Search Results

This product shall be used in conjunction with the Endoscopic Video Image Processor and other peripheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney.

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

This product shall not be used for other purposes.

The Single-Use Video Flexible Cysto-Nephroscope mainly consist of insertion portion, handle and connector section which include a detachable video cable which connect the endoscope to the Endoscopic Video Image Processor.

The provided FDA 510(k) clearance letter and summary describe a physical medical device (Single-Use Video Flexible Cysto-Nephroscope), not an AI/ML-driven software device. Therefore, the information requested about acceptance criteria and studies (especially those related to AI performance, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable to this document.

The document discusses the substantial equivalence of the new device to a predicate device based on non-clinical performance testing of the physical properties and functionality of the endoscope itself. There is no mention of any AI component or software that processes images or provides diagnostic assistance.

Here's a breakdown of what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The proposed device has met the testing acceptance criteria in accordance with internal requirements and applicable standards to support substantial equivalence of the proposed device." However, it does not provide a specific table listing detailed acceptance criteria and the corresponding reported performance values for each physical test. It only lists the types of tests performed.

• Sterilization Validation:
  • Acceptance Criteria: Determined by ISO 11135:2014 half-cycle method to establish routine control and monitoring parameters.
  • Reported Performance: Method validated. (Specific parameters not provided).
• Shelf Life and Simulated Transportation Distribution followed by Sterile Packaging Integrity Test:
  • Acceptance Criteria: Validated according to ASTM F1980-21, ISO11607-1:2019, ISO11607-2:2019, ASTM F1929-23, ASTM F88/F88M-23, ASTM F1886/F1886M-16, ASTM D4169-23.
  • Reported Performance: Validated. (Specific results not provided).
• Performance Testing (using methods and acceptance criteria from K241500):
  • Surface and Edges:
    • Acceptance Criteria: Not specified but refers to previous submission K241500.
    • Reported Performance: Met testing acceptance criteria.
  • Deflection system and Fatigue test of Rocker and Bending Section: (Note: Downward deflection angle changed from 135° to 225° for all models).
    • Acceptance Criteria: Not specified but refers to previous submission K241500.
    • Reported Performance: Met testing acceptance criteria.

Information Not Applicable to this Device/Document (for AI/ML products):

The following points are typically relevant for AI/ML device submissions but are not found in this document because it pertains to a physical, non-AI medical instrument.

• Sample sized used for the test set and the data provenance: Not applicable. Evaluation was based on physical device testing, not a dataset.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI algorithm.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Study Type:

The study described is a non-clinical performance testing study for a physical medical device (endoscope), designed to demonstrate substantial equivalence to a previously cleared predicate device. It involves component and system-level testing of physical characteristics, sterilization, packaging integrity, and functionality based on established industry standards and previous submission's methodologies. There is no AI or software performance evaluation in this clearance.

Ask a specific question about this device

The Endoscopic Video Image Processor is used in conjunction with the Single-Use Video Flexible Cysto-Nephroscope (Models: RP-U-C01F, RP-U-C01FS) to process the images collected by the video endoscope and send them to the display, and provide power for the endoscope.

The Endoscopic Video Image Processor is a video processing system intended for use during endoscopic procedures. It receives and processes image signals from a compatible video endoscope and produces live video images during endoscopic procedures. Apart from the image processing functions, it also provides the power supply for the endoscope.

The Endoscopic Video Image Processor is a reusable device. It does not require sterilization before use, as there is no direct/indirect patient contact. The device needs to be cleaned and disinfected before use. and the cleaning and disinfection method is outlined in the Instructions for Use.

The provided text describes the Endoscopic Video Image Processor (RP-IPD-V1000F) as a video processing system for endoscopic procedures. It details its functions, such as processing image signals from compatible video endoscopes, producing live video images, and providing power to the endoscope. The document specifies that the device does not require sterilization as there is no direct/indirect patient contact but needs cleaning and disinfection before use.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail thresholds alongside "reported device performance" in a quantitative manner as typically expected. Instead, it lists general performance characteristics that were tested and states that the "Performance Testing demonstrated that the subject device and the predicate device have similar performance, and the subject device is as safe and effective as the predicate device."

Here's a reconstruction based on the available information:

The standards referenced are:

• ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices. General requirements
• ISO 8600-3:2019 Endoscopes. Medical endoscopes and endotherapy devices. Part 3: Determination of field of view and direction of view of endoscopes with optics

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

The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "the Cysto-Nephroscope System" as the subject of testing.

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

The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth. The testing appears to be primarily technical performance testing against ISO standards rather than a clinical evaluation requiring expert interpretation of medical images.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Given that the testing appears to be technical performance testing of the device's imaging capabilities, a traditional adjudication method for medical image interpretation would likely not be applicable.

