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The SPY Cystoscopes/Hysteroscopes are intended to provide visualization in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

The SPY Cystoscope/Hysteroscope is part of Stryker's rigid endoscope product portfolio. The SPY Cystoscope/Hysteroscope is an optical instrument used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Cystoscope/Hysteroscope transmits light in the visible spectrum to illuminate the anatomy, then forms and relays the image of the surgical site to a camera system for image processing and display.

Based on the provided FDA 510(k) clearance letter for the SPY Cystoscope/Hysteroscope (K252012), here's a description of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) clearance letter, which summarizes the information submitted by the manufacturer. It does not contain the full details of the testing performed. Therefore, some of the requested information (especially regarding specific test methodologies, exact sample sizes for training/test sets, expert qualifications, and ground truth establishment details) is not explicitly stated in this summary. I will highlight what is present and what is inferred based on standard regulatory practices for this type of device.

Study Proving Device Meets Acceptance Criteria

The study performed to demonstrate the device meets acceptance criteria was a non-clinical performance and safety evaluation, primarily involving bench testing. This approach is common for optical, non-diagnostic devices like endoscopes, where functionality can be objectively measured. The submission explicitly states, "The subject device does not require clinical studies to support the determination of substantial equivalence."

1. Table of Acceptance Criteria and Reported Device Performance

The letter outlines the types of non-clinical tests performed, implying these are the areas for which performance criteria were established. While the letter doesn't provide specific numerical acceptance thresholds or the exact measured values, it states that the testing "demonstrates the device conforms with design input requirements, user needs and intended uses."

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of devices tested) for the non-clinical bench tests. For most bench testing, typically a representative sample or a statistically significant number of production units are tested to ensure consistency and meet specifications.
• Data Provenance: This was non-clinical bench testing, not human data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply to the primary performance testing.

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

• Not Applicable: Since this device is an optical instrument for visualization (not an AI/diagnostic algorithm interpreting images), and the testing was non-clinical bench testing, "experts" in the sense of clinical reviewers establishing ground truth for a test set (e.g., radiologists reading images) were not involved in the direct performance evaluation of the device's optical properties. The "ground truth" for these tests would be the established engineering and optical performance specifications.

4. Adjudication Method for the Test Set

• Not Applicable: Given that the performance evaluation was based on objective, quantitative bench testing (e.g., measuring MTF, FOV, transmission), there was no need for human adjudication of test results in the way one would adjudicate case labels for diagnostic AI. The results are based on instrumental measurements compared against specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No: The document explicitly states: "The subject device does not require clinical studies to support the determination of substantial equivalence." An MRMC study is a clinical study involving human readers. Therefore, no MRMC study was performed or required for this 510(k) clearance.
• Effect Size: Not applicable as no MRMC study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable: This device is a physical optical instrument (cystoscope/hysteroscope), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" does not apply. Its performance is its ability to transmit light and form an image according to specifications, which was evaluated via bench testing.

7. The Type of Ground Truth Used

• Engineering/Optical Specifications: The ground truth for this device's performance evaluation was established through pre-defined engineering and optical specifications (design input requirements) that the device must meet (e.g., a specific MTF value, a defined FOV range, acceptable levels of distortion, etc.). These specifications are typically derived from industry standards, predicate device performance, and user needs.

8. The Sample Size for the Training Set

• Not Applicable: This is a hardware device; thus, it does not have a "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering, prototyping, and iterative testing, not through training on data.

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

• Not Applicable: As there is no "training set," this question is not relevant for this device. Ground truth for hardware development is established through engineering design principles, materials science, and manufacturing tolerances.

Summary of Approach:

The clearance for the SPY Cystoscope/Hysteroscope relied on a "Comparison to Predicate" approach, underpinned by extensive non-clinical bench testing to demonstrate that the new device's different technological characteristics (specifically smaller outer diameter and increased field-of-view) "do not raise different questions of safety or effectiveness" compared to the predicate devices. The safety and effectiveness were established by confirming the device met its design specifications for various optical and mechanical parameters.

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The resectoscope system devices are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and gynecological electrosurgical procedures.

The Resectoscope System from RZ Medizintechnik GmbH consists of a working element, a shaft and an electrode. The Resectoscope System is used during endoscopic surgery in the fields of urology and gynecology with an optical system for visualization. The electrode is inserted into the shaft for use and the shaft is connected to the working element.

The working element and shaft are supplied non-sterile, are intended for multiple use and must be sterilized before each use according to the instructions for use. The electrodes are supplied sterile and are intended for single use only.

