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The IRIDEX Wireless Footswitch is intended for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities.

The IRIDEX Wireless Footswitch is indicated for use as an accessory to provide input control of laser emission to compatible IRIDEX Laser Systems. This accessory includes a wireless footswitch and a receiver. It is cleared for use for the particular indications of the laser system to which it is attached.

The Wireless Footswitch is an alternate option to the existing cabled footswitch for users of IRIDEX laser consoles. It consists of two discreet parts - a footswitch/transmitter and receiver. The wireless footswitch receiver connects to the laser through the same connector as the current wired footswitch, and operates with the console by directly emulating the functionality of the current wired footswitch.

This document describes the IRIDEX Wireless Footswitch, seeking clearance as an accessory for existing IRIDEX laser systems. As an accessory that emulates the functionality of a wired footswitch, the submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria.

Therefore, the requested information fields related to clinical efficacy studies, expert ground truth, and training data are largely not applicable in the context of this 510(k) submission. The FDA clearance is based on the device's functional similarity to predicate devices and its adherence to general controls for safety and effectiveness.

Here's an attempt to populate the table and answer the questions based on the provided text, indicating "Not Applicable" where the information is not present or relevant to a substantial equivalence submission for an accessory device:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an accessory (wireless footswitch) demonstrating substantial equivalence to wired and other wireless footswitches, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity or specificity. Instead, acceptance is based on functional equivalence and safety to predicate devices. The document implies functional equivalence to existing wired and wireless footswitches as the primary criterion.

Study Details:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Applicable. The submission is for substantial equivalence of an accessory device (wireless footswitch) based on functional emulation and comparison to predicate devices, not requiring a clinical performance study with a test set of patient data. The documentation does not mention such a study.

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. No clinical test set or ground truth validation by experts is mentioned or required for this type of 510(k) submission.

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

   • Not Applicable. No clinical test set.

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

   • Not Applicable. This device is a hardware accessory (wireless footswitch), not an AI-powered diagnostic tool. MRMC studies are irrelevant.

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

   • Not Applicable. This is a hardware accessory, not an algorithm. Performance is assessed based on its ability to emulate the wired footswitch function and comply with relevant standards (though not explicitly detailed in this summary).

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

   • Not Applicable. Not a clinical diagnostic device requiring ground truth for clinical performance. The "ground truth" for this device's functionality would be the successful and consistent control of the laser system, as performed by the wired equivalent.

7. The sample size for the training set

   • Not Applicable. This is a hardware accessory, not a machine learning algorithm requiring a training set.

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

   • Not Applicable. No training set for an algorithm.

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The VariLite Laser System is intended for use in dermatological applications:

The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for:

• the treatment of vascular lesions including:
  • Telangiectasia
  • Cherry Angiomas
  • Leg Veins
  • Neovascularization
  • Spider Angiomas
  • Port Wine Stains
  • Roscea
  • Venous Lakes
• the treatment of benign pigmented lesions including:
  • Lentigines
  • Freckles
  • Dermatosis Papulosis Nigra
  • Poikloderma of Civatte
  • Café- au- lait Stains
  • Melasma
• the treatment of cutaneous lesions including:
  • Verruca
  • Keratoses
  • Skin Tags
• the treatment of moderate inflammatory acne vulgaris.

The 940 nm wavelength delivered with VariLite handpieces is indicated for:

• the treatment of vascular lesions including:
  • Telangiectasia
  • Cherry Angiomas
  • Leg Veins
  • Neovascularization
  • Spider Angiomas
  • Port Wine Stains
  • Roscea
  • Venous Lakes
• the treatment of benign pigmented lesions including:
  • Lentigines
  • Freckles
  • Dermatosis Papulosis Nigra
  • Poikloderma of Civatte
  • Café- au- lait Stains
  • Melasma
• hair removal.

The VariLite is a dual wavelength medical diode laser source that delivers laser light at either 532 nm or 940 nm. Its main components are a laser console, footswitch, and a variety of fiber optic handpiece delivery devices, including manual handpieces and the ScanLite Scanner, which are all considered part of the VariLite Laser System. The VariLite console is also intended to be compatible with other delivery devices that have been the subject of previous 510(k) applications. These devices include DioLite 532 handpieces (K964074).

The provided text is a 510(k) summary for the IRIDEX VariLite Laser System, which is a premarket notification for a medical device in the United States. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical effectiveness through extensive clinical trials with acceptance criteria and statistical analyses.

Therefore, many of the requested elements for acceptance criteria and study design are not applicable in this context. The document explicitly states "Clinical performance Data: None."

Here's a breakdown of the information as it relates to your request:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. The 510(k) summary does not define specific clinical acceptance criteria or report a "performance" in the way a clinical trial would (e.g., sensitivity, specificity, accuracy). The submission relies on demonstrating substantial equivalence to existing predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Performance is inferred from the safety and effectiveness profile of the 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)

• Not Applicable. No clinical "test set" of patients was used as part of this 510(k) submission. Non-clinical performance data relied on "applicable consensus and voluntary standards" (e.g., electrical safety, electromagnetic compatibility), as indicated by a Declaration of Conformity.

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

• Not Applicable. No clinical test set requiring ground truth establishment by experts was part of this submission.

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

• Not Applicable. No clinical test set was used.

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 a laser system for dermatological treatment, not an AI-assisted diagnostic or interpretative device. Therefore, MRMC studies and AI-related effectiveness are not relevant.

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

• Not Applicable. This is a hardware device (laser system), not an algorithm.

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

• Not Applicable. No clinical ground truth was established for this submission. The "ground truth" for showing substantial equivalence essentially lies in the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. The device is not learning from data in the way an AI or diagnostic algorithm would.

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

• Not Applicable. See point 8.

Summary of Device Acceptance (as per 510(k) process):

The VariLite Laser System was accepted by the FDA based on a demonstration of substantial equivalence to existing, legally marketed predicate devices. This means the FDA concluded that the device is as safe and effective as the predicate devices, has the same intended use, and generally the same technological characteristics.

The "study" or evidence provided to meet this "acceptance criteria" (substantial equivalence) consists of:

• Predicate Device Comparison: Detailed comparison of the VariLite Laser System's intended use, indications for use, and technological characteristics (wavelengths, delivery methods) to four predicate devices:
  • IRIDEX Corporation DioLite 532 (K964074)
  • Laserscope Aura (K951034 / K024206)
  • Nidek, Inc. Prima KTP (K973828)
  • Dornier MedTech Medilas D SkinPulse S (K003993)
• Non-Clinical Performance Data: A "Declaration of Conformity" indicating that the device meets "applicable consensus and voluntary standards." This typically covers aspects like electrical safety, electromagnetic compatibility, and laser safety standards (e.g., IEC 60601-1, IEC 60825-1).
• Absence of Clinical Data: Explicitly stated as "None," meaning no new clinical trials were conducted by the manufacturer for this specific 510(k) submission to demonstrate effectiveness or safety. The safety and effectiveness are inferred from the predicate devices.

The FDA's letter (K041930) confirms that the device was found "substantially equivalent" and thus permitted to market, based on the information provided in the 510(k) submission.

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