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SOOTHE-N-SEAL™ Canker Sore Relief creates a thin, protective barrier that provides immediate and long lasting relief of pain associated with canker sores, mouth sores, and traumatic ulcers, such as those caused by braces.

SOOTHE-N-SEAL™ Canker Sore Relief (formulated 2-octyl cyanoacrylate) is a non-sterile, clear, colorless, free-flowing liquid protectant packaged in high-density polyethylene multipleuse, controlled dropper bottles. The device package contains one gram of liquid protectant and 10 double-ended applicator swabs in a transparent polyethylene terephthalate tray with cardboard display label. Each end of the swab handle consists of a polyurethane foam sponge tip, one end rounded for drying the ulcer area and one end pointed for device application.

SOOTHE-N-SEAL™ Canker Sore Relief is composed of 2-octyl cyanoacrylate (>99%) with small amounts of polymerization inhibitors added to enhance shelf life.

This document describes a medical device called SOOTHE-N-SEAL™ Canker Sore Relief, a liquid protectant for oral ulcers. The document focuses on the claim of substantial equivalence to predicate devices based on clinical performance data. However, it does not explicitly define "acceptance criteria" through numerical targets for the studies. Instead, the studies aim to demonstrate safety, effectiveness in pain reduction (immediate and long-term), and non-detrimental effect on ulcer healing, comparing the device to sham or predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit numerical acceptance criteria are not stated, the table below reflects what the studies aimed to demonstrate to show substantial equivalence and the reported outcomes:

2. Sample Sizes and Data Provenance

• Test Set 1 (Single-center study):

  • Sample Size: 42 subjects.
  • Data Provenance: Not explicitly stated, but "single-center study" suggests a localized study, likely within the country where the device was developed or intended to be marketed (implied US, given the FDA submission).
  • Retrospective/Prospective: Prospective (subjects were randomized to treatment, pain assessments recorded during the study).

• Test Set 2 (Multi-center clinical study):

  • Sample Size: 155 subjects.
  • Data Provenance: Not explicitly stated, but "multi-center" suggests multiple sites, likely within the US given the FDA submission.
  • Retrospective/Prospective: Prospective (subjects randomized and observed over time).

3. Number of Experts and Qualifications for Ground Truth

• The document states that subjects were "examined daily by the clinical investigator until ulcer healing." It does not specify the exact number of clinical investigators or their specific qualifications (e.g., medical doctors, nurses, etc.) beyond being a "clinical investigator." It also describes the investigator applying the device in the first study. No specific "experts" for establishing ground truth in the sense of independent review of data, like radiologists for imaging, are mentioned for this type of device.

4. Adjudication Method for the Test Set

• The document implies that "clinical investigators" performed daily examinations. There is no mention of a formal adjudication method (like 2+1 or 3+1 consensus) for the assessments of pain or healing. Pain was self-reported by subjects (unchallenged pain) and measured by their response to an irritant (challenged pain). Healing was assessed by the clinical investigator.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context described. This type of study is more common for diagnostic imaging devices where multiple human readers assess cases with and without AI assistance. The described studies are clinical trials comparing the device to sham or predicate devices in terms of patient-reported outcomes and investigator assessment of healing.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a physical product (a liquid protectant) and not an algorithm or AI system. Therefore, a standalone performance study in the context of an algorithm's performance without human intervention is not relevant.

7. Type of Ground Truth Used

• Clinical observation and patient-reported outcomes:
  • Patient-reported pain: Subjects recorded "unchallenged, or ambient, pain" and "challenged pain" (in response to orange juice). They also recorded unchallenged pain four times daily in a study diary.
  • Clinical Investigator assessment: Ulcer healing was assessed daily by the clinical investigator.

8. Sample Size for the Training Set

• Not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are clinical trials for product validation.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As above, there is no training set for this device.

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