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The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

Fiber Optic Delivery Systems and Handpieces are intended to vaporize, coagulate, incise and excise tissue and which are designed for any indication for which compatible laser systems have been cleared by FDA. Similarly, the predicate devices are also components of delivery systems designed to deliver laser radiation to a specified point. FiberTech's Fiber Optic Delivery System's fiber optical Handpiece and Tip has a similar material composition as its predicate devices. Third, the Fiber Optic Delivery System is available in sizes between 200 micron and 1000 micron. Ceramoptec's and Coherent Laser Delivery Systems is available also in sizes ranging from 200 micron to 1000 micron. Fourth, the reusable and the disposable Fiber Optic Delivery Systems are available in the same tip shapes and handpiece configurations. Further, both the reusable and the disposable devices are prepackaged sterile and fit lasers which employ SMA 905 connectors or lasers which have suitable adapters to allow SMA 905 connectors to be used. Finally, the reusable Fiber Optic Delivery System can be reused only once the optical fiber tip is properly cleaned, inspected, stripped and cleaved.

The provided text is a 510(k) summary for the FiberTech's USA Fiber Optic Delivery System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/ML-based device performance evaluations (e.g., accuracy, sensitivity, specificity studies).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the standard for 510(k) clearances. The "Performance Data" section primarily refers to certifications, not clinical performance metrics.

Therefore, I cannot fulfill your request for the specific points about acceptance criteria and study details because the provided document does not contain that type of information. It's a regulatory document for a physical medical device, not an AI/ML software as a medical device.

Here's a breakdown of why the requested information is absent:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "no new questions of safety and effectiveness raised by the introduction of this devices" based on similarity to predicates, rather than quantifiable performance metrics against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable. Performance is established through comparison to predicate devices and existing certifications, not through a separate clinical test set in the traditional sense for an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Section 2) mentions:

• CE marking (Medical Device Directive 95.E.02)
• Certification under EN ISO 19407:2009
• Certification for Quality EN ISO 9001:2000

These are quality management system and regulatory compliance certifications, not direct performance metrics of the device itself (like accuracy of an AI algorithm). The basis for clearance is substantial equivalence to the predicate devices listed (Ceramoptec's Fiber Optic Delivery Sytems, InnovaQuartz Fiber Optic Delivery System, Laser Peripherals Fiber Optic Delivery System, Trymedyne Inc., Fiber Optic Delivery System). The argument for substantial equivalence is based on:

• Intended Use
• Technological Characteristics (material composition, available sizes, tip shapes, handpiece configurations, sterile packaging, connector types, reusability)

In summary, this document is a 510(k) submission for a physical medical device. It relies on demonstrating similarity to already cleared devices and adherence to manufacturing and quality standards, rather than presenting a performance study with acceptance criteria and ground truth, as would be expected for an AI/ML-based medical device.

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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.

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