(288 days)
The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories will be indicated for use for the treatment of psoriasis. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated devices. SurgiLight, Inc. seeks no new indications for the EX-308 Excimer Laser.
The SurgiLight EX-308 Excimer Laser is a medical device that is capable of emitting a treatment laser beam at a wavelength of 308nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.
Here's an analysis of the provided text regarding the SurgiLight, Inc. EX-308 Excimer Laser:
Important Note: The provided document is a 510(k) summary and FDA clearance letter, not a detailed study report. As such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the device itself. Therefore, many of the requested sections below will indicate that the information is "Not Delineated in the Provided Text" or point to the reliance on predicate device data.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics for the EX-308 itself. Instead, the acceptance is based on its substantial equivalence to predicate devices. The "reported device performance" for the EX-308 is implicitly that it performs equally to its predicates for the indicated use.
| Acceptance Criterion | Reported Device Performance (SurgiLight EX-308) | Notes |
|---|---|---|
| Similar Technology | "are of similar technology" | Implies that the core laser mechanism and function are comparable to predicates. |
| Same Intended Use | "have the same intended use" | Explicitly for the "treatment of psoriasis," matching predicate devices. |
| No Significant Differences | "no significant differences exist" | This is the overarching "performance" criterion for equivalence. The device is deemed to perform as safely and effectively as predicates. |
| Safety and Effectiveness | "should not raise any concerns regarding its overall safety and/or effectiveness." | Conclusion drawn from the similarity to predicate devices. |
| Wavelength | 308nm | Matches the wavelength typically used in excimer lasers for psoriasis, consistent with predicate technologies. |
| Pulsed Mode Capability | Capable of emitting in a pulsed mode at various repetition rates. | Standard feature for excimer lasers and implied to be comparable to predicates. |
Study Details (or lack thereof, based on provided text)
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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):
- Not Delineated in the Provided Text. The document explicitly states: "No new indications were sought in this premarket notification, clinical data was presented." This indicates that a specific clinical study with a test set for the EX-308 was not conducted or submitted for this 510(k) clearance. The clearance is based on substantial equivalence to existing devices.
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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 / Not Delineated in the Provided Text. Since no specific clinical data or test set for the EX-308 was presented, there was no ground truth establishment through expert consensus for this device's performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Delineated in the Provided Text. No specific test set was used for the EX-308's performance.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a laser for medical treatment, not an AI diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device (excimer laser) intended for therapeutic use, not a standalone software algorithm. Its operation involves a human operator (clinician).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implicitly, the ground truth is established by the long-standing clinical use and safety/effectiveness of its predicate devices. For the EX-308 itself, no new ground truth was established as its clearance is based on equivalence. The predicate devices would have undergone their own studies and established their ground truth through clinical outcomes data for psoriasis treatment.
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The sample size for the training set:
- Not Applicable / Not Delineated in the Provided Text. This is a hardware medical device, not a machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable. As above, this device does not utilize a "training set" in the context of machine learning.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.