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In the YAG mode (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy.

In the SLT mode (Tango Neo, Tango Reflex Neo) : -Selective Laser Trabeculoplasty (SLT)

These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma.

All these devices consist of the below main parts: Delivery Head, Microscope and Slit lamp Illumination, Console and Table Top, Joystick fire button, Total solution table, Display unit.

This FDA 510(k) summary does not contain the information required to populate a table of acceptance criteria and reported device performance related to clinical effectiveness. This submission is for an ophthalmic laser system (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo) and the FDA has determined that clinical data is not required because the new devices use the same technology and principles as a previously cleared predicate device (Ellex YAG/SLT, K212630).

Therefore, many of the requested fields cannot be filled. However, based on the non-clinical testing performed, we can infer some "acceptance criteria" related to safety and performance specifications, though not in the typical format of clinical outcomes.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As clinical data was not required, there are no specific clinical acceptance criteria or reported clinical device performance metrics in this summary. The "acceptance criteria" are implied by compliance with various safety and performance standards for medical devices and lasers.

2. Sample size 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 per Section IX, "clinical data is not required" for the substantial equivalence determination. The "tests" mentioned are non-clinical safety and performance tests against standards, not clinical studies with patients.

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 ground truth was established for a test set in this submission.

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

Not applicable, as no clinical test set requiring adjudication was used.

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. This is a laser device, not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This is a physical laser device, not a standalone algorithm.

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

Not applicable, as no clinical ground truth was established for a clinical study in this submission. For the non-clinical tests, the "ground truth" is adherence to international and federal safety and performance standards.

8. The sample size for the training set

Not applicable. No AI/ML component requiring a training set is mentioned.

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

Not applicable. No AI/ML component requiring a training set is mentioned.

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In the YAG mode (Tango, Ultra Q, Ultra Q Reflex, Tango Reflex): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy.

In the SLT mode (Tango, Solo, Tango Reflex): -Selective Laser Trabeculoplasty (SLT)

These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma.

The provided text is a 510(k) summary for the Ellex YAG/SLT Laser. It describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence. It does not contain information about a study that proves the device meets specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, or accuracy) or a multi-reader, multi-case comparative effectiveness study involving human readers and AI assistance.

The document states: "Since the Ellex YAG/SLT devices use the same technology and principles as the predicate device, clinical data is not required." This means that traditional clinical performance studies (like those that would establish detailed acceptance criteria for diagnostic accuracy or reader improvement) were not conducted or submitted for this 510(k) clearance. The focus of this submission is on demonstrating fundamental safety and technological equivalence to a previously cleared device.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study design, as this information is not present in the provided document.

The document primarily covers non-clinical tests (electrical safety, EMC, laser safety, biocompatibility, and software verification/validation) to support the safety and substantial equivalence of the new device to the predicate device.

Key takeaway from the document: The applicant relied on substantial equivalence to a predicate device (Lumenis Selecta Duet, K021550) and extensive non-clinical testing to demonstrate the safety and effectiveness of the Ellex YAG/SLT Laser, rather than conducting new clinical performance studies with specific acceptance criteria that would assess diagnostic or treatment effectiveness in a quantitative manner.

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The Eye Prime is intended for ophthalmic imaging when the following conditions are present or suspected:
•Cataracts
•Retinal Detachment (separation of the retina from the middle coat of the eyeball)
•Orbital Lesions
•Tumors
•Foreign Bodies
•Inflammation
•Vascular Irregularities

The Eye Prime is a new, diagnostic ophthalmic ultrasound Track 1 device. Its function is to perform B-mode ultrasound scans. The system consists of 1) A console which supports 12 and 18MHz Posterior B scan probes and Anterior B- Scan. Ultrasound Bio-microscopy (UBM) probes with either 35 or 50MHz transducers. 2) A laptop which performs the image processing requirements of the system; provides the user interface for operating the device and viewing the resultant images. The laptop also provides data storage, export, archiving and networking for the device and includes the connection for footswitch.

The provided text describes the Eye Prime device, which is an ophthalmic ultrasound system. However, the document provided does not contain information about acceptance criteria, device performance metrics, sample sizes, expert adjudication, or clinical study results (MRMC or standalone) for the Eye Prime device itself.

The document primarily focuses on establishing "substantial equivalence" of the Eye Prime device to a predicate device (Eye Cubed Version 4) based on similar indications for use, technological characteristics, and safety testing. It explicitly states in Section IX: "Since the Eye Prime device uses the same technology and principles as the predicate device, clinical data is not required." This implies that no specific clinical study was conducted for the Eye Prime to prove its performance against acceptance criteria in the way a new, non-substantially equivalent device might.

