Search Results

The EyeQ nanoECP System is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view.

Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures.

Not Found

The provided FDA 510(k) clearance letter for the EyeQ nanoECP describes the device's indications for use and regulatory classification but does not contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria.

This document is a clearance letter, which means the FDA has already reviewed the submitted data and determined substantial equivalence. The detailed performance data and study design (including acceptance criteria, sample sizes, ground truth establishment, etc.) are typically part of the 510(k) submission, which is not fully disclosed in the public clearance letter.

Therefore,Based on the provided text, I cannot extract the information required to populate the table or answer the questions about the study design that proves the device meets the acceptance criteria. The clearance letter only states that the device has been found substantially equivalent for its stated indications for use.

To answer your request, I would need access to the actual 510(k) submission summary or a more detailed performance study report for the EyeQ nanoECP.

Ask a specific question about this device

The Leos system is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, retinal detachment, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view.

Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures.

Vitreoretinal Surgery - The endoscopically controlled endophotocoagulation that is possible with the ophthalmic laser endoscope is also useful for endophotocoagulation:

• During vitreous surgery to produce chorioretinal scar around retinal breaks or retinotomy sites.
• To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies.
• To perform intraoperative retinal photocoagulation on a scleral buckle.
• To perform intraoperative photocoagulation around focal neovascularization

The Leos Laser and Endoscopic System is a next generation ophthalmic laser and endoscopy system used for the treatment of glaucoma, vitreoretinal diseases, and intraocular visualization. The system contains an 810 nm powered diode laser delivered by the stainless-steel endoscopic laser probe (trade name: VueProbe), which is placed into eye tissue to illuminate and visualize the target tissue and deliver laser energy under direct visualization. The console is a fully integrated portable device, containing a laser module assembly, viewing and control monitors, and a wireless footswitch for activating the laser. The larger passive monitor is for viewing the endoscopic video image and key treatment information, while the smaller touchscreen is used for parameters selection, rotation and viewing. The camera chip uses CMOS technology and is located at the tip of the probe. The LED light source is located within the plastic handpiece of the probe and illumination fibers carry the light to the tip. Additionally, the probe contains a laser fiber within its full length.

Based on the provided FDA 510(k) Clearance Letter for the Leos Laser and Endoscopy System, here's an analysis of the acceptance criteria and study that proves the device meets them:

It's important to note that the provided document is a 510(k) clearance letter, which focuses on substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria from a clinical trial. Therefore, explicit acceptance criteria are not detailed in this document in the way they would be for a clinical study report. Instead, the "acceptance" is based on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The "study" in this context is primarily a non-clinical bench testing regimen designed to ensure the device performs within acceptable parameters and is comparable to predicate devices. Clinical studies were explicitly stated as not applicable and not required for this clearance.

Here's the breakdown of the information requested, as extractable from the provided document:

Acceptance Criteria and Device Performance Study (Based on 510(k) Substantial Equivalence)

The "acceptance criteria" for a 510(k) clearance are primarily met by demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and performance. The performance data presented are primarily from non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since specific quantitative clinical "acceptance criteria" are not given in a 510(k) clearance letter (which relies on equivalence, not novel performance claims), this table will reflect the performance characteristics demonstrating equivalence as described in the document. The "criteria" are implicitly that the performance is comparable or superior to the predicate and meets relevant safety standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The "test set" in this context primarily refers to bench testing of the device and its components. The document indicates:
  • Design Verification and Validation Testing: Confirms product meets requirements.
  • Software Verification and Validation: Completed successfully.
  • Biocompatibility, Sterilization, Shelf life testing.
• Data Provenance: Not applicable in terms of patient data. The provenance is from internal lab bench testing and verification activities. The study is non-clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. For non-clinical bench testing, "ground truth" is established by engineering specifications, regulatory standards (e.g., IEC, ISO, ASTM), and validated test methods. Human expert review of data is inherent but not quantified in this summary.
• Qualifications of Experts: Not specified. This would typically be internal R&D, Quality, and Regulatory personnel with expertise in device design, testing, and regulatory compliance.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This refers to the process of resolving discrepancies among human readers or raters in clinical studies. For non-clinical bench testing, "adjudication" is achieved through adherence to specifications, standards, and robust quality control processes.

