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Nuvola® aligner is intended for the orthodontic treatment of malocclusion.

The Nuvola® device is a doctor-prescribed series of removable plastic aligners intended as an alternative to conventional wire and bracket technology. The Nuvola® gently moves teeth in small increments from their original state to a final, treated state for improved dental alignment. The system is used in patients with primary, mixed, and permanent dentition. The system consists of a series of doctor prescribed and customized plastic aligners (thermoformed PET-G sheeting material) that gently move the patient's teeth in rements from their original state to a more optimal, treated state to address malocclusion. The first device of the treatment matches the patient's dentition in its current state and then each subsequent aligner stage of the dentition shifted gradually toward the final desired position.

The provided document for the K222418 submission of the Nuvola aligner does not contain the detailed information necessary to fully address all aspects of acceptance criteria and the study proving device performance as requested. Specifically, it lacks a dedicated section outlining acceptance criteria with corresponding performance metrics from a study dataset.

However, based on the non-clinical studies summarized, we can infer some aspects related to device validation. The document emphasizes that "Non-clinical tests have been conducted to verify that the Nuvola® aligner meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate and reference devices."

Here's an attempt to construct the information based on the provided text, highlighting where data is not available or explicitly stated.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for Nuvola® Aligner

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Invisalign System K220287) and a reference device (Ortho Aligner System K212496) primarily through non-clinical testing and comparison of technological characteristics. A formal study explicitly outlining acceptance criteria and a detailed performance study against a predefined test set with quantified metrics is not presented in the provided text in the typical format for AI/algorithm performance.

The "acceptance criteria" here appear to be framed around meeting pre-established specifications for manufacturing accuracy, biocompatibility, shelf life, packaging, and treatment planning software validation to support the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Manufacturing Validation: "The test has been repeated for 5 times with 5 different patient 3rd party software was used to perform point-to-point and critical displacement."
  • Data Provenance: The document does not explicitly state the country of origin for these 5 patient cases or whether they were retrospective or prospective. Given the company is based in Italy, the data could be European. The description suggests these were real patient cases used for validation.

3. Number of Experts Used and Qualifications:

• Manufacturing Validation (Aligner Fitting): The "prescribing doctor" checked the suitability, function, and form of the aligners. The number of doctors is not specified beyond "the prescribing doctor" checking the 5 treatment plans.
  • Qualifications: "Prescribing doctor" implies a dental practitioner, likely an orthodontist, but no specific years of experience or board certifications are stated.
• Other validations (Biocompatibility, Shelf life, Packaging, Software): These appear to be laboratory or engineering tests run against industry standards and regulations, rather than requiring expert adjudication of clinical outcomes.

4. Adjudication Method for the Test Set:

• Manufacturing Validation: For aligner fitting, the "prescribing doctor" checked. This implies a single expert review for each of the 5 cases. There is no mention of consensus or multiple adjudicators (like 2+1, 3+1). For manufacturing accuracy via software, it was likely an automated comparison to a tolerance.

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

• No MRMC comparative effectiveness study was done.
• The clinical performance testing for the device was not conducted, as stated: "Clinical Studies was not conducted for this 510(k) Notification. Clinical Performance testing was not needed to establish substantial equivalence to the predicate and reference devices." This suggests no human-in-the-loop performance evaluation was performed or necessary for this submission.

6. Standalone (Algorithm Only) Performance:

• The Nuvola®Web software is a "Treatment Planning platform," and the 3Shape Ortho System software is used for "tooth alignment" and "to produce standard 3D printer files."
• While the software components (Nuvola®Web and 3Shape Ortho System) were validated for compliance with specific standards (IEC 62304:2006+AMD1:2015 and 21 CFR part 11 for Nuvola®Web; implicit for 3Shape Ortho System which is an already cleared device K152086), there is no standalone performance study of the algorithm's output (e.g., predicted tooth movement accuracy) independent of the physical aligner or human intervention. The validation focused on the software's ability to manage treatment plans and produce correct 3D printer files, and the physical aligners' fit.

7. Type of Ground Truth Used:

• Manufacturing Validation (Digital to 3D Print): The ground truth appears to be the intended digital model (CAD/CAM model) from the treatment planning software, against which the 3D printed molds were measured.
• Manufacturing Validation (Aligner Fitting): The ground truth was based on the "pre-established specifications and acceptance criteria" for fit and function, assessed by the "prescribing doctor." This implies a clinical assessment or expert consensus on the desired fit.
• Biocompatibility, Shelf Life, Packaging: Ground truth for these was established by industry standards and regulatory guidelines (e.g., ISO 10993-1, ISTA 2A) and manufacturer's pre-defined specifications.
• Software Validation: Ground truth was compliance with specified software development and quality standards (IEC 62304, 21 CFR Part 11).

