Search Results

Strauss Surgical Cystoscopes are intended to illuminate and visualize the male urethra, prostate, and bladder for the purpose of performing diagnostic and surgical procedures.

Strauss Surgical Hysteroscopes are intended to illuminate and visualize the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The cystoscopes/hysteroscopes described herein are rigid endoscopes for visualizing the urethra, the urinary bladder or uterus, fallopian tube ostium and the cervical canal during the performance of endoscopic procedures in urology or gynecology.

A rigid endoscope consists of a fiber optic cable and sensitive image transmission system with eyepiece. The fiber optic cable is used to illuminate the site inside the body. The connector for connecting the light guide to the light source is situated at the proximal end of the endoscope. The adapters required to connect the light guide are included in the scope of delivery.

The distal end of the endoscope features an objective lens that captures the image from inside the body. The image is sent through the image transmission system to the eyepiece.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Strauss Surgical Cystoscopes & Hysteroscopes." This type of document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the newly cleared device itself.

Crucially, the document explicitly states under the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section that:

"The subject and predicate devices have identical technological characteristics. Therefore, no performance testing was necessary to demonstrate that the subject device is equivalent to the predicate device in terms of safety and performance."

This means that a study proving the device meets individual acceptance criteria, as typically understood for new device performance validation, was not performed or not deemed necessary by the FDA for this 510(k) clearance due to the identical technological characteristics with a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding specific acceptance criteria and the study that proves the device meets them because the document clearly states such testing was not performed for this clearance.

However, I can still address some of your points based on the information provided, even if it's to state the absence of the requested detail:

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

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 for Test Set: Not applicable, as no performance testing was conducted.
• Data Provenance: Not applicable, as no performance testing was conducted.

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, as no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

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 device is a rigid endoscope for visualization, not an AI-powered diagnostic tool. Furthermore, no performance testing was conducted.

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

• Not applicable. This device is a rigid endoscope, not an algorithm. Furthermore, no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

8. The sample size for the training set

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

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

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

Summary of Document's Key Information regarding Performance:

The FDA clearance for the Strauss Surgical Cystoscopes & Hysteroscopes (K251652) was based on substantial equivalence to existing predicate devices (K150158 Schoelly Cystoscopes/Hysteroscopes and accessories). The manufacturer asserted, and the FDA accepted, that the subject device and the predicate device have identical technological characteristics. Therefore, no new performance testing (non-clinical or clinical) was deemed necessary or performed to demonstrate safety and effectiveness for this specific 510(k) submission. The clearance relies on the established safety and performance of the predicate device.

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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 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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AVETA SYSTEM:
Hysteroscopy:
The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.
Cystoscopy:
The Aveta System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the system allows the user to perform various diagnostic and therapeutic procedures.

AVETA DISPOSABLE HYSTEROSCOPE (Pearl/Opal/Coral):
The Aveta Disposable Hysteroscope (Pearl/Opal/Coral) is intended to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

AVETA DISPOSABLE CYSTOSCOPE (Coral):
The Aveta Disposable Cystoscope (Coral) is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the Cystoscope allows the user to perform various diagnostic and therapeutic procedures.

The Aveta System is an integrated system which allows for visualization of the intended cavity for the purpose of performing diagnostic and operative procedures (hysteroscopy and cystoscopy). The Aveta System consists of the components listed in Table 1. The system includes a Controller with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the cavity. The Controller provides continuous monitoring of the cavity pressure to the set pressure. For hysteroscopy, it also monitors the volume differential between saline inflow from the uterus (fluid deficit). The Controller connects to a sterile, single use disposable Scope (available in various configurations, see below) that allows visualization of the cavity and displays the images obtained from the Scope on a standard monitor. For operative hysteroscopy procedures, the Aveta System includes sterile, mechanical Disposable Resecting Device (available in various configurations, see below) powered by an integrated motor in the device handset or by use of an external Resecting Handset (available in two configurations, as a disposable device or a reusable device). The resecting device is inserted through the working channel of the sterile hysteroscope to resect the target tissue/pathology. For cystoscopy, when combined with accessory instruments the cystoscope is used for diagnostic and therapeutic procedures.

The provided document is a 510(k) Premarket Notification for the Meditrina Aveta System. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch in the same way a PMA (Premarket Approval) would. As such, the information provided focuses on comparative performance and engineering tests, rather than clinical efficacy studies with specific acceptance criteria related to disease detection or treatment outcomes.

Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 as it pertains to acceptance criteria for algorithmic performance, sample sizes for test sets, expert-established ground truth, MRMC studies, or multi-reader studies. The "performance data" section (Section VII) lists various engineering and bench tests, but these are not for the purpose of demonstrating diagnostic or clinical performance in a "study" as implied by the request.

