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The Electronic Caries Detector is for use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

The ECD is a portable instrument that provides an electrical current source, a meter with a digital read-out between 00 and 100, and indicator and reference electrodes to aid in the detection and monitoring of non-cavitated and cavitated caries lesions in teeth.

The ECD indicator electrode is comprised of a replaceable, single-use, stainless steel probe tip. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures electrical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The ECD indicator electrode is paired with a reference electrode to complete the necessary electrical circuit. The reference electrode is a stainless steel lip hook that rests on the patient's lower lip.

The device is powered by a 9 volt alkaline battery, regulated down to 5 volts. The unit has a 2 ½ digit LCD display, two timer circuits, and a beeper. The first timing circuit is triggered upon circuit completion. The beeper sounds for 3 seconds, the probe is then removed, and the second timer holds the display for 5 seconds. Then the display returns to zero, ready for the next measurement.

Here's a breakdown of the acceptance criteria and study information for the Electronic Caries Detector, based on the provided text:

Electronic Caries Detector Study Information

1. Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" but rather presents performance metrics from a comparative study to establish substantial equivalence.

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

The document states that the testing included:

• In vitro performance testing on extracted teeth
• In vivo performance testing on teeth before and after extraction

However, it does not specify the sample size for either of these test sets, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. The term "in vivo" implies prospective collections from human subjects, and "in vitro on extracted teeth" would be a lab-based study with human teeth.

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

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human reader improvement with or without AI assistance. The device description suggests it's a direct measurement tool, not an AI-assisted diagnostic.

6. Standalone Performance Study (Algorithm Only)

The provided text describes performance testing of the device itself, stating "In vitro performance testing on extracted teeth" and "In vivo performance testing on teeth before and after extraction." The reported sensitivity and specificity values are for the device's performance when compared to biopsy. This indicates a standalone performance study of the device's measurement capabilities.

7. Type of Ground Truth Used

The ground truth used for the reported performance metrics (sensitivity and specificity) was biopsy. The document states, "Performance: When compared to biopsy: 92% sensitivity, 100% specificity." It further notes, "Ortek believes that biopsy is considered the current gold standard and the performance scores are more significant compared to visual-tactile readings."

8. Sample Size for the Training Set

The document does not provide information on a separate training set or its sample size. The testing described appears to be for validation/performance evaluation rather than machine learning model training.

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

Since no separate training set is mentioned for a machine learning model, there is no information on how ground truth for a training set was established. The ground truth for the performance evaluation was established via biopsy.

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A visual aid for the identification of infected carious dentine.

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I am sorry, but the provided text does not contain the detailed study information needed to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the SEE-IT™ Caries Detector, stating that the device is substantially equivalent to a legally marketed predicate device.

The letter mentions the device's regulation number, regulation name, regulatory class, and product code, but it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, ground truth establishment, or expert qualifications.
3. Information on adjudication methods or multi-reader multi-case (MRMC) studies.
4. Data regarding standalone algorithm performance.
5. Training set details.

Therefore, I cannot fulfill your request for these specific details based on the provided text.

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CARIES DETECTOR is indicated for the following applications: Detection of carious dentin

This product is classified into Caries Detection Device, CFR 21 Section 872. 1740. Two of the predicate devices listed in section 3 operate by means of applying dyes to teeth to stain areas of decay. They do not involve chemical reactions, nor use electrical current or optical instruments. The methods of operation of these devices is similar to that of plaque disclosing agents in that they stain the affected areas.

The provided text is a 510(k) summary for the "CARIES DETECTOR" device by Kuraray Medical Inc. It explicitly states that the submission is for an alteration of the name and address of the manufacturer and not to intend other changes to the device itself.

It further clarifies that the "technological characteristics, chemical ingredients and safety of this device are completely the same as CARIES DETECTOR manufactured by Kuraray Co., Ltd. (K951813)."

This means that a new study to prove device performance or establish new acceptance criteria was not conducted for this specific 510(k) submission (K012733). The substantial equivalence is based on the predicate device (K951813), which presumably had its performance proven at the time of its own clearance.

Therefore, the requested information regarding acceptance criteria and the study proving the device meets them cannot be directly extracted from this document for K012733, as no such new study was performed for this submission. The document relies on the previous clearance of the predicate device.

To answer your request, one would need to refer to the original 510(k) submission for the predicate device, K951813 (CARIES DETECTOR by Kuraray Co., Ltd.), if that information is publicly available.

Based solely on the provided text for K012733:

1. Table of acceptance criteria and the reported device performance:

   • No new acceptance criteria or reported device performance studies are included in this 510(k) summary for K012733, as it is a manufacturer name/address change and not a device modification. The device is stated to be "completely the same" as the predicate K951813.

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

   • Not applicable to this 510(k) submission, as no new performance study was conducted.

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

   • Not applicable to this 510(k) submission, as no new performance study was conducted.

4. Adjudication method:

   • Not applicable to this 510(k) submission, as no new performance study was conducted.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • No MRMC study was conducted or reported in this 510(k) submission.

6. Standalone performance study:

   • No standalone performance study was conducted or reported in this 510(k) submission for K012733.

7. Type of ground truth used:

   • Not applicable to this 510(k) submission, as no new performance study was conducted.

8. Sample size for the training set:

   • Not applicable to this 510(k) submission, as it is a dye-based caries detection device and typically does not involve algorithm training in the context of AI.

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

   • Not applicable to this 510(k) submission.

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CARIES INDICATOR PLUS ( CARIES STAIN ) is indicated for detection of caries through the staining of the outer layer of carious dentin.

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This document is a 510(k) summary for the American Dental Products Caries-Detector Plus. It states that the product's efficacy is comparable to or better than other brands on the market, as shown by third-party testing. However, it does not provide detailed information about the acceptance criteria, the specific study conducted, or any of the other information requested in the prompt.

Therefore, I cannot provide the requested information based on the given text. The document is too high-level and lacks the specific details about the study design, sample sizes, ground truth establishment, or expert involvement.

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