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For use as an aid in the diagnosis of dental caries

SmarTooth (STL-02-BK) is an optical dental caries diagnostic device that uses a laser to help diagnose dental caries. The SmarTooth (STL-02-BK) is composed of a portable hardware main body with batteries, a main body holder, and a mobile application. The hardware components provide a laser source, an LED indicator, and a zero point adjustment (calibration) unit to aid in the detection and monitoring of dental caries lesions in teeth. The software component provides a meter with a digital read-out between 0 and 99. The hardware device is a pen-type device consisting of a laser diode that generates a laser and a photodiode sensor to detect fluorescent light. Both the sensor and laser diode are mounted at the tip of the device to be introduced into the mouth of the patient for scanning of the teeth. The tooth is exposed to irradiation of a 650 nm wavelength laser by this device, and a value from the detected fluorescent light is displayed to refer to the diagnosis of dental caries. The information from the scanner is handled by the Software, which holds the interface to the user.

As a battery-operated, portable laser source with a photodiode sensor, the subject device is designed for handheld operation. The dental probe is a replaceable, single-use component made from ABS material. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures physical and optical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The main body holder is used to calibrate the device before measuring the teeth.

The main body is powered by a 1.5-volt AA-type alkaline battery. This unit has two LED lamps (status and measurement), one power button, one laser output, and a beeper sounds one time when pushing the power button for 1 second to turn on and 3 seconds to turn off the device. The main body should be paired with the zero point adjustment unit on the main body holder before use to calibrate the necessary optical zero point. Users can start the measurement by clicking the "Measure" button on the application screen.

Unfortunately, the provided text does not contain the information requested about the acceptance criteria and the study that proves the device meets those criteria.

The document is an FDA 510(k) clearance letter and a 510(k) summary. These documents primarily focus on:

• Substantial Equivalence: Comparing the new device (SmarTooth) to a legally marketed predicate device (KaVo DIAGNOdent 2190).
• Technological Characteristics: Highlighting similarities and differences between the new device and the predicate.
• Non-Clinical Testing: Listing standards met for electrical safety, EMC, biocompatibility, and software validation.
• Absence of Clinical Testing: Stating that clinical testing was not necessary due to the nature of the device and sufficient bench testing.

Therefore, I cannot provide the detailed information requested in the prompt, such as:

1. A table of acceptance criteria and reported device performance: This information is not present. The document states "Adequate bench testing results should be sufficient in supporting our claim of substantial equivalence," implying that the performance was likely compared to the predicate's known operating characteristics rather than against specific, predefined acceptance metrics with reported values.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment: Since no clinical study was performed or needed for this 510(k) submission, none of this information is available or relevant to the data provided. The "performance test - bench" section is very brief and does not offer these details.

In summary, based only on the provided text, there is no clinical study described that proves the device meets specific acceptance criteria in the manner requested. The clearance was based on demonstrating substantial equivalence through non-clinical testing and similarity to a predicate device.

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The SMARTO is intended for use in drilling in conjunction with craniofacial (does not include oromaxillofacial applications), craniotomnies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and single use only.

The SMARTO is an DC-powered device that includes a hand-held motor, switch and hold for the rotation attachment for surgery. It is supplied radiation-sterile and disposable use.

The provided text describes the SMARTO device, a surgical motor unit, and outlines its technical specifications and comparison with a predicate device for 510(k) clearance. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of AI-driven performance metrics (e.g., sensitivity, specificity, AUC).

The document is a 510(k) summary for a surgical motor unit. The "acceptance criteria" discussed are related to electrical safety, electromagnetic compatibility, and performance tests for torque and speed, using existing standards (IEC 60601-1, IEC 60601-1-2) and internal standards. These are typical for hardware medical devices.

Therefore, I cannot fulfill parts of your request that pertain to performance metrics like sensitivity, specificity, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies, as these types of studies and criteria are generally associated with AI/software medical devices that interpret images or data for diagnostic or prognostic purposes.

