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The intended use for these Semi-Rigid ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures.

ACMI Circon's Semi-Rigid Ureteroscopes are intended for use by qualified physicians to provide access to the urinary tract to perform various diagnostic and therapeutic procedures.

ACMI Circon's Semi-Rigid Ureteroscopes are substantially equivalent to other currently marketed ureteroscopes, referenced above. The Semi-Rigid Ureteroscopes and their predicate device(s) are all telescopes that incorporate fiber optical lenses and working channels within a semirigid shaft. The working channels of the Semi-Rigid Ureteroscopes and predicate device(s) allow the insertion of accessory instrumentation during urinary tract procedures. Both the Semi-Rigid Ureteroscopes and the predicate device(s) may be connected to an external light source to permit better illumination of the bladder surfaces.

The provided text is a 510(k) summary for the ACMI Circon Semi-Rigid Ureteroscopes. This document is a premarket notification to the FDA for a medical device and does not contain a study or data proving the device meets acceptance criteria in the way a clinical trial or performance study would for an AI/ML device.

Instead, the submission focuses on substantial equivalence to a predicate device. This means the manufacturer is asserting their new device is as safe and effective as a device already legally marketed. Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available in this type of document because it is not a performance study report for an AI/ML device.

Here's an assessment based on the available information:

1. Table of acceptance criteria and reported device performance:

   • Not applicable / Not provided. For a 510(k) based on substantial equivalence for a physical medical device like a ureteroscope, "acceptance criteria" are generally related to demonstrating similar technological characteristics, materials, and intended use as the predicate device, rather than performance metrics from a study against specific clinical endpoints. The document explicitly states the device "raise no new issues of safety or effectiveness," which serves as the primary "acceptance criterion" for this type of submission.

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

   • Not applicable / Not provided. No test set or data provenance is mentioned as this is not a study reporting on a specific performance measurement.

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

   • Not applicable / Not provided. No ground truth establishment for a test set is discussed. The device's safety and effectiveness are established by comparison to a predicate device, which itself would have been approved based on similar principles or pre-amendment status.

4. Adjudication method for the test set:

   • Not applicable / Not provided. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is a physical medical device (a ureteroscope), not an AI/ML device. Therefore, no MRMC study or AI-related effectiveness is relevant or discussed.

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

   • Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

   • Not applicable / Not provided. Ground truth, in the context of AI/ML device performance, is not relevant here. The "ground truth" for this submission is the legally marketed status and established safety/effectiveness of the predicate device (an ACMI Circon preamendment ureteroscope from circa 1971).

8. The sample size for the training set:

   • Not applicable / Not provided. This is not an AI/ML device developed using training data.

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

   • Not applicable / Not provided. No training set or ground truth establishment for it is mentioned.

Summary of Device and Approval:

• Device Name: ACMI Circon Semi-Rigid Ureteroscopes
• Intended Use: For use by qualified physicians to provide access to the urinary tract for diagnostic and therapeutic procedures.
• Predicate Device: ACMI Circon preamendment ureteroscope (circa 1971).
• Basis for Approval: Substantial equivalence to the predicate device. The submission asserts that the new ureteroscopes have similar technological characteristics (fiber optical lenses, working channels, semi-rigid shaft, connection to external light source) and intended use, and "raise no new issues of safety or effectiveness" compared to the predicate.
• Regulatory Status: Cleared by the FDA on April 9, 2002 via a 510(k) premarket notification as a Class II device (Endoscope and accessories, 21 CFR §876.1500).

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The DOLPHIN® II Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the DOLPHIN® II Fluid Management System. This type of document primarily addresses the substantial equivalence of a new device to a legally marketed predicate device, rather than providing details of a de novo study proving new acceptance criteria.

Therefore, the input does not contain the information requested in the prompt, such as:

• A table of acceptance criteria and reported device performance.
• Details of a study (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance).
• Information about ground truth (type, establishment).
• Training set details.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the approval is based on equivalence to existing devices, not on a new study that establishes a device's performance against specific acceptance criteria for a novel functionality.

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The intended use for these Ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Circon ™ MR Series Ureteroscopes

I am sorry, but I am unable to answer your request. The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device (Circon™ MR Series Ureteroscopes). This document primarily serves as an approval letter and discusses regulatory aspects.

The text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. These details would typically be found in a separate submission report or technical documentation that supports the 510(k) application, not in the FDA's approval letter itself.

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The intended use for the AUR-735 Flexible Pediatric Cystoureteroscope is to examine the urinary tract of pediatric patients, and with the use of additional accessories, perform various diagnostic and therapeutic procedures on pediatric patients.

USA Series™ AUR™ 735 Flexible Pediatric Cystoureteroscope

The provided text is a 510(k) premarket notification letter from the FDA to Circon Corporation regarding a medical device called the USA Series™ AUR™ 735 Flexible Pediatric Cystoureteroscope. This document confirms the FDA's finding of substantial equivalence for the device and its permitted marketing.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods. The letter is a formal communication of regulatory approval, not a scientific study report.

Therefore, I cannot provide the requested information based solely on the input provided. The requested details would typically be found in the 510(k) submission itself, which is a much more extensive document than this approval letter.

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The CIRCON ACMI USA Series™ APN-2 Flexible Choledochoscope may be used in the biliary tract for diagnostic and therapeutic treatment of ductal stones during laparoscopic cholecystectomy.

