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G.o.c.c.l.e.s. is intended to be used by a qualified health-care providers to enhance the identification and visualization of the oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer and premalignant dysplasia. G.o.c.l.e.s. eyewear is reusable filtered eyewear that is worn by a health care professional to enhance the visual effects of blue light during oral exam.

The G.o.c.c.l.e.s device consist of one eyewear with specific filtering features that shall be used with the G.o.c.c.l.e.s. light proprietary light source (emission range 440-490nm), in order to allow the examination of autofluorescence of the oral cavity and consequently detect oral abnormalities such as dysplastic or anaplastic lesions (carcinomas of the oral mucosa).

The device looks like a pair of glasses, characterized by reduced dimensions, good wearability, easy portability and proper filtering performances in order to allow to filter the fluorescence emission, resulting from the fluorophore of interest (Flavin Adenine Dinucleotide (FAD)), which in its oxidized form responds to a light of 450nm (blue-violet) emitting a fluorescence wavelength of around 515nm (green).

Here's a breakdown of the acceptance criteria and study information for the G.o.c.c.l.e.s. device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for G.o.c.c.l.e.s. primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting explicit quantifiable acceptance criteria as one might see for a novel device. However, the performance data highlights specific characteristics that serve as de facto acceptance criteria for its optical properties and its ability to detect oral abnormalities.

• Transmittance % remains over 90% of its max value (60%) from 500nm to 541nm, covering the 515-530 nm range for FAD. |
  | - Compatible with light sources emitting in the FAD excitation peak (around 450 nm). | - G.o.c.c.l.e.s. light emission range: 440-490 nm (includes 450 nm).
• Demonstrated performance with other light sources (Optilux 501, Eliparfreelight) that also emit in a range including FAD's excitation peak. |
  | Clinical Performance (Ability to identify oral abnormalities): | |
  | - Ability to detect autofluorescence changes indicative of oral abnormalities. | - Study 1 (A. Moro et al.): Out of 15 suspected cancers detected by autofluorescence, 14 were confirmed by histological analysis.
• Study 2 (Multicenter Study): G.o.c.c.l.e.s. identified loss of fluorescence in 35 cases, of which 29 were confirmed by histological analyses to be dysplasia, carcinoma in situ, or invasive cancer (True Positive Rate: 82.8%). No relevant differences in performance with different compatible light sources. |

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Study 1 (A. Moro et al.): 32 patients (12 with potentially malignant diseases, 20 previously operated for oral cancer).
  • Study 2 (Multicenter Study): Number of patients not explicitly stated, but "a total of 35 cases" of fluorescence loss identified. Thus, at least 35 cases were part of the diagnostic assessment.
• Data Provenance:
  • The document does not explicitly state the country of origin for the clinical studies.
  • Both clinical studies appear to be prospective as they involve patient recruitment and subsequent clinical and histological analysis based on the device's findings ("underwent autofluorescence test," "surgical excision," "recruiting patients").

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated how many experts were involved in diagnosing the lesions or performing the surgical excisions/histological analyses.
• Qualifications of Experts: The studies mention "qualified health-care providers" and "histological analyses," implying the involvement of oral pathologists and surgeons, but specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method

• The document does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for establishing the ground truth.
• The ground truth was established by histological analysis of surgically excised lesions, which is generally considered the gold standard for definitive diagnosis of oral cancer and dysplasia. This implies that the histological diagnosis was taken as the definitive truth, rather than requiring further expert consensus on the initial clinical findings.

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

• No, an MRMC comparative effectiveness study was not explicitly conducted to measure human reader improvement with AI vs. without AI assistance.
• The studies described assess the device's standalone performance in aiding visualization and identifying abnormalities that are then confirmed by histology. The focus is on the G.o.c.c.l.e.s. eyewear's ability to facilitate detection, rather than quantifying the improvement in human reader performance when using the device compared to not using it. While the device enhances visualization, it's not positioned as an AI-powered independent diagnostic tool in this context, but rather an enhancement for human examination.

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was done for the device in the sense that the G.o.c.c.l.e.s. eyewear, in conjunction with a light source, was used to identify abnormalities, and these findings were then validated against a ground truth (histology).
• The device itself is a passive optical filter (eyewear) that enhances visualization, it's not an "algorithm" in the typical AI sense. The performance tests ("Results" sections of the clinical studies) present how many lesions the G.o.c.c.l.e.s. system identified before histological confirmation, indicating its standalone diagnostic utility as an enhancement tool.

7. Type of Ground Truth Used

• Histology (Pathology): In both clinical studies, "histological analyses" of surgically excised lesions were used to confirm the diagnosis of suspected tumors, dysplasia, carcinoma in situ, or invasive cancer. This is explicitly stated as the method for confirming the findings from the autofluorescence inspection.

