Search Results

450 nm, 635 nm and 980 nm Diode Laser:
· Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tıssue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening:
• Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy:
· Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

810 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology
· Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue

• · Gingival troughing for crown impression
• · Gingivectomy
• · Gingivoplasty
• · Gingival incision and excision
• · Hemostasis and coagulation
• · Excisional and incisional biopsies
• · Fibroma removal
• · Frenectomy and frenotomy
• · Oral papillectomies
• · Soft tissue crown lengthening
• · Treatment of aphthous ulcers
• · Treatment of herpetic lesions
• · Periodontology;
• · Laser soft tissue curettage
• · Laser soft tissue curettage
• · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
• · Cosmetic Dentistry;
• · Laser-assisted bleaching/whitening of the teeth
• · Light activation for bleaching materials for teeth whitening
• · Implant recovery

810 nm Diode Laser in therapy:
· Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

1064 nm Diode Laser in dentistry:

• · Excisional and incisional biopsies;
• · Excision and vaporization of herpes simplex I and II;
• · Frenectomy and frenotomy;
• · Gingivectomy;
• · Gingivoplasty;
• · Gingival incision and excision;
• · Hemostasis;
• · Implant recovery;
• · Operculectomy;
• · Pulpotomy and pulpotomy as an adjunct to root canal therapy;
• · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;
  · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility):
  · Treatment of aphthous ulcers and herpetic lesions

The Dawn Diode Laser System manufactured by SWOT LASERS is a surgical device at the cutting edge of technology, designed for a wide variety of soft tissue procedures. The Dawn Diode Laser System utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of footswitch.
This laser instrument consists of fiber connecting diode laser system, power supply system and microcomputer control system.
The Dawn Diode Laser System employs the diodes with wavelengths of 450nm, 635nm, 810nm, 980nm and 1064nm, and the device emits laser output energy in blue (450nm), red (635nm), orange (980nm) spectra respectively.

The provided text is a 510(k) summary for the "Dawn Diode Laser System." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in these documents. This is typical for a 510(k) submission where the primary goal is to show that a new device is as safe and effective as a legally marketed predicate device, often by demonstrating similar technological characteristics and performance through non-clinical testing.

Here's a breakdown of what can be extracted and what cannot:

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

This information is not provided in the format requested. The document focuses on comparing the proposed device's technological characteristics to predicate devices. It states that "non-clinical tests" were performed to "verify the performance requirements" and that "the testing results do support substantial equivalence." However, it does not specify what those performance requirements (acceptance criteria) were or numerically report the device's performance against them.

The tables provided (Table 1 and Table 2) are comparison tables of technological characteristics between the proposed device and predicate devices, not performance against acceptance criteria.

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

Not applicable/Not provided. The document explicitly states: "No human clinical data is needed for Dawn Diode Laser System." The non-clinical tests mentioned are likely laboratory-based and do not involve human subjects or data provenance in the clinical sense.

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/Not provided. As no human clinical data was used, there was no "test set" requiring expert ground truth establishment in this context.

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

Not applicable/Not provided. Given the absence of a human clinical test set, no adjudication method 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/Not provided. This device is a laser system, not an AI 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 hardware device; the concept of "standalone performance" for an algorithm doesn't apply directly. The non-clinical tests assess the device's physical and functional properties.

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

Not applicable/Not provided. For non-clinical tests, "ground truth" would typically refer to established engineering standards or physical measurements, not clinical outcomes or expert consensus on patient data.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of a "training set," as this isn't an AI/machine learning device.

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

Not applicable/Not provided. No training set was used.

