(45 days)
The Designs for Vision Melide Fiberoptic Light is indicated for use in surgery and medical applications where high intensity illumination is required.
The Designs for Vision Melide Fiberoptic Light (Melide Fiberoptic Light) is a modification of other legally marketed Designs for Vision surgical headlight systems. The Melide Fiberoptic Light consists of a lamp mounted in a chassis that also holds the AC power supply, dimmer for light intensity control, and a 530 nm filter. Light is passed through a fiberoptic cable to a set of optics in the headlight. The Melide Fiberoptic Light is compatible with all of the headsets available for use with the Designs for Vision surgical headlight systems described in K032283.
Here's an analysis of the provided text regarding the Designs for Vision Melide Fiberoptic Light, focusing on acceptance criteria and study details.
Important Note: The provided text is a 510(k) summary for a medical device submitted to the FDA. 510(k) summaries primarily focus on demonstrating substantial equivalence to a predicate device, not necessarily on detailed clinical trial-style acceptance criteria and studies as one might find for a novel drug or a high-risk device requiring a PMA.
The document primarily describes a modification to an existing device (a change in the light source bulb) and demonstrates its equivalence to a predicate device. Therefore, the "acceptance criteria" here are largely implicit in demonstrating that the new light source maintains safety and effectiveness and that its performance, particularly intensity, is within a desired and pre-defined range or matches a predicate.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for intended use. | Confirmed through performance testing. |
| Light Intensity (Min): Not explicitly stated, but implied to be sufficient for surgical/medical applications. | 0 Foot-candles |
| Light Intensity (Max): Not explicitly stated as a separate criterion, but the target range is implied by the predicate device and the new bulb's capabilities. | 8000 Foot-candles (±5%) |
| Compatibility: With existing Designs for Vision surgical headlight systems. | Compatible with all headsets available for parent device. |
| Regulatory Compliance: Adherence to FDA regulations (e.g., general controls). | Substantially equivalent to predicate device. |
Study Details
Given the nature of the 510(k) for a device modification, the "study" is referred to as "Performance Testing" rather than a comprehensive clinical trial.
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Sample Size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. "Performance testing was conducted," but no details on the number of units tested are given.
- Data Provenance: Not specified, but generally, such testing for a US 510(k) would be conducted internally by the manufacturer or a contracted lab, likely in the US.
- Retrospective or Prospective: Likely prospective, as it involved testing of the modified device.
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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)
- Not Applicable. This type of expert-based ground truth is typically for image-based diagnostic or assessment devices (e.g., AI for radiology). For a surgical light, "ground truth" would be established through objective physical measurements (e.g., light meters, electrical safety checks) against industry standards or internal specifications, not expert consensus on performance.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 2. Adjudication methods are relevant for subjective assessments, particularly in clinical trials or evaluations of diagnostic accuracy.
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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
- Not Applicable. This is a surgical light, not an AI-assisted diagnostic device. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance, which is not relevant here.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device would be based on objective physical measurements (e.g., light intensity in foot-candles, electrical safety parameters, thermal performance) compared against established engineering specifications, safety standards, and the performance characteristics of the predicate device. It is a functional device, not one that generates data requiring human interpretation for accuracy.
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The sample size for the training set
- Not Applicable. This device does not involve machine learning or AI, so there is no training set.
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How the ground truth for the training set was established
- Not Applicable. See point 7.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.