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Like the predicate devices, the BAHO autoclavable Cystoscope is indicated for use in the visual examination of body cavities, hollow organs and canals and using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Description

The BAHO autoclavable Cystoscope has a basic design similar to those legally available for sale in the U.S.A. Like others legally sold in the U.S.A.,it consists of an evepiece.body and insertion tube. The insertion tube is double walled surgical steel with illumination fibers in between. The insertion tube contains the optical rod lens system. ( identical to BAHO autoclavable Laparoscope 510(k) Number K982276 )

AI/ML Overview

The provided text describes a 510(k) submission for a medical device (BAHO Autoclavable Cystoscope) and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data and acceptance criteria from a study.

Therefore, many of the requested data points (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not available in the provided text, as they are not typically part of a 510(k) submission that relies on demonstrating equivalence through material and design similarity to already approved devices.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

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

Acceptance Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Design Equivalence	Basic design similar to legally available devices in the U.S.A. (eyepiece, body, insertion tube, double-walled surgical steel with illumination fibers, optical rod lens system).	"The BAHO autoclavable Cystoscope has a basic design similar to those legally available for sale in the U.S.A. Like others legally sold in the U.S.A., it consists of an eyepiece, body and insertion tube. The insertion tube is double walled surgical steel with illumination fibers in between. The insertion tube contains the optical rod lens system." (identical to K982276)
Material Equivalence	Selection of materials demonstrating appropriate levels of biocompatibility, similar or identical to predicate devices and other approved BAHO endoscopes.	"The biological safety of the BAHO autoclavable Cystoscope has been defined through the selection of materials that demonstrated appropriate levels of biocompatibility which constitute the building blocks of the proposed device. These materials are similar or identical to those used for the manufacturing of the predicate devices as well as other brands legally sold in the U.S.A. and other approved BAHO endoscopes (Arthroscope, Laparoscope)"
Functional Equivalence	Biocompatibility, function, indications, and designs developed to ensure safety and substantial equivalence to commercially approved cystoscopes.	"In summary : biocompatibility, function, indications and designs have been developed to ensure the safety of this device. It is substantially equivalent to commercially approved cystoscopes available for sale in the U.S.A."
Indication for Use	Indicated for visual examination of body cavities, hollow organs, and performing diagnostic/therapeutic procedures with accessories.	"Like the predicate devices the BAHO autoclavable Cystoscope is indicated for use in the visual examination of body cavities, hollow organs and using additional accessories, to perform various diagnostic and therapeutic procedures."

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

Sample Size: Not applicable/Not provided. The submission relies on claiming substantial equivalence based on material and design similarity to existing predicate devices, not on a new testing study with a "test set" in the context of performance metrics for an AI/diagnostic device.
Data Provenance: Not applicable/Not provided.

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

Not applicable/Not provided. No dedicated "test set" requiring expert-established ground truth is mentioned. The submission is about device design and materials.

4. Adjudication method for the test set

Not applicable/Not provided.

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/Not provided. This is not a diagnostic device involving human readers or AI assistance.

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

Not applicable/Not provided. This is a physical, optical medical device, not an algorithm.

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

Not applicable/Not provided. The "ground truth" for this submission is the established safety and efficacy of the predicate devices and the biocompatibility of the materials used in the new device, rather than diagnostic accuracy.

8. The sample size for the training set

Not applicable/Not provided. This device does not involve machine learning or a "training set."

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

Not applicable/Not provided.

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