Summary of what is available regarding "acceptance criteria" and "study":

The document lists several non-clinical tests that were performed to demonstrate substantial equivalence and meet "performance requirements":

• Study Type: Non-clinical (laboratory/engineering) tests.
• Proof of Meeting Acceptance Criteria: The document states, "It shows that the testing results do support substantial equivalence." and "Demonstrated by the safety and performance tests, the characteristics of Dawn Diode Laser System are respectively equivalent to those of the predicate devices."
• Specific Standards/Tests Mentioned:
  • IEC 60601-1 Edition 3.2 2020-08: Medical electrical equipment - General requirements for basic safety and essential performance.
  • IEC 60601-1-2 Edition 4.1 2020-09: Electromagnetic disturbances.
  • IEC 60825-1 Edition 2.0 2007-03: Safety of laser products - Equipment classification, and requirements.
  • IEC 60601-2-22 Edition 3.1 2012-10: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
  • IEC 62366-1 Edition 1.1 2020-06: Application of usability engineering to medical devices.
  • IEC 62304 Edition 1.1 2015-06: Medical device software - Software life cycle processes.
  • ISO 10993-1 Fifth edition 2018-08: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
  • ISO 10993-5 Third edition 2009-06-01: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
  • ISO 10993-10 Fourth edition 2021-11: Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
  • ISO 10993-23 First edition 2021-01: Biological evaluation of medical devices - Part 23: Tests for irritation.
  • ISO 14971 Third Edition 2019-12: Medical devices - Application of risk management to medical devices.
  • IEC 60601-1-6 Edition 3.2 2020-07: Usability.
  • IEC 60601-1-9: Requirements for environmentally conscious design.
  • ISO 17664-1 First edition 2021-07: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.

The "acceptance criteria" can be inferred to be compliance with these international standards for safety, performance, EMC, biological compatibility, usability, and software. The "study" is the collection of tests performed according to these standards, which are stated to support substantial equivalence. No specific numeric performance results against these standards are detailed in this summary.

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D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; implant recovery; gingivectomy; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining: incisions and draining of abscesses: tissue retraction for impressions: papillectory; vestibuloplasty ; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

The dental diode laser systems, D-Laser Blue and D-Laser 16, realize oral soft tissue surgery, periodontal disease, endodontic disease, pain treatment, soft laser therapy and other oral diseases by vaporizing, carbonizing and solidifying the tissue by laser. The device features include: Using a capacitive touch screen which has the clear display and is easy to operate; Builtin large-capacity rechargeable lithium battery with longer time of endurance; The handpiece sleeve and the fiber tip can be autoclaved to prevent from cross infection; Preset more than 20 treatment procedures to reduce the difficulty of use; A secure protection mechanism that automatically shuts down the device after 5 minutes of inactivity.

The D-Laser Blue and the D-Laser 16 respectively consist of a main unit, a laser transmission system and a power adapter. The main unit includes a semiconductor laser, a power supply system and a control device, a safety protection device and a display device.

The D-Laser Blue employs the diodes with wavelengths of 976nm, 650nm and 450nm, and the device emits laser output energy in the infrared, red and blue spectra respectively. The D-Laser 16 employs the diodes with wavelengths of 976nm and 650nm, and the device emits laser output energy in the infrared, red spectra respectively.

The provided text does not contain typical acceptance criteria and a study design for evaluating a medical device's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity). Instead, this document is a 510(k) summary for laser surgical instruments (D-Laser Blue and D-Laser 16), primarily focusing on demonstrating substantial equivalence to legally marketed predicate devices.

The "acceptance criteria" presented are primarily comparisons of technological characteristics, indications for use, and a list of non-clinical tests confirming compliance with various electrical, safety, and biocompatibility standards. The study mentioned is a non-clinical comparison of cutting efficiency.

Therefore, many of the requested fields (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and training set ground truth establishment) are not applicable to the type of information presented in this 510(k) summary.

Here's an attempt to extract and format the available information according to your request, with "N/A" for criteria not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like the D-Laser Blue and D-Laser 16, substantial equivalence is often demonstrated by showing that the proposed device has the same intended use and similar technological characteristics to a predicate device, or that any differences do not raise new questions of safety or effectiveness. The "acceptance criteria" here are largely met by demonstrating these similarities and confirming compliance with relevant standards and functional tests.

