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OralID™ is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer.

OrallD™ is a battery operated (CR123A), hand-held, oral illumination and examination light designed for use by dental and medical professionals to be used as an adjunctive tool for fluorescence visualization of oral mucosal tissue. OralID™ accessories include two pair of filtered eyewear for both the clinician and patient.

The provided document is a 510(k) summary for the OralID™ device, primarily focusing on its substantial equivalence to predicate devices and regulatory compliance. It does not present a detailed study on the device's performance against specific acceptance criteria in terms of diagnostic accuracy or clinical effectiveness.

Therefore, I cannot fulfill most of your request as the information is not present in the provided text.

Here's what can be extracted based on the document:

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

The document lists performance tests conducted, but does not provide quantitative acceptance criteria or detailed results for these tests in terms of clinical performance. Instead, it focuses on technical and safety aspects.

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

This information is not provided in the document. The performance testing mentioned appears to be related to technical specifications and safety rather than a clinical study with a test set of patient data.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any indication of an AI component in the OralID™ device. The device is a physical illumination and examination light.

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

The OralID™ device is an adjunctive tool for human examination; it is not an algorithm-only device, so this question is not applicable.

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

This information is not provided in the document, as no clinical study with ground truth establishment is detailed.

8. The sample size for the training set

This information is not provided in the document. The device description and performance testing do not suggest a machine learning model that would require a training set.

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

This information is not provided in the document.

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Identafi™ 3000 is intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia.

Identafi™ 3000 allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescene and reflectance, and vasculature.

Identaff™ 3000 is also intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion to aid in determining the appropriate margin for surgical excision.

Identafi™ 3000 eyewear is reusable filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. Identafi™ 3000 eyewear bacbeen designed to allow transmission of 430-580 nm light.

The TRIMIRA™ IDENTAFI 3000® is a "AA" battery operated, hand-held, multispectral oral examination light used in conventional and specialized oral examination. Accessories outli oldi glasses and disposable mirrors.

The Identaff™ 3000, with multispectral identifi™ technology (patents pending), uses "AA" batteries to operate high-intensity LEDs to produce white, violet and amber light. These safe, visible lights allow health professional to perform Conventional Oral Examination (COE) using white ight, and specialized or enhanced visual examinations of tissue using violet and amber lights.

The Identafi™ 3000 violet light enhances normal tissue's natural fluorescence. Visual examination under violet light shows healthy tissues fluorescing blue (when using rose colored filtered glasses) while suspicious tissue appears dark because of its loss of fluorescence. Amber light enhances the withio suspicious assus app and makes visualization of the vasculature possible.

The direct visualization of fluorescent and reflective tissues is using the body's natural system to identify suspicious tissue quickly that may require further investigation.

The provided text is a 510(k) Summary for the TRIMIRA™ Identafi™ 3000 device. It describes the device's intended use and technological characteristics, and claims substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for either test or training sets, as this information is not present in the provided text.

The document primarily focuses on establishing substantial equivalence to a predicate device (Trimira OCS 3000 K082603) based on similar intended use and technological characteristics (multispectral lights for visualizing tissue fluorescence and reflectance to identify oral tissue abnormalities). The claim of substantial equivalence implies that the device performs comparably to the predicate, but it does not detail any specific performance metrics or a study to demonstrate this.

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OCS 3000® is intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia.

OCS 3000® allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescence and reflectance, and vasculature.

OCS 3000® is also intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion to aid in determining the appropriate margin for surgical excision. OCS 3000 eyewear is reusable polarized filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. OCS 3000 eyewear has been designed to allow transmission of 430-580 nm light.

The TRIMIRA™ OCS 3000® is a "AA" battery operated, hand-held, multispectral oral examination light used in conventional and specialized oral examination. Accessories include safety glasses and disposable mirrors.

OCS 3000® eyewear is reusable polarized filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. OCS 3000® eyewear has been designed to allow transmission of 430-580 nm light.

The OCS 3000 with multispectral identifi™ technology (Patent No. 7,365,844 and patents pending) uses "AA" batteries to operated high-intensity LEDs to produce white, violet and amber light. These safe, visible lights allow health professional to perform Conventional Oral Examination (COE) using white light, and specialized or enhanced visual examinations of tissue using violet and amber lights.

The OCS 3000 violet light enhances normal tissue's natural fluorescence. Visual examination under violet light shows healthy tissues in fluorescing green (when using filtered glasses) while suspicious tissue appears dark because of its loss of fluorescence. Amber light enhances the tissue's natural reflectance and makes visualization of the vasculature possible.

The direct visualization of fluorescent and reflective tissues is using the body's natural system to identify suspicious tissue quickly that may require further investigation. The loss of natural tissue fluorescence and reflectance can identify subclinical high-risk fields with cancerous and precancerous changes Clinical Cancer Research Vol. 12, 6716-6722. November 15, 2006.

The provided text is a 510(k) summary for the TRIMIRA™ OCS 3000® device, which is an oral examination light. It primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device's technological characteristics and intended use. However, it does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or any performance metrics from such a study.

Therefore, I cannot extract the requested information to populate the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document states that the device is "substantially equivalent" to predicate devices based on its intended use and technological characteristics (fluorescence and reflectance for enhanced visualization). This generally implies that the performance is expected to be similar to the already approved predicate devices, but specific performance data or acceptance criteria are not detailed in this summary.

