Search Results

The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories is indicated for use for the treatment of psoriasis and for the treatment of vitiligo.

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 quidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.

This 510(k) submission (K020973) for the SurgiLight, Inc. EX-308 Excimer Laser does not contain the type of detailed information typically found in studies for AI/ML-driven devices. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through a comparison of technological characteristics and intended use, rather than presenting a performance study against specific acceptance criteria.

Therefore, many of the requested fields cannot be filled based on the provided text, as this device is a laser for medical treatment, not a diagnostic or AI-powered device that relies on performance metrics like sensitivity, specificity, or reader studies.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This submission doesn't define acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant to an AI/ML device study. The "performance" described is about the laser's physical characteristics and its ability to emit light at a specific wavelength, which are compared to a predicate device for substantial equivalence.

2. Sample size used for the test set and the data provenance

Not applicable. No test set or data provenance related to a performance study for an AI/ML device is mentioned. This submission is for a physical medical device (excimer laser).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth establishment for a test set is discussed, as this is not an AI/ML performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is mentioned.

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

Not applicable. This is not a diagnostic AI/ML device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. Ground truth for an AI/ML performance study is not discussed.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. No training set ground truth establishment is discussed.

Summary of Device and Approval from the Provided Text:

The SurgiLight, Inc. EX-308 Excimer Laser is a medical device designed to emit a treatment laser beam at a wavelength of 308nm for the treatment of psoriasis and vitiligo.

The 510(k) submission (K020973) sought to establish substantial equivalence to existing predicate devices (e.g., PhotoMedix K003705). The core argument for approval was that:

• The candidate and predicate laser devices are of similar technology.
• They have the same intended use (treatment of psoriasis and vitiligo).
• Based on an analysis of overall performance characteristics (implicitly, the physical characteristics and laser output, not clinical outcome studies in this document), no significant differences exist.

The FDA's approval letter confirms the determination of substantial equivalence, allowing the device to be marketed. The submission did not seek new indications for use; it relied on the existing clearances for the predicate devices.

Ask a specific question about this device

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.

Study Details (or lack thereof, based on provided text)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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).

6. 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.

7. 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.

8. 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.

Ask a specific question about this device