(87 days)
The Solid State Procedure Headlight is indicated for providing illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
This product features an articulated projector that is mounted to a comfortable adjustable headband. The range of adjustability accommodates the majority of users. The actual source for the illumination is a high intensity white LED.
This submission describes a medical device, the "Solid State Procedure Headlight," and its comparison to a predicate device. However, it does not contain a study that presents specific acceptance criteria and detailed device performance data in a way that would allow for a complete answer to all parts of your request.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for performance specifications (e.g., light intensity, beam uniformity, color temperature, etc.) nor does it report specific device performance data against such criteria. Instead, it refers to general safety standards and an overall statement of effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC60601-1, IEC60601-1-2, IEC60825-1 (Safety) | "The system will be certified to the following general safety standards..." |
| Performs within design parameters and intended environment | "Completed design reviews and testing ensures that the Solid State Procedure Headlight System performs within the environment(s) for which is to be marketed." |
| Safety and Effectiveness | "Based on these results, and above referenced testing it is our determination that the device is safe, effective and performs within its design parameters as well as the legally marketed predicate device." |
| Substantial Equivalence to Predicate Device | FDA letter states: "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." |
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 submission mentions "design reviews and testing" but does not detail the nature of these tests, the number of units tested, or the type of data collected.
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. The device is an illumination tool, not an imaging or diagnostic AI device that would typically rely on expert-established ground truth for its performance evaluation in this context. The evaluation described here focuses on safety standards and functional comparisons to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable given the type of device and the evaluation described.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not relevant for this device. This is a spotlight/headlamp, not an AI-powered diagnostic tool. There is no AI component or "human readers" in the context of interpretation of images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study in the context of an algorithm is not applicable as this device is an illumination tool and does not contain an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. The assessment of this device is based on its ability to provide illumination and meet safety standards, as well as being substantially equivalent to a predicate device. "Effectiveness" is determined by its ability to fulfill its intended purpose (providing illumination) rather than making a diagnostic determination that requires a ground truth standard.
8. The sample size for the training set
This information is not provided and is not applicable for this type of device. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for this type of device.
§ 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.