8. Sample Size for the Training Set

• The document does not mention any training set or any machine learning/AI models that would require one. The G.o.c.c.l.e.s. device is a passive optical system, not an AI/ML algorithm. The "studies" described are performance validation studies, not studies for training or validating an algorithmic model.

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

• Not applicable, as there is no training set for this device.

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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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The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist as an adjunct to traditional oral examination by incandescent light, combined with further examination with one of three oral examination lights manufactured by AdDent, Inc. The Microlux DL (K041614), Microlux BLU (K072309), and Bio/Screen (K082668). The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.

The ORABLU Oral Lesion Marking System is a three component swab system.

This document is a 510(k) premarket notification decision letter from the FDA for the ORABLU Oral Lesion Marking System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms substantial equivalence to a predicate device and states that the device can be marketed.

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

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VELscope Vx is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer and premalignant dysplasia.

VELscope Vx is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.

The VELscope Vx system is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination.

The main components of VELscope are the Handpiece, incorporating light source, viewing optics and rechargeable battery. Charging Cradle and external power supply. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, abnormal tissue typically appears as an irregular, dark area that stands out against the otherwise normal green fluorescence pattern of surrounding health tissue.

The document provided does not contain specific acceptance criteria outlined in a table or a detailed study proving the device meets particular numerical performance targets. Instead, it focuses on demonstrating substantial equivalence to a predicate device (VELscope, K070523).

Here's an analysis of the provided information related to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The core "acceptance criteria" presented in this 510(k) summary are based on demonstrating substantial equivalence to the predicate VELscope device (K070523). The key "criteria" for equivalence are:

• Identical Indications for Use.
• Equivalent essential performance specifications, specifically:
  • Excitation band (400-460nm) is the same as the predicate.
  • Optical output power in that excitation band is comparable.
  • Emission (viewing) optics are identical to the predicate.
• Clinical equivalence demonstrated through comparative imaging of oral mucosal lesions between the new device and the predicate.

Reported Device Performance:

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

• Sample Size for Test Set: The document states that "Clinical photographs were taken of a variety of oral mucosal lesions." It does not specify the exact number of lesions or patients included in this "variety."
• Data Provenance: The patients were "referred to oral medicine and oral dysplasia clinics," suggesting a clinical setting. The country of origin is not explicitly stated, but the submitter's address is in Burnaby, BC, Canada. The data appears to be prospective in the sense that images were specifically "acquired" for the comparison, but it's not clear if these were newly diagnosed cases or existing cases.

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

This information is not provided in the document. The study relies on "conventional (white light) as well as fluorescence photographs" and a comparison of these images. There is no mention of independent experts evaluating the images or establishing ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. It states "A comparison of the predicate VELscope and VELscope Vx images supports the substantial equivalence," implying a qualitative assessment, but the process of this comparison (e.g., blinded, adjudicated, single reviewer) is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The study's purpose was to demonstrate substantial equivalence between the new VELscope Vx and its predicate (VELscope) through comparative imaging, not to evaluate the improvement of human readers with AI assistance. The VELscope Vx is described as an "adjunct to traditional oral examination" and a "natural tissue fluorescence direct visualization system," not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the VELscope Vx is a direct visualization device, not an algorithm. Its operation inherently involves a human observer (dentist or healthcare provider) viewing the fluorescence to identify abnormalities.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the visual identification of "oral mucosal lesions" and "diseased tissue" by conventional examination and the use of the predicate VELscope. The clinical context is "oral medicine and oral dysplasia clinics," suggesting that these lesions would have a known clinical or pathological status. However, the document does not explicitly state if pathology or outcomes data was used to confirm the nature of the "variety" of lesions imaged. The substantial equivalence is based on the visual comparability of images, not on a definitive ground truth of diagnosis for each lesion.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The VELscope Vx is a medical device, not an AI/machine learning algorithm that requires a "training set." The engineering and design of the device would have been based on established principles of fluorescence and previous knowledge from the predicate device.

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

This information is not applicable as there is no "training set" in the context of this device.

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Dentlight Oral Exam Light Kit is indicated to be used by a dentist and physician for illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.

Dentlight Oral Exam Light Kit is a rechargeable-battery-powered cordless unit designed for illumination and examination for dental and physician's office on any procedures which require a small homogenous and well-defined spot and natural tissue reflectance and fluorescence visualization of healthy and abnormal tissue.

Dentlight Oral Exam Light Kit consists of a cordless unit with interchangeable light head (White and Violet), custom adaptable Fluorescence Loupe Filters and Filter Caps, Charging Stand, Power Adapter, and Patient Protective Eyewear Goggle.

This document is a 510(k) summary for the Dentlight Oral Exam Light Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with acceptance criteria in the way a clinical trial for an AI diagnostic device would.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic tools, is not present in this document.

