Search Results
Found 3 results
510(k) Data Aggregation
(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:
-
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.
-
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.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set.
-
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.
-
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).
-
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.
-
The sample size for the training set
- Not Applicable. This is a hardware accessory, not a machine learning algorithm requiring a training set.
-
How the ground truth for the training set was established
- Not Applicable. No training set for an algorithm.
Ask a specific question about this device
(90 days)
The Viridis Twin laser is indicated for the photocoagulation or ablation of pigmented tissue within the eye.
The 532 nm wavelength is indicated for use for:
retinal photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. peripheral photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. endophotocoagulation (EPCP) intraocular photocoagulation as an adjunct in vitrectomy surgery, complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, retinopathy, and retinal vascular tumors.
The 810 nm wavelength is indicated for use for:
photocoagulation or ablation of pigmented tissue within the eye, transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments), limited and pan-retinal photocoagulation, transpupillary photocoagulation, endophotocoagulation, treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choriodal neovasculature, and age-related macular degeneration (AMD) treatments.
The Viridis Twin Ophthalmic Photocoagulator is a combination system consisting of a Nd:YAG frequency doubled laser which emits a beam of coherent light at 532 nm and a diode laser which emits a beam of coherent light 810 microns. The treatment beam is selected by the user, the delivery system is attached to the appropriate laser aperture, and the energy is delivered to the treatment site(s) via delivery systems/devices.
The provided text indicates that no performance data was required for the Viridis Twin Ophthalmic Photocoagulator. The FDA's 510(k) summary states, "Performance Data: None required." The conclusion of the 510(k) summary is based on the substantial equivalence of the Viridis Twin Ophthalmic Photocoagulator to legally marketed predicate devices, not on a study proving the device meets specific acceptance criteria through performance metrics.
Therefore, I cannot populate the table or provide information about a study proving the device meets acceptance criteria because the submission explicitly states that performance data was not required. The approval was based on substantial equivalence to predicate devices, not on the demonstration of specific performance metrics or clinical study results.
Ask a specific question about this device
(90 days)
The Quantel Iridis Ophthalmic Photocoagulator is indicated for the photocoagulation or ablation of pigmented tissue within the eye. Examples include: photocoagulation of pigmented tissue within the eye, transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments), limited and pan-retinal photocoagulation, transpupillary photocoagulation, endophotocoagulation, treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choriodal neovasculature, and age-related macular degeneration (AMD) treatments.
The Iridis Ophthalmic Photocoagulator consists of a main console with controls and a foot switch. The laser emits a coherent beam of light at 810 nm. Delivery systems attached to the laser then transmit the beam to treatment sites within the eye. The delivery systems are independent devices, manufactured by independent manufacturers, which attach to the Iridis Ophthalmic Photocoagulator either by direct connection at the laser aperture or through attachments, such as the slit lamp adapter.
This document, a 510(k) summary for the Iridis Ophthalmic Photocoagulator, does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.
The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy or meet specific performance criteria through a dedicated study.
Here's a breakdown of why the requested information cannot be found in the provided text:
- Acceptance Criteria and Reported Device Performance: This document states "Performance Data: None required." (Section 1). This explicitly indicates that specific performance data, including acceptance criteria and how the device met them, was not part of this submission.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set): Since "Performance Data: None required" was stated, there is no mention of any study that would typically involve these elements. The submission relies on demonstrating substantial equivalence to predicate devices based on design and intended use, rather than a clinical or performance study.
In summary, none of the requested information regarding acceptance criteria or a study proving the device meets them is present in the provided text. The 510(k) clearance for this device was based on demonstrating substantial equivalence to already legally marketed predicate devices, negating the need for new performance studies in this specific submission.
Ask a specific question about this device
Page 1 of 1