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The intended use for Söhniks Endoscopy, Inc.'s Cystoscopes are for examining, diagnosing, visualizing and to aid in treating the interior problems of the urether, prostate, bladder, and other urologic problems. This device is used m a visualization device and can be used in conjunction with other instruments to perform various diagnostic and therapeutic procedures.

The Söhniks Cystoscopes are reusable manually operated surgical devices that are provided in non-sterile and must be cleaned and sterilized by the user prior to use. The parts that contact the body are composed of surgical grade stainless steel, which has a long history of biocompatibility for human use.

Based on the provided text, there is no acceptance criteria and no study that demonstrates the device meets acceptance criteria.

The document is a 510(k) summary for a "Cystoscope," which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. The core of a 510(k) submission is to argue substantial equivalence, not to prove performance against specific acceptance criteria through a clinical study.

Here's why the requested information cannot be extracted from this document:

• Type of Document: This is an FDA 510(k) summary and approval letter. It focuses on regulatory approval based on "substantial equivalence" to existing devices, not on detailed performance studies with acceptance criteria.
• Content: The document describes the device, its intended use, device description, and claims substantial equivalence to predicate devices (e.g., "The basic design, materials and intended uses are the same and the device is constructed with the same materials as a [predicate device name, e.g., K023783], there are no new issues of safety and effectiveness."). It doesn't present data from a clinical trial or performance study against specific, quantified acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions because the provided text does not contain the information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.

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The Sohniks Endoscopy Arthroscopes are intended for use by qualified surgeons during procedures of small and large joints. The intended use for Sohniks Endoscopy, Inc.'s arthroscopes are for examining, diagnosing, visualizing and to aid in treating the interior problems of orthopedic joints, otolaryngology, thinology, endoscopic plastic and reconstructive surgery. Our arthroscopes are intended for use in the shoulder, wrist, knee, ankle, elbow, and jaw and visualization of the hip joint to diagnose disease and removal of loose bodies.

The Söhniks Arthroscopes are reusable manually operated surgical devices that are provided in 0. 30. 45. and 70 degree direction of view. The Arthroscopes are provide non-sterile and must be cleaned and sterilized by the user prior to each use. The components that contact the body are composed of surgical grade stainless steel, which is commonly used in medical devices and has a long history of biocompatibility for human use.

This document is a 510(k) summary for the Sohniks Endoscopy Arthroscope from 2003. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance data on a novel AI-powered device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and AI-specific metrics (like MRMC studies) cannot be extracted from this document.

Here's what can be gathered based on the provided text, and where gaps exist:

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

This document does not specify quantitative acceptance criteria or report specific performance metrics for the Sohniks Arthroscope in the way one would for a new diagnostic or AI-powered device. The submission focuses on demonstrating substantial equivalence.

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

• Sample size: Not applicable/not specified. This document is a 510(k) summary for a manual surgical device (arthroscope), not a data-driven AI device. There is no mention of a "test set" of data in the context of evaluating performance.
• 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. There is no mention of a "test set" or establishing ground truth by experts for the evaluation of this device.

4. Adjudication method for the test set:

• Not applicable. No test set mentioned.

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 not an AI-powered device.

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

• Not applicable. This is a manual surgical device.

7. The type of ground truth used:

• Not applicable. No ground truth is mentioned for the evaluation of this arthroscope. The evaluation relies on demonstrating equivalence to existing, legally marketed arthroscopes.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable.

Summary of Device and Regulatory Context (Based on Document):

• Device: Arthroscope
• Intended Use: Examining, diagnosing, visualizing, and aiding in treating interior problems of orthopedic joints (shoulder, wrist, knee, ankle, elbow, jaw, hip joint visualization for diagnosis and loose body removal), otolaryngology, rhinology, endoscopic plastic and reconstructive surgery. For use by qualified surgeons during procedures of small and large joints.
• Device Description: Reusable, manually operated surgical device available in 0, 30, 45, and 70-degree directions of view. Provided non-sterile, requiring user cleaning and sterilization. Components are surgical grade stainless steel.
• Regulatory Basis: The FDA determined the device is substantially equivalent to predicate devices marketed prior to May 28, 1976. This means the FDA believes the device is as safe and effective as legally marketed devices, and does not require a rigorous performance study with specific acceptance criteria as would be needed for a novel device or an AI/software as a medical device. The focus is on similar design, materials, and intended uses to existing devices, with "no new issues of safety and effectiveness."

In conclusion, this document describes a 510(k) submission for a traditional, manually operated medical device where substantial equivalence to existing devices is the primary criterion for market clearance, rather than a study demonstrating performance against specific acceptance criteria for a novel technology like AI.

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