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

• MRMC Study: No. The device is an Ophthalmic Laser and Endoscopy System, not an AI-powered diagnostic imaging device requiring a comparative effectiveness study with human readers.
• Effect Size of Human Reader Improvement: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This refers to AI algorithm performance. The Leos system is a direct medical intervention device (laser and endoscopy), not an AI diagnostic algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical tests, the "ground truth" is based on:
  • Engineering specifications: The device is designed to meet certain performance parameters (e.g., laser power, resolution).
  • Regulatory standards: Compliance with international and national standards (e.g., IEC 60601 series, ISO 10993 series, ANSI Z80.36, ASTM D4169-22, ISO 11135, ISO 11607-1, AAMI TIR 28).
  • Predicate device characteristics: The Leos system's performance is compared against the established characteristics of the predicate devices for substantial equivalence.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of the "Study" Proving Acceptance:

The "study" proving the device meets the (implicit) acceptance criteria for 510(k) clearance is a comprehensive non-clinical testing program that includes:

• Bench Testing: Verifying electrical safety, electromagnetic compatibility (EMC), laser and optical safety, and general design performance against engineering specifications and relevant industry standards.
• Software Verification and Validation: Ensuring the software operates correctly and safely, given its "Major" level of concern.
• Biocompatibility Testing: Confirming the materials used in the probe are safe for contact with patients.
• Sterilization and Shelf Life Testing: Validating the sterilization process and ensuring the product maintains sterility and functionality over its intended shelf life.

The conclusion drawn from this testing is that the Leos Laser and Endoscopy System is substantially equivalent to its predicate devices, performing similarly (or better in some aspects like image resolution) while not raising any new safety or effectiveness concerns. This substantial equivalence is the basis for its FDA clearance.

Ask a specific question about this device

The Norlase LYNX Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the LYNX Photocoagulator does not contain information on the acceptance criteria and the study that proves the device meets those criteria.

This document is a clearance letter, which confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device. It briefly touches on device classification, regulations, and mentions the intended use of the device.

To describe the acceptance criteria and the study that proves the device meets them, I would need access to the actual 510(k) submission summary or a more detailed technical report which would typically include sections on performance testing, design specifications, and clinical or non-clinical data. The provided document only details the regulatory clearance, not the underlying performance data.

Therefore, I cannot fulfill your request with the given input.

Ask a specific question about this device

VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including:
• Photocoagulation of the retina

• Trabeculoplasty
• · Iridotomy
• · Posterior capsulotomy
  · Posterior membranectomy

This device is Prescription Use (Rx) only.

VISULAS combi is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength and standard photodisruption treatments of ocular tissues at a wavelength of 1064 mm. VISULAS combi is operated in the following treatment modes:

• single-spot mode (software license VERTE) -
• multi-spot mode (software license VITE)
• YAG disruption mode (software license YAG). -

VISULAS combi consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.

The provided text is a 510(k) premarket notification for the VISULAS combi ophthalmic laser. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device type through clinical studies. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test sets, expert involvement for ground truth, MRMC studies, and detailed training set information, is not explicitly provided in this document.

However, based on the document, I can extract information related to the acceptance criteria in the context of demonstrating substantial equivalence and the types of studies performed.

Here's an analysis of the provided text:

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

The document primarily focuses on demonstrating substantial equivalence to predicate devices, VISULAS green (K232051) for photocoagulation and VISULAS yag (K230350) for photodisruption. The "acceptance criteria" are implied by the similarity to these predicate devices in terms of indications for use, technological characteristics, and principle of operation.

• Trabeculoplasty
• Iridotomy
• Posterior capsulotomy
• Posterior membranectomy (combines indications of both predicates) |
  | Laser Type | Solid state laser, frequency-doubled (for photocoagulation) Q-switched Nd:YAG laser (for photodisruption) | - Photocoagulation: solid state laser, frequency-doubled
• Photodisruption: Q-switched Nd:YAG laser |
  | Wavelength | 532 nm (for photocoagulation) 1064 nm (for photodisruption) | - Photocoagulation: 532 nm
• Photodisruption: 1064 nm |
  | Power/Energy | 50 to 1500 mW (photocoagulation) 9.0 mJ to 45.0 mJ (photodisruption) | - Photocoagulation: 50 to 1500 mW
• Photodisruption: Pulse Mode 1 (Single Pulse): 9.0 mJ to 13.0 mJ
  Pulse Mode 2 (Double Pulse): 18.0 mJ to 28.0 mJ
  Pulse Mode 3 (Triple Pulse): 29.0 mJ to 45.0 mJ |
  | Pulse Duration/Length | 10 - 2500 ms and cw (photocoagulation)

