(87 days)
The Solid State Portable Headlight is indicated for providing a portable, battery powered illumination for performing general exams, foreign body removal, and minor suturing.
This product consists of a light source that is held in place by a comfortable, adjustable and consumable Terrycloth headband with Velcro adjustments. The range of adjustability accommodates the majority of users. The portable Headlight is small, light weight and adjustable in both pointing direction and illuminated spot size.
The provided text is a 510(k) summary for the "Solid State Lamp (LED) Headlight" and primarily focuses on regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria in the context of clinical or diagnostic accuracy.
Therefore, many of the requested sections about acceptance criteria and study details (like sample size for test sets, expert ground truth, MRMC studies, standalone performance) cannot be filled from the provided document. The document describes conformity to general safety standards and states that design reviews and testing ensure the device performs within its environment.
Here's an attempt to extract the available information based on your request:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated as Compliance) | Reported Device Performance (Stated as Design Intent/Compliance) |
|---|---|
| IEC60601-1 (Medical Electrical Equipment, Part 1: General requirements for Safety, Amendment 1, and Amendment 2) | Design reviews and testing ensure performance within environment; Safety testing complies with indicated standards. |
| IEC60601-1-2 (Medical Electrical Equipment, Part 1: General requirements for safety 2: Electromagnetic Compatibility - Requirements and tests) | Design reviews and testing ensure performance within environment; Safety testing complies with indicated standards. |
| IEC60825-1 (Safety of laser products, Part 1: Equipment classification, requirements and user's guide) | Design reviews and testing ensure performance within environment; Safety testing complies with indicated standards. |
| Device performs within its design parameters | Device is safe, effective and performs within its design parameters as well as the legally marketed predicate device. |
| Meets design intent and safety functions | Welch Allyn, Inc. will not market this device if it does not completely meet its design intent and safety functions. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text refers generally to "testing" and "design reviews" but does not detail the specific test sets, their sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The nature of this device (a headlight) suggests that "ground truth" in the diagnostic sense is not applicable. The evaluations would likely focus on engineering performance, safety, and functional effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not applicable / not provided. This device is a headlight, not an AI-powered diagnostic tool. Therefore, MRMC studies with human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable / not provided. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. For a medical device like a headlight, "ground truth" would likely relate to objective measurements of light output, battery life, durability, and ergonomic performance, evaluated against engineering specifications and relevant safety standards, rather than diagnostic outcomes.
8. The sample size for the training set
This information is not applicable / not provided. This device is not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable / not provided. This device is not an AI/ML model.
§ 886.4335 Operating headlamp.
(a)
Identification. An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.(b)
Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.