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The ViziLite Blue Oral Exam Product consists of the Vizilite and ViziLite Blue Oral Lesion Identification and Marking System.

The Vizilite (OralLite) is a chemiluminescent light source system indicated for use as an adjunct to conventional oral mucosal screening by trained health care providers for the identification, evaluation, and monitoring of oral mucosal abnormalities in a population at increased risk for oral cancer.

The ViziLite Blue Oral Lesion Identification and Marking-System, is a threecomponent swab system which is indicated as an adjunct to the ViziLite Test for oral mucosa lesions, for further evaluation and monitoring of lesions already differentially identified with Vizil ite in a population at increased risk for oral cancer

The ViziLite Blue Oral Lesion Identification and Marking System is not being proposed for use in the initial oral mucosal examination without initial lesion identification with ViziLite. Furthermore, this ViziLite Blue Oral Lesion Identification and Marking System is not intended to be used as an indicator of lesions warranting further study, including biopsy. Whether a lesion is marked with the dye or not should not alter the clinician's clinical behavior as dictated by the results of the ViziLite examination. The marking dye, when positive, acts as a lesion marker that allows for the removal of the ViziLite device while preserving the anatomic character of the lesion.

ViziLite Blue Oral Exam Kit includes the ViziLite used as an adjunct to visual examination of the oral mucosa with incandescent light for identification of oral mucosal abnormalities and ViziLite Blue Oral Lesion Identification and Marking System to further assist with the evaluation and monitoring of ViziLiteldentified oral white mucosal abnormalities in patients at increased risk for oral cancer.

The ViziLite-Blue™ Oral Exam Kit is a visualization system that is intended as an adjunct to conventional visual examination with incandescent light of oral mucosa and employs the same components and mechanism of action as the previously cleared ViziLite Test Kit (a.k.a. ViziLite Comprehensive Exam Tray K012070 and the OralLite Test Kit, K03995 and Acetic Acid Rinse) and is indicated for the same patient population and intended use. The ViziLite examination light source and accessories, including the 1% Acetic Acid Rinse, have not been changed nor significantly modified for production of the ViziLite-Blue Oral Exam Kit.

The ViziLite Blue Oral Lesion Identification and Marking System, consists of three swab components, two swabs of 1% Acetic Acid Rinse, including a postdye decolorizer, and one swab with a metachromatic vital tissue dye, Tolonium chloride, also called Toluidine Blue. The application of the dye to ViziLite-Identified oral white mucosal lesions in a population at increased risk for oral cancer, during clinical trials was able to assist with evaluation, monitoring, and tissue sampling and helped physically mark and stain 51% of the ViziLite-Identified white lesions to allow the health care provider to visualize lesions with incandescent light.

The document describes the ViziLite Blue Oral Exam Product (K033033), which includes the ViziLite and the ViziLite Blue Oral Lesion Identification and Marking System. The ViziLite is a chemiluminescent light source, and the ViziLite Blue system uses a metachromatic vital tissue dye (Tolonium chloride/Toluidine Blue) for marking lesions.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as typically seen for AI/ML device performance. Instead, it describes the expected performance and utility of the device based on previous clearances and a clinical study.

• "Thus, it appears that the ViziLite is a useful adjunct to help direct the examiner to lesions that would be difficult or poorly seen with incandescent light alone." |
  | ViziLite Blue Oral Lesion Identification and Marking System Performance: | |
  | Ability to assist with evaluation, monitoring, and tissue sampling of ViziLite-Identified oral white mucosal abnormalities. | - The system "was able to assist with evaluation, monitoring, and tissue sampling and helped physically mark and stain 51% of the ViziLite-Identified white lesions to allow the health care provider to visualize lesions with incandescent light."
• "When the Tolonium Chloride dye marked the acetowhite lesions, the health care provider was able to remove the ViziLite device from the patient's mouth and see the lesion with incandescent illumination."
• "This allows the examiner to measure the lesion size, observe the lesions borders, and obtain an appropriate tissue sample (biopsy) when clinically indicated." |
  | Indication for use as an adjunct to ViziLite test, not as an initial screening tool. | The system is "not for "initial identification" of abnormalities" and "not intended to be used as an initial screening examination." Its use is "as an adjunct or an accessory to the ViziLite examination." |
  | Clinical behavior should not be altered by marking dye results in terms of warranting further study/biopsy. | "Whether a lesion is marked with the dye or not should not alter the clinician's clinical behavior as dictated by the results of the ViziLite examination." |

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

• Sample Size (Clinical Trials): 86 adult patients and 92 biopsied lesions.
• Data Provenance: The clinical trials were "conducted at three University Hospital sites." The country is not explicitly stated, but given FDA submission, it is typically in the U.S. or international studies following U.S. regulatory standards. The study appears to be prospective clinical trials.

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

The document does not specify the number of experts or their qualifications for establishing ground truth from the clinical trials. It mentions "examiners" and "health care provider," but details on their roles in determining ground truth (e.g., biopsy results interpretation) are not provided.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the clinical trial results or ground truth establishment.

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

• None. This device (ViziLite Blue Oral Exam Product) is a physical device (light source and dye system), not an AI/ML algorithm. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and was not performed. The "improvement" described relates to the device's ability to aid human clinicians directly.

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

• None. As noted above, this is a physical diagnostic aid, not an algorithm. Its performance is always "human-in-the-loop" as it is an adjunct to a clinical examination.