Ask a specific question about this device

The MR Q and the MR SUPINE are intended to perform:

• Posterior capsulotomy -
• Iridotomy -

The MR Q SLT in YAG mode is intended to perform:

• Posterior capsulotomy -
• -Iridotomy

The MR Q SLT in SLT mode is intended to perform:

• Selective laser trabeculoplasty

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria, study details, and specific performance metrics of the device.

The document is a 510(k) clearance letter from the FDA, which confirms that the device (Meridian AG's MR Q, MR Q SUPINE, MR Q SLT) is substantially equivalent to legally marketed predicate devices for its stated indications for use. It outlines regulatory requirements and general information but does not include the results of clinical studies, acceptance criteria, or detailed performance data for the device.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for test sets.
• Information on Multi-Reader Multi-Case (MRMC) studies or the effect size of AI assistance.
• Results from standalone algorithm performance studies.
• Details on the type of ground truth used.
• Sample sizes for training sets or how ground truth for training data was established.

The "Indications for Use" section (page 3) describes what the device is intended to do (e.g., Posterior capsulotomy, Iridotomy, Selective laser trabeculoplasty), but not the performance metrics or studies used to demonstrate those capabilities.

Ask a specific question about this device

The Eagle device is a prescription device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam. The Eagle device has the same intended use as the predicate device. The Eagle device has the following Indications for Use (IFU) statement:

The Eagle device is indicated for use in selective laser trabeculoplasty (SLT).

The Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser that is intended for use in performing selective laser trabeculoplasty. The laser spots produced by the Eagle device have a 400 um spot size, a 3 ns pulse duration, and a 50-Hz pulse repetition rate. The sequence of laser spots consists of 120 spots in a predefined circumferential elliptical pattern delivered at a pre-defined pulse energy level. The spots are delivered through the limbus to the trabecular meshwork in a non-contact fashion, without the need for the use of a contact gonioscopy lens. The device automatically locates the treatment location. The treatment location may be adjusted slightly by the operator. Once confirmed by the operator, the device then automatically applies the laser treatment sequence to the limbal region of the eye, while the eye tracker compensates for any eye movement. The default energy setting is 1.8 mJ/pulse.

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list "acceptance criteria" for the device's performance in the typical sense of numerical thresholds for a specific metric that must be met. Instead, it describes a non-inferiority study where the Eagle device (subject device) is compared to a conventional SLT device (predicate). The implicit acceptance criteria appear to be the demonstration of non-inferiority in effectiveness (IOP reduction) and a comparable safety profile to the predicate device.

