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The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens).

The Smart LIO is indicated for use in the following photocoagulation procedures:

• Panretinal photocoagulation;
• Segmental peripheral photocoagulation;
• Retinopexy; and,
• Pediatric retinal repairs (under general anesthesia).

The Smart LIO is intended to work in conjunction with the following Lumenis laser systems in ophthalmic photocoagulation procedures:

• Lumenis Novus Spectra Laser System;
• Lumenis Vision One Laser System; and
• Lumenis Smart532TM Laser System.

The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens). The Smart LIO is used in conjunction with a compatible Lumenis ophthalmic laser systems. The LIO illuminates and magnifies the fundus image for observation, and when connected to a Lumenis ophthalmic laser system, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO.

The Smart LIO is a wireless headset worn on the physician's head and is used to treat patients in a supine position or who could not otherwise be treated using a standard slit lamp delivery system.

The provided text describes the regulatory filing for a medical device (Smart Laser Indirect Ophthalmoscope) and includes a summary of its performance testing for substantial equivalence. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria, reported performance, sample sizes, expert qualifications, or ground truth establishment in the context of diagnostic accuracy or effectiveness.

The document focuses on demonstrating that the Smart LIO performs similarly to its predicate device and meets safety and performance standards for a laser delivery device. It does not describe a study to assess diagnostic performance with human readers or AI.

Therefore, I cannot populate the requested table and provide answers to questions 2 through 9 based on the provided text.

Here is why:

• No Acceptance Criteria for Diagnostic Performance: The acceptance criteria listed are mostly related to engineering and safety standards (e.g., ISO 14971, IEC 60601-1) and physical characteristics of the device (e.g., laser spot size, transmission, communication with laser systems). There are no criteria provided for diagnostic accuracy, sensitivity, specificity, or similar metrics typically found when evaluating the performance of an AI-powered diagnostic device.
• No Reported Device Performance for Clinical Outcomes: The performance reported is that the device "performs in accordance with its requirements and specifications, in similarity to its predicate device" and "perform as well as its predicate, to be as safe and effective for its intended use as its predicate." This refers to its functionality as a laser delivery system, not its ability to interpret or diagnose.
• No Clinical Study Details: The document mentions "Performance testing was conducted," but this refers to engineering, electrical safety, electromagnetic compatibility, light hazard protection, and verification/validation testing of the device's optical and laser delivery components. It does not describe a clinical study involving patients, experts establishing ground truth, or an AI algorithm.
• Device Type: This device is a "Smart Laser Indirect Ophthalmoscope" used for viewing and delivering laser energy for photocoagulation procedures. It is a tool for a physician to perform a procedure, not a diagnostic AI system that interprets images or makes diagnoses.

In summary, the provided document does not contain the information requested in your prompt because the device being described is a surgical instrument (laser delivery device) and not a diagnostic device that would typically involve acceptance criteria, reported performance, sample sizes, and expert adjudication related to diagnostic accuracy or AI performance.

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The Novus 3000 Laser System is intended for use in the treatment of ocular pathology. The Novus 3000 Laser System 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, detachments;
• retinopathy of prematurity.
• Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

Laser Indirect Ophthalmoscope
The Laser Indirect Ophthalmoscope is indicated for the delivery of laser energy in eyes with retinal pathology. The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments and conditions: diabetic retinopathy (panretinal photocoagulation); peripheral neovascularization, retinal breaks, detachments, and tears, lattice degeneration, pneumatic retinopexy reattachment procedures, segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; pediatric retinal repairs (under general anesthesia), delivery of laser energy through small pupils or to eyes with focal lens opacities.

Endophotocoagulation
When used with a Novus 3000 Laser System, the Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe, and Acculite Illuminating EndoOcular Probe) are intended 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 laser delivery function of the Acculite Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe and Acculite Illuminating EndoOcular Probe) is indicated for use in ocular surgery to deliver laser energy to the treatment area selected by the surgeon.