To use the Resectoscope System, the electrosurgical unit, pump and light source must be connected to the working element via appropriate connections such as cables, tubing and light guide cables. These components are not part of this 510(K).

The provided FDA 510(k) Clearance Letter for the RZ Resectoscope System (K243382) details the process of demonstrating substantial equivalence to a predicate device. However, it does not include information about a study proving the device meets specific acceptance criteria in the context of an AI-powered medical device or a device that relies on complex data-driven performance metrics for its primary function.

The RZ Resectoscope System is a traditional medical device (surgical tools – resectoscope, electrodes, sheaths, obturators) and its clearance is based on substantial equivalence to a predicate device (Henke-Sass Wolf Resection Instruments K173070) regarding its design, materials, intended use, and technological characteristics. The performance testing described is primarily bench testing to verify physical properties, functionality, and manufacturing quality, not a study involving AI assessment, human expert reads, or clinical outcomes data for a diagnostic/interpretive purpose.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of AI or advanced diagnostic studies, as the provided document does not contain any such details. The product is a physical surgical instrument, not an AI/software-as-a-medical-device.

However, I can extract the "acceptance criteria" and "device performance" as understood within the context of this traditional medical device 510(k) submission:

Acceptance Criteria and Device Performance (in the context of a traditional medical device 510(k) focusing on substantial equivalence):

For traditional medical devices seeking 510(k) clearance, "acceptance criteria" are typically met by demonstrating that the device is as safe and effective as a legally marketed predicate device. This is primarily achieved through comparative analysis of technological characteristics and non-clinical performance (bench) testing that confirms the device performs as intended and is safe for its stated Indications for Use.

Here's how the provided document addresses these concepts:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (for bench testing): The document states "all the products tested have passed the respective tests" for bench tests. It does not specify the sample size for these bench tests (e.g., how many units were visually inspected, leak tested, or subjected to mechanical force testing).
• Data Provenance: The RZ Medizintechnik GmbH is based in Tuttlingen, Germany. The tests conducted would presumably be internal company tests or performed by contracted labs, likely in Germany or Europe. The data is retrospective in the sense that it was generated prior to submission for clearance.

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

• This question is not applicable as this is a physical medical device clearance, not an AI/diagnostic device. There's no "ground truth" derived from expert reads of images or clinical data in the same way an AI device would require. Performance is established through engineering and physical property testing.

4. Adjudication Method for the Test Set

• Not applicable for the same reason as above. There are no "readers" or "adjudication" in the context of testing a surgical instrument's physical properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging or diagnostic AI devices to assess the impact of AI assistance on human reader performance. The RZ Resectoscope System is a surgical instrument.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This concept is only applicable to software algorithms. The RZ Resectoscope System is a physical device.

7. Type of Ground Truth Used

• Not applicable in the context of AI/diagnostic devices. For this traditional medical device, "ground truth" equates to established engineering specifications, material properties, functional requirements, and safety standards (e.g., does it leak? Does it withstand mechanical force? Is it biocompatible? Is it sterilizable?). These are verified through various bench tests and adherence to recognized standards.

8. Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.

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

• Not applicable. As above, no training set or AI model is involved.

In summary, the FDA 510(k) clearance for the RZ Resectoscope System is based on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics, materials, and comprehensive non-clinical (bench) testing, rather than studies involving clinical data, human reader performance, or AI algorithms.

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The SeleneView® (model: HC29, HC29-G, HC35, HC35-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures.

The SeleneView® (model: HO35, HO35-G, HO42, HO42-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures.

SeleneView® is intended for use in professional healthcare facility environments such as hospitals and clinics. SeleneView® is designed for use in adults.

SeleneView® Single-Use Digital Hysteroscope consists of a handle, insertion and endoscope cable. SeleneView® is provided sterile (sterilized by ethylene oxide [EO]) and intended to be single-use.

The built-in light emitting diode (LED) at the distal tip of SeleneView® Single-Use Digital Hysteroscope provides a light source, the lens module captures the light signal, then the complementary metal-oxide-semiconductor (CMOS) image module converts the light signal into an electrical signal; the endoscope cable connects SeleneView® Video Processor, which provides power and processes video signal from the endoscope.

The SeleneView® is intended to be used combined with ViewHub® Video Processor to perform its intended function and the ViewHub® has been 510(k) cleared in K233779.

SeleneView® Single-Use Digital Hysteroscope has the following physical and performance characteristics:

• Camera and LED light source at the distal tip

• Sterilized by Ethylene Oxide

• For single-use

This FDA 510(k) summary describes the "SeleneView® Single-Use Digital Hysteroscope" and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI-powered diagnostic device.