Implicit Acceptance Criteria and Reported Device Performance

• Eagle: 5.48 ± 0.52 mmHg reduction
• Conventional SLT: 6.29 ± 0.53 mmHg reduction
  Difference (SLT - Eagle): -0.80 mmHg (95% Cl -2.28, 0.68). The study concluded that the Eagle device demonstrated acceptable effectiveness comparable to conventional SLT. |
  | Safety (Adverse Events) | Primary Safety Outcome: Rate of ocular adverse events (AEs) in the Eagle treatment group at or prior to 12 months should be comparable to the conventional SLT group. | Overall Safety Profile:
• Serious Ocular SAEs (0-6 months): 1 in Eagle (0%) vs 1 in conventional SLT (1.1%) (subluxation of pre-existing IOL deemed related to conventional SLT).
• Serious Ocular SAEs (6-12 months): 1 in Eagle (1.0%) (acute optic neuropathy, non-glaucomatous) vs 0 in conventional SLT.
• Most Common Non-Serious AE (0-6 months): Punctate subconjunctival hemorrhage (20.8% in Eagle vs 1.1% in conventional SLT) - resolved without sequelae.
• Cataract progression (0-6 months): 3.1% in Eagle vs 1.1% in conventional SLT.
• Overall, comparable safety profile to the conventional SLT device, with some differences in types and frequencies of non-serious AEs. |
  | SLIT Lamp Examination (AC Cells & Flare) | Changes in anterior chamber cells and flare from screening should be minimal and comparable between groups. | AC Cells (Increase +0.5 or more):
• Post Procedure: Eagle 31.3% vs SLT 20.9%
• 1 Day: Eagle 18.9% vs SLT 12.1%
• Rapid reduction over time, with negligible increases beyond 1 month for both groups.
  AC Flare (Increase +0.5 or more):
• Post Procedure: Eagle 20.8% vs SLT 16.5%
• 1 Day: Eagle 11.6% vs SLT 7.7%
• Rapid reduction over time, with negligible increases beyond 1 month for both groups. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set:
  • Randomized Participants (ITT Population): 196 participants (99 to Eagle, 97 to conventional SLT)
  • Participants Underwent Assigned Procedure: 187 participants (96 Eagle, 91 conventional SLT)
  • Modified Per Protocol (mPP) Population: 152 participants (77 Eagle, 75 conventional SLT)
• Data Provenance: Prospective, multi-center, randomized, controlled trial. The specific countries of origin for the data are not explicitly stated, but it's a multi-center study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This was a clinical trial involving patients, not an AI review of images needing expert consensus for ground truth. The "ground truth" for effectiveness was objective physiological measurements (Intraocular Pressure reduction) and for safety, it was the occurrence of adverse events monitored by clinical investigators. Therefore, standard expert-based ground truth establishment (e.g., from radiologists) is not applicable here. Clinicians at the 14 sites would have assessed patients, but "experts" for ground truth in the AI sense are not mentioned.

4. Adjudication Method for the Test Set

This was a clinical trial with objective measures and adverse event reporting. Therefore, an adjudication method like "2+1" for discrepancies in expert readings (common in AI imaging studies) is not directly applicable. Clinical trial protocols typically have methods for reporting, verifying, and adjudicating adverse events and protocol deviations, but this isn't detailed in the provided summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study directly compared two laser devices (Eagle vs. conventional SLT) in a randomized controlled trial on human patients, measuring clinical outcomes (IOP reduction and adverse events), not human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm-only performance study was not conducted in the traditional sense of evaluating an AI's diagnostic accuracy. The Eagle device is a laser system that automatically locates treatment areas and applies laser sequences, with the operator able to make slight adjustments and confirm. The study evaluates the device's clinical performance when used by an operator, not a purely autonomous AI algorithm against a manual process.

7. The Type of Ground Truth Used

The ground truth used in this clinical study was based on:

• Effectiveness: Objective physiological measurement of unmedicated Intraocular Pressure (IOP).
• Safety: Clinical observation and reporting of ocular adverse events (AEs).

8. The Sample Size for the Training Set

The provided document describes a clinical validation study for the Eagle device, which is a medical device (laser system), not an AI algorithm that requires a separate training set. Therefore, there is no "training set" in the context of machine learning. The clinical trial directly evaluated the device's performance in patients.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI algorithm, this question is not applicable. The device itself is the subject of the clinical investigation, with its internal automation being part of its design.

Ask a specific question about this device

VISULAS green is intended for use in photocoagulating ocular tissues of the treatment of diseases of the eve, including

• · Photocoagulation of the retina
• Trabeculoplasty
• · Iridotomy

VISULAS green is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength. VISULAS green is operated in single-spot mode or in multi-spot mode.
VISULAS green consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.

The provided FDA 510(k) summary for the VISULAS green device (K232051) focuses on establishing substantial equivalence to a predicate device (VISULAS green, K181682) rather than presenting a study demonstrating the device meets a specific set of clinical performance acceptance criteria. Therefore, much of the requested information regarding a comparative effectiveness study, standalone performance, ground truth, and expert involvement is not present in this document.

However, I can extract information about the types of testing performed and the general conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for clinical performance that the device was tested against. Instead, it states that the device underwent various forms of testing to demonstrate equivalence and compliance with standards.

