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Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction.

The USA Elite Bipolar Resectoscope consists of a Telescope, Sheath, Bipolar Working Element, and Obturator. The USA Elite Bipolar Resectoscope is designed to work with currently marketed Electrosurgery Systems consisting of a electrosurqical generator called the Controller, a disposable Bipolar Loop, and a reusable or disposable Loop Cable or Cord.

Here's an analysis of the provided text regarding the ACMI Bipolar Resectoscope, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a modification to an existing device, not a de novo clearance or a 510(k) for a completely new device. This means the primary evidence presented is for substantial equivalence to a predicate device, rather than extensive clinical efficacy or performance studies with specific numerical acceptance criteria. Therefore, many of the requested data points (like sample sizes for test/training sets, expert ground truth details, MRMC studies, standalone performance studies with quantitative metrics) are not typically present or required in a 510(k) of this nature and are absent from this document.

The "acceptance criteria" here refer to demonstrating that the modified device remains as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. This 510(k) is for a modification to a mechanical/electrical surgical instrument, not an AI/software device that typically uses "test sets" of data. The "test" here refers to demonstrating safety and performance equivalence through engineering verification and validation, rather than data-driven clinical prediction on a patient cohort. The document emphasizes that the modifications do not significantly affect safety or efficacy, implying internal company testing (e.g., bench testing, biocompatibility for material changes) rather than clinical studies on patient data.

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

• Not Applicable / Not Provided. See point 2. Ground truth in this context would likely refer to engineering specifications or validated performance characteristics rather than expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided. See point 2 and 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not an AI/software device; it's a surgical instrument. An MRMC study is not relevant here.

6. If a Standalone (algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

• Not Applicable (in the context of clinical data/AI). For this device, "ground truth" generally refers to:
  • Engineering Specifications: Design tolerances, material properties, electrical output specifications, etc.
  • Performance Benchmarks: Comparison against the predicate device's known performance characteristics (e.g., cutting efficacy, coagulation properties, structural integrity, electrical safety).
  • Regulatory Standards: Adherence to relevant national and international standards for medical devices.
    The document states the modifications are "not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices," implying that internal testing (bench, possibly animal) was performed to show that the modified device performs comparably to the predicate.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. This is not a machine learning or AI device.

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

• Not Applicable. There is no training set mentioned or implied for this type of device.

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The Olympus working element for probes (e.g. laser fibers), guiding tubes and injection cannula are intended to examine and to perform various diagnostic and therapeutic procedures in the urological tract.

Subject Devices:
Model A2765 Working element, for probes
Model A0561 Guiding tube, for probes, with retractor
Model A0562 Guiding tube, for probes
Model A2891 Injection cannula, 1,2 mm x 420 mm

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Olympus Working Element for Probes.

Crucially, the provided document is a 510(k) summary for a medical device submitted to the FDA. 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than presenting detailed, independent clinical studies with specific acceptance criteria and performance metrics like those for a novel AI device.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, and AI-specific metrics is not available in this type of regulatory document. This summary primarily outlines the device's intended use and lists predicate devices.

Let's break down what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) are stated, nor is there a report of device performance against such criteria.

This document is a 510(k) premarket notification, which establishes substantial equivalence through comparison to legally marketed predicate devices, not through a formal clinical trial with quantitative performance outcomes and pre-defined acceptance criteria. The "performance" demonstrated is implicitly that the device is as safe and effective as the predicate devices.

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

Not applicable. The document does not describe a "test set" in the context of an AI or diagnostic performance study. The 510(k) process relies on equivalence to predicate devices, material safety, and functionality, not a clinical study on a specific test set.

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

Not applicable. There is no mention of a study involving experts to establish ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is more common for evaluating diagnostic devices, especially those incorporating AI, to compare human performance with and without AI assistance. This document is for a medical instrument, not a diagnostic AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical working element for endoscopic procedures, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. As a mechanical device, the "ground truth" concept in the statistical sense for diagnostic or AI performance does not apply. Safety and efficacy are typically established through engineering tests, biocompatibility, sterilization validation, and comparison to predicate devices, not "ground truth" derived from patient data.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, 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, this question is irrelevant.

In summary: The provided 510(k) document is a regulatory submission for a medical instrument. It focuses on demonstrating substantial equivalence to existing devices rather than presenting the results of a clinical study with detailed performance metrics, acceptance criteria, or ground truth establishment, which are typical for diagnostic or AI-powered devices.

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THE INTENDED USE FOR THE RESECTOSCOPE AND WORKING ELEMENTS IS IN UROLOGICAL PROCEDURES TO ENDOSCOPICALLY REMOVE, CUT, COAGULATE, AND OR TRANSECT TISSUE IN THE BLADDER, PROSTRATE, AND URETHRA. THE SURGEON PERFORMS THE EXAMINATION THROUGH THE URETHRA. THE DOCTOR CONTROLS THE BACK AND FORTH MOVEMENT OF THE ELECTRODE USING FINGER CONTROLS. THE WORKING ELEMENTS ALSO HOUSE A CYSTOSCOPE FOR VISALIZATION. THE HIGH FREQUENCY CABLE TRANSMITS ELECTRICAL CURRENT

The Resectoscope is a reuasble non sterile urological instrument used with disposable sterile, single use electrodes for electro-cautery. The sheath and electrodes will be marketed in 24-27 French sizes.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth.

The document describes a 510(k) premarket notification for a medical device called the MAHE Resectoscope. It details:

• Device Description: A reusable, non-sterile urological instrument used with disposable, sterile, single-use electrodes for electro-cautery.
• Intended Use: Endoscopic removal, cutting, coagulation, and/or transection of tissue in the bladder, prostate, and urethra during urological procedures.
• Technological Characteristics: Claims substantial equivalence to a predicate device (Karl Storz and Wolf) based on similar materials, function, indications for use, and overall design.
• Regulatory Information: The FDA's review and determination of substantial equivalence to a legally marketed predicate device, allowing the device to be marketed.

The content focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study with acceptance criteria.

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