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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

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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.

Note on "Acceptance Criteria": The primary "acceptance criteria" for a 510(k) submission are demonstrating that the new device (Integre LP561) is substantially equivalent to a legally marketed predicate device (Integre Duo LP1RG) in terms of intended use, technological characteristics, and performance. The modification (yellow wavelength) is justified by its clinical benefits (high absorption by melanin, high absorption by hemoglobin, no absorption in macular xanthophylls, higher transmission through cloudy media) without introducing new questions of safety or effectiveness.

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

This a 510(k) submission for a modified laser device, not a diagnostic AI device requiring a "test set" in the context of image analysis. The submission primarily relies on design verification and validation testing of the new laser's technical specifications and safety standards, as well as a comparison to an existing predicate device. No patient-specific "test set" data (e.g., images for diagnostic evaluation) is mentioned for this type of device. The data provenance would be internal engineering and quality assurance testing, likely conducted by Ellex Medical Pty. Ltd. in Australia.

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)

Not applicable. This device is an ophthalmic laser for treatment, not a diagnostic device requiring expert interpretation for ground truth establishment.

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

Not applicable. See point 3.

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 therapeutic laser device, not a diagnostic AI system for human readers.

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

Not applicable. This is a therapeutic laser device. Its performance is evaluated based on its physical properties (wavelength, power, spot size, safety) and its demonstrated ability to achieve its intended clinical effect through photocoagulation, which is user-controlled.

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

For a therapeutic laser device like this, "ground truth" would relate to its functional performance and safety. This involves:

• Engineering specifications and measurements: Verifying that the laser emits the specified wavelength, power, and operates within safety limits.
• Biocompatibility and sterilization validation: Ensuring materials are safe for patient contact and the device can be properly sterilized.
• Electrical safety and electromagnetic compatibility (EMC) testing: Conforming to relevant medical device standards.
• Clinical context based on predicate: The historical clinical use and efficacy of the predicate device (Integre Duo LP1RG) and similar lasers establish the "ground truth" for the principle of photocoagulation for the indicated conditions. The new device's yellow wavelength is presented as a beneficial modification to this established principle.

No specific patient outcomes data or pathology "ground truth" from a new clinical study is detailed in this 510(k) summary; rather, the safety and effectiveness are established through technological comparison to the predicate.

8. The sample size for the training set

Not applicable. This is a therapeutic laser device, not an AI system that requires a "training set."

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

Not applicable. See point 8.

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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

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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

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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)

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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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The indications for use for the above product family is:

• Iridectomy/Iridotomy.
• Posterior Capsulotomy.
• Posterior Membranectomies.

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I'm sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Laserex Q-S/W Nd:YAG Lasers). It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, not necessarily a demonstration of meeting specific performance acceptance criteria through a clinical or technical study as you've outlined.

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

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The indication for use for this product are;

• · Retinal Photocoagulation
• · Pan Retinal Photocoagulation
• · Photocoaqulation for Macular Degeneration · Laser Trabeculoplasty
• · Endophotocoagulation.

The LP1532 is a compact, solid state laser photocoagulator intended for ophthalmic use. It produces laser energy intended to be directed into the eye by a suitably qualified physician, via a range of laser delivery accessories namely;

• Laser Endoprobes .
• Laser Indirect Ophthalmoscope .
• Slitlamp Delivery Systems .
  The LP1532 is a frequency doubled Nd:YAG Laser operating in the visible green wavelength spectrum ( 532 nanometers ).

The provided text is a 510(k) summary for the Laserex Model LP1532, a solid-state laser photocoagulator. This documentation is for regulatory clearance and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way a traditional scientific study would.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance simply does not exist within this document.

The document primarily focuses on technical specifications, intended uses, and a comparison to predicate devices to establish substantial equivalence.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary doesn't define specific "acceptance criteria" for clinical performance in the way a clinical study would. Instead, its acceptance criteria for clearance are based on demonstrating substantial equivalence to predicate devices. The "performance" reported is primarily the device's technical specifications and a direct comparison to those of the predicate devices.

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

• Sample Size: Not applicable. This document does not describe a clinical study with a test set of patients or medical images. It's a technical submission for regulatory clearance based on substantial equivalence.
• Data Provenance: Not applicable for clinical performance data. The "data" provided is primarily technical specifications and comparative analysis against existing, legally marketed devices.

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

• Number of Experts: Not applicable. No clinical ground truth establishment process is described in this document.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set or adjudication process 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

• MRMC Study: No, this document does not mention or present any MRMC comparative effectiveness study. The device is a laser photocoagulator, not an AI-assisted diagnostic or therapeutic system that would typically be evaluated in such a study.

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

• Standalone Performance: Not applicable. The device is a medical device (laser system) operated by a physician, not a standalone algorithm.

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

• Ground Truth: Not applicable for clinical performance. The "ground truth" for the 510(k) submission is the established safety and effectiveness of its predicate devices. The new device demonstrates "substantial equivalence" to these predicates.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device being developed through data training.

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

• Ground Truth Establishment: Not applicable. No training set is mentioned.

Summary of Device Evidence for Substantial Equivalence (from the document):

The primary "study" proving the device meets its "acceptance criteria" (i.e., substantial equivalence) is a comparison of its technical specifications and intended uses to those of legally marketed predicate devices.

• "Study" Methodology: A table-based comparison (Sections 5.4 and 7) of the Laserex LP1532's characteristics (e.g., laser power, wavelength, accessories, physical dimensions, electrical requirements, scientific concepts) against four predicate devices: Alcon Ophthalas 532, Alcon EyeLite, Iris Occulite, and Nidek Prima.
• Key Findings: The document asserts, "There are no significant changes or modifications from the predicate products that affect safety, effectiveness, or the intended use of the product." The detailed comparative tables support this by showing that the LP1532's specifications fall within the range or are similar to those of the predicate devices.
• Biocompatibility and Sterilization: For patient-contacting components (endo probes), the submission relies on the 510(k) approvals of the supplier (Creative Medical Products, Inc.) for those specific probes (K954307, K954308).
• Software Validation: The document notes that software validation and verification processes are ongoing but believes equivalence can be determined before completion, with a commitment from the CEO to complete these processes (Section 9). The level of concern for the software was identified as "Minor to Moderate."

This 510(k) summary provides evidence of technical and functional equivalence to existing devices, which is the basis for regulatory clearance in the absence of new safety or efficacy questions. It is not designed to present de novo clinical performance data in the format of a research study.

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