The document focuses on non-clinical tests demonstrating the device's technical performance, sterility, biocompatibility, and electrical safety, comparing these aspects to a predicate hysteroscope. It explicitly states in section {6} related to non-clinical tests that "It is concluded form the nonclinical tests that the subject devices are as safe, as effective, and perform as well as the legally marketed predicate device identified above to support a substantial equivalence determination." This implies that the device is being cleared based on its equivalence in fundamental operating principles and safety features, not on the performance of a diagnostic algorithm meeting specific acceptance criteria for a clinical outcome.

Therefore, I cannot provide the requested table and information as it is not present in the provided text. The document does not describe an AI component or a study with clinical endpoints that would involve ground truth, expert adjudication, or sample sizes for AI model testing.

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Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

The device is suitable for professional healthcare facility environments such as hospitals and clinics.

The subject device, Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

The device is suitable for professional healthcare facility environments such as hospitals and clinics.

The subject device consists of an endoscope (a hysteroscope) which includes an insertion portion and handle, and the following accessories: 2 pieces of two-way valves and 1 piece of silicone cap.

The provided document, K241987, describes a 510(k) premarket notification for a medical device and does not contain information about acceptance criteria and a study that proves the device meets those criteria from an AI/algorithm performance perspective.

The document is a K241987 submission for a Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101). This device is a traditional medical instrument used for viewing the cervical canal and uterine cavity. It is not an AI/algorithm-based device.

Therefore, many of the requested fields related to AI/algorithm performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

The "Performance" section within the document refers to non-clinical performance testing of the physical device, such as mechanical, optical, and biocompatibility tests, not an algorithm's performance.

Here's a breakdown of the information that is available in the document, framed against your request:

Acceptance Criteria and Device Performance for Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)

As this is a physical medical device (a hysteroscope) and not an AI or algorithm, the acceptance criteria and performance data relate to its physical and functional attributes. The document states that "Verification testing including performance testing using previously submitted methods and acceptance criteria cleared under K232003... were conducted to evaluate the modifications. The subject device passed all the testing in accordance with internal requirements and applicable standards."

Due to the nature of the device, many of the requested fields are not relevant.

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

The document lists performance tests conducted but does not explicitly detail the quantitative acceptance criteria or the specific reported device performance values beyond stating that the "subject device passed all the testing." The acceptance criteria are implicitly those established for the predicate device (K232003) and internal requirements/applicable standards.

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

• Sample Size: Not specified for individual performance tests. The testing refers to "subject device" and implies a representative number of units were tested.
• Data Provenance: Not specified. Testing was conducted internally by Guangzhou Red Pine Medical Instrument Co., Ltd.

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)

• Not applicable. This relates to human expert review for AI/algorithm performance. The device is a physical hysteroscope. The "truth" for physical performance tests (e.g., leakage, dimensions, biocompatibility) is determined by objective measurements against established standards, not expert consensus on medical images or diagnoses.

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

• Not applicable. See point 3.

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 a physical medical device, not an AI system. No MRMC study was conducted.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• For Biocompatibility: "Ground truth" is established by adherence to recognized international standards (e.g., ISO 10993 series, USP ) and observable biological responses in tests.
• For Mechanical/Optical Performance: "Ground truth" is based on engineer specifications, physical measurements, and conformity to applicable industry standards (e.g., ISO 80369-7:2021).
• For Sterilization/Shelf Life: "Ground truth" is based on validated methods (e.g., ISO 11135:2014) demonstrating sterility assurance levels and packaging integrity per standards (e.g., ISO 11607).

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it's not an AI/algorithm-based device.

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

• Not applicable. See point 8.

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HTx Disposable Hysteroscope System is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
Note: Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves a method of surgery.

The HTx Disposable Hysteroscope System is a single use hysteroscope endoscope intended for gynecology procedure applications. It includes a single-use, disposable hysteroscope cannula (HTx40 or HTx60), a reusable imaging system (HTx1000/Htx2000), and optional accessories (medical keyboard, barcode reader and IV pole mounting rack). The disposable hysteroscope contains a miniature CMOS camera, a light-emitting diode (LED) illumination module, and channels for fluid in/out flow as well as for instrument insertion. HTx60 has a cannula outer diameter of 6.2 mm and adapts to tools up to 3 mm (9 Fr), while HTx40 has an outer diameter of 4.5 mm and adapts to tools up to 5 Fr. The cannula connects directly to the image processor via an image cable. The image processor processes the raw image signal from the cannula and outputs the video on a display for real-time visualization. The image processor includes input/output ports for interfacing with different peripherals such as a keyboard or a USB flash disk. Fluid irrigation is achieved through a tube which is connected to an IV bag and pressured via peristaltic pump (not included in the subject device). The fluid inflow channel shares the same with the working channel.

