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The E-Z SPACER® Mask (Small) uses FDA approved materials: Dynaflex G2706 Kraton thermoplasiic rubber designed for medical applications, and 21 CFR 178.3297 colorant pigments as specified by the Food and Drug Administration (Colorants for polymers). The E-Z SPACER Mask is injected molded with cavity I.D. mask (E-Z SPACER®MASK (Small) for identification.
This document is a "Summary of Safety and Effectiveness" for the E-Z SPACER® Mask (Small). It describes the materials used, some testing conducted, and general compliance with regulations.
However, it does not provide the type of information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of typical medical device performance evaluation (e.g., diagnostic accuracy, sensitivity, specificity, or other quantitative performance metrics).
Here's why and what information is missing:
- No explicit "acceptance criteria" table: The document doesn't define specific numerical targets or thresholds for performance that the device is intended to meet.
- No "reported device performance" metrics: While it mentions "fatigue testing" and "particle size studies," it doesn't provide quantitative results or a comparison against predefined criteria for these studies.
- No diagnostic or clinical efficacy study: The document focuses on material safety, manufacturing compliance, and durability. It does not describe a study to evaluate the clinical effectiveness or diagnostic accuracy of the spacer mask in a patient population.
- No information on "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," or "ground truth for training set." These are all relevant to studies evaluating the performance of a medical device, especially those involving algorithms or diagnostic capabilities, which this device does not appear to have.
Summary of missing information based on your request:
| Information Requested | Status in Document |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not provided. No explicit acceptance criteria or quantitative performance metrics are listed. |
| 2. Sample size for test set and data provenance | Not applicable/Not provided. No clinical or diagnostic test set described. |
| 3. Number of experts and qualifications for ground truth | Not applicable/Not provided. No ground truth establishment for a diagnostic or clinical performance. |
| 4. Adjudication method for test set | Not applicable/Not provided. |
| 5. MRMC comparative effectiveness study and effect size | Not applicable/Not provided. This is not a device that would typically undergo such a study. |
| 6. Standalone (algorithm only) performance study | Not applicable/Not provided. This is not an algorithmic device. |
| 7. Type of ground truth used | Not applicable/Not provided. |
| 8. Sample size for the training set | Not applicable/Not provided. This is not an algorithmic device. |
| 9. How the ground truth for the training set was established | Not applicable/Not provided. |
What the document does describe in terms of "testing":
- Fatigue Testing:
- Test performed: E-Z SPACER Mask attached to E-Z SPACER device, opened and closed 1,460 times (based on 4 uses/day for a year). Washed following patient instructions (once a week).
- Evaluation: Mask evaluated every 50 cycles.
- Result: "There were no signs of breakdown."
- Discussion: This is a durability/material integrity test, not a performance study in the sense of clinical efficacy or diagnostic accuracy. There are no explicit acceptance criteria stated ("no signs of breakdown" is a qualitative observation, not a quantitative metric).
- Particle Size Studies:
- Mentioned: "Particle size studies are submitted showing E-Z SPACER with Mask and without."
- Discussion: The results of these studies are not included in this summary. It only states they were submitted. To meet your request, the results and their comparison to acceptance criteria would need to be provided.
In conclusion, this document primarily serves as a declaration of material safety, manufacturing compliance, and some durability testing for the E-Z SPACER Mask. It does not contain the detailed performance study information with explicit acceptance criteria and quantitative results typically found for devices requiring clinical or diagnostic efficacy data.
§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).
(a)
Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.(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 § 868.9.