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The CST-2000A and Slide-On® EndoSheath® System provides for endoscopic access and examination of the lower urinary tract including the bladder, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The CST-2000A and Slide-On® EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures.

Note: The CST-2000A and Slide-On Endosheath System is not indicated for electrosurgical procedures.

The device system described in this 510(k) consists of a flexible, fiberoptic endoscope and sterile, single use protective sheath. This 510(k) adds a hysteroscopy indication to the currently marketed VSI Cystoscope with EndoSheath® System.

The provided text describes the 510(k) submission for the "Vision-Sciences Flexible Cystoscope with EndoSheath® System" with an added hysteroscopy indication. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.

The document focuses on substantiating equivalence to predicate devices and lists the types of tests performed. It does not present quantitative acceptance criteria or detailed performance metrics in the way a clinical study or detailed technical report would.

Here's an analysis of the provided information in the context of your request:

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

This information is not present in the provided document in a detailed, quantitative table format. The document generically states that "Substantial equivalence for scope and sheath for hysteroscopy indications was based on design characteristics, comparison to legally marketed predicate devices, and performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing."

It implies that the device met the necessary performance standards for these tests to be deemed substantially equivalent, but it does not specify what those standards (acceptance criteria) were or the exact numerical results (reported device performance).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document mentions "performance testing" but does not detail the sample sizes for these tests, nor does it specify the provenance of any data (e.g., whether it involved human subjects, animal models, or purely bench testing, or its geographical origin or retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable or not provided. The described tests are primarily engineering performance tests (e.g., sheath burst, tensile, articulation, image quality, cycle testing) rather than clinical studies requiring expert interpretation of diagnostic results. Therefore, there's no mention of experts establishing a "ground truth" for a test set in the sense you're asking.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable or not provided. Adjudication methods are typically used in clinical studies where multiple experts evaluate ambiguous cases. The described tests are performance tests of the device itself, not evaluations of diagnostic accuracy by human readers.

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

This information is not applicable. This submission is for a flexible endoscope system, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

This information is not applicable. As stated above, this is not an AI algorithm.

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

This information is not applicable in the context of diagnostic accuracy. For the described engineering performance tests, the "ground truth" would be the engineering specifications and established test methods themselves (e.g., a burst test must withstand X pressure, a tensile test must withstand Y force).

8. The sample size for the training set

This information is not applicable. This is not an AI or machine learning device requiring a training set.

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

This information is not applicable. This is not an AI or machine learning device.

Summary of what the document does provide regarding safety and performance:

• Basis for Substantial Equivalence: Design characteristics, comparison to predicate devices (K040215, K053560, K891451), and performance testing.
• Types of Performance Testing:
  • Sheath burst/leak testing
  • Sheath tensile/elongation testing
  • Sheathed scope articulation testing
  • Sheathed scope image quality evaluation
  • Scope cycle testing

The document concludes that "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed scope and sheath system has been shown to be safe and effective for its intended use." This statement implies that the device met the acceptance criteria for these tests, but the specific criteria and results are not detailed.

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