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

The document explicitly states "IX. Clinical Evidence N/A." This indicates that no human factors or comparative effectiveness study involving human readers with and without AI assistance was conducted or provided for this submission. The device is an image processor, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was done in the form of "non-clinical performance testing." This testing evaluated the device's technical specifications and imaging capabilities (e.g., resolution, signal-to-noise ratio, color performance, image frame frequency, system delay) against relevant ISO standards. This is considered standalone performance as it assesses the device's intrinsic functional properties independent of human interaction or a clinical scenario.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance testing was based on technical specifications and compliance with international standards (ISO 8600-1:2015 and ISO 8600-3:2019), rather than expert consensus on medical findings, pathology, or outcomes data, as this device primarily processes images.

8. Sample Size for the Training Set

The document does not mention a training set. This is expected as the device described is an "Endoscopic Video Image Processor" and is not presented as an AI/ML-driven diagnostic algorithm that would typically require a training set. It processes existing video signals rather than performing analysis for diagnostic insights.

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

Since there is no mention of a training set, this information is not applicable.

Ask a specific question about this 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, 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.

Ask a specific question about this device

Endoscopic Video Image Processor

This device is used in conjunction with the video endoscopes produced by our company to process the images collected by the video endoscopes and send them to the display, and provide power for the endoscope.

Single-Use Video Flexible Cysto-Nephroscope

This product shall be used in conjunction with the Endoscopic Video Image Processor and other peripheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney. The device is suitable for professional healthcare facility environments such as hospitals and clinics.

This product shall not be used for other purposes.

The proposed device, Cysto-Nephroscope System, which includes a Single-Use Video Flexible Cysto-Nephroscope and an Endoscopic Video Image Processor is intended for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney.

The Single-Use Video Flexible Cysto-Nephroscope is available in two models with the different position of "U" and "D" mark on the handle and different deflection, RP-U-C01F, RP-U-C01F5. The Endoscopic Video Image Processor has only one model, RP-IPD-V2000EF.

The Single-Use Video Flexible Cysto-Nephroscope is sterile and single-patient-use device. The Endoscopic Video Image Processor is nonsterile and multi-patient-use device, and it will be cleaned and disinfected before first use and after each use.

The provided text describes a 510(k) premarket notification for an Endoscopic Video Image Processor and Single-Use Video Flexible Cysto-Nephroscope. The document focuses on demonstrating substantial equivalence to a predicate device through performance testing. However, it does not contain specific acceptance criteria, numerical performance metrics for the device against these criteria, or a detailed study description with sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot provide the detailed table and study information you've requested from the provided text. The document states that the system "complies with the standard requirements" of ISO 8600 and IEC 62471:2006, and that optical and mechanical performance is "similar as those of the predicate device," but it does not quantify these compliance levels or similarities.

Below is what can be extracted or inferred based on the provided text, highlighting the absence of the specific data you requested.

Absence of Detailed Acceptance Criteria and Device Performance:

The document broadly states that the device was evaluated for performance but does not provide a table specifying predefined acceptance criteria (e.g., minimum resolution, specific signal-to-noise ratio values) and the corresponding reported device performance values. It generally concludes that the device "complies with the standard requirements" (e.g., ISO 8600, IEC 62471:2006) and that its performance is "similar as those of the predicate device," but no quantitative data to support these statements is present.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes used for any of the performance tests (e.g., number of instruments tested, number of images/frames evaluated). The data provenance is not explicitly stated beyond the company being Guangzhou Red Pine Medical Instrument Co., Ltd. from China. It is not specified if the tests involved retrospective or prospective data.

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

The document does not mention the use of experts to establish ground truth for the test set, nor does it specify their number or qualifications. The performance evaluation seems to be based on instrumental measurements and comparisons to a predicate device, rather than expert interpretation of images.

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

No adjudication method is mentioned, as there is no indication of expert review or consensus building for ground truth.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned. The document primarily focuses on technical performance characteristics of the device itself and comparison to a predicate device, not on human reader performance with or without AI assistance. The device described (Endoscopic Video Image Processor and Cysto-Nephroscope) is an imaging system, not an AI-driven diagnostic aid that assists human readers.

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

This point is not applicable as the device is an imaging system and not an AI algorithm.

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

The document does not describe the establishment of a "ground truth" in the diagnostic sense (e.g., expert consensus for disease presence or absence, pathological confirmation). Instead, the "ground truth" for these engineering and performance tests would largely be the established specifications within the relevant ISO and IEC standards, and the performance characteristics of the predicate device for comparative testing.

8. The sample size for the training set

This is not applicable, as the document describes an endoscopic imaging system, not an AI algorithm that requires a training set.

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

This is not applicable, as there is no training set for an AI algorithm.