Therefore, I cannot fulfill all parts of your request with the provided information. I can, however, extract details about the acceptance criteria assumed by demonstrating substantial equivalence, and other relevant information present in the document.

Here's a breakdown of what can and cannot be provided based on the input:

Acceptance Criteria and Device Performance

Since no specific performance metrics or acceptance criteria for the Eye Prime device itself are reported, we can infer that the acceptance criteria for this 510(k) submission were likely focused on demonstrating equivalence in safety and general performance characteristics to the predicate device, rather than specific diagnostic accuracy metrics.

Table of Performance (Based on "Substantial Equivalence" claim):

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The Ellex Integre Pro Scan is indicated for use photocoagulation of both anterior and posterior segments of the eye including:

• Retinal photocoagulation and pan retinal photocoagulation of vascular and structural . abnormalities of the retina and choroid including:
  • proliferative and nonproliferative diabetic retinopathy;
  • choroidal neovascularization; .
  • retinal vein occlusion; - -
  • wet age-related macular degeneration; :
  • retinal tears and detachments; -
  • retinopathy of prematurity; -
• Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle . glaucoma

Not Found

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for the Ellex Integre Pro Scan Ophthalmic Laser, detailing its regulation, indications for use, and compliance requirements. It does not include details on acceptance criteria, specific device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.

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The 2RT (LR1532) is indicated for use by a trained ophthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment, in the treatment of; Clinically Significant Macular Edema (CSME) .

2RT (model number LR1532) ophthalmic laser system

This document is a 510(k) clearance letter for the Ellex 2RT ophthalmic laser. It states that the device is substantially equivalent to legally marketed predicate devices for the indication of treating Clinically Significant Macular Edema (CSME) by producing a wound to the Retinal Pigmented Epithelium (RPE) of the retina.

However, the provided text does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed study parameters requested in the prompt. This document is a regulatory approval notice, not a clinical study report.

Therefore, I cannot provide the requested information from the provided text.

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The Integre family of Ophthalmic laser and Delivery Devices are intended to be used in the treatment of ocular pathology.

The Ellex Integre Pro L2RY is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:

• Retinal photocoagulation and pan retinal photocoagulation 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, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma

The Integre Pro L2RY is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office.

It is capable of producing focused pulses of red or yellow light with wavelengths of 670 nanometres (nm) and 561 nm respectively. The red and vellow beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas.

The Integre Pro L2RY is based upon the Integre Duo LP1RG with a modification to the laser cavity optical components which results in a yellow (561 nm) treatment laser output.

As with the Integre Duo, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used.

The Integre Pro is an ophthalmic photocoagulator laser designed to be used by ophthalmologists for treatment of ocular pathology of the eye.

The provided text describes the Ellex Integre Pro L2RY ophthalmic laser, a modified version of the Ellex Integre Duo LP1RG. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for validation studies of diagnostic or AI-driven devices.

Instead, the document is a 510(k) Summary submitted to the FDA for market clearance. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested information points (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training sets) cannot be extracted from this document as these types of studies were not conducted or reported for this device's 510(k) submission.

The document primarily compares the technical characteristics and intended uses of the new device (Integre Pro L2RY) with its predicate devices (Integre Duo LP1RG and Integre LP561) to establish substantial equivalence.

Here's a breakdown of what can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or a pass/fail threshold. Instead, it demonstrates "substantial equivalence" based on similar technological characteristics and identical intended uses to predicate devices. The "performance" reported is therefore a comparative table of specifications.

The acceptance criterion for this 510(k) submission is that "modification to the predicate device... does not adversely affect the intended use, technological characteristics or safety and effectiveness." The study proving this is the comparison of technological characteristics and intended uses against the predicate devices, showing they are substantially equivalent.

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

• Not applicable / Not provided. This is a hardware device modification, not a diagnostic algorithm undergoing validation on a test set of patient data.

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

• Not applicable / Not provided. There is no "ground truth" derived from experts for a test set in this context. The determination of device characteristics is based on engineering specifications and testing.

4. Adjudication Method:

• Not applicable / Not provided.

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 / Not provided. This device is an ophthalmic laser for treatment, not an AI-assisted diagnostic tool.

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

• Not applicable / Not provided. This is a standalone laser system for treatment, not an AI algorithm.