The aspiration function of the Acculite Aspirating EndoOcular Probe is indicated for use when unwanted fluid is present in the eye during ocular surgery, causing refraction or scattering of the laser beam from the intended treatment site.

The illumination function of the Acculite Illuminating EndoOcular Probe is indicated for use during ocular surgery to illuminate the interior of the eye.

Lumenis, Inc.'s Novus® 3000 Laser System with the Delivery Devices is an air cooled, diode-pumped, solid state, Nd: YAG Laser System, which produces a wavelength of 532 um of laser light with a treatment beam output ranging from 50 mw to 3.0 W. The main parts of the Novus® 3000 system include the laser console, a footswitch, a remote control and assorted laser accessories.

This 510(k) summary for the Lumenis Novus® 3000 Laser System and Delivery Devices does not include any performance data or a study to demonstrate that the device meets specific acceptance criteria.

The document explicitly states:

"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). No data was submitted for section 807.92 6[(b)(1)(2)(3c)]."

Therefore, I cannot provide the requested information. The submission relies on demonstrating substantial equivalence to predicate devices based on similarities in intended use, indications for use, and technological characteristics, rather than on new performance data for this specific device.

If this were a submission that included a performance study, the requested information would typically be provided as follows:

Hypothetical Example if performance data were submitted:

Here's how the information would be presented if a study was conducted and acceptance criteria were defined, based on a typical medical device submission structure:

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical Example)

2. Sample Size Used for the Test Set and Data Provenance (Hypothetical Example)

• Sample Size for Test Set: E.g., 5 units of the Novus® 3000 Laser System and a representative sample of each delivery device (e.g., 10 Laser Indirect Ophthalmoscopes, 15 Endophotocoagulation Probes).
• Data Provenance: Prospective, collected at the manufacturer's facility in Santa Clara, CA, USA, under controlled laboratory conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications (Hypothetical Example)

This type of assessment would typically involve engineering and quality control experts rather than clinical experts for ground truth establishment.

• Number of Experts: 3-5 Engineers and Quality Control personnel.
• Qualifications: E.g., Lead Optical Engineer (15 years experience in laser systems), Senior Electrical Engineer (10 years experience in medical device electronics), Quality Assurance Manager (12 years experience in medical device testing and regulatory compliance).

4. Adjudication Method for the Test Set (Hypothetical Example)

• Adjudication Method: For quantitative measurements, results would be recorded by trained technicians/engineers. Any discrepancies or outliers would be investigated and resolved by the lead engineer and QA manager through re-testing or thorough review of methodology. For subjective assessments (e.g., ergonomic evaluation), a consensus approach among the expert panel might be used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical Example)

• Given this is a physical laser device, an MRMC study related to interpretation of results or diagnostic performance (like for an imaging AI) is not applicable. The device's direct performance is based on its physical properties and output.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop) (Hypothetical Example)

• Again, this term is more relevant for AI/software devices. For a hardware device like a laser, the "standalone performance" is exactly what the hypothetical performance table above would describe – the device's intrinsic operational metrics without a human actively making real-time adjustments for the test. The clinician is always "in the loop" during actual treatment.

7. Type of Ground Truth Used (Hypothetical Example)

• Ground Truth: Primarily based on metrology standards and established physical principles. This would involve using calibrated measurement equipment (e.g., power meters, beam profilers, oscilloscopes) traceable to national standards to objectively quantify the laser's output characteristics against its design specifications.

8. Sample Size for the Training Set (Hypothetical Example)

• For a hardware device, the concept of a "training set" is usually not applicable in the same way it is for AI/machine learning algorithms. Device design and manufacturing processes are refined through iterative testing and quality control during development. The "training" for such a device comes from engineering principles, material science, and prior models.

9. How the Ground Truth for the Training Set Was Established (Hypothetical Example)

• As above, not directly applicable in the AI sense. Ground truth in the development phase would be established through engineering specifications, design verification, and validation testing against intended performance requirements, using calibrated equipment and standard test methods.

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