Based on the provided text, the following information is missing:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any performance evaluation.
• Sample size for the training set.
• How the ground truth for the training set was established.

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The LCG (Liquid Crystal Glasses) System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.

The LCG System comprises the following main components:
The Spectacles Unit (LCGU) comprised of the refractive optical lens, Liquid Crystal Module (LCM) and the electronic control that resides in the holding strap. The adjustable holding strap contains an electronic controller with an activation button (Tact Switch) and small rechargeable batteries that provide the electric power.
The Reporting and Compliance Box (RCB) is a bedside device that serves as a charger of the spectacle's batteries. In addition, it provides a means to monitor the compliance of the patient, while providing a feedback to the user, as it records the actual wear-time of the glasses, comparing it to the prescribed time.
Technician/Factory Setup Software (LCG Set) is software residing on a PC at the factory and is used for setting the LCGU performance parameters. During setup, the LCGU is connected to the PC via the RCB by means of RS232 link.

The LCG System's acceptance criteria and studies are summarized below, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Electromagnetic compatibility (compliance with IEC 60601-1-2)
• Hazard analysis and risk mitigation (compliance with EN 1441 and ISO 14971) | - Device underwent and passed Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 (and amendments), and IEC 60601-1-2 standards.
• Hazard analysis including risk level and solutions performed in compliance with EN 1441 (1997) and AAMI/ISO 14971-1, 2000 for the entire system and for the software. |
  | Effectiveness/Performance| - Ability to provide intermittent occlusions of the eye (equivalent to eye patching)
• Software performs as specified
• Physical integrity and function (in-vitro bench testing) | - The LCG System provides a means of occlusion for the eye, with the technique being the primary difference from traditional eye patching.
• Software verification and validation testing conducted.
• A set of in vitro (bench) performance testing was performed. |
  | Substantial Equivalence | Device does not raise any new safety and effectiveness issues compared to predicate devices (Eye Patches, Spectacle frame, Prescription spectacle lens, Sunglasses). | - "Tests results demonstrate the safe and effective performance of the LCG System according to its specifications."
• "Based on the safety and performance testing results, including software verification and validation process and the analysis of similarities and differences as compared to its predicate devices, OphthoCare Ltd. believes that the LCG System is substantially equivalent to its predicate devices, without raising new safety and/or effectiveness issues." |

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

The provided document does not specify a sample size for a clinical test set for evaluating the LCG System's performance for its intended use. The studies mentioned are primarily in vitro (bench) testing, electrical safety, electromagnetic compatibility, and software verification/validation. These tests do not typically involve patient-specific clinical data in the same way an efficacy study would. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) is not applicable in this context.

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

Not applicable. The reported studies are primarily engineering and bench tests, not clinical performance studies requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication is described.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence based on engineering tests and the established method of eye occlusion, rather than a direct comparison of human reader performance with and without AI assistance. The device is the therapeutic intervention (eye occlusion), not an AI diagnostic aid for human readers.

6. Standalone Performance Study:

A standalone performance evaluation was done in the sense that the LCG System itself underwent "a comprehensive testing program... to verify that the LCG System does not raise any new safety and effectiveness issues." This included:

• Electrical safety and electromagnetic compatibility testing
• Software verification and validation testing
• A set of in vitro (bench) performance testing
• Hazard analysis

These studies assessed the device's functionality and safety independently. However, this is not a "standalone performance" in the context of an algorithm's diagnostic accuracy, but rather the performance of the physical device and its software.

7. Type of Ground Truth Used:

For the engineering and safety tests, the "ground truth" would be established by:

• Engineering specifications and regulatory standards: For electrical safety, EMC, and software function.
• Physical measurements and observation: For in-vitro bench testing.
• Risk assessment methodologies: For hazard analysis.

There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for the verification of the LCG System, as it's not a diagnostic device. Its "performance" is its ability to occlude the eye, which is a functional rather than interpretive outcome.

8. Sample Size for the Training Set:

Not applicable. The LCG System is a hardware device with embedded software, not a machine learning or AI algorithm that requires a "training set" of data in the conventional sense. The "LCG Set" software is described as "residing on a PC at the factory and is used for setting the LCGU performance parameters," indicating it's for configuration, not for training a predictive model.

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

Not applicable, as there is no training set for an AI/ML model described for this device.

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Riviera Sunglasses are intended to be worn by a person to protect the eyes from bright, but do not provide for refractive correction.

Sunglasses, Nonprescription, Class I 886.5850, 86HQY

The provided text is a 510(k) clearance letter from the FDA for "Riviera Sunglasses." This document outlines the agency's determination of substantial equivalence for the device. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter is a regulatory document confirming that the sunglasses are substantially equivalent to pre-amendment devices and can be marketed. It does not delve into the detailed technical or clinical validation studies that would typically define acceptance criteria and prove performance for a more complex medical device.

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

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The COIL Pathfinder Sunglasses are intended to be worn by a person to protect the eyes from bright sunlight, but do not provide for refractive correction.

Sunglasses, Nonprescription, Class I 886.5850, 86HQY

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria.

The document is an FDA 510(k) clearance letter for "Pathfinder Sunglasses." It states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device and does not require a new Pre-Market Approval (PMA) application.

A 510(k) clearance typically relies on demonstrating substantial equivalence, often through comparisons to predicate devices and adherence to relevant performance standards, rather than requiring extensive clinical trials with detailed acceptance criteria and performance reports like those detailed in your request.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment based on this document.

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