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

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided text. The document refers to "Performance Testing and Compliance" but does not define specific acceptance criteria or report quantitative results against them. The testing listed is:

• Optical Power Testing
• Optical wavelength
• Beam Quality
• Illumination and Fluorescence Image

The document states, "The Dentlight Oral Exam Light Kit is designed to comply with electrical safety... and will comply with electrical safety requirement established by IEC 60601-1-2." This is a compliance statement rather than a performance acceptance criterion.

2. Sample size used for the test set and the data provenance

This information is not provided. As this is a submission for a physical medical device (an examination light) rather than a diagnostic algorithm, the concept of a "test set" in the context of data for an algorithm is not applicable. The performance testing mentioned (optical power, wavelength, beam quality, illumination, and fluorescence image) would have been conducted on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable/not provided. The device is an illumination tool to aid visualization, not a diagnostic tool that produces a "result" needing ground truth establishment by experts in a study context. Its intended use is to "enhance the visualization for oral examination of mucosal abnormalities and oral lesions," meaning human clinicians still interpret the visual information.

4. Adjudication method for the test set

This information is not applicable/not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. The device is not an AI system. While a clinical study could be performed to assess if the device improves human visualization and diagnosis, this document does not present such a study.

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

This information is not applicable/not provided. This is not an algorithm.

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

This information is not applicable/not provided.

8. The sample size for the training set

This information is not applicable/not provided. This is not an AI algorithm requiring a training set.

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

This information is not applicable/not provided. This is not an AI algorithm requiring a training set.

Summary of what the document does provide regarding performance and equivalence:

• Device Type: The Dentlight Oral Exam Light Kit is a rechargeable, cordless unit for illumination and enhanced visualization of oral tissue abnormalities using fluorescence and/or reflectance.
• Intended Use: To provide illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.
• Substantial Equivalence Claim: The device is claimed to be substantially equivalent to three predicate devices (Velscope K070523, Sapphire O/E K073483, Identafi 3000 K090135) in intended use and operation. All use fluorescence and/or reflectance for enhanced tissue visualization.
• Technological Characteristics Comparison:
  • Predicate K070523: 120V AC powered metal halide light, views fluorescence via filtered lens.
  • Predicate K073483: 120V AC powered Xenon plasma arc light, views fluorescence via filtered lens.
  • Predicate K090135: AA-battery-powered low power LED, views fluorescence through a broadband polarized filter glass, selectable wavelength (polarized white and amber LED).
  • Proposed Device: Uses LED light source in multiple wavelength spectra for illumination/excitation, offers two illumination modalities and one common detection/viewing mechanism.
• Claimed Advantages of Proposed Device: Magnified high contrast filter for detection/viewing, increased light intensity from "new reason LED" for improved clarity, improved portability with cordless hands-free or wand operation, benefits in size and weight for patient operations and counter space.
• Performance Testing Listed: Optical Power Testing, Optical wavelength, Beam Quality, Illumination and Fluorescence Image. (No results or acceptance criteria are given).
• Compliance: Designed to comply with electrical safety requirements established by IEC 60601-1-2.

In essence, this 510(k) submission relies on demonstrating that the Dentlight Oral Exam Light Kit has similar technological characteristics and the same intended use as already-marketed (predicate) devices, supported by general performance testing and electrical safety compliance, rather than proving a specific diagnostic accuracy against defined criteria in a clinical study as would be expected for a novel AI diagnostic device.

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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 ViziLite Eyewear is reusable and intended to be an optional accessory worn by health care professionals during chemiluminescent oral exam.

INDICATIONS FOR USE: The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.

The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.

The provided document, K080043, is a 510(k) summary for ViziLite Eyewear, indicating FDA clearance based on substantial equivalence to a predicate device. This type of submission focuses on demonstrating equivalence rather than comprehensive clinical efficacy studies with predefined acceptance criteria. Therefore, the document does NOT contain the detailed information requested in the prompt regarding acceptance criteria, extensive clinical trial data, or detailed ground truth methodologies that would typically be found in a PMA (Premarket Approval) submission or a more rigorous clinical study report.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly define quantitative acceptance criteria or report specific device performance metrics in the format of a table as typically seen in efficacy studies. The "performance" described is in the context of its intended use to reduce ambient light effects.