The provided text is a 510(k) Premarket Notification for a general medical device (HTx Disposable Hysteroscope System), not an AI/ML-driven device. Therefore, the document does not contain the specific information required to describe acceptance criteria and associated studies for AI/ML performance, such as:

• A table of acceptance criteria and reported device performance for AI metrics (e.g., sensitivity, specificity, AUC). The document focuses on general device performance characteristics.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for ground truth.
• MRMC comparative effectiveness study, effect size.
• Standalone (algorithm only) performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily addresses the substantial equivalence of a new version of a hysteroscope system (HTx2000 image processor) to a previously cleared predicate device (HTx1000). The "non-clinical performance testing" section on page 12 refers to:

• Bench-top tests: Color performance (spectrophotometer measurements, working distance, color contrast enhancement) for the HTx2000.
• Basic electrical safety: IEC 60601-1:2005+AMD1:2012.
• Electromagnetic compatibility (EMC): IEC 60601-1-2:2020.
• Software testing: Validated as "Basic Documentation Level" according to FDA guidance (which is about software documentation for any medical device with software, not specific to AI/ML performance).
• Battery safety: IEC 62133-2:2017/AMD1:2021 and UN38.3.

These tests are standard for general medical device clearance and do not involve the specific types of performance studies or acceptance criteria associated with AI/ML functionality (e.g., diagnostic accuracy, clinical classification, or segmentation performance).

In conclusion, based on the provided text, it is not possible to describe the acceptance criteria and study proving device performance in the context of an AI/ML device, as the submission does not pertain to such a device.

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The Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. The devices is suitable for professional healthcare facility environments such as hospitals and clinics.

The Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity and it is provided sterile (sterilized by EO) and intended for single use only. The Single-Use Video Hysteroscope is composed of a handle part, including the video cable interface, working channel port and instrument channel port, and an insertion portion, of which a camera module and LED light source are integrated inside the distal tip. There are two models of The Single-Use Video Hysteroscope, RP-G-C24 and RP-G-C0101. The model RP-G-C24 is identical to RP-G-C0101 except for the direction of view, width size of insertion port and width size of instrument channel. The principle of optical imaging: the light source illuminates the inspected site of the patient, which is imaged by the photosensitive surface of CMOS camera module. The optical signal received by the CMOS sensor is converted into electrical signal after processing. The electrical signal is then transmitted by the cable to the signal processing chip embedded on the Endoscopic Video Image Processor where it is restored after processing and finally displayed on the screen of Endoscopic Video Image Processor.

The FDA 510(k) summary provided does not describe an AI/ML-based device, but rather a Single-Use Video Hysteroscope. Therefore, the acceptance criteria and study detailed in the document pertain to the safety and performance of this medical device, not an AI/ML algorithm.

The request asks for information relevant to an AI/ML device, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), sample size for test sets (distinguishing between training and test sets), expert adjudication, multi-reader multi-case studies, and ground truth establishment using pathology or outcomes data. These concepts are not applicable to the evaluation of the hysteroscope as described in the document.

The document discusses performance data related to:

• Biocompatibility (cytotoxicity, skin sensitization, intracutaneous test, acute systemic toxicity)
• Electrical Safety and Electromagnetic Compatibility
• Photobiological safety
• Sterilization Validation
• Shelf Life and Sterile Barrier System (Packaging)
• Bench Performance Data for optical (Direction of view, Resolution, Depth of Field, Field of view, Geometric Distortion, Signal-To-Noise Ratio, Dynamic Range, Image Intensity Uniformity (IIU), Color Performance, Surface Safety) and mechanical properties (Basic Size, Water Supply System, Sealing Performance, Tensile strength).

Therefore, I cannot provide the requested information in the format of AI/ML device evaluation criteria based on the provided text. The document confirms that clinical evidence and animal studies were not applicable for this device submission (Sections VIII.A and IX).

If the intent was to understand the regulatory submission for the RP-G-C24, RP-G-C0101 Single-Use Video Hysteroscope, the relevant acceptance criteria and studies would be derived from the non-clinical performance testing summarized in Section VIII. These are performance metrics for a physical device, not an AI algorithm.

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The SPY Cystoscopes/Hysteroscopes are intended to provide visualization in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

The SPY Cystoscope/Hysteroscope is part of Stryker's rigid endoscope product portfolio. The SPY Cystoscope/Hysteroscope is an optical instrument used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Cystoscope/Hysteroscope transmits light in the visible spectrum to illuminate the anatomy, then forms and relays the image of the surgical site to a camera system for image processing and display.