Here is what can be extracted from the document regarding the acceptance criteria and study, based on the provided text's focus on a physical medical device:

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

Notes:

• The document states, "The test was conducted to verify that the proposed device met all design specifications." and "The test results demonstrated that the proposed device complies with the following standards and worst case criteria report." This implies that the device did meet these criteria.
• The specific magnitude of the acceptance criteria for the internal standards is not explicitly stated as a pass/fail threshold, but the reported performance values are given. The inference is that the reported performance meets the internal standard.

Regarding the other requested information:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device (physical surgical motor). The "tests" are engineering performance tests, not clinical studies with 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): Not applicable. "Ground truth" in this context refers to the measured physical properties of the device against engineering specifications.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable. This is not an AI-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For physical characteristics like torque and speed, the "ground truth" would be the measured physical properties against designed specifications. For electrical safety and EMC, it's compliance with established international standards.
• 8. The sample size for the training set: Not applicable. This device is not an AI algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

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The SMARTO is used to drive screws, and drilling in conjunction with craniofacial (does not include maxillofacial applications), craniotomies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and is for single use only.

The SMARTO is a sterile battery powered screwdriver. The device includes a DC motor, battery, switch and holder for the rotation attachment. It is disposable.

The provided document describes a 510(k) submission for the SMARTO surgical motor unit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria based on a defined performance standard.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, an AI algorithm, or detailed statistical analysis, is not applicable to this type of regulatory submission. This document describes a traditional medical device (a surgical motor unit), not an AI-powered device or one that requires extensive clinical performance studies to achieve marketing clearance via the 510(k) pathway.

Here's a breakdown of the available information and why other points are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: For a 510(k) submission like this, "acceptance criteria" are primarily established by demonstrating substantial equivalence to a legally marketed predicate device. The performance criteria are therefore implied to be met if the new device performs comparably to the predicate for its intended use. Bench testing of mechanical properties (motor speed, torque) is mentioned as evidence of safety and effectiveness, which are the fundamental requirements.

Information NOT available or NOT applicable based on the provided document:

• 2. Sample size used for the test set and data provenance: Not applicable. The document refers to "bench testing" on mechanical properties, but details such as sample size, specific test configurations, or data provenance (country, retrospective/prospective) are not provided. This is not a clinical study with a "test set" in the sense of patient data.
• 3. Number of experts used to establish ground truth and qualifications: Not applicable. There is no mention of "ground truth" established by experts in this context as this is a mechanical device, not an AI or diagnostic tool.
• 4. Adjudication method: Not applicable. No expert review or adjudication process is described.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study and effect size: Not applicable. This type of study is for diagnostic devices where human readers interpret data, often with AI assistance. The SMARTO is a surgical motor.
• 6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. The SMARTO is a physical surgical tool, not an algorithm.
• 7. Type of ground truth used: Not applicable. Ground truth typically refers to a definitive diagnosis or outcome for a diagnostic or AI study. For a surgical motor, the "truth" is its mechanical performance and functional safety.
• 8. Sample size for the training set: Not applicable. There is no AI model or algorithm being trained.
• 9. How the ground truth for the training set was established: Not applicable. No AI model or training set.

In summary, the provided document is a 510(k) summary for a surgical motor. Its primary goal is to establish substantial equivalence through bench testing of mechanical properties and comparison of intended use, technology, energy source, claims, and material composition with a predicate device. It does not contain the detailed study information typically associated with AI/ML devices or complex clinical performance studies.

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The SmartOAE device is intended to be used for the purpose of determining the distortion product response of the human cochlea. The device is intended to be used by hearing health professionals to determine cochlear function. The test administered by the device does not require any patient behavioral response, such as pushing a button switch. The device delivers sound signals into the outer ear and subsequently records the sound in the outer ear which contain sounds produced by normal cochleas. The device also measures the level of sound near the distortion product frequency to estimate the noise level present while the test was performed.

Not Found

This looks like a 510(k) clearance letter from the FDA for a device called "SmartOAE." While it describes the device's intended use, it does not contain the detailed information about acceptance criteria, study design, or performance metrics that you've requested.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It doesn't include a study summary or the specific data you're looking for.

Therefore, I cannot provide the requested information based on the provided text. To get this information, you would typically need to refer to the original 510(k) submission documentation, which is usually more extensive and includes the technical details and study reports.

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