The eyewear is designed to "allow transmission of 430-580nm light," which aligns with the chemiluminescent light source (ViziLite) it's designed to be used with. The functional performance is that it enables the procedure to be performed effectively without a darkened room. |
| Secondary: Not altering safety and efficacy of the ViziLite Plus with TBlue procedure. | "without altering safety and efficacy." |
| Functional: Allows transmission of light in the 430-580nm range. | "The ViziLite Eyewear has been designed to allow transmission of 430-580nm light." |

2. Sample size used for the test set and the data provenance

• The document explicitly mentions "clinical testing" in the "Instructions for Use" section but does not provide details about the sample size (number of patients or cases) of the test set.
• Data provenance (e.g., country of origin, retrospective or prospective) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The document does not provide any information on the number of experts used or their qualifications to establish ground truth for any test set. The phrase "trained health care professional" is used in the instructions for use, implying clinical judgment, but no details on expert panels for ground truth determination are given.

4. Adjudication method for the test set

• The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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 MRMC comparative effectiveness study is mentioned. The device is an optical filter (eyewear), not an AI-based diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here. The comparison is between performing the ViziLite procedure with the eyewear vs. requiring a darkened room, and maintaining diagnostic performance.

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

• This question is not applicable as the ViziLite Eyewear is a passive optical filter designed for human use, not a standalone algorithm.

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

• The document does not explicitly state the type of ground truth used for its "clinical testing." Given the context of oral lesion identification, clinical assessment and possibly biopsy/histopathology would be the typical ground truth in such evaluations, but this is not detailed.

8. The sample size for the training set

• The document does not mention a training set sample size. As this is a 510(k) for an optical accessory, a "training set" in the machine learning sense is not applicable. If "training set" refers to data used to initially establish the eyewear's specifications or demonstrate its function, those details are not provided.

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

• This question is also not applicable for the same reasons as point 8.

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The Sapphire O/E oral examination light is intended for use by a dentist or qualified health-care provider as an adjunct to traditional oral examination by white light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or pre-malignant dysphasia. Sapphire O/E oral examination light is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.

Not Found

The provided text primarily focuses on the FDA's regulatory decision regarding the Sapphire™ O/E Oral Examination System and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) premarket notification approval letter, indicating that the device has been deemed substantially equivalent to a predicate device. It defines the device's indications for use but does not delve into the specific performance studies, acceptance criteria, or statistical details of those studies.

Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval notice, not a study report.

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VELscope is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia.

VELscope is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.

VELscope is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination.

The main components of VELscope are the Light Source Unit (LSU) and the viewing Handpiece. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, healthy tissue typically shows up as a brighter green color while suspicious tissue can cause a loss of fluorescence, which thus appears dark.

Here's an analysis of the provided text regarding the VELscope device, focusing on the acceptance criteria and the study details:

The provided text does not explicitly state acceptance criteria in a table format nor does it describe a specific study (with detailed methodology, sample sizes, expert qualifications, etc.) that directly proves the device meets pre-defined quantitative acceptance criteria.

Instead, the submission refers to "peer-reviewed and published scientific studies" as evidence to support the expanded indications for use. This suggests that the regulatory body (FDA) is relying on external, previously conducted research rather than a de novo clinical study described within the 510(k) submission itself.

Here's a breakdown of the requested information based on the provided text, with notes on what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified.
• Data Provenance (country of origin, retrospective/prospective): Not specified. The submission refers generally to "peer-reviewed and published scientific studies," which would contain this information, but it's not present in the 510(k) summary itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: Not specified. The VELscope is a direct visualization system, not an AI software. The concept of "human readers improve with AI" does not directly apply here. It's an adjunctive tool for a human healthcare provider.
• Effect Size: Not applicable/not specified.

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

• Standalone Performance: Not applicable. VELscope is a direct visualization tool used by a human healthcare provider; it's not an algorithm that provides an output independently.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated within the provided text. However, given the nature of the device (detecting cancerous/dysplastic lesions and aiding surgical margins), the ground truth in the underlying studies would most likely be pathology results (histopathologic diagnosis) obtained from biopsies. Outcomes data (e.g., long-term patient follow-up) could also contribute.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not specified. The VELscope is not an AI/machine learning device that requires a training set in the conventional sense. Its function relies on the physical properties of tissue fluorescence.

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

• Ground Truth Establishment for Training Set: Not applicable, as detailed above.

Summary of what the K070523 submission does say about evidence:

The FDA 510(k) summary for VELscope (K070523) states that its expanded indications for use are "based on recently published clinical data in peer-reviewed publications." It further asserts that these publications provide evidence that:

• "VELscope is effective in helping detect occult cancerous and dysplastic lesions."
• "VELscope can help an oral surgeon assess the extent of occult diseased tissue... and thus aid in determining the appropriate margin for surgical excision."

This implies that the burden of proof for effectiveness, and thus meeting an implicit acceptance criteria of being "effective" and "helpful," was satisfied by referencing existing scientific literature rather than by conducting and detailing a new, specific clinical trial within this 510(k) submission. The exact quantitative acceptance criteria and detailed study methodologies would need to be found within those referenced "peer-reviewed and published scientific studies" themselves, which are not included in this document.

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