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Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for: Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eve or lipid deficiency dry eve, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.

The Lumenis Stellar M22 System incorporates a touch-screen control panel, power supply modules, cooling unit, switching module and service panel, monitored and controlled by its control software. Selected parameter treatment options and corresponding relevant user information are displayed on the monitor screen. The subject device (ophthalmic use) uses the spectrum range of 400-1200 nm. The cut-off filters used in the Lumenis presets for Universal IPL pigmented lesions treatment with the Stellar M22 system are the 515, 560, 590, 615, 640 or 695nm filters. Each filter cuts off all light with a wavelength shorter than the number indicated on the filter. The filter is inserted inside the handpiece and is exchangeable.

Universal IPL skin treatments with the Stellar M22 may use one of the three lightguides, 8x15, 15x35 mm rectangles and 6 mm round, which are supplied as accessories. Lightguides are made of sapphire and couple the optical energy from the module to the treatment site.

The provided text describes the regulatory acceptance of the Lumenis Stellar M22 for use in dry eye disease management, focusing on the clinical study that supports its effectiveness and safety. However, the document does NOT contain information about acceptance criteria for a device that uses AI/algorithm or any MRMC (Multi-Reader Multi-Case) comparative effectiveness study. Similarly, there's no mention of standalone algorithm performance or the sample size and ground truth establishment for a training set if an AI component were present.

The information primarily revolves around the performance of the IPL device itself, in conjunction with Meibomian Gland Expression (MGX), and is evaluated through clinical endpoints in human subjects.

Therefore, for aspects related to AI/algorithm performance, ground truth, and MRMC studies, the provided text does not contain the necessary details. I will answer the questions based on the information available in the text, and clearly state when information is not present.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance (Based on Clinical Study Outcomes)

The device's acceptance is primarily based on its clinical performance in improving a specific sign of Dry Eye Disease (DED) and its safety profile.

• IPL+MGX arm: Change in TBUT from baseline (BL) to follow-up (FU) was 1.99 ± 0.36 sec.
• Control (Sham+MGX) arm: Change in TBUT from BL to FU was 0.75 ± 0.34 sec.
• Between-group mean difference in TBUT: 1.24 ± 0.50 sec.
  Support for "meaningful clinical benefit" based on exploratory and post-hoc analyses (e.g., proportion of patients improving by two or more TBUT severity categories, proportion improving to non-MGD TBUT). |
  | Secondary Effectiveness Endpoints: Improvement in self-reported DED symptoms (OSDI questionnaire, Eye Dryness Score (EDS) VAS). | Not Met: The study did not demonstrate significantly greater benefit for the IPL device group with regard to self-reported dry eye symptoms (similar overall mean improvement in both groups, no statistically significant difference between groups).
• OSDI p=(b)(4), EDS VAS p=(b)(4).
  However, exploratory protocol-planned analysis of "OSDI responders" (OSDI (b)(4) interpreted as improvement to "mild or better") showed clinical benefit for active IPL treatment group ((b)(4)%) vs. control group ((b)(4)%). This outcome supports clinically meaningful benefit for a proportion of the study population. |
  | Supportive Effectiveness Endpoints (Signs of DED): Change in Meibomian Gland Score (MGS). | Clinical Benefit: Exploratory analysis of change in MGS showed clinical benefit for the IPL treatment group.
• Improvement of (b)(4) units in active arm vs. (b)(4) units in control arm.
• Between-group difference of (b)(4) units.
  This outcome supports clinically meaningful benefit for a subset of the study population. |
  | Safety: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events (UADEs). | Acceptable:
• No Serious Adverse Events (SAEs) or UADEs reported.
• AE incidence: 8.9% in IPL active treatment arm (2 ocular AEs, 2 skin AEs) compared to 20% incidence in the control arm.
• With proper eye protection, no ocular AEs attributed to the IPL system were reported. |
  | Other Non-Clinical Criteria (addressed through testing/declarations for device components):
• Thermal Safety
• Electrical Safety and Electromagnetic Compatibility (EMC)
• Biocompatibility
• Software Verification, Validation, and Hazard Analysis | Met:
• Thermal safety assessed (leveraging previous clearances).
• Complies with IEC 60601-1 and IEC 60601-1-2 (similar to previous K193500 device).
• Handpiece identical in materials and manufacturing to K193500, so previous biocompatibility assessments are applicable. Warnings for coupling gel eye contact included.
• Consistent with FDA guidance for software in medical devices; moderate Software Level of Concern (LOC); risks addressed by labeling and risk management process. |

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • The document mentions "Up to male or female subjects". It does not explicitly state the final enrolled sample size. However, it indicates:
     • Type I error of 0.05 (two-tailed test)
     • Type II error of (b)(4) (power = (b)(4))
     • 1:1 ratio of Treatment to Control
   • Data Provenance:
     • The study was a "multi-center, prospective, randomized, sham-controlled, superiority study."
     • Country of Origin: Not explicitly stated, but Lumenis Ltd. is based in Yokneam, ISR (Israel). Clinical trials are often multi-national, but this is not specified.
     • Retrospective or Prospective: Prospective.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • The clinical study evaluates the device's effect on clinical endpoints directly measured or self-reported by patients (TBUT, OSDI, EDS, MGS). These are objective or subjective measures, not interpretations by experts needing to establish ground truth from, for example, images.
   • Therefore, the concept of "experts used to establish ground truth" in the typical sense (e.g., for image annotations) does not apply to this clinical trial design. Measurements like TBUT and MGS are taken by trained clinical personnel, and OSDI/EDS are patient-reported.

3. Adjudication Method for the Test Set:

   • Not applicable as the study relies on direct clinical measurements and patient self-assessment, not interpretive tasks requiring adjudication like image reads.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. The study was a clinical trial evaluating a device's effect on physiological and symptomatic endpoints, not a study assessing the performance of human readers with or without AI assistance.
   • Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no AI assistance was being evaluated for human readers.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • No, this was not done. The product being evaluated is a medical device (IPL system), not an AI algorithm. The performance discussed is the direct effect of the device on patients.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context refers to the clinical endpoints measured in the study:
     • Tear Break-up Time (TBUT): A direct physiological measurement (time from blink to tear film break-up).
     • Meibomian Gland Score (MGS): An objective clinical scoring system for meibomian gland function.
     • OSDI and EDS VAS: Patient-reported outcome measures (subjective symptoms).
   • These are considered the gold standard for evaluating DED and MGD in clinical trials. There is no mention of pathology or other external outcomes data beyond these clinical measures.

7. The Sample Size for the Training Set:

   • Not applicable. The document describes a clinical trial for a medical device, not the training of an AI model. Therefore, there is no "training set" in the context of an algorithm.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As there is no AI model training described, there is no "ground truth for a training set" to be established.

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