcium Phosphosilicate Classification Name: (EJR) Agent, Polishing, Abrasive, Oral Cavity

3. LEGALLY MARKETED PREDICATE DEVICE:

Device Name: OSspray Cleaning Compound 510(k) Number: K062502 Applicant: OSspray Ltd, Hodgkin Building, King's College London, Guys Hospital Campus, London, SE1 1UL

4. DEVICE DESCRIPTION:

The device when applied as a dry powder via an air polishing or air abrasion delivery system to a decayed enamel surface will abrade away the decayed tissue.

The process of cleaning the tooth surface physically occludes exposed dentin tubules for the management of sensitive teeth.

OSspray cares removal powder is a dry inorganic particulate, (calcium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). To aid powder flow less than 2% by weight of silicon dioxide (Aerosil R972 Pharma) is added to the calcium phosphosilicate.

Bench testing has shown that Sylc CR is a more accurate method for selectively removing decayed dental tissue than traditional dental burs and aluminum oxide air abrasion

Confidential

3/10/2011

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5. INTENDED USE:

OSspray Sylc CR compound is a single-phase calcium phosphosilicate ceramic product intended for the removal of weakened or decaved small enamel lesions, in addition to the cleaning of enamel surfaces and providing relief of hypersensitivity associated with exposed dentin and open dentinal tubules.

6. Technological Characteristics:

The technological characteristics of OSspray Sylc CR and FDA cleared OSspray Cleaning Compound (K062502) are identical, except for particle size and the addition of up to 2 wt% silicon dioxide flow aid (Aerosil R972 Pharma). Both devices clean tooth enamel, desensitize and are a single-phase dry powder.

The primary difference between the two devices is that OSspray Sylc CR has a smaller particle size distribution of 5-50 microns. Sylc CR is designed to selectively remove weakened enamel or caries decay. This process requires the particle flow, delivered via an air polishing or abrasion unit, to be focused onto the weakened enamel site for a short period of time. The kinetic energy of the particles is such that it is able to selectively remove any weakened or infected enamel and leave healthy or affected enamel intact. The OSspray Cleaning Compound has a mean particle size distribution of 55-75 microns and is designed to remove heavy stain and plaque.

Neither OSspray Cleaning Compound nor Sylc CR is suitable for the removal of bulk healthy enamel.

The OSspray Sylc CR is a bioactive glass intended to remove decayed enamel by abrasion of weakened enamel when the powder is directed at the tooth surface in a compressed air stream.

7. SAFETY AND PERFORMANCE DATA:

The biocompatibility of OSspray Sylc CR, with 2% by weight silicon dioxide flow aid (Aerosil R972 Pharma) was evaluated for cytotoxicity (L-929), intracutaneous irritation sensitization sensitization. The results of these tests indicate that there is no evidence of any hazardous effects to the patient if the product is used as directed.

The tubule occlusion efficacy of OSspray Svlc CR was evaluated using an in vitro dentin block model. The results indicate that OSspray Sylc CR compound occludes a statistically equivalent number of tubules when compared with OSspray Cleaning Compound.

8. CONCLUSIONS:

OSspray Sylc CR compound is considered to be equivalent in cleaning and desensitization properties to that of OSspray Cleaning Compound. The provided in vitro performance and biocompatibility data demonstrate the substantial equivalence of OSspray Sylc CR compound for the intended uses.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract bird or a series of interconnected human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Ian Thompson Technical Director OSspray, Limited Hodgkin Building, Kings College London London, United Kingdom SE1 1UL

MAR 1 4 201

Re: K103114 Trade/Device Name: OSspray Sylc CR Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: December 12, 2010 Received: February 2, 2011

Dear Dr. Thompson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Dr. Thompson

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default .htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony D. Martson

Anthony D. Watson, B.S., M.S., M.B.A. 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 D STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): 上 () 3/14

Device Name: OSspray Sylc CR

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

OR (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Susan Bunner

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

510(k) Number:

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.