2. Sample size used for the test set and the data provenance

Not applicable. The document describes engineering and software verification and validation, as well as biocompatibility testing, but does not detail a clinical test set for evaluating device performance against diseases of the eye. The focus is on demonstrating equivalence to a predicate device through technical specifications and non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical test set is described, there's no mention of experts establishing a ground truth for such a set.

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

Not applicable. No clinical test set 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

Not applicable. The device (VISULAS green) is an ophthalmic laser for photocoagulation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's submission.

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

Not applicable. The VISULAS green is a medical device (laser system), not a standalone algorithm. Its performance is inherent to its physical operation and interaction with ocular tissues, guided by a human operator.

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

For the technical testing detailed (biocompatibility, safety, software, bench testing), the "ground truth" would be the established engineering specifications, recognized industry standards, and the performance characteristics of the predicate device. No clinical "ground truth" (e.g., pathology, outcomes) is described as being directly used to measure the subject device's efficacy in treating specific diseases in a clinical study.

8. The sample size for the training set

Not applicable. This device is a laser system, not an AI/ML algorithm that requires a training set of data.

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

Not applicable. This device is a laser system, not an AI/ML algorithm.

Ask a specific question about this device

VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.

This device is for Prescription Use (Rx) only.

VISULAS yag uses a Q-switched, flashlamp-pumped solid-state laser for photodisruption treatments of diseases of the eye, including posterior capsulotomy, iridotomy and membranectomy. Laser radiation is generated by means of a neodymium-doped yttrium aluminum garnet (Nd:YAG) gain medium inside the laser source. The emitted laser radiation with a near-infrared wavelength of = 1064 nm has a pulse duration of

I am sorry, but the provided text is a 510(k) summary for a medical device (VISULAS yag), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study design with acceptance criteria and device performance results as requested.

The document does not contain:

• A table of acceptance criteria and reported device performance for a specific study.
• Information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for a clinical study.
• Details regarding training set size or how ground truth was established for a training set.

Instead, the document primarily compares the subject device's indications for use and technical characteristics to two predicate devices (Ellex YAG Laser K212630 and VISULAS YAG III K042139) to establish substantial equivalence. It mentions "Non-Clinical Performance Testing" and "functional and system level testing showed that the system met the defined specifications," and "Software verification and validation testing were conducted... All testing passed," but these are general statements and do not provide the detailed study information you've asked for.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device

The MERILAS 810 shortpulse laser is indicated for:

• Photocoagulation
• Iridotomy
• Trabeculoplasty
• Thermotherapy

The MERILAS 532 shortpulse laser is indicated for:

• Photocoagulation
• Iridotomv
• Trabeculoplasty

The MERILAS 577 shortpulse laser is indicated for:

• Photocoagulation
• Iridotomy
• Trabeculoplasty

Not Found

I apologize, but the provided text is an FDA 510(k) clearance letter for three ophthalmic laser devices (Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse). This document does not contain information about acceptance criteria or a study that proves a device meets acceptance criteria, specifically for an Artificial Intelligence (AI) enabled device.

The document primarily focuses on:

• Confirmation of 510(k) clearance: Stating that the devices are substantially equivalent to legally marketed predicate devices.
• Regulatory information: Details about class II classification, compliance requirements, and contact information.
• Indications for Use: Listing the medical conditions each Merilas laser model is intended to treat (photocoagulation, iridotomy, trabeculoplasty, thermotherapy).

Since the request specifically asks for details about acceptance criteria and a study proving an AI device meets them, and the provided text does not contain any such information, I cannot fulfill the request based on this document.

To answer your question, I would need a different type of document, such as a clinical study report, a scientific publication detailing the validation of an AI medical device, or a 510(k) summary specifically for an AI-enabled device that includes performance data.

Ask a specific question about this device

The Iridex® Laser Console (532 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse® mode, for ophthalmic applications (532 and 577 models) and for Ear, Nose, and Throat (Otolaryngology) applications (532 model only).

