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510(k) Data Aggregation
(79 days)
Intended Use:The V-Raser is intended for Incision, excision, ablation, vaporization and coagulation of soft tissue.
Specific Indications: Treatment of vascular lesions.
The V-RASER Diode System is a modified Diodent Micro 980. It will use similar specifications (laser medium, excitation method, fiber optic beam delivery, electrical requirements, physical specifications) as the Diodent Micro 980. The laser source of this device is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode. It produces invisible laser energy at the 980-nanometer wavelength. The delivery system consists of removable flexible HCS (hard clad silica) optical treatment fiber assembly connected to a lightweight, hand piece that has two different size end pieces (tips) to adjust the laser beam to specific spot sizes. Activation occurs when the operator enables the laser by a key switch, enters the Ready Mode and presses the footswitch. Releasing the footswitch suspends laser treatment. A color LCD and touch-screen display panel allows the operator to adjust or set the laser output level. The laser operates in a pulsed mode and will have a removable stainless steel end piece for establishing the proper focal length for the treatment. The hand piece will be manually attached (i.e., screwed on) to a connector to the fiber assembly. The spot size will be selected on the control panel and the software will calculate the treatment fluence accordingly.
The provided 510(k) summary for the V-RASER Diode Laser System does not contain information about acceptance criteria or a study proving the device meets them.
Instead, it's a premarket notification for a medical device seeking substantial equivalence to a predicate device. The document explicitly states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
Therefore, I cannot provide the requested information. This device was cleared based on its similarity to existing, legally marketed devices, rather than through a study demonstrating its performance against specific acceptance criteria.
The information regarding the training set, test set, ground truth, expert qualifications, and adjudication methods is typically found in clinical or performance studies, which were not submitted for this 510(k) application.
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(116 days)
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.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The wireless footswitch must directly emulate the functionality of the current wired footswitch of IRIDEX laser consoles. It must provide input control of laser emission to compatible IRIDEX Laser Systems in the same manner as the wired footswitch. Its use should be cleared for the particular indications of the laser system to which it is attached. | "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." |
| Indications for Use | The device's indications for use must be similar to or the same as predicate devices and compatible with the existing IRIDEX laser systems. | "The IRIDEX Wireless Footswitch shares the same indications for use... with, and thus is substantially equivalent to, the predicate devices." |
| Safety and Effectiveness | The device must be demonstrated to be substantially equivalent to predicate devices in terms of technical characteristics and operation, implying it meets the same safety and effectiveness standards as those devices. This includes general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration). Compliance with applicable standards is usually demonstrated. | "The review of the indications for use and technical characteristics provided demonstrates that the IRIDEX Wireless Footswitch is substantially equivalent to the predicate devices." |
| Design Features | The design features (e.g., wireless transmission) should be similar to other legally marketed wireless footswitches. | "The IRIDEX Wireless Footswitch shares... similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices." |
Study Details:
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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 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.
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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. No clinical test set or ground truth validation by experts is mentioned or required for this type of 510(k) submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set.
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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 device is a hardware accessory (wireless footswitch), not an AI-powered diagnostic tool. MRMC studies are irrelevant.
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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 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).
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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.
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The sample size for the training set
- Not Applicable. This is a hardware accessory, not a machine learning algorithm requiring a training set.
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How the ground truth for the training set was established
- Not Applicable. No training set for an algorithm.
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