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The MAHE Pediatric Naso-Pharyngoscope is intended for use only by qualified surgeons. Do not use the instrument for any purpose other than its intended application.

The MAHE Pediatric Naso-Pharyngoscope has been designed to be used with a light source, documentation equipment and video monitor for sinuscopy diagnosis and treatment within the nasal cavity and nasal pharynx.

The MAHE Pediatric Naso-Pharyngoscope is indicated for visual exam during diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.

The MAHE International Pediatric NASOPHARYNGOSCOPE is indicated for visual examination during a diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.

The MAHE Pediatric Naso-Pharyngoscope has been designed to be used with a light source, documentation equipment and video monitor for sinuscopy diagnosis and treatment within the nasal cavity and nasal pharynx.

The provided text is a 510(k) summary for the MAHE Pediatric Naso-Pharyngoscope, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than conducting a detailed clinical study with acceptance criteria, ground truth establishment, or specific performance metrics in the way a new diagnostic algorithm might.

Therefore, many of the requested categories are not applicable or not explicitly stated in this type of regulatory submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Study for MAHE Pediatric Naso-Pharyngoscope:

The device's acceptance is based on demonstrating substantial equivalence to a predicate device (KARL STORZ NASOPHARYNGOSCOPE K945381). This means that the new device does not incorporate any significant change in intended use, method of operation, material, or design that could affect safety or effectiveness compared to the predicate. The "study" in this context is the comparison against the predicate device's specifications and the adherence to voluntary safety standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Met by the Study:

The "study" presented is a direct comparison of physical and functional characteristics to a legally marketed predicate device. The implicit acceptance criterion is that the new device's specifications are either identical to, or within a range considered safe and effective compared to, the predicate, without introducing new safety or effectiveness concerns. The provided table demonstrates that for most critical dimensions (e.g., shaft, distal end, depth of view, material), the new device is identical or very similar. While some parameters like "Field of view" and "Bending Section" show differences, the FDA's clearance (K030857) implies these differences were deemed not to affect safety or effectiveness negatively for the stated indications. Adherence to Voluntary Safety Standards IEC 601-1 and IEC 601-2-18 is also stated as an acceptance criterion.

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

• Sample Size for Test Set: Not applicable. This is not a study involving patient data or a test set in the traditional sense of evaluating an algorithm's performance on a dataset. It's a comparison of device specifications.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth for a test set is not established in this type of submission. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

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 device is an instrument, not an AI-powered 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:

• The "ground truth" in 510(k) for devices like this is the established safety and effectiveness of the legally marketed predicate device and adherence to relevant voluntary safety standards (IEC 601-1 and IEC 601-2-18).

8. The sample size for the training set:

• Not applicable. This is not a machine learning or algorithm-based device.

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

• Not applicable.

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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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