Iridex® 532 Laser

The Iridex® 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, ear, nose and throat (ENT)/otolaryngology, and ophthalmology as follows:

Ophthalmology

Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:

• · Retinal photocoagulation (RPC) for the treatment of
  • o Diabetic retinopathy, including:
    • Nonproliferative retinopathy
    • Macular edema
    • Proliferative retinopathy
  • o Retinal tears and detachments
  • o Lattice degeneration
  • o Age-related macular degeneration (AMD)
  • o Retinopathy of prematurity
  • o Sub-retinal (choroidal) neovascularization
  • o Central and branch retinal vein occlusion
• · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
  • o Primary open angle/Closed angle

Ear, Nose, and Throat (ENT)/Otolaryngology

Otosclerotic Hearing loss and/or diseases of the inner ear:

• · Stapedectomy
• · Stapedotomy
• · Myringotomies
• · Lysis of Adhesions
• · Control of Bleeding
• · Removal of Acoustic Neuromas
• · Soft tissue Adhesion in Micro/Macro Otologic Procedures

Iridex® 577 Laser

The Iridex® 577 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialty of ophthalmology as follows:

Ophthalmology

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: o Proliferative and nonproliferative diabetic retinopathy o Choroidal neovascularization o Branch retinal vein occlusion o Age-related macular degeneration (AMD) o Retinal tears and detachments o Retinopathy of prematurity · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

The Iridex 532/577 Laser consoles are solid state lasers that are used to deliver laser energy in continuous wave and MicroPulse® for ophthalmic applications and (for 532 only) ear, nose, and throat (ENT) / otolaryngology applications. The Iridex® 532 Laser delivers a 532 nm wavelength (green) laser emission, and the Iridex® 577 Laser delivers a 577mm wavelength (true-yellow) laser emission.

The Iridex 532 Laser and the Iridex 577 Laser systems are comprised of a laser console with footswitch and an optical fiber delivery device. Each laser console model contains two laser diodes as follows:

• Iridex 532 Laser: 532 nm for Treatment and 650 nm for Aiming beam ●
• Iridex 577 Laser: 577 nm for Treatment and 650 nm for Aiming beam ●

imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch.

Optical fiber Delivery Devices are provided separately.

The provided text describes a 510(k) summary for the Iridex® Laser, demonstrating substantial equivalence to a predicate device. The information primarily focuses on non-clinical performance data rather than a detailed clinical study involving human readers and AI assistance.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The study primarily evaluates the safety and performance of the Iridex® Laser against established standards and internal specifications, not a comparative effectiveness study with human readers and AI. Thus, the performance is measured against technical and safety benchmarks.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical testing was not required for this product change." This indicates that the regulatory submission relies on non-clinical performance and safety data, as well as a comparison to a predicate device. Therefore, there is no test set of clinical images or patient data as would be used in an AI/imaging device. The "test set" here refers to the units of the device itself and its components undergoing engineering validation.

The provenance of this data is from internal Iridex testing and external test houses (e.g., Westpak testing for shipping/packaging). The data is prospective in the sense that the tests were conducted specifically for this regulatory submission on the subject devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Given that this is a non-clinical device performance and safety study, not a diagnostic AI study, there were no clinical experts (e.g., radiologists) involved in establishing ground truth for a test set of images. The ground truth for the device's technical performance (e.g., power output accuracy, pulse duration) would be established by calibrated measurement equipment and engineering standards, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Since there's no clinical test set requiring image interpretation or diagnosis, there's no need for an adjudication method (like 2+1 or 3+1 consensus) for ground truth establishment. Technical performance metrics are typically measured against established engineering tolerances directly.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a laser system for treatment, not an AI or diagnostic imaging device. The submission focuses on demonstrating substantial equivalence to a predicate laser device based on technical specifications and safety standards, not on improving human reader performance with AI assistance. Therefore, there is no effect size related to AI improvement for human readers.

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

Not applicable. This device is a therapeutic laser system, not an algorithm, and does not operate as a "standalone" diagnostic or AI tool. Its performance is intrinsic to its hardware and embedded software controlling laser emission.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• International Electrotechnical Commission (IEC) Standards: For electrical, laser, EMI/EMC safety, usability, and software lifecycle processes (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304).
• ISTA Standards: For shipping and packaging integrity (ISTA 3A).
• Internal Iridex Performance Specifications: For parameters like treatment beam power output, pulse duration/interval, and aiming beam power output.

This is a technical and engineering ground truth, established through calibrated measurements and adherence to recognized industry standards, rather than clinical consensus or pathology findings.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI model requiring a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model.

Ask a specific question about this device