Search Results

Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills

Endo Smart, Model ES-100 is a controller for micro motor and contra angle headpieces which is designed to assist dentists and dental surgeons perform standard endodontic procedures. It provides power to the hand-held micromotor and contra angle which holds the drill bit and/or file used in endodontic procedures.

Endosmart is only intended to be used with motor hand piece (manufactured by Saeshin Precision Company; part name CUBE EP) and Contra angle headpiece (Manufactured by Saeshin Precision Company; part name ACL (B) - 42P) at 16:1 gear ratio.

The Metabiomed, Inc. Endo Smart, ES-100 is an endo motor designed to assist dentists and dental surgeons in standard endodontic procedures using rotary endodontic files and drills.

Here's an analysis of the acceptance criteria and the study presented:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates that conformity to standards (IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2, and FDA Software Validation Guidance) was used to establish performance and safety. There is no mention of a traditional "test set" in the context of clinical or diagnostic performance with a specified sample size of patients/cases. The studies performed are engineering tests demonstrating adherence to safety and performance standards for an electro-mechanical device.

Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) submission for this device type, as it relies on engineering testing rather than clinical study data.

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

Not applicable. The performance testing described relates to adherence to technical standards and the functional characteristics of the device, not a diagnostic or clinical assessment where ground truth would be established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication pertains to clinical studies where expert consensus often establishes ground truth for diagnostic accuracy, which is not the nature of the testing described for this endo motor.

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. The device is not an AI-based diagnostic tool. It is an electro-mechanical device.

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

Not applicable. The device is not an algorithm, and its function inherently involves a human operator (dentist/dental surgeon).

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

The "ground truth" for the device's acceptable performance is established through adherence to recognized international and electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2) and FDA Software Validation Guidance. For the functional aspects, the ground truth is comparative equivalence to legally marketed predicate devices in terms of intended use and technological characteristics (e.g., torque range, mode of operation, use of specific micro motor/contra angle).

8. The sample size for the training set

Not applicable. The device is not a machine learning or AI model that requires a "training set."

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

Not applicable. No training set for an AI/ML model is mentioned.

Ask a specific question about this device

MD-flex Heavy Body is used to record the shape of the patient's teeth and alveolar ridges.

MD-flex Heavy body is hydrophilic Polyvinylsiloxane Impression Material with thixotropic property, dimensional accuracy and excellent recovery from deformation. It complies with the requirements of ISO 4823:2000 Type 1 for dental elastomeric impression materials. It is supplied as a two-part base/catalyst formulation preloaded in a dual-barrel cartridge.
The MD Flex Heavy Body package includes two dual-barrel 50 ml cartridges, and six mixing tips that allows for easy mixing of the base and catalyst. The device (cartridge) and accessories (mixing tip) are to be sold non-sterile. Testing demonstrates that MD-Flex has a shelf life 2 years from the manufacturing date.
MD-Flex can be used to make a mold of a patient teeth and alveolar ridges. The mold can be used to generate Gypsum model within 30 minutes of removal of the mold from patient's mouth. The Gypsum model will be effectively reproduced without transformation due to an excellent reproducibility and volume stability of MD Flex.

The provided text is a 510(k) summary for the MD-Flex Heavy Body dental impression material. This type of document focuses on demonstrating substantial equivalence to a predicate device, primarily through physical and chemical properties and intended use, rather than clinical study data involving human subjects or AI performance.

Therefore, many of the requested details related to clinical trials, AI performance, ground truth establishment for AI, and expert adjudication are not applicable to this submission.

Here's a breakdown of the information that can be extracted and how it relates to your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for MD-Flex Heavy Body are primarily based on its compliance with ISO 4823:2000 Type 1 for dental elastomeric impression materials. The summary states that the device "complies with the requirements of ISO 4823:2000 Type 1".

Study Information (Based on Available Text)

1. Sample size used for the test set and the data provenance: Not explicitly stated. The performance testing is based on compliance with ISO 4823:2000. It doesn't detail a "test set" in the context of clinical or AI performance. The data provenance is generally from laboratory testing of the material itself.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI or diagnostic studies (e.g., expert consensus on clinical images) is not relevant here. The "ground truth" for material properties is derived from standardized laboratory measurements.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There is no expert adjudication for material property testing.

4. 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 device is a dental impression material, not an AI-powered diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For material properties, the "ground truth" is established through standardized laboratory measurement methods as defined by ISO 4823:2000. For biocompatibility, it's based on biocompatibility testing results according to ISO 10993.

