(93 days)
The Aromatic and Flavored Tongue Depressor is intended to displace the tongue to facilitate examination of the surrounding organs. They are available in the following colors: Yellow. blue, orange, magenta, pink. green and red.
The Aromatic and Flavored Tongue Depressor is for medical use which is comprised of a non-toxic thermoplastic material and an aromatic sweetener. The device is molded through a process of injection molding originating an article of vibrant colors, with taste and smell, 8 to 20 cm. long; 1 to 4 cm wide and 0.1 to 0.3 cm thick.
The provided 510(k) summary for the "Aromatic and Flavored Tongue Depressor" (K992995) does not describe a study that uses acceptance criteria in the typical sense of a performance study for a medical imaging or AI device.
This device is a basic medical instrument, and the regulatory submission focuses on material safety and equivalence to a predicate device, rather than quantifiable performance metrics like sensitivity, specificity, or accuracy. Therefore, many of the requested categories are not applicable to this document.
Here's the information that can be extracted, and an explanation of why other categories are not present:
Acceptance Criteria and Device Performance Study for K992995: Aromatic and Flavored Tongue Depressor
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Safety | Non-toxic thermoplastic material. | Material Testing Certifications were supplied, confirming the plastic (polypropylene), pigments/colors, aroma, and flavor/taste meet safety standards. |
| Biocompatibility | Patient-contacting materials must be biocompatible. | Biocompatibility testing results revealed "passing data." |
| Functional Equivalence | Ability to displace the tongue to facilitate examination of surrounding organs, comparable to predicate. | ("Discussion of Non-Clinical Tests Performed"): No specific functional tests are detailed, but the submission implicitly relies on the mechanical similarity of the device to the predicate for functional equivalence. The description states it is "molded through a process of injection molding originating an article of vibrant colors, with taste and smell, 8 to 20 cm. long; 1 to 4 cm wide and 0.1 to 0.3 cm thick." |
| Physical Dimensions | Similar size range to predicate device. | "similar" sizes reported in the comparison table: 8 to 20 cm. long; 1 to 4 cm wide and 0.1 to 0.3 cm thick. |
| Intended Use | Same as predicate device (displace tongue for examination). | "same" intended use as predicate. |
| Manufacturing Quality | Compliance with Good Manufacturing Practice (GMP) regulation (implied for all medical devices). | The FDA's letter states: "A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The document describes material and biocompatibility testing, not a clinical "test set" in the context of imaging or AI. The material testing certifications and biocompatibility assessments would have involved specific test samples as per relevant standards (e.g., ISO 10993 for biocompatibility), but the exact number of samples or data provenance (country, retrospective/prospective) for these lab tests are not detailed in this summary.
- Data Provenance: Not specified, as it pertains to internal lab testing, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This device does not generate diagnostic interpretations requiring expert ground truth establishment. Biocompatibility testing is assessed against established standards by laboratory professionals.
4. Adjudication Method for the Test Set:
- Not applicable. There is no "test set" requiring adjudication in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not an AI or imaging device, and therefore, no MRMC study was performed or is relevant.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- Material Safety: Ground truth is based on established materials science standards, chemical analyses, and regulatory guidelines for non-toxicity, colorants, flavorings, and aroma additives.
- Biocompatibility: Ground truth is established by recognized international standards for biocompatibility testing (e.g., ISO 10993 series), using in-vitro or in-vivo models to assess biological responses.
- Intended Use/Functionality: Ground truth for functional equivalence is based on the predicate device's established safe and effective use through manual physical displacement of the tongue.
8. Sample Size for the Training Set:
- Not applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no "training set" or "ground truth" establishment in the AI/machine learning sense for this device.
§ 880.6230 Tongue depressor.
(a)
Identification. A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.(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 § 880.9. If the device is not labeled or otherwise represented as sterile, it is 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.