8. Sample Size for the Training Set:

• The document describes the device as a physical aligner and associated software for treatment planning. It does not indicate the use of machine learning or AI models developed by G.E.O. requiring a "training set" in the deep learning sense.
• The software components (Nuvola®Web and 3Shape Ortho System) are either COTS (Commercial Off-The-Shelf) software (3Shape Ortho System is K152086) or custom-developed traditional software validated per IEC 62304. Therefore, discussions of "training sets" are not applicable in this context.

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

• Not applicable, as no AI/ML training set is mentioned or implied. The software validation is based on traditional software engineering principles and regulatory compliance.

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The Nuvolase 532 Laser System for Ophthalmology is intended for use in the treatment of vascular lesions of the skin, including capillary hemangioma (port wine stain), strawberry hemangioma, telangiectasia, and rosacea. It is also intended for pigmented lesions including freckles, age spots, café-au-lait, and lentigo.

The Nuvolase 532 Cutaneous Laser System is a continuous-wave frequencydoubled diode-pumped Nd: Y AG laser system. Treatement beam power output for the system is 50 milliwatts to 1.5 watts at a wavelength of 532 nm. The maximum power level to tissue is 2.5 Watts CW. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure durations for the Nuvolase 532 Laser System for Ophthalmology (in seconds) are 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via fiber optic and handpiece.

The provided text describes a 510(k) premarket notification for the "Nuvolase 532 Cutaneous Laser System" and explicitly states it is a modification of a previously cleared device (Nuvolase 660 Laser System, K970667). The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a regulatory submission for substantial equivalence based on technological characteristics and intended use, not a clinical study report. Therefore, I cannot provide the requested information.

Here's why each specific point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are present. The submission focuses on demonstrating equivalence to a predicate device.
2. Sample size used for the test set and the data provenance: No test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process is described.
4. Adjudication method for the test set: Not applicable as there is no test set or study.
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 device is a laser system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Conclusion from the document:

The provided document details a 510(k) submission for a laser device, emphasizing its technological equivalence to a predicate device for the treatment of vascular and pigmented skin lesions. It is a regulatory submission asserting substantial equivalence, not a report of a study proving performance against acceptance criteria.

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The Nuvolase 532 Laser System for Ophthalmology is intended for use in retinal and macular photocoagulation and trabeculoplasty.

The Nuvolase 532 Laser System for Ophthalmology is a continuous-wave frequency-doubled diode-pumped Nd:YAG laser system. Treatement beam power output for the system is 50 milliwatts to 1.5 watts at a wavelength of 532 nm. Depending on the delivery device efficiency, the maximum power level may be as much as 2.0 Watts CW. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure durations for the Nuvolase 532 Laser System for Ophthalmology (in seconds) are 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via fiber optic and laser slit lamp.

I am sorry, but the provided text does not contain information on acceptance criteria or a study that proves the device meets specific criteria. The document is a 510(k) summary for the Nuvolase 532 Laser System for Ophthalmology, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, and confirms that its modifications do not affect its indications for use, materials, method of manufacture, or technology.

Therefore, I cannot provide the requested table and information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

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The NuvoLase 720 Laser System is intended for use in retinal and macular photocoagulation, trabeculoplasty, and iridotomy.

The NuvoLase Model 720 is a continuous wave argon ion laser system, emitting a maximum of 2.5 watts, primarily at 488 nm and 514.5 nm wavelengths. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 720 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via Rodenstock RO 5000 LS laser slit lamp, connected by fiber optic.

The provided text is a 510(k) summary for the NuvoLase 720 Laser System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with predefined acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not typically found in a 510(k) summary for a device like the NuvoLase 720 Laser System.

510(k) submissions primarily compare the new device's technological characteristics and intended use to a predicate device. The "study" in this context is a comparison of specifications and intended uses, not a clinical trial proving performance against acceptance criteria in the way you've described.

Here's an explanation of why the requested information is absent and what can be extracted from the document:

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

• Not applicable for a 510(k) of this nature. The NuvoLase 720 Laser System is an ophthalmic laser. For such devices, substantial equivalence is typically based on comparing technical specifications (e.g., wavelength, power output, exposure times, aiming beam) and intended uses with predicate devices, rather than clinical performance metrics like sensitivity, specificity, or reader improvement.

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

• No test set or clinical study described. The 510(k) regulatory pathway does not mandate clinical trials for all devices, especially when substantial equivalence can be demonstrated through technological comparison. There is no mention of a test set, data provenance, or retrospective/prospective studies.