7. The sample size for the training set: Not applicable. This is not an AI device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary of the "Study"

The device meets the acceptance criteria by demonstrating compliance with the ISO 4823:2000 Type 1 standard for dental elastomeric impression materials. This compliance is achieved through performance testing of the material's physical and chemical properties in a laboratory setting. Additionally, biocompatibility tests (Cytotoxicity, Irritation, Sensitization) conducted in compliance with ISO 10993 confirm its biological safety. These tests are the "study" that proves the device meets its acceptance criteria, showing it is substantially equivalent to predicate devices in its properties and intended use.

Ask a specific question about this device

REXTAR X is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray lmages using intraoral image receptors. It is intended for both adult and pediatric subjects.

The REXTAR X consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The Rextar model contains additional accessories. The REXTAR X is an extraoral source x-ray system with a DC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source a, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

The provided text does not contain detailed information about specific acceptance criteria, a scientific study with performance metrics, or the methodologies for establishing ground truth, as would be expected for an AI/ML device.

This document describes a conventional X-ray device, the REXTAR X, and its substantial equivalence to a predicate device (REXTAR LCD) for FDA 510(k) clearance. The comparison focuses on technical and operational specifications rather than AI/ML performance.

Therefore, many of the requested sections about acceptance criteria, study details, human reader improvement, and ground truth establishment cannot be answered from the provided input.

However, based on the information available, here's what can be extracted:

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

The "acceptance criteria" for this device appear to be primarily based on demonstrating substantial equivalence to a predicate device (REXTAR LCD) and compliance with relevant safety and performance standards for X-ray systems.

The "study" that proves the device meets "acceptance criteria" is essentially the comparison table demonstrating substantial equivalence and the EMC testing results. The conclusion states: "Based on comparison with the predicate devices and the results of testing Metabiomed believes its REXTAR and REXTAR LCD devices are substantially equivalent" (Section 13).

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

Not applicable for this type of submission. The performance assessment is based on technical specifications and comparison to a predicate device, not a diagnostic accuracy 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

Not applicable.

4. Adjudication method 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 a conventional X-ray device, not an AI-assisted diagnostic tool.

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

Not applicable. The "ground truth" for this submission concerned the technical specifications and safety compliance of the device itself, rather than diagnostic accuracy against a clinical gold standard.

8. The sample size for the training set

Not applicable. No AI/ML component.

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

Not applicable. No AI/ML component.

Ask a specific question about this device

REXTAR LCD is a portable X-ray systems to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

The REXTAR LCD consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The REXTAR LCD is an extraoral source x-ray system with a DC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source a, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

The provided text describes a 510(k) submission (K122016) for the REXTAR LCD, a portable X-ray system. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader agreement.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth establishment is not available in the provided document. The document primarily highlights compliance with performance standards and a comparison of technical specifications with predicate devices.

However, based on the information provided, here's what can be inferred and what is explicitly stated:

Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide a table of explicit "acceptance criteria" for clinical performance metrics (e.g., sensitivity, specificity, or diagnostic accuracy) or "reported device performance" against such criteria. Instead, it demonstrates compliance with recognized electrical and safety standards and compares technical specifications to predicate devices to establish substantial equivalence.

Study and Data Information:

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

   • Not provided. The document does not describe a clinical study with a test set of images or patients for performance evaluation. The submission relies on technical comparisons and compliance with standards.

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

   • Not applicable/Not provided. No clinical test set or ground truth establishment by experts is described for performance evaluation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided. No clinical test set involving expert adjudication is described.

4. 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. This device is an X-ray system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

   • No. This is a hardware device for image acquisition, not an algorithm.

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

   • Not applicable/Not provided. The substantial equivalence claim is based on comparison of technical specifications and compliance with safety and electrical standards, not on clinical ground truth.

7. The sample size for the training set:

   • Not applicable/Not provided. This is not an AI/algorithm-based device requiring a training set.

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

   • Not applicable/Not provided.

Summary of what the document explicitly states regarding compliance/testing:

• Compliance with performance standards: "All components to which the standard applies are certified to conform to diagnostic equipment standards, 21 CFR 1020.30 and 1020.31." (Section 8)
• The device "will comply with applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32." (Section 11)
• "EMC testing was conducted by (EMC Compliance Co., Ltd. in accordance with Standard EN/IEC 60601-1-2). All test results were satisfactory." (Section 11)

The "study" in this context is the comparison to predicate devices and the demonstration of compliance with various electrical, safety, and diagnostic equipment standards, rather than a clinical performance study. The "acceptance criteria" are implied by the requirements of these standards and the characteristics of the predicate devices.

Ask a specific question about this device