Examples of comparisons and reported findings:

• Product Code: Matches GEX, ILY.
• Regulation Number & Classification: Matches 21 CFR 878.4810, Class II.
• Surgical IFU: Matches predicate devices.
• Laser Periodontic IFU: Matches predicate devices.
• Tooth Whitening IFU: Matches predicate devices.
• Low Level Laser Therapy IFU: Matches predicate devices.
• Application: Dental Laser (Matches).
• Laser Classification:
  • D-Laser Blue: 976 nm (Class IV), 650 nm (Class II), 450 nm (Class IV). Predicate: 970 nm (Class IV), 660 nm (Class II), 445 nm (Class IV). Accepted based on reference devices.
  • D-Laser 16: 976 nm (Class IV), 650 nm (Class II). Predicate: 970 nm (Class IV), 660 nm (Class II). Accepted based on reference devices.
• Laser Type: Solid state diode (Matches).
• Laser Wavelength:
  • D-Laser Blue: 976 nm (+/-20 nm), 650 nm (+/-20 nm), 450 nm (+/-20 nm). Accepted based on range compatibility with predicate/reference devices (e.g., K103753, K163128, K071687, K930210).
  • D-Laser 16: 976 nm (+/-20 nm), 650 nm (+/-20 nm). Accepted based on range compatibility with predicate/reference devices (e.g., K103753, K163128, K071687).
• Optical Power:
  • D-Laser Blue: 976 nm (0.2-4W CW, 7W peak), 650 nm (25-200 mW CW), 450 nm (0.2-3W CW, 4W peak). Accepted based on predicate/reference devices (e.g., K163128, K071687, K180044).
  • D-Laser 16: 976 nm (0.3-7W CW, 16W peak), 650 nm (25-200 mW CW). Accepted based on predicate/reference devices (e.g., K163128, K071687, K170500).
• Emission Modalities: Continuous Wave, Chopped (1 Hz - 20 kHz). Accepted based on reference device K163128.
• Pulse Duration: Chopped Mode (5 µsec - 0.9 sec). Accepted based on reference device K163128.
• Aiming Beam: 650±20 nm, Pmax

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Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Streamline for procedures in trabeculoplasty in open angle glaucoma.

Pattern Scanning Laser Trabeculoplasty (PSLT) is a software option for the currently marketed PASCAL Streamline (K100019 and K111108). It represents an enhancement intended to simplify the laser trabeculoplasty procedure by applying a fixed pattern of locations to the trabecular meshwork instead of a single spot. Additionally, this modification offers greater multi-functionality for the management of glaucoma. PSLT provides rapid, defined, uniform and minimally traumatic (sub-visible) computer-guided treatment with exact abutment of the patterns readily align to the trabecular meshwork, allowing more rapid and easier applications. Once the software is enabled, the PSLT feature is always available.

Here's a breakdown of the acceptance criteria and study information for the PSLT for PASCAL Streamline device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document generally states that the device met the clinical endpoints and had similar safety and efficacy profiles to the comparator, but it does not provide specific numerical values for the achieved IOP reduction or success rate for the PSLT device itself. It only mentions the target difference for the sample size calculation (an inter-group IOP difference of 3 mmHg).

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

• Sample Size (Test Set): 58 eyes.
• Data Provenance: The study was a "prospective, randomized, controlled study" of patients with open-angle glaucoma. The text does not explicitly state the country of origin, but it implies a single investigational site ("standard criteria of the investigational site"). The study design describes patients requiring bilateral laser trabeculoplasty, suggesting each patient received both PSLT and a comparator treatment (likely standard SLT, though not explicitly named as "SLT" in the study design section, it's mentioned in inclusion/exclusion for prior procedures).

