Under the supervision of a healthcare professional, SINCLAIR SST™ promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SST TM provides temporary relief for damaged salivary function.

Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms.

Device Description

SST™ is formulated as a tablet that is allowed to dissolve slowly in the mouth. The tablets are presented in containers of various counts. They contain a mixture of electrolytes in a pleasant flavored tablet.

AI/ML Overview

The provided 510(k) summary for Sinclair SST™ focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving quantitative measurements like those typically associated with AI/ML device evaluations.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission. The device is a "Saliva Supporting Tablet" for dry mouth relief, not an AI/ML diagnostic or prognostic tool.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not present specific quantitative acceptance criteria or detailed performance metrics from a clinical study for the Sinclair SST™ in the way that would be expected for an AI/ML device. Instead, the "acceptance criteria" for a 510(k) submission like this are primarily based on demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.

The "performance" is implicitly deemed acceptable if it is substantially equivalent to the predicate devices.

Acceptance Criteria (Implied by 510(k))	Reported Device Performance (Summary from 510(k))
Safety and Effectiveness:	"Functional and performance testing has been conducted to assess the safety and effectiveness of SSTTM and all results are satisfactory."
- No new questions of safety/effectiveness are raised compared to predicates.	Directly addressed by substantial equivalence claim.
- Device functions as intended for its stated indications for use.	As described in Section 5, the device "promotes lubrication of oral mucosa that may be dry (xerostomia)... provides temporary relief for damaged salivary function."
Technological Characteristics:	Method of Use: Ready to use (similar to Salivart, Caphosol requires mixing)
- Similar method of use, number of applications, claim, area of use, disease state, and presentation compared to predicates.	# of applications per day: Take as needed up to 16 tablets per day (similar to predicates "Take as needed")
	Claim: Symptomatic treatment of xerostomia (identical to predicates)
	Area of Use: Oral cavity (identical to predicates)
	Disease State: Xerostomia (identical to predicates)
	Type of Product: Tablet (different from predicates which are solutions, but not considered a new question of safety/effectiveness)
	Presentation: Non Sterile (identical to predicates)

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

Not Applicable. This 510(k) summary does not describe a clinical "test set" in the context of an AI/ML device evaluation. The "functional and performance testing" mentioned is general and not detailed with specific sample sizes or data provenance for a clinical trial. The basis of equivalence is largely on the comparison of technological characteristics and intended use.

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

Not Applicable. As there is no described clinical test set with a ground truth assessment by experts in the context of an AI/ML evaluation.

4. Adjudication method for the test set:

Not Applicable. No clinical test set with expert adjudication is described.

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 is not an AI-assisted diagnostic or prognostic device, so an MRMC study is irrelevant.

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

Not Applicable. This is a physical product (a tablet), not an algorithm.

7. The type of ground truth used:

Not Applicable. There is no "ground truth" used in the context of an AI/ML evaluation, as this is a physical device submission focused on substantial equivalence. The "safety and effectiveness" assessment would have involved standard medical device testing, likely chemical and physical property evaluations for the tablet, and possibly small-scale human user perception studies (though not detailed here) rather than a diagnostic 'ground truth.'

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no training set.

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

Not Applicable. This is not an AI/ML device, so there is no ground truth for a training set.

Summary based on the provided document:

The 510(k) submission for Sinclair SST™ is for a medical device (saliva supporting tablets) and is based on demonstrating substantial equivalence to existing legally marketed predicate devices (Gebauer Company Salivart and Inpharma AB Caphosol). The determination of substantial equivalence means the device is considered as safe and effective as the predicate devices. The "tests and conclusions" section states that "Functional and performance testing has been conducted to assess the safety and effectiveness of SSTTM and all results are satisfactory," but does not provide specific details about these tests, methodologies, or quantitative results that would be expected in a performance study for an AI/ML algorithm.

Summary

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K023044

Image /page/0/Picture/1 description: The image shows the logo for Sinclair Broadcast Group. The logo consists of the word "SINCLAIR" in a sans-serif font, with a stylized oval shape above and below the word. The oval is broken into two parts, with the top part curving downwards and the bottom part curving upwards, creating a visual effect of an orbit or ring around the word.

Attachment 7 510(k) Summary

September 10, 2002

DEC 0 2 2002

Submission Applicant & Correspondent: Sinclair Pharmaceuticals Limited Name: Address:

Borough Road Godalming Surrey GU7 2AB United Kingdom

Phone No.: +44 1483 428 611 Contact Person: Denise Swift, Director of Regulatory Affairs

Name of Device: SSTTM SALIVA SUPPORTING TABLETS

Trade/Proprietary/Model Name: Common or Usual Name: Classification Names:

SSTTM SALIVA SUPPORTING TABLETS Dental: Saliva, artificial Dental: Saliva, artificial

Devices to Which New Device is Substantially Equivalent:

Gebauer Company: Salivart cleared in 510(k) K981693 and Inpharma AB: Caphosol cleared in 510(k) K991938

Device Description:

Intended Use of the Device:

Under the supervision of a healthcare professional, SINCLAIR SST™ promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SST™ provides temporary relief for damaged salivary function.

Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms.

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1. Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
  SST™ has the same intended/indications for use as the predicate devices Gebauer Company Salivart and Inpharma AB Caphosol.

ProductName	SST	Salivart	Caphosol
Method ofUse	Ready to use	Ready to use	Mix solutionsA & B
# ofapplicationsper day	Take asneeded up to16 tablets perday	Take as needed	Take as needed
Claim	Symptomatictreatment ofxerostomia.	Symptomatictreatment ofxerostomia.	Symptomatictreatment ofxerostomia.
Area of Use	Oral cavity	Oral cavity	Oral cavity
Disease State	Xerostomia	Xerostomia	Xerostomia
Type ofProduct	Tablet	Solution	Solution
Presentation	Non Sterile	Non Sterile	Non Sterile

Tests and Conclusions:

Functional and performance testing has been conducted to assess the safety and effectiveness of SSTTM and all results are satisfactory.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The logo is black and white and appears to be slightly distressed or aged.

Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850 .

Ms. Denise Swift Director, Regulatory Affairs Sinclair Pharmaceuticals, Limited Borough Road, Godalming. Surrey GU7 2AB UNITED KINGDOM

Re: K023046

Trade/Device Name: Sinclair SSTTM Regulation Number: None Regulation Name: Dental, Saliva Artificial Regulatory Class: Unclassified Product Code: LED Dated: September 10, 2002 Received: September 12, 2002

Dear Ms. Swift:

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 vour 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. Swif

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours

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

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Attachment 3

Indications for Use Statement

510(k) Number (if known)

Device Name

N2 5046

SINCLAIR SST™

Indications for Use

Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms.

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109) OR

Over-The Counter Use

Swear Rourty

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

KO23046 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 864.1850 Dye and chemical solution stains.

(a)
Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.(b)
Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.