The provided text describes a 510(k) premarket notification for the Stryker Endoscopy SPY Cystoscope/Hysteroscope. It focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study proving specific clinical performance metrics with a test set, ground truth, or human reader involvement for an AI/ML device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device with details like sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this document.

This document details:

• Device Type: A traditional medical device (optical instrument for visualization in surgery), not explicitly an AI/ML powered device.
• Regulatory Pathway: 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to an existing legally marketed predicate device.
• Performance Testing: Primarily non-clinical bench testing and compliance with recognized voluntary consensus standards.

Here's a breakdown of what is provided, framed as closely as possible to your request, but highlighting the absence of AI/ML specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests and their "Pass" results, indicating that the device met the criteria set by the respective standards or comparative testing. The acceptance criteria themselves are implicitly defined by compliance with these standards (e.g., "In accordance with FDA-recognized voluntary consensus standard IEC 60601-1:2020").

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical testing of a physical medical device, not a performance study on a test set of data (e.g., images for an AI algorithm).

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 an AI/ML algorithm is not relevant to the described testing.

4. Adjudication method (e.g., 2+1, 3+1, none) 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. The device is a direct visualization tool, not an AI-assisted diagnostic or interpretative system for human readers.

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 (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is compliance with established engineering and safety standards, and equivalence to a predicate device's performance.

8. The sample size for the training set: Not applicable. The device does not involve a training set as it's not an AI/ML product.

9. How the ground truth for the training set was established: Not applicable.

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The Caldera Medical BenestaTM Tissue Removal Device is intrauterine use by trained surgeons to hysteroscopically resect and remove tissue, such as: submucous myomas, endometrial polyps, and retained products of conception.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Benesta™ Tissue Removal Device), which confirms substantial equivalence to a predicate device. However, it does not include details about acceptance criteria, specific device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies. Therefore, I cannot generate the table or answer the specific questions regarding the device's technical validation.

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The HOPKINS Telescopes when used with sheaths are intended to be used to permit viewing of the cervical and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 12° and 30° direction of view, 2mm, 2.9mm, 4mm diameter and 26cm, 30cm, 36cm working lengths.

The provided text is a 510(k) Summary for the HOPKINS Telescopes, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria for a novel AI/software component.

Therefore, the provided document does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/software performance.

The document states:

• "Clinical studies were not required to demonstrate substantial equivalence to the predicate device." (Page 9)
• "The conclusions drawn from the nonclinical test demonstrate that the subject device is as safe and effective as the predicate device to support a substantial equivalence determination." (Page 9)

This means the submission relies on bench testing and comparison of technological characteristics to a legally marketed predicate device, not on a clinical performance study with defined acceptance criteria and human readers (or AI algorithms) in the way your prompt describes.

To directly answer your questions based only on the provided text, the answer is that this information is not present for the HOPKINS Telescopes device.

If this were an AI/software device and the information was present, here's how I would answer each point:

1. Table of acceptance criteria and reported device performance: This would be a table detailing metrics like sensitivity, specificity, AUC, or agreement rates, with specific target thresholds (acceptance criteria) and the actual performance achieved in the study.
2. Sample size and data provenance: This would specify the number of cases/patients in the test set (distinct from training data), whether the data was collected retrospectively or prospectively, and from which countries or institutions.
3. Number of experts and qualifications: This would state how many experts (e.g., radiologists, pathologists) were involved in establishing ground truth and their relevant experience (e.g., board-certified, years of experience, subspecialty).
4. Adjudication method: This would describe how discordant readings or interpretations among experts were resolved (e.g., 2+1 means two initial readers, with a third if they disagree; 3+1 means three initial readers, with a fourth for adjudication if necessary).
5. Multi-reader multi-case (MRMC) comparative effectiveness study: If conducted, this would provide details on how the AI system impacted human reader performance, including statistical metrics like the effect size (e.g., mean increase in AUC, sensitivity, or specificity when AI assistance was used compared to no AI assistance).
6. Standalone performance: This would report the performance of the algorithm itself, without any human interaction, against the ground truth.
7. Type of ground truth: This would specify the reference standard used (e.g., expert consensus, pathology results, follow-up clinical outcomes, surgical findings).
8. Sample size for training set: This would state the number of unique cases/patients used to train the AI model.
9. Ground truth for training set: This would explain the methodology used to label or establish the ground truth for the data utilized during the training phase of the algorithm.

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