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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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The DU Series Portable Dental Unit is intended to supply power and serve as a base for dental devices and accessories. This device delivers air, water, vacuum, and electricity to handheld instruments, for use in dental clinics and hospitals. It is designed to be used by professional dental practitioners.

1. The DU Series Portable Dental Unit is a combination of the speed handpieces, ultrasonic scaler, curing light, 3-way syringe, saliva ejector, clean water bottle, drain bottle, oil free air compressor, and footswitch.
2. The external AC power source provides electric power to the unit. The self contained air compressor provides air source to speed handpieces. The self contained water system provides water source for the syringe, handpieces and ultrasonic scaler.
3. The speed handpiece is supplied by the manufacturer of Predicate Device K991701; the ultrasonic scaler is supplied by K053555; the curing light is supplied by K080025. Other accessories are self-produced.
4. The patient contacting components are in the accessories of speed handpieces and the ultrasonic scaler. All the patient-contacting materials have passed biocompatibility testing according to ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.

The provided 510(k) summary (K111907) details the acceptance criteria and the study conducted for the DYNAMIC® DU Series Portable Dental Unit.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "Bench testing has been performed on a sample against the standards..." and "The DU Series Portable Dental Unit has passed bench testing...". However, the specific sample size used for the test set (i.e., the number of units tested) is not explicitly stated.

The data provenance is from bench testing conducted by the manufacturer, Shanghai Dynamic Industry Co., Ltd. in China. It is a prospective test of newly manufactured devices against established performance and safety standards.

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 to this type of device and study. The "ground truth" for this device's performance is determined by adherence to established engineering and safety standards (e.g., water/air pressure, electrical safety, biocompatibility). There are no human experts involved in establishing a subjective "ground truth" in the way one would for diagnostic imaging. The standards themselves serve as the objective performance targets.

4. Adjudication Method for the Test Set:

This is not applicable. The testing involves objective measurements against predefined criteria in the standards. There is no need for adjudication as the results are quantitative and pass/fail based on the standards.

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:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a dental operative unit, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

A standalone performance study was not done in the context of an algorithm or AI. The performance studies described are for the physical device itself (bench testing and safety testing) as a standalone unit.

7. The Type of Ground Truth Used:

The "ground truth" used for this device's evaluation is based on established international performance and safety standards (ISO and IEC standards) and biocompatibility guidelines. Compliance with these objective, measurable standards constitutes the ground truth for its safety and effectiveness.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.

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

This information is not applicable for the reasons stated in point 8.

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