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)

• No ground truth establishment described. Since no clinical test set or study is detailed, there's no mention of experts or ground truth establishment.

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

• No adjudication method described. Again, without a clinical test set, adjudication methods are irrelevant to this submission type.

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 device is a laser system, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study, especially concerning AI assistance, would not be relevant.

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

• Not applicable. This is a hardware laser system, not a software algorithm.

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

• No ground truth discussed. As explained, the 510(k) focuses on technological equivalence, not clinical performance against a ground truth.

8. The sample size for the training set

• No training set described. This device is not an AI/ML model that requires a training set.

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

• No training set or ground truth described.

Information that can be extracted from the document relevant to a "device comparison" which serves as the "study" for this 510(k) submission:

"Acceptance Criteria" (Implied from Predicate Comparison) and "Reported Device Performance" (Specifications):

For a 510(k), the "acceptance criteria" are implicitly met if the new device's specifications and performance fall within the established safe and effective parameters of the predicate devices, or if any differences do not raise new questions of safety or effectiveness.

The "Study" (Comparison for Substantial Equivalence):

The "study" for this 510(k) is the direct comparison of the NuvoLase 720 Laser System with two predicate devices:

• AC 2200 Argon Laser Photocoagulator (Nidek, Inc.)
• Ultima 2000 Argon Laser Photocoagulator (Coherent, Inc.)

This comparison is documented under the "Technological Characteristics/Device Comparison" section. The conclusion states that the NuvoLase 720 is substantially equivalent based on matching materials, design, intended use, method of manufacture, warnings, cautions, and precautions.

Summary Conclusion from 510(k) Context:

The NuvoLase 720 Laser System met the "acceptance criteria" of being substantially equivalent to legally marketed predicate devices by demonstrating that its technological characteristics and intended uses were sufficiently similar, and any differences did not raise new questions of safety or effectiveness. This determination was made through a comparative analysis rather than a clinical study with performance metrics.

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The NuvoLase 660 Laser System is intended for use in retinal and macular photocoagulation and trabeculoplasty.

Indications For Use:

1. Retinal and Macular photocoagulation
2. Trabeculoplasty

The NuvoLase Model 660 is a continuous wave frequency-doubled diode-pumped Nd: YAG laser system. Treatment beam power output for the NuvoLase 660 laser is adjustable to a maximum of 2.0 Watts continuous wave at 532 nm. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 660 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via Rodenstock RO 5000 LS laser slit lamp, connected to the laser by fiber optic.

Here's a breakdown of the acceptance criteria and the study information for the Nuvo-Lase 660 Laser System, based on the provided text.

Note: The provided document is a 510(k) summary for a medical device submitted in 1997. It describes a substantial equivalence determination rather than a novel clinical effectiveness study with strict acceptance criteria and performance metrics as might be seen for newer AI/machine learning devices. Therefore, many of the requested categories related to AI performance, sample sizes for training/test sets, expert consensus, and comparative effectiveness studies are not applicable or cannot be extracted from this type of document. The study's "acceptance criteria" here refer to demonstrating substantial equivalence to predicate devices, rather than meeting specific performance thresholds for diagnostic accuracy, for example.

Nuvo-Lase 660 Laser System Acceptance Criteria and Study Information

The Nuvo-Lase 660 Laser System gained market clearance through the 510(k) pathway, demonstrating substantial equivalence to legally marketed predicate devices. This means that the "acceptance criteria" were primarily focused on showing that the device has the same intended use and similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable and not provided in the 510(k) summary. A 510(k) submission for this type of laser device in 1997 relies on technical specifications and comparison to predicate devices, not on a clinical "test set" in the context of diagnostic performance or AI validation.

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

This information is not applicable and not provided. Ground truth establishment in the context of expert review for AI algorithms is not relevant to this type of device and submission.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are used in studies involving human interpretation or performance evaluation, which is not the primary focus of this 510(k) submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable and not provided. An MRMC study is not relevant for a laser photocoagulator device seeking substantial equivalence based on technical specifications.

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

This information is not applicable and not provided. This is a hardware laser system, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate devices (Nidek Prima 532 and IRIS Oculight GL) allowed by their prior marketing. The manufacturer asserted that the NuvoLase 660 shared the same fundamental characteristics and intended use, thus making it "substantially equivalent."

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" in the context of an AI algorithm, as this is a physical medical device.

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

This information is not applicable and not provided. There is no "training set" or corresponding ground truth establishment in the context of an AI algorithm for this device.

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