Ask a specific question about this device

Ask a specific question about this device

Endoscopic Video Image Processor: This device is used in conjunction with the video endoscopes produced by our company to process the images collected by the video endoscopes and send them to the display, and provide power for the endoscope.
Single-Use Video Gastroscope: This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of upper digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use in adults.
Single-Use Video Colonoscope: This product is used in conjunction with Endoscopic Video Image Processor and other peripheral equipment for the observation, diagnosis, photography and treatment of lower digestive tract. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product is designed for use in adults.

The proposed device, Digestive Endoscopy System, which includes a Single-Use Video Gastroscope and Single-Use Video Colonoscope, and Endoscopic Video Image Processor is intended for observation, diagnosis, photography and treatment of the upper and lower gastrointestinal tract.
The Single-Use Video Gastroscope is available in two models with different length of image processor connection section, RP-Gl-G02A, RP-Gl-G02B. The Single-Use Video Colonoscope is available in two models with different length of image processor connection section and different diameters, RP-GI-C02B. The Endoscopic Video Image Processor is available in four models with disk space, RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D.
The Single-Use Video Gastrocope and Single-Use Video Colonoscope are sterile and single-patient-use device. The Endoscopic Video lmage Processor is non-sterile and multi-patient-use device, and it will be cleaned and disinfected before first use.

The provided text is a 510(k) summary for an Endoscopic Video Image Processor, Single-Use Video Gastroscope, and Single-Use Video Colonoscope. It does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/human performance study. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and comparison testing.

Therefore, for aspects like acceptance criteria for AI algorithms, sample size for test sets (in an AI context), expert details, adjudication methods, MRMC studies, standalone AI performance, and AI training set details, the information is not available in the provided text.

Based on the provided document, here's what can be extracted regarding performance testing, which is primarily focused on the device's functionality and image quality as an endoscopy system, rather than an AI component:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance values for an AI component. Instead, it describes various performance tests conducted. The implicit acceptance criterion for these tests is that the proposed device performs comparably to or meets the standards of the predicate device or relevant ISO standards.

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

This information is not available in the provided text. The "test set" in the context of this document refers to the physical devices (Endoscopic Video Image Processor, Single-Use Video Gastroscope, Single-Use Video Colonoscope) subjected to performance tests, not a dataset for an AI algorithm.

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

This information is not available in the provided text. The studies described are non-clinical engineering and performance tests, not clinical studies requiring expert ground truth for interpretation of medical images.

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

This information is not available in the provided text. Adjudication methods are typically employed in clinical image interpretation studies, which this document does not describe.

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

This information is not available in the provided text. The device described is an endoscope system, not an AI-assisted diagnostic tool.

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

This information is not available in the provided text. There is no mention of an algorithm or AI functionality in this submission.

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

This information is not available in the provided text. The "ground truth" for the non-clinical performance tests would be established by engineering specifications, calibration standards, and comparison with the predicate device.

8. The sample size for the training set

This information is not available in the provided text. The document does not describe an AI training set.

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

This information is not available in the provided text. The document does not describe an AI training set.

Ask a specific question about this device

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.

Ask a specific question about this device

The device has been developed to be used with endoscopic accessories such as a biopsy forceps and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.

The Single-Use Video Flexible Ureterorenoscope System consists of a sterile Single-Use Video Flexible Ureterorenoscope (consists of handle and insertion portion) and an Endoscopic Video Image Processor (the video system, touch PC ) with its accessories power adapter, footswitch.The Ureterorenoscope is provided sterile (sterilized by EO) and intended to be single-use.The video system is powered by the main line.

The handle includes a deflection lever, a lever lock, and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion portion contains one working channel and wiring to transmit the image signals to the Video Image Processor. The distal bending section of the insertion portion controlled by the user via the deflection lever on the handle. The distal end of the insertion portion contains a CMOS sensor for capturing image and transmitting it to the Video Image Processor, LEDs for illumination, and the distal opening of the working channel. The video cable connects the endoscope handle to the Video Image Processor, which provides power and processes video signals from the endoscope.

Flexible Ureterorenoscope has the following physical and performance characteristics:

• Flexible insertion portion
• Camera and LED light source at the distal tip

The provided text describes a submission for a Single-Use Video Flexible Ureterorenoscope System seeking 510(k) clearance.

However, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does NOT present acceptance criteria or a study proving the device meets specific performance criteria through a clinical or performance study in the way typically seen for AI/ML devices or novel diagnostic tools.

Instead, the submission details a comparison of the subject device's technological characteristics to a legally marketed predicate device and summarizes various engineering and bench tests, along with biocompatibility and sterilization validations, to show that the new device performs similarly and is safe and effective for its intended use.

Therefore, many of the requested sections regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies are not applicable to the information provided in the given text.

Based on the provided text, here is what can be inferred:

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

The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) with numerical targets. Instead, it indicates that the device's characteristics and performance were evaluated against established specifications and recognized standards, and compared to a predicate device.

Ask a specific question about this device