7. The Type of Ground Truth Used

For the ViziLite performance:

• "Biopsy proven squamous cell dysplasia and malignancy in squamous epithelium" is mentioned in the context of the predicate device's mechanism of action, implying that pathology (biopsy) is the ultimate ground truth for identifying significant lesions.
  For the ViziLite Blue Marking System:
• Its role is to "assist with evaluation, monitoring, and tissue sampling," and its ability to help "physically mark" lesions that are "ViziLite-Identified white lesions" is highlighted. The ultimate "ground truth" for the significance of these marked lesions would still be pathology (biopsy), though the dye helps visualize them for that purpose. The document states its marking capability "should not alter the clinician's clinical behavior as dictated by the results of the ViziLite examination," implying the ViziLite examination (which could lead to biopsy) is a primary consideration for decision-making.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is not an AI/ML algorithm that requires training. The clinical studies described are for validation/demonstration of effectiveness.

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

Not applicable, as this is not an AI/ML device.

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SpiraBrush Cx is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining a tissue diagnosis in women with intraepithelial disease. Tissue samples obtained by the SpiraBrush Cx biopsy instrument should be evaluated using a histologic technique.

The SpiraBrush Cx is a biopsy instrument consisting of a sampling head and a handle. The sampling head is placed directly onto the exocervical lesion or cervical area to be biopsied, and rotated to collect a tissue sample. The head is then snapped off the handle and placed in a preservative solution for laboratory processing.

This document describes the SpiraBrush Cx, a device intended for obtaining biopsies of visible exocervical lesions. The clinical trial focused on comparing its performance to a standard cervical punch biopsy.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document does not explicitly state quantitative "acceptance criteria" for the SpiraBrush Cx. Instead, the study's conclusion focuses on demonstrating substantial equivalence to a standard cervical punch biopsy. The primary performance metric reported is related to the adequacy of the biopsy and a secondary benefit regarding hemodynamics.

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

• Sample Size for Test Set: 37 subjects (out of 41 enrolled, 90% completed evaluation).
• Data Provenance: The document does not explicitly state the country of origin, but it mentions "4 investigation sites," suggesting the study was conducted in a clinical setting. It is a prospective study as subjects underwent both SpiraBrush Cx biopsy and cervical punch biopsy prior to LEEP.

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

• Number of Experts: The document states that a "reviewing pathologists" utilized the tissue specimens. The exact number of pathologists is not specified.
• Qualifications of Experts: The qualifications are referred to as "reviewing pathologists." No specific experience level (e.g., "10 years of experience") is provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for the test set regarding the comparison of SpiraBrush and punch biopsy results. It implies that pathologists independently reviewed specimens to arrive at a diagnosis. However, "tissue confirmation by LEEP or conization" served as an overarching confirmation of the findings for both biopsy methods. This implies LEEP/conization served as the definitive ground truth, against which the diagnostic capability of both biopsy types was assessed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study involving AI assistance was not mentioned. The device is a manual biopsy instrument, not an AI-powered diagnostic tool. The document focuses on the equivalence of the biopsy sample quality, not on improving human reader performance with AI.

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

No, a standalone algorithm performance study was not performed. The SpiraBrush Cx is a physical biopsy instrument that collects tissue, which is then interpreted by a pathologist. It is not an algorithm.

7. The Type of Ground Truth Used

The ground truth for assessing the "adequacy" and "meaningful clinical diagnosis" of the biopsy samples was pathology (microscopic classification by reviewing pathologists) and outcomes data in the form of "tissue confirmation by LEEP or conization." LEEP (Loop Electrosurgical Excision Procedure) or conization is a definitive surgical procedure that typically removes the entire affected area and provides a comprehensive histological diagnosis, serving as a strong gold standard.

8. The Sample Size for the Training Set

A training set is not applicable here as the study is comparing a physical biopsy instrument to a standard biopsy instrument, not training an algorithm.

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

Not applicable, as there was no algorithm training set.

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The OralLite Test Kit, when used in combination with conventional visual oral mucosal in The OralLite Test Kit, when used in other used in cardification, evaluation, and examination by nealth care providers, improved facilities in the reased risk for oral cancer.

Not Found

This document is a 510(k) clearance letter from the FDA for the ViziLite™ Comprehensive Exam Tray and the OralLite Test Kit. However, it does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The letter primarily confirms that the devices are substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. The "Indications For Use" section for the OralLite Test Kit mentions its intended use in combination with conventional visual oral mucosal examination for improved facilities in "reased risk for oral cancer," but it does not provide any performance metrics or study details.

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

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• Speculoscopy is indicated for use in those women who are currently recommended for cervical screening with pelvic examination and Pap smear.
• Speculoscopy is only to be used as an adjunct to the Pap smear, and only the combination of the two tests affords the clinician improved sensitivity in identifying women with mucosal abnormalities visualized on colposcopy.
• The combined results of the Pap smear with Speculoscopy in the screening examination, designated Pap Plus Speculoscopy, can allow for the identification of more women who are appropriate referrals for colposcopy or close follow up than Pap smear alone.

Not Found

This document is a 510(k) clearance letter from the FDA for the Speculite®/Speculoscopy device and its Indications for Use statement. It does not contain information about acceptance criteria or a study proving that acceptance criteria were met. Therefore, I cannot fulfill the request.

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