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Vesair Cystoscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. Vesair Cystoscopes are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

The Vesair Cystoscopes described in this submission are rigid reusable endoscopes for visualization of the operating site during cystoscopic minimally invasive procedures in conjunction with a commercially available light guide, light source, video camera, monitor, and printer. Light that is created by an external light source is transmitted from the endoscope's light guide connector through the endoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid lens system.

Technical parameters of the Vesair Cystoscopes that characterize the optical view are the Direction of View (0°, 30°, 70°) and the Field of View (105°). The image can be displayed by a camera/monitor system which can be connected to the endoscope eyepiece. The Vesair Cystoscopes have the same diameter (4mm), and are available in different lengths of the insertion tube (0° - 280mm length, 30° - 185mm or 278mm length, 70° - 185mm or 281mm length). None of the cystoscope models have a working channel. Like other currently marketed rigid cystoscopes, all models have patient-contacting outer surfaces mainly made from metal (304 stainless steel) and incorporate fiber optics for light transmission and rigid lenses for image transmission.

Each cystoscope model is provided non-sterile and requires cleaning and steam sterilization prior to use and between subsequent uses.

The provided text describes the Vesair Cystoscopes, which are rigid reusable endoscopes, and details their comparison to predicate and reference devices for a 510(k) submission. However, it does not describe an AI/ML device or a study that establishes ground truth through expert consensus, pathology, or outcomes data, nor does it include information on a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or training set details.

Therefore, most of the requested information regarding AI device acceptance criteria and study details cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and performance testing relevant to an endoscope, not an AI/ML system.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the context of an AI/ML device's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests conducted for a medical device (endoscope) and reports that these tests met the required specifications.

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

• Test set sample size: Not applicable/Not provided. The performance testing described (reprocessing, biocompatibility, safety, shelf-life, optical quality) relates to the physical and functional characteristics of the endoscope, not an AI model evaluated on a data set.
• Data Provenance: Not applicable/Not provided. The tests described are bench tests or laboratory analyses on the device itself, not data derived from patients or clinical sources.

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

• Not applicable/Not provided. Ground truth in the context of expert consensus for AI/ML performance is not relevant to this device's submission which is for an endoscope. The tests performed would have relied on standard testing methodologies and equipment, not clinical experts establishing ground truth for data interpretation.

4. Adjudication method for the test set:

• Not applicable/Not provided. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations to establish ground truth for AI/ML models. This is not relevant to the described device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No, a MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic AI/ML devices in conjunction with human readers, which is not what the Vesair Cystoscopes are.

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

• No, a standalone algorithm performance study was not done. The Vesair Cystoscopes are physical medical devices (endoscopes) and do not involve an algorithm.

7. The type of ground truth used:

• Not applicable/Not provided. The concept of "ground truth" (expert consensus, pathology, outcomes data) as it applies to AI/ML device validation is not relevant here. The "truth" for the performance tests would be established by reference standards, validated methods, and compliance with specifications.

8. The sample size for the training set:

• Not applicable/Not provided. This device is not an AI/ML system and therefore does not have a training set.

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

• Not applicable/Not provided. As there is no AI component, there is no training set or associated ground truth establishment.

In summary, the provided text describes a traditional medical device (cystoscope) submission and its performance testing, which does not involve AI or the associated methodologies for validating AI/ML performance.

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The CystoSure™ Urinary Access System provides catheterization and visualization for the female urinary bladder.

The CystoSure™ rigid metal scope is used to visualize the urinary bladder for diagnostic procedures. The CystoSure™ access catheter accessory provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of the CystoSure™ scope.

The Emmy Medical CystoSure Urinary Access System is intended for use in the diagnostic visualization of the female bladder. The CystoSure cystoscope is a reusable, rod lens optic that can be used with standard O.R. camera couplers and light guides. The length and field of view of the Emmy Medical cystoscope are optimized for inspection of the female bladder. The Emmy Medical cystoscope does not include the traditional outer sheath as those functions are provided by the access catheter accessory.

The CystoSure Access Catheter accessory provides a single use access catheter with four ports: One for bladder drainage, one for bladder irrigation, one for balloon inflation and one for the CystoSure cystoscope. The access catheter encompasses only one balloon size (5 cc) and length (female only) and it does not include any hydrophilic or antimicrobial coatings or features to make it radiopaque.

This document is a 510(k) Premarket Notification for the CystoSure™ Urinary Access System. It does not contain information about an AI-powered device or a study comparing AI with human readers. Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details as these are not relevant to the content provided.

The document focuses on demonstrating substantial equivalence of the CystoSure™ Urinary Access System to legally marketed predicate devices based on design, materials, construction, intended use, and technological characteristics, supported by nonclinical testing, biocompatibility, and sterilization validation.

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Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).

Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. The Stryker Arthroscope is a long tube containing a series of lenses. At the distal end, an objective lens captures the image of the object. Lens along the rod relay the image. At the proximal end, a proximal coupling lens relays the image to a CCD (Camera).

The Stryker Arthroscopes come in various diameters including 1.9mm, 2.7mm, and 4.0mm. Larger size arthroscopes are used for general viewing, while smaller diameter arthroscopes are used for restricted surgical sites. The Stryker Arthroscopes come in several directions of view including, 0°, 30°,45°, 70°. The direction of view enables viewing of different parts. Materials of the Arthroscope include stainless steel, titanium, PEEK, Glass, and Sapphire.

The provided text describes a 510(k) summary for the Stryker Arthroscope, focusing on establishing substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific performance acceptance criteria based on clinical outcomes or diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable or cannot be extracted from this document, as it concerns a medical device (an arthroscope) that's primarily a viewing instrument for internal examination. The "performance testing" mentioned refers to engineering and safety standards, not clinical performance in terms of diagnostic accuracy or reader improvement.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, AUC) or diagnostic accuracy. Instead, it demonstrates compliance with voluntary safety and performance standards and highlights technological characteristics compared to a predicate device.

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

• Sample Size for Test Set: Not applicable. The document discusses performance testing related to engineering standards (biocompatibility, electrical safety, sterilization, optics) and a comparison of technological characteristics to a predicate device. It does not describe a clinical "test set" in the context of diagnostic accuracy or clinical outcomes.
• Data Provenance: Not applicable for clinical performance data. The data presented is from internal engineering tests and a comparison to a predicate device's specifications.

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

• Number of Experts: Not applicable. This type of information is relevant for studies involving human interpretation or clinical judgment. The 510(k) pertains to the physical and functional characteristics of an arthroscope, not its interpretative output.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" of cases requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC study was not done. The device is an arthroscope, a visually guided surgical instrument, not an AI-powered diagnostic or interpretive tool.
• Effect Size of Human Reader Improvement: Not applicable.

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

• Standalone Performance Study: No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The Stryker Arthroscope is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of clinical outcomes or diagnostic accuracy. For the engineering performance tests, the "ground truth" would be defined by the specifications in the relevant ISO and IEC standards (e.g., a material is biocompatible if it passes ISO 10993 tests; an arthroscope meets optical resolution if it conforms to ISO 8600-5). The substantial equivalence claim is based on direct comparison of design and material specifications between the proposed device and the predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Ground Truth for Training Set: Not applicable.

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