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

The document does not provide details on the number of experts or their qualifications specifically used to establish ground truth for the test set beyond the general term "observational site" and patients' diagnosis of open angle glaucoma. Clinical endpoints were measured by tonometry and CLS derived parameters. It is implicitly assumed that ophthalmologists or trained clinical staff performed these measurements.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The clinical study was a patient-level comparative effectiveness study comparing two laser modalities (PSLT and an implied standard SLT) on clinical outcomes (IOP reduction and success rates), not a diagnostic study evaluating reader performance with or without AI assistance.

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

No, the PSLT software is an enhancement to the PASCAL Streamline laser system, simplifying the laser application procedure. It assists the clinician in applying the laser, rather than performing an autonomous diagnostic or treatment decision. Therefore, a standalone performance study in the sense of an "algorithm-only" diagnostic AI was not applicable or performed.

7. Type of Ground Truth Used

The ground truth for the clinical study was based on clinical outcomes data measured directly from patients:

• Change in Intraocular Pressure (IOP) from baseline, measured by tonometry.
• "Success" at 1-month post-surgery, measured by tonometry and CLS derived parameters.

8. Sample Size for the Training Set

The provided text does not mention a training set because the PSLT is a software option for a laser surgical instrument, simplifying treatment delivery. It's not a machine learning model that requires a distinct training and test set in the traditional sense of AI diagnostics. The software capabilities were validated through a clinical performance study.

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

As no training set is mentioned or implied for an AI/ML model, the establishment of ground truth for a training set is not applicable here. The software's functionality was validated through engineering verification and validation, as well as the clinical study described.

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The Bausch & Lomb StellarisPC Vision Enhancement System is intended for the emulsification and removal of catarior and posterior segment virectory. The system is designed for use in both anterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimigation, bipolar coagulation, virectory, viscous fluid injection/removal and sir/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laster trabeculaplasty.

The Bausch + Lomb Stellaris PC Vision Enhancement System is an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, this model includes an optional 532nm laser module for photocoagulation.

The system is based on the technology and the performance of the existing Stellaris PC Vision Enhancement System, and this traditional 510(k) incorporates software revisions, a hardware revision to the power supply, and the additional of an optional laser photocoagulation module.

The system enhances the ability to perform as one combined anterior and posterior system for increased efficiency.

This submission describes the Bausch + Lomb Stellaris® PC Vision Enhancement System, an integrated ophthalmic microsurgical system. The submission focuses on demonstrating the substantial equivalence of the updated device to previously cleared predicate devices, rather than establishing de novo acceptance criteria for a novel device. Therefore, the information provided does not align with a typical AI/ML device submission that would include acceptance criteria and a study proving those criteria were met through performance metrics like sensitivity, specificity, etc.

However, based on the provided documents, I can extract the relevant information pertaining to the "acceptance criteria" (understood here as compliance with standards and functional requirements for safety and performance) and the "study" (referring to the nonclinical tests conducted) that "proves" (demonstrates compliance) the device meets these.

Here’s an interpretation of the requested information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Bausch + Lomb Stellaris® PC Vision Enhancement System are primarily met through compliance with established electrical, safety, usability, and software standards, as well as successful functional, simulated use, environmental, and transport testing. The "reported device performance" is essentially that the device passed all these tests and demonstrated substantial equivalence to predicate devices, thus fulfilling its intended use.

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

This submission is for a traditional surgical system, not an AI/ML device in the modern sense. Therefore, the concept of a "test set" for performance evaluation in terms of AI model predictions (e.g., images for classification or detection) is not applicable. The "tests" performed were nonclinical engineering and functional tests on representative units of the device.

• Sample Size for Test Set: "Representative units" of the Stellaris PC Vision Enhancement System were used for functional, simulated use, environmental, and transport testing. Specific numbers are not provided in this summary but would be detailed in the full test reports.
• Data Provenance: Not applicable in the context of an AI/ML device where "data provenance" typically refers to the origin of training or test data (e.g., patient demographics, clinical sites, geographical distribution). The testing here relates to the engineering performance and safety of the physical device and its software.

