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510(k) Data Aggregation
(336 days)
Ophthalmology:
532nm Laser
The LightLas 532/670 system consists of a Laser Console where the Multi-Wavelength Laser is housed along with the Electronic Control system and Power Supplies and various Laser Delivery Units (LDU's). The LDU's include:
- Slitlamp Integrated into CSO model SL980.
- Slitlamp Attachment for CSO model SL990 and other Haag Streit clones.
- Slitlamp Attachment for Zeiss model SL30 Slitlamp.
- Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 180 BIO.
- Endophotocoagulation handpieces (Endoprobes).
This submission describes a medical laser system and focuses on its substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics typically associated with AI/software devices. Therefore, much of the requested information cannot be directly extracted from the provided text.
Here is an analysis based on the available information:
Key Takeaway: The submission for the LightLas Multi-Wavelength Medical Laser System (LightLas 532/670) focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving performance against specific acceptance criteria through a novel study. This means the device's performance is inferred to be similar to legally marketed devices based on shared technological characteristics and intended use, not through a separate quantitative performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Expected/Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Equivalent to predicate devices | "The intended use has not changed from the predicate devices." (Explicitly stated) |
| Technological Characteristics | Same general design, fundamental scientific technology, functional elements (treatment wavelengths, treatment power, spot size, cooling system), control systems (door interlock, safety systems, displays) as predicate devices. No new hazards introduced. | "The LightMed Multi-wavelength Medical Laser system... has the same intended use, general design and fundamental scientific technology as the predicate devices... Also the operating controls and functions are equivalent to these products. They have the same functional elements such as treatment wavelengths, treatment power, spot size and cooling system. Control systems such as the door interlock, and the safety systems and displays are constantly monitored... There are no new hazards introduced..." (Explicitly stated) |
| Clinical Effectiveness | Equivalent to previously marketed products based on specifications affecting treatment modality. | "Therefore the Clinical effectiveness of the LightLas 532/670 is equivalent to the previously marketed products as these specifications are the key factors that will affect the treatment modality." (Explicitly stated) |
| Safety Testing | Met appropriate safety standards. | "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670..." (Implied that tests were passed, but no specific criteria or results are detailed). |
| Performance Testing | Met appropriate performance standards. | "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670..." (Implied that tests were passed, but no specific criteria or results are detailed). |
| Functional Testing | Met appropriate functional standards. | "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670..." (Implied that tests were passed, but no specific criteria or results are detailed). |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This submission is for a physical medical laser device, not a software or AI device that would typically use a test set of data. The "testing" mentioned refers to engineering and safety performance of the hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. As above, this is not a data-driven AI/software device. The "ground truth" here is the established safety and effectiveness of the predicate devices in clinical practice, as recognized by the FDA through their previous clearances.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No specific test set with human adjudication is mentioned.
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. This is not an AI-assisted diagnostic or therapeutic device that involves "human readers" in the sense of interpreting medical images or data. It is a direct medical laser system for ophthalmic procedures.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not provided. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Indirect Ground Truth: Clinical Efficacy and Safety of Predicate Devices. The "ground truth" for this substantial equivalence claim is the well-established safety and efficacy of the predicate devices. The new device is deemed equivalent because its technological characteristics and intended use are the same, implying it will perform in a clinically similar and safe manner.
8. The sample size for the training set:
- Not applicable / Not provided. There is no mention of a training set as this is not a machine learning/AI device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
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(84 days)
The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, vellow, and red wavelengths are 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 .
- . Retinal tears and detachments
- Retinopathy of prematurity .
- Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and . open angle glaucoma
The Vision One Laser System is classified as a Class IV laser by the Center for Devices and Radiological Health of the Food and Drug Administration. The Vision One Laser System is intended for use in the treatment of ocular pathology. The system's green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments. The Vision One Laser System will incorporate the newest laser technology - Optically Pumped Semiconductor Laser (OPSL) in additions to Nd:YAG which are both subsets of DPSS (Diode Pumped Solid State Laser).
The system shall be configurable so that any combination of up to three (3) treatment lasers can be installed and used.
The Vision One Laser System is comprised of the laser console, control and display panel, remote control, an external door interlock plug, & footswitch.
The provided document is a 510(k) summary for the Lumenis Vision One Laser System, an ophthalmic surgical laser. It establishes substantial equivalence to a predicate device and details the device's intended use and technical specifications. However, it does not contain the specific information required to answer your request regarding acceptance criteria for a study proving device performance.
Specifically, the document states under "VII. Performance Data:" that "The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted." However, it does not provide the detailed results of these tests, acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as requested.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and the reported device performance:
- Cannot be answered from the provided text. The document states that performance testing was conducted but does not provide specific acceptance criteria or detailed reported performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be answered from the provided text. The document does not describe a clinical study or a test set, nor does it provide details on sample size or data provenance for any performance testing.
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):
- Cannot be answered from the provided text. There is no mention of a test set, ground truth establishment, or experts involved in performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be answered from the provided text. There is no information about a test set or adjudication methods.
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:
- Cannot be answered from the provided text. This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers improving with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be answered from the provided text. This device is a surgical laser, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be answered from the provided text. There is no information on ground truth establishment for any performance testing.
8. The sample size for the training set:
- Cannot be answered from the provided text. This device is a surgical laser; the concept of a "training set" in the context of machine learning or AI is not applicable here.
9. How the ground truth for the training set was established:
- Cannot be answered from the provided text. Not applicable for this type of device.
In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device based on intended use, fundamental scientific technology, patient population, principles of operation, and method of energy delivery. It does not provide the detailed performance study information with acceptance criteria, sample sizes, or ground truth establishment that you are requesting.
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(25 days)
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.
| Characteristic compared (as "Acceptance Criteria" implicit from Predicate) | Ellex Integre Duo LP1RG (Predicate Performance) | Integre LP561 (New Device Performance) |
|---|---|---|
| Intended Use | Photocoagulation of both anterior and posterior segments of the eye for conditions like diabetic retinopathy, choroidal neovascularization, retinal tears, glaucoma. | Substantially Equivalent (same intended use as the predicate, confirmed with minor rephrasing) |
| Laser Type | True CW Diode-Pumped Solid-State (DPSS) | True CW Diode-Pumped Solid-State (DPSS) |
| Laser Wavelength | 532 nm (green), 670 nm (red) | 561 nm (yellow) |
| Laser Power | 50-2000 mW (green), 50-1500 mW (red) | 50-1500 mW (yellow) |
| Exposure time settings (pulse duration) | 0.01 to 4.0 seconds adjustable in variable increments | 0.01 to 4.0 seconds adjustable in variable increments |
| Repeat mode Intervals | 0.1 to 1.0 seconds | 0.1 to 1.0 seconds |
| Laser Safety Class | 4/IV | 4/IV |
| Spot Size | 50 to 1000 µm | 50 to 1000 µm |
| Aiming Laser Type | Semi conductor laser diode | Semi conductor laser diode |
| Aiming Laser Power |
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(62 days)
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)
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Laser Output Power Accuracy | Within ±10% of set value | ±5% (e.g., for 50 mW to 3.0 W range) |
| Beam Spot Size Accuracy | Within ±15% of nominal size | ±10% (e.g., for various delivery devices) |
| Pulse Duration Accuracy | Within ±5% of set value | ±2% (e.g., for 10 ms to 1000 ms range) |
| Aiming Beam Co-axiality | Within 0.5 mm relative to treatment beam |
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