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Endoscopic Camera System is a camera control unit (CCU) for use with camera heads and video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.

The device consists of a camera control unit (CCU) and a camera head.

The device is intended to be used to connect with an optical endoscope during the endoscopic diagnosis and/or treatment/surgery, and to capture, process and transmit images in the human body cavity under the field of view observed by the endoscope to the monitor.

There are 4 models of the device. The hardware configuration of the device of 4 models are same, and difference is different functions which opened up through software.

The provided FDA 510(k) clearance letter describes an Endoscopic Camera System (K250204) and its substantial equivalence to a predicate device (Image1 SPIES System, K160044). However, it does not provide detailed acceptance criteria or the specific results of a study (e.g., clinical study) that quantitatively proves the device meets strict performance thresholds.

The letter primarily focuses on the device's technical specifications and compliance with non-clinical performance tests relevant to the safety and fundamental function of an endoscopic camera system. It highlights that the device "met all its specifications" and that bench tests demonstrated the device's characteristics have been met, but it does not specify what those specifications or characteristics are in measurable terms related to clinical performance.

Based on the provided text, here's an attempt to answer your questions, highlighting what is available and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The bench test data for the Endoscopic Camera System demonstrates that the design characteristics used as the basis for the comparison have been met. The results show that the subject device has met all its specifications." and "The bench testing performed verified and validated that the Endoscopic Camera System has met all its design specification and is substantially equivalent to the predicate device, Image1 SPIES System."

However, the specific acceptance criteria (measurable thresholds) and the quantitative reported device performance for these specifications are NOT detailed in this public FDA 510(k) clearance letter.

The letter mentions "minor technology differences" in:

• Horizontal resolution
• Spatial frequency response
• Field of view
• Focal length
• Dimensions
• Weight of camera head
• Image delay
• Video output
• USB port of CCU

For these parameters, the letter ambiguously states that these differences "does not raise new issues of safety and effectiveness." It implies that the new device's performance for these characteristics is either equivalent or acceptably different without introducing new risks compared to the predicate, but specific numbers are not provided.

Crucially, the document explicitly states: "The performance validation test report can be provided upon request." This means the detailed quantitative data is part of the full 510(k) submission but not typically released in the public clearance letter.

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

• Sample Size: Not specified in the clearance letter. The testing mentioned (bench testing, software verification) would imply testing of the device units and their software, but the "sample size" in terms of patient data or clinical cases (which is what your question typically refers to for AI/diagnostic devices) is not applicable or not disclosed for this type of device and submission pathway based on the provided text. This device is a general endoscopic camera system, not an AI-powered diagnostic device trained on patient data itself, but rather a visualization tool. Its performance is typically assessed through technical specifications and bench testing for image quality, safety, and functionality.
• Data Provenance: Not applicable in the context of patient data for a clinical test set. The data would originate from the bench tests conducted by the manufacturer.

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

• Not applicable / Not disclosed. For an endoscopic camera system, the "ground truth" for its performance is typically based on objective physical measurements (e.g., resolution charts, light intensity, color accuracy) and engineering test standards, rather than expert human interpretation of medical images for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable / Not disclosed. Adjudication is relevant for studies involving human