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

This request is not directly applicable to the type of device and submission.

• Number of Experts: Not applicable. Ground truth, in the context of this device, refers to the established standards and specifications that the device must meet, verified through engineering and functional tests.
• Qualifications of Experts: The "experts" involved would be the Bausch + Lomb engineers and testers responsible for performing and evaluating the nonclinical tests, ensuring compliance with the cited regulatory standards. Their qualifications would be in engineering, quality assurance, and regulatory compliance for medical devices.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. There was no "test set" requiring expert adjudication in the context of AI/ML evaluation. The evaluation was based on passing predefined engineering and performance metrics against established standards.

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

• Was an MRMC study done? No. This type of study is typically used for diagnostic or screening AI/ML devices where reader performance is a key metric. The Stellaris PC Vision Enhancement System is a surgical system, and its evaluation focuses on safety, functional performance, and substantial equivalence, not human reader improvement with AI assistance.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Was a standalone study done? No. This device is a surgical system; it does not feature a standalone algorithm that performs a diagnostic or prognostic task without human-in-the-loop performance in the way an AI/ML-based diagnostic device would. Its "performance" is integrated into its function during surgery.

7. Type of Ground Truth Used

The "ground truth" for this submission is implicitly defined by:

• International Standards: Compliance with electrical safety (IEC 60601 series), usability (IEC 60601-1-6, IEC 62366), software quality (EN ISO IEC 62304), and laser safety (IEC 60825-1) standards.
• Functional Specifications: The device's ability to perform its intended functions (e.g., phacoemulsification, vitrectomy, laser photocoagulation) as designed and specified, verified through functional and simulated use testing.
• Predicate Device Performance: The established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use an AI/ML model that would require a "training set" of data in the typical sense. Any software development would follow standard software engineering practices, with internal testing and validation, but not "training" on a dataset for algorithmic prediction.

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

• How Ground Truth for Training Set was Established: Not applicable. As there is no AI/ML training set in this context, the concept of establishing ground truth for it does not apply.

Summary of Device and Acceptance:

The Bausch + Lomb Stellaris® PC Vision Enhancement System obtained 510(k) clearance by demonstrating substantial equivalence to existing predicate devices (K101325, K022760, K071687). The "acceptance criteria" are the regulatory and engineering standards that the device must meet to ensure safety and effectiveness, and the "study" comprises a series of nonclinical tests (electrical, functional, simulated use, environmental, transport, and software verification/validation) that demonstrated the device's compliance with these standards and its ability to perform its intended functions. The FDA's letter (K133486) confirms this substantial equivalence based on the provided data.

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For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

The 23ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, an acetal handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an acrylic fiber with PVC jacket and an acetal connector. Both connectors plug into existing laser and light sources.

The device is designed to be an accessory for an Iridex medical laser (cleared under K071687) in the Vis-NIR transmission range of 532 nm to 810 nm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The device can be used with other lasers but they must be FDA approved and also meet the above specifications. The light portion of the device was designed for use with the Bausch & Lomb Stellaris PC light source which is a component of the Bausch & Lomb Stellaris PC Vision Enhancement System (cleared under K101325). The Stellaris PC uses a 75 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 441nm to 665nm (photocoagulation is not applicable to the illumination aspect of the probe).

Here's an analysis of the provided text regarding the acceptance criteria and study for the 23ga Curved Illuminating Laser Probe (K122997).

It's important to note that this 510(k) summary is for a substantially equivalent device, meaning much of the performance evaluation relies on demonstrating equivalence to an already cleared predicate device (Peregrine's Illuminated Laser Probe, K031023) rather than proving de novo safety and effectiveness through extensive clinical trials. Therefore, the information provided isn't as detailed as what might be found for a novel device.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for substantial equivalence, the "acceptance criteria" are primarily defined by the performance characteristics of the predicate device. The goal is to show that the new device either meets or performs similarly to the predicate in key areas, or that any differences do not raise new questions of safety or effectiveness.

