(105 days)
SafetyMate® Talking First Aid, SM200 Series is an electronic device intended for use to provide verbal information from established sources to refresh how to handle common medical emergencies through utilization of button options, voice queries and prompts which remind the user of important points in the management of identified emergency situations for infant, child, and adult emergencies.
SafetyMate® Talking First Aid, SM200 Series is a hand-held, interactive talking first aid guide for adult, child or infant emergencies. It includes eight themed first aid categories including CPR/Unconscious, Choking/Breathing, Allergic Reaction, Bleeding, Burns, Falls/Bone Injury, Poison/Bites/Stings, and Seizures. Besides providing guidance for what to do in case of an emergency, SafetyMate also highlights what not to do to prevent further injury. SafetyMate is designed to reinforce and remind users of the correct steps and procedures to provide established first aid care.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: SafetyMate® Talking First Aid, SM200 Series
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Device does not impair appropriateness of care. | Clinical usability and human factors studies indicated that the use of a prompting device did not lead subjects to render inappropriate care in a simulated first aid emergency situation. While initial issues were noted, changes were implemented and addressed. |
| Device does not impair speed to treat (i.e., does not cause significant delays in treatment). | Clinical usability and human factors studies concluded that overall, no significant delays in treatment were noted. While initial issues were noted, changes were implemented and addressed. |
| Users are able to use the device correctly without prompting from an observer. | Usability studies indicated that 100% of the users were able to use the device correctly without any prompting from the observer. |
| Compliance with Electromagnetic Compatibility (Emissions) | The device met EN 55014-1, EN 55022, and FCC Part 15 Section 15.109 standards for Electromagnetic Compatibility (Emissions). |
| Compliance with Electromagnetic Compatibility (Immunity) | The device met EN 55014-2 and EN 61000-4-2 standards for Electromagnetic Compatibility (Immunity). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size used for the clinical usability and human factors studies (test set). It is referred to as "users" and "subjects" in the plural, but no number is given.
The provenance of the data (country of origin, retrospective/prospective) is not specified in the provided text. However, given the context of a 510(k) submission to the FDA, it's highly likely to be prospective studies conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used or their qualifications to establish ground truth for the usability and human factors studies. The ground truth for correct first aid procedures would likely be based on established medical guidelines, but the method for assessing subject performance against this ground truth (e.g., observation by medical professionals or trained evaluators) is not detailed.
4. Adjudication Method for the Test Set:
The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It states "Clinical usability and human factors studies were conducted to assess..." and "Conclusions indicated that overall, no significant delays in treatment were noted." This implies an assessment and conclusion were made, but the exact process of reaching consensus on "appropriateness of care" and "speed to treat" is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly done in the traditional sense of comparing multiple human readers' diagnostic accuracy. The studies focused on human factors and usability of the device for first aid assistance, specifically comparing performance with the device versus without a prompting device to assess delays in treatment and appropriateness of care.
The "effect size" mentioned, while not a standard MRMC metric, indicates that the device did not cause significant delays and did not lead to inappropriate care, with 100% of users able to use the device correctly without prompting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone performance study in the sense of an "algorithm only" without human interaction was not relevant or performed for this device. The SafetyMate® is an interactive, talking first aid guide that by its nature requires human interaction (selection of categories, response to voice prompts) to function. Its performance is inextricable from human-in-the-loop use.
7. The Type of Ground Truth Used:
The ground truth for the clinical usability and human factors studies implicitly relied on established best practices and protocols for first aid and common medical emergencies. The device itself "provides verbal information from established sources" and "reminds the user of important points in the management of identified emergency situations." The studies assessed whether users could correctly follow these established procedures with the device's assistance.
8. The Sample Size for the Training Set:
The document describes non-clinical tests for electromagnetic compatibility (EMC) and clinical usability/human factors studies for performance. It does not mention a "training set" in the context of machine learning. The device is an electronic talking first aid guide, not an AI/ML algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" for an AI/ML algorithm, this question is not applicable. The information provided by the device (first aid instructions) is stated to be from "established sources."
§ 878.4014 Nonresorbable gauze/sponge for external use.
(a)
Identification. A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.