7. The Type of Ground Truth Used:

• Not applicable / Not provided for patient data. The "ground truth" here is the engineering specifications and performance of the device itself (e.g., accurate wavelength, power output, exposure time). This is established through internal testing and measurement against design specifications, not clinical "outcomes data" or "expert consensus" related to patient diagnoses.

8. The Sample Size for the Training Set:

• Not applicable / Not provided. There is no "training set" as this is not a machine learning device.

9. How the Ground Truth for the Training Set was Established:

• Not applicable / Not provided.

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The Ellex Integre is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:

• Retinal photocoagulation and pan retinal photocoagulation 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, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma

The Integre LP561 is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office. The Integre Duo LP1RG device is capable of producing focused pulses of red or green light with wavelengths of 670 nanometres (nm) and 532 nm respectively. The red and green beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas. The Integre LP561 is essentially the same device with a modification to the laser cavity optical components which results in a vellow (561 nm) treatment laser output. The reason for developing the new device is because the yellow wavelength is characterised by high absorption by melanin in the retinal pigment epithelium and choroids that reduces the penetration depth of the beam in the choroids, high absorption by haemoglobin that facilitates direct treatment for retinal/choroidal neovascularisation and no absorption in macular xanthophylls and higher transmission through cloudy media such as cataract or haze on the cornea. As with the Integre LP1RG, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used.

This document describes a 510(k) premarket notification for a modified medical device, the Ellex Integre LP561 ophthalmic laser. The submission aims to demonstrate substantial equivalence to a predicate device, the Ellex Integre Duo LP1RG. As such, it focuses on comparing the modified device to the predicate device and other commercially available equivalents, rather than presenting a standalone study with defined acceptance criteria and performance results in the typical sense for a brand new device.

Therefore, the requested information, particularly regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria," does not directly apply in the context of this 510(k) submission. Instead, the "acceptance criteria" can be interpreted as demonstrating substantial equivalence to the predicate device, especially concerning safety and effectiveness. The "study" proving this is primarily the comparison tables and narrative provided within the 510(k) submission itself, highlighting technological similarities and equivalent intended use.

Here's an attempt to extract and frame the information according to your request, with caveats reflecting the nature of a 510(k) submission:

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

In a 510(k) for a modified device, the "acceptance criteria" are implicitly the characteristics and performance of the predicate device. The "reported device performance" is the characteristics and expected performance of the modified device, ideally showing it is at least as safe and effective as the predicate.

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The Laserex Duo family of dual wavelength ophthalmic lasers are intended for use in the treatment of ocular pathology.

The Laserex Duo is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:

• Retinal photocoagulation and pan retinal photocoagulation 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, suturelysis and trabeculoplasty in angle closure glaucoma . and open angle glaucoma

Not Found

The provided text is a 510(k) summary for the Laserex Duo family of ophthalmic lasers. It describes the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device.

*However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the detailed study parameters you've requested.

This type of FDA clearance letter (510(k) summary) primarily focuses on establishing substantial equivalence to a legally marketed predicate device, not on presenting detailed performance data from new clinical studies against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given text.

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The Laserex LP4532 Ophthalmic Laser is intended for use in the treatment of ocular pathology

The Laserex LP4532 is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:

• Retinal photocoagulation, pan retinal photocoagulation and intravitreal endophotocognilation of vascular and structural abnormalities of the retina and choroid including:
  • proliferative and nonproliferative diabetic retinopathy:
  • choroidal neovascularization;
  • branch retinal vein occlusion;
  • age-refated macular degeneration;
  • retinal tears and detachments;
  • retinopathy of prematurity;
  • macular grid;
  • macular focal;
• Iridotomy, tridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Ellex Medical Pty. Ltd. regarding their Laserex LP4532 Ophthalmic Laser. This document is a regulatory approval letter and an "Indications for Use" statement, not a scientific study report or clinical trial summary.

Therefore, the document does not contain the information requested about acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or training set details.

The letter confirms that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices for the stated indications for use. It lists the medical conditions the laser is intended to treat, such as various retinal pathologies and glaucoma treatment procedures, but it does not provide data or a study description to prove performance against specific acceptance criteria.

To answer your request, a different type of document, such as a clinical study report or a summary of safety and effectiveness, would be needed.

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CAPSULOTOMY
POSTERIOR IRIDOTOMY / IRIDECTOMY
POSTERIOR MEMBRANECTOMY
SELECTIVE LASER TRABELULOPLASTY (SLT)

Not Found

This document is a FDA 510(k) substantial equivalence determination letter for the Lumenis Selecta Duet. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use, but it does not provide performance data, study design, or ground truth information.

Therefore, I cannot extract the requested information from the provided text.

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