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The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

The Endo SmartCap™ supplies sterile water and either air or CO2 to an endoscope during endoscopic procedures when connected to a sterile water source and an air or CO2 source. Two tubes are arranged coaxially; air or CO2 supplied through the outer tube pressurizes the sterile water container, forcing water up through the inner tube and to the endoscope. The proximal end of the tube set includes a bottle cap for attachment to a user-provided sterile water container; the Endo SmartCap™ is compatible with all major brands of sterile water containers. The proximal end of the tube set terminates in a tube weight which keeps the tip of the tubing submerged. A pinch clip prevents water from dripping from the tube's distal end when the device is detached from the endoscope. The distal end of the tube set terminates in a connector which mates with the corresponding brand of endoscope; Endo SmartCap™ models are available for all major brands of endoscopes. The device is provided sterile (EtO). The device is fabricated from metals, plastics, and elastomers. The Endo SmartCap™ is intended for 24 hour multi-patient use and should be discarded daily. No portion of the device comes in direct contact with patients.

The provided text is a 510(k) Premarket Notification for the "Endo SmartCap™" device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML device meets specific performance criteria. The document describes a medical device accessory, not an AI/ML system.

Therefore, many of the requested details about acceptance criteria for AI/ML performance, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be found in this document because the device is a physical accessory (Endoscope and Accessories), not an AI/ML software.

However, I can extract the information related to the device's functional performance testing.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance (for functional testing):

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

• Sample Size: Not explicitly stated as a number of devices/tests, but implies multiple production samples for the flow rate test ("average mean flow of the 100551-production sample").
• Data Provenance: The document does not specify the country of origin of the data. The tests conducted are functional performance tests of the device itself, not data-driven performance. The tests are retrospective in the sense that they were conducted for the 510(k) submission.

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

• This is not applicable as the device is a physical accessory undergoing functional engineering tests (flow rate, backflow prevention), not an AI/ML algorithm requiring expert interpretation of medical images or data for ground truth. The "ground truth" here is the objective measurement of physical properties.

4. Adjudication method for the test set:

• Not applicable for functional engineering tests. The results are objective measurements against predefined engineering specifications.

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 device is a physical medical accessory, not an AI/ML system for diagnostic assistance. No human reader studies with or without AI were conducted or are relevant.

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

• Not applicable. This is not an algorithm. The reported tests are for the standalone physical device's functional performance.

7. The type of ground truth used:

• For flow rate and backflow prevention tests, the "ground truth" is established by engineering specifications and direct physical measurement. For example, for flow rate, it would involve direct measurement of water/gas volume over time. For backflow, it's the observation of whether water backflows into the insufflator.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth for a training set.

In summary, this document is for a traditional medical device accessory (Endo SmartCap™) seeking 510(k) clearance based on substantial equivalence. The "study that proves the device meets the acceptance criteria" in this context refers to engineering performance testing rather than the clinical validation or AI algorithm performance studies typically associated with the detailed questions provided.

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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.

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The EndoSmart Bottle is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

Endo Smart Bottle is designed to be attached to an endoscope, to help supply water, air/CO2. The device consists of a connector cap, a water bottle, a threaded cap, a small tube, and a male luer. The main function of the subject device is -

• . To provide water for rinsing the lens.
• To provide air or CO2 to insufflate the anatomical lumen, to help the end user to see . the inner wall more clearly.

Similar to its predicate device, the subject device is provided sterile to the end user, fabricated from plastics, and elastomers, intended for daily (24 hour) multi-patient use and must be discarded daily. Both the subject device and its predicate device do not come in direct contact with patients.

This document is a 510(k) summary for the Medivators Endo Smart Bottle, an endoscopic irrigation/suction system. It primarily focuses on demonstrating substantial equivalence to a predicate device, the Endo Smart Cap. The document describes the device, its intended use, and non-clinical performance data to support its safety and effectiveness.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum accuracy, sensitivity, or specificity thresholds). Instead, it lists types of performance tests designed to demonstrate equivalence to the predicate device. The "reported device performance" is described qualitatively as having passed these tests, indicating equivalence.

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

The document does not provide details on the specific sample sizes used for each non-clinical performance test (e.g., how many bottles were tested for lens rinsing function). It also does not mention data provenance (country of origin or retrospective/prospective nature) as these are non-clinical engineering and bench tests, not clinical studies involving patient data.

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. The evaluations described are "Design Verification," "Biocompatibility," "Shelf-life validation," and "Sterilization validation," which are engineering and laboratory tests based on established standards and protocols, not expert consensus on medical interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical engineering and laboratory tests, not clinical performance studies requiring adjudication of results.

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

No such study was conducted or is mentioned. This product is a physical medical device (endoscopic irrigation/suction system) and does not involve AI or human "readers" in the context of diagnostic interpretation.

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

This is not applicable. This device is a manual accessory for an endoscope and does not involve algorithms or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance tests would be defined by established engineering and biological standards, specifications, and test methodologies relevant to medical device performance (e.g., maintaining specific flow rates, successfully clearing a lens, demonstrating no cytotoxic effects, maintaining sterile barrier integrity). It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This is not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

This is not applicable, as there is no training set for this device.

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The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

Not Found

This document does not contain the detailed information necessary to complete the request regarding acceptance criteria and a study proving a device meets them. The provided text is a 510(k) clearance letter and summary for the "Endo SmartCap™," which primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance study results or acceptance criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, or details about the ground truth establishment for a test set.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Results from a standalone algorithm performance study.
• Sample size for a training set or ground truth establishment for a training set.

The document primarily states the intended use of the device and its regulatory classification. It lists predicate devices but does not delve into their performance or comparison in detail.

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