(81 days)
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.
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.
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.
§ 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.