Search Results

The Novus Varia Ophthalmic Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The Lumenis Varia is indicated for use in photocoagulation of both anterior and posterior segments including:

• Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
  • proliferative and nonproliferative diabetic retinopathy;
  • choroidal neovascularization;
  • branch retinal vein occlusion;
  • age-related macular degeneration
  • retinal tears and detachments
  • retinopathy of prematurity
• Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments: diabetic retinopathy (panretinal photocoagulation); retinopexy; segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; and, pediatric retinal repairs (under general anesthesia)

The Acculite Endoprobe is indicated for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization.

The Novus Varia Laser System is an air cooled, diode-pumped, solid state, Nd: Y AG, threecolor laser system (green, yellow and red) intended for use in the treatment of ocular pathology. A red diode laser provides a visible aiming beam. The Novus Varia system is comprised of the following functional components: a laser console; control and display panel; system microprocessor control electronics; two fiber ports for delivery systems; eye safety filter port; a covered footswitch; operating software; an optional remote control unit; an optional printer; delivery devices with accessories

Compatible delivery devices include: the LaserLink Z and LaserLink Z-1000 Slit Lamp Delivery Adapters; the Laser Indirect Ophthalmoscope (Heine and Keeler models) and the Acculite Endophotocoagulation Probe Delivery System.

The provided document is a 510(k) Summary Statement for the Novus® Varia™ Ophthalmic Laser and Delivery Devices. It focuses on establishing substantial equivalence to previously cleared predicate devices, rather than detailing a study with specific acceptance criteria and performance results for the Novus® Varia™ itself.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth cannot be extracted directly from this document.

Here's an analysis based on the information available:

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

This information is not provided in the document. The submission is a 510(k) for substantial equivalence, meaning it argues that the new device is as safe and effective as predicate devices based on similar technological characteristics and intended use, rather than presenting a de novo performance study against specific acceptance criteria.

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

This information is not provided as no specific "test set" for a performance study is described. The document relies on comparison to predicate devices, not on new clinical data or a specific test set.

3. 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)

This information is not provided. Ground truth established by experts is typically relevant for studies evaluating diagnostic accuracy or image interpretation, which is not the focus of this 510(k) summary for a laser surgical instrument.

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

This information is not provided. As no specific test set or performance study is described, adjudication methods are not applicable.

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

An MRMC comparative effectiveness study is not mentioned or indicated. This document concerns a laser surgical device, not an AI-powered diagnostic or assistive tool for human readers.

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

A standalone performance study of an algorithm is not mentioned or indicated. The device is a laser surgical instrument, and the 510(k) submission doesn't describe any algorithmic components that would require such a study.

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

This information is not provided. Since no specific performance study is detailed, the type of ground truth used is not relevant to this submission. The 510(k) relies on the established safety and effectiveness of predicate devices.

8. The sample size for the training set

This information is not provided. As there's no mention of an AI algorithm or a training set for machine learning, this detail is not applicable.

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

This information is not provided. Similar to point 8, this is not applicable to the content of this 510(k) summary.

Summary of available information regarding performance:

• Rationale for Substantial Equivalence (Section VI): The Novus Varia Ophthalmic Laser with Delivery Devices and Accessories share the "same intended use, indications for use and the same or similar technological characteristics (including treatment wavelengths, laser active medium, pumping system, aiming beam, mode of operation, exposure duration, power, treatment intervals, spot sizes, controls and displays, laser energy delivery control (footswitch), and delivery systems)" as the predicate devices.
• Performance Data (Section VII):
  • "System and software hazard analysis information and software verification and validation information was submitted in conjunction with this Premarket Notification submission." (Details of these analyses are not included in the provided summary.)
  • "The determination of substantial equivalence was based upon the comparison of the technical characteristics between the Novus Varia Ophthalmic Laser with Delivery Devices and the predicate laser systems."