Not Found

This document is a 510(k) premarket notification letter from the FDA to Circon Corporation regarding their APN-2™ USA Series™ Flexible Choledochoscope. It is a regulatory approval letter and does not contain information about acceptance criteria or a study proving device performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance, substantial equivalence determination, and general controls, rather than detailed performance data or clinical study results.

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The intended use for this device is for therapeutic and diagnostic procedures in the entire intrarenal collecting system. These devices are marketed as reusable devices. The methods for cleaning, disinfection, and sterilization are presented in "Sterility Information," Section 5 of this document.

Flexible Ureteropyeloscope

I am sorry, but the provided text is a 510(k) premarket notification FDA letter for a medical device (USA Series™ DUR™ - 8 Flexible Ureteropyeloscope). This document determines the substantial equivalence of the device to legally marketed predicate devices.

This type of document does not contain any information regarding:

1. Acceptance criteria and reported device performance.
2. Sample size or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text. This document is a regulatory approval letter, not a study report or a technical performance specification.

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The intended use for the Metal Halide Light Sources is to provide optimized light for viewing procedures carried out with flexible and rigid endoscopes.

Metal Halide Light Sources Models, MV-9088-T and MV-9088

The provided document is a 510(k) premarket notification approval letter for a medical device: "Metal Halide Light Sources Models, MV-9088-T and MV-9088." This letter states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. It is a regulatory approval letter based on substantial equivalence, not a detailed study report.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.

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The intended use for the Circon Lowsley™ Suprapubic Tractor is for conventional Open Perineal Prostatectomy Procedures and for Suprapubic Catheter Placement.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for the Lowsley™ Suprapubic Tractor. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document is a regulatory approval notice, indicating that the device has been deemed substantially equivalent to a predicate device and can therefore be marketed. It does not include technical study details.

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The Circon AEH-4 Electrohydraulic Lithotripter (EHL) Probes are to be used with the Circon AEH-4 Electrohydraulic Lithotripter to fragment stones (calculi) in the urinary and biliary tracts.

Not Found

The provided document is an FDA 510(k) clearance letter for the CIRCON AEH-4 Electrohydraulic Lithotripter Probes. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about the acceptance criteria, study design, or performance data of the device.

Therefore, I cannot provide the requested information. The letter only confirms that the device can be marketed in the US based on its substantial equivalence to previously approved devices, but it does not include details on the specific studies conducted to establish that equivalence or any performance metrics.

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The Circon Endotek OM-4 Urodynamics Monitoring System is indicated for urodynamic diagnostic procedures only. It is to be operated only be qualified physicians or qualified personnel under the direction and supervision of a physician trained in urodynamic monitoring techniques.

The Circon Endotek OM-4 H2O Cystometry Pump is used to pressurize the filling media during water cystometry diagnostic procedures. The device is designed to be used with the Circon Endotek OM-4 Urodynamic Monitoring System.

The Circon Endotek OM-4 H2O Cystometry Pump is a peristallic pump used with the The Olicon Endotek OM-4 Urodynamic Monitoring System for pressurizing the filling media during cystometry measurements.

The provided document is a 510(k) premarket notification for the Circon Endotek OM-4 Cystometry Pump. This type of submission is for establishing substantial equivalence to existing devices, not for demonstrating novel performance or conducting advanced clinical studies. Therefore, many of the requested elements for AI/ML device studies (like MRMC studies, specific performance metrics against an established ground truth, or details on sample sizes for training/test sets for AI models) are not applicable to this 1997 medical device submission.

This document describes a device used for measuring during cystometry, not an AI-powered diagnostic tool. The "performance criteria" described are typically related to the functional specifications and safety of the pump itself, rather than diagnostic accuracy metrics.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present or not applicable for this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of specific numerical performance targets for diagnostic accuracy or device output error rates that would be typical for an AI/ML device.

Instead, the submission focuses on meeting voluntary standards and demonstrating substantial equivalence to predicate devices. The implicit "acceptance criteria" for a 510(k) of this nature are that the device is safe and effective for its intended use and performs comparably to legally marketed predicate devices.

The document states:

• "The OM-4 H₂O Cystometry Pump is designed to meet the following voluntary standards:" (However, the list of those standards is not provided in the excerpt.)

For this type of device, performance would typically relate to its ability to accurately pressurize the filling media, its flow rate, pressure consistency, safety features, and reliability. Specific numerical performance data for these aspects are not included in the provided excerpt.

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

Not Applicable (N/A) / Not Provided. This document describes a new hardware device (a pump) for cystometry, not an AI/ML diagnostic tool that would typically involve a "test set" of patient data in the modern sense. The submission would have involved engineering tests and perhaps a limited clinical evaluation for safety and basic functionality, but not "test sets" for diagnostic performance in the way AI/ML devices do.

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

Not Applicable (N/A). As this is not an AI/ML diagnostic device, there would be no "ground truth for a test set" related to diagnostic outcomes or classifications.

4. Adjudication method for the test set

Not Applicable (N/A). See explanation for question 3.

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. This device is a pump, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted or is applicable.

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

Not Applicable (N/A). This is a hardware pump, not an algorithm.

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

Not Applicable (N/A). No "ground truth" as typically understood for AI/ML diagnostic performance was established for this pump. The device's performance would be evaluated against its technical specifications (e.g., pressure accuracy, flow rate stability) and safety standards.

8. The sample size for the training set

Not Applicable (N/A). This is a hardware device submission, not an AI/ML algorithm requiring a "training set."

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

Not Applicable (N/A). See explanation for question 8.

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