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a number of "samples" in a traditional clinical study sense. The testing involved comparing parameters of one new device (23ga Curved Illuminating Laser Probe) against one predicate device (PD600.10).
   • Data Provenance: The testing was conducted by the manufacturer, Peregrine Surgical. No information on the country of origin or whether it was retrospective/prospective is provided, but it would have been prospective testing specifically for this 510(k) submission.

2. 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 in the context of this device. This is a comparison of physical and functional characteristics of medical instruments, not an evaluation requiring expert consensus on images or diagnoses. The "ground truth" for performance is established by direct measurement and comparison to the predicate's known performance or accepted engineering standards.
   • The document mentions that "Surgeons understand that light outputs are compromised due to the use of smaller needle/tube gauges," implying a general expert consensus or understanding within the ophthalmic surgical community, but no specific experts were involved in a formal ground truth establishment process for the test set.

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

   • Not applicable. This is not a study requiring adjudication of findings. Performance measurements were objective.

4. 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 physical ophthalmic instrument, not an AI-powered diagnostic device, so no MRMC study was performed.

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

   • Not applicable. This is a physical medical device, not an algorithm. Performance tests were done on the device itself.

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

   • The "ground truth" for demonstrating substantial equivalence was the measured performance of the legally marketed predicate device (PD600.10) and established engineering/biocompatibility standards. For biocompatibility, testing results demonstrating 100% biocompatibility according to recognized standards served as the ground truth. For sterility, the specified SAL and validation method (AAMI Overkill, ISO 11135-1) serve as the ground truth.

7. The sample size for the training set

   • Not applicable. This is a physical device, not an AI-based system requiring a training set.

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

   • Not applicable given that no training set was used.

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The SUPRA 577.Y Laser 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 choroids 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 and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

The Quantel SUPRA 577.Y Laser is a semi conductor laser which emits a beam of coherent light The Qualiter SUPRA 577.1 Lase 16 a delivery site(s) via delivery systems/devices.

The provided text describes a 510(k) premarket notification for the Quantel SUPRA 577.Y Laser, a medical device for ophthalmic photocoagulation. The application focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with acceptance criteria and performance data.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance are not available in the provided document. The submission relies on non-clinical data and comparison to the predicate device to establish safety and effectiveness.

Here's a breakdown of what can be extracted based on your request:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" in the sense of predefined performance targets for a clinical study are not reported. Instead, the acceptance is based on the device meeting design specifications and demonstrating safety and effectiveness equivalent to a legally marketed predicate device.

Study Details

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

   • Not applicable / Not provided. The submission states "No Clinical information is required" (Section VII, Clinical Conclusion). The equivalence is based on non-clinical laboratory testing and comparison of technical specifications to the predicate device.

2. 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 / Not provided. No clinical test set requiring expert ground truth was performed for this 510(k) submission.

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

   • Not applicable / Not provided. No clinical test set requiring adjudication was performed.

4. 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 device is a laser for photocoagulation, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

   • Not applicable. This device is a therapeutic laser operated by a human, not a standalone algorithm. Performance validation relates to its physical output and safety, not an algorithmic assessment.

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

   • For the non-clinical validation, the "ground truth" was adherence to established engineering and medical device standards (e.g., IEC standards, CFR regulations) and validation against the design specifications of the device itself and the predicate device's specifications. No biological or clinical ground truth (like pathology or outcomes data) was used or required for this submission.

7. The sample size for the training set:

   • Not applicable / Not provided. This is not an AI/machine learning device that requires a training set. The device's design and performance are based on engineering principles and regulatory standards.

8. How the ground truth for the training set was established:

   • Not applicable / Not provided. As there is no training set, there is no ground truth for it.

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