In essence, the document states that the device meets criteria for substantial equivalence due to its similarity in design and intended use to existing, legally marketed devices. It does not provide data from a specific performance study against defined acceptance criteria for the Novus® Varia™ itself, but rather implies that its performance is presumed adequate because it is substantially equivalent to predicates that have already demonstrated safety and effectiveness.

Ask a specific question about this device

Clinical Indications with a Slit Lamp Delivery System: This system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including: Proliferative Diabetic retinopathy, macular degeneration, and retinal detachment. Clinical Indications with a Laser Indirect Ophthalmoscope Delivery System: This system has the same clinical indications as the slit lamp delivery system, but it can only be used for peripheral photocoagulation. Clinical Indications with an Endophotocoagulation (EPCP) Delivery System: The EPCP probe has been designed as a means for intraocular photocoagulation as an adjunct to vitrectomy surgery. Specific indications for use for the EPCP include treatment of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, and various retinal vascular tumors.

The devices that are subject to this Special 510(k) Premarket Notification are the Coherent Laser Indirect Ophthalmoscope, the Acculite Endokit/Endoprobe, the LaserLink HS and LaserLink Z Slip Lamp Laser Delivery Adapter and the Coherent Novus Verdi Frequency-Doubled Nd: Y AG Ophthalmic Photocoagulator.

The provided document is a 510(k) summary statement for a medical device and a subsequent FDA approval letter. It does not include information about specific acceptance criteria, a study proving the device meets those criteria, or the detailed aspects of a clinical study that would lead to such data.

The document primarily focuses on establishing "substantial equivalence" of the new "Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd:YAG Photocoagulator" to existing predicate devices. This means the device is considered safe and effective because it is similar in design, function, and intended use to devices already on the market.

Therefore, most of the requested information cannot be extracted from the provided text. I can only fill in the parts that are explicitly mentioned or can be inferred.

Here's what can be extracted and why other parts cannot be:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or other performance metrics) nor does it report specific device performance data from a dedicated study against such criteria. The basis for approval is substantial equivalence to predicate devices, not meeting novel performance criteria.

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

• Cannot be provided. No specific test set, sample size, or data provenance from a performance study is mentioned. The submission relies on demonstrating similarity to already approved devices.

3. 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)

• Cannot be provided. No "test set" requiring ground truth establishment by experts is described as part of this 510(k) submission for the device's performance.

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

• Cannot be provided. No "test set" requiring adjudication is described.

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

• Cannot be provided. This document is for a laser delivery system, not an AI-assisted diagnostic or treatment system. Therefore, no MRMC study or AI-related effectiveness data is present.

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

• Cannot be provided. As above, this is not an algorithm-based device.

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

• Cannot be provided. No performance study requiring ground truth is described.

8. The sample size for the training set

• Cannot be provided. This device does not involve machine learning or a "training set" in the context of AI.

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

• Cannot be provided. As above, no training set or ground truth establishment for such a set is relevant to this device's approval process based on the provided text.

Summary of what is available from the document:

The regulatory approval for the Coherent Medical Group Delivery Devices relies on substantial equivalence to previously approved predicate devices, rather than a new clinical study demonstrating specific performance against predefined acceptance criteria. The document states:

• Rationale for Substantial Equivalence: "The Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd: YAG Photocoagulator share the same indications for use, similar design features, functional features and are therefore substantially equivalent to the predicate Viridis Surgical Laser (K960867) and Coherent Medical Group predicate devices (K913127, K885196, K812219)."
• Safety and Effectiveness: "Safety and effectiveness information was provided to demonstrate that the Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd:YAG Photocoagulator are safe and effective for use in surgical procedures as indicated in K960867." (This implies that the demonstrated safety and effectiveness is tied to its similarity to the predicate devices and their known performance, not new performance data from this submission.)

Therefore, the "acceptance criteria" were effectively the criteria for establishing substantial equivalence, and the "study" proving it met these criteria was the comparison outlined in the 510(k) submission, not a new clinical performance trial with specific metrics.

Ask a specific question about this device