The "study that proves the device meets the acceptance criteria" in this context refers to the bench and engineering tests conducted to demonstrate that the modified Aveta System performs equivalently to its predicate and meets safety standards.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria and reported device performance in the sense of accuracy metrics (e.g., sensitivity, specificity) for a diagnostic AI/ML device. The "performance data" section lists types of tests performed (e.g., "Pressure accuracy and control," "Optical testing," "Motor/Oscillation speed"), but it does not specify the numerical acceptance criteria for these tests nor the exact quantitative results achieved by the device against those criteria. It only states that the tests were performed "per approved test protocols."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information about sample sizes for a clinical "test set" or data provenance (country, retrospective/prospective) is provided. The performance data listed (Section VII) refers to engineering and bench tests on the device's components and system function (e.g., integrity, dimensional inspection, functional testing). These are not data sets for an AI/ML algorithm.

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 provided. The study is a 510(k) submission, focused on engineering and functional equivalence rather than clinical diagnostic performance that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/not provided. No clinical test set requiring adjudication is 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:
No MRMC study or any study involving human readers with or without AI assistance is mentioned. The device described appears to be an endoscopic system, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/not provided. The device is a physical system for visualization and surgical procedures, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable/not provided. The "ground truth" in this context would be the design specifications and functional requirements met by the engineering tests, not a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set:
Not applicable/not provided. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable/not provided. This device is not an AI/ML algorithm that requires a training set with established ground truth.

In summary, the provided document details a 510(k) submission for a medical device (Aveta System, a hysteroscope/cystoscope system). It focuses on demonstrating substantial equivalence to a predicate device through engineering and bench testing, rather than reporting on the performance of an AI/ML model for diagnostic purposes as implied by the structure of your questions.

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The Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.

The Hystero-V hysteroscope is a handheld, battery operated portable hysteroscope consisting of a sterile, single-use cannula and a reusable handle with an LCD touchscreen monitor. It is intended to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and endometrial tissue sample (biopsy) in an outpatient or office setting. The disposable cannula has a light source and camera at the distal end that are used for visualization and to capture image and video of the diagnostic area. The image and video signals are transferred electronically from the cannula to the monitor on the handle via an electrical connection so that the physician can view the anatomy during the procedure. The cannula also has a fluid channel that can infuse fluids during the procedure or evacuate tissue. The fully assembled Hystero-V hysteroscope has an overall length of 465 mm (18.3 inches); the working length of the disposable cannula component is 254 mm (10 inches). When assembled, the Hystero-V hysteroscope weighs 0.5 pounds. The materials used in construction of the cannula-stainless steel, nylon, and polycarbonate-contact tissue for less than 24 hours. The device has been tested for biocompatibility and was shown to be biocompatible. The handle does not contact the patient.

The provided text describes a 510(k) premarket notification for the Hystero-V Hysteroscope, asserting its substantial equivalence to a predicate device. The information details various non-clinical performance tests but explicitly states that no clinical or animal testing was necessary or performed. Therefore, the following response will be based on the non-clinical testing reported.

Here's an analysis of the acceptance criteria and the study (non-clinical testing) proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each individual test. The context implies that the testing was performed on a sample of the Hystero-V Hysteroscope devices/components as part of the validation process.
• Data Provenance: The data comes from bench tests and engineering evaluations performed by the manufacturer, Hysterovue, Inc. It is therefore prospective in nature, as it was conducted specifically for this submission. The origin is implied to be within the company's testing facilities, likely in the US (Bellevue, WA). For biocompatibility, data was leveraged from a previously cleared device (K17500).

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

• Number of Experts: Not applicable. The ground truth for these non-clinical tests is established by objective engineering standards (e.g., ISO, IEC) and the device's own specifications. These are not subjective interpretations requiring expert consensus.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The testing would have been conducted by engineers and technicians with expertise in medical device testing, regulatory compliance, and relevant standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. These were objective pass/fail tests against predefined standards and specifications, not subjective assessments requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was explicitly stated as not necessary and not performed.

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

• Standalone Performance: Not applicable in the context of an AI algorithm. This device is a hardware hysteroscope. The software component described is for controlling the device and displaying images, not for AI-powered diagnostics or analysis.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical tests, the ground truth was established by:
  • International Standards: ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-18 (thermal safety), ISO 8600-5 (image quality), ISO 8600-3 (field of view/direction of viewing).
  • Device Specifications: The manufacturer's internal product specifications for mechanical integrity (bending, torque, pull tests) and functional performance (no leaks in working channel, image quality).
  • Predicate Device Data: For biocompatibility, the ground truth was largely established by the prior clearance of the Uro-V cystoscope (K17500), which used identical materials, manufacturing, and sterilization.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set." The software mentioned is an operating system/control software, not an AI algorithm.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm. The software functionality was verified and validated against its design requirements and specifications, which are based on standard software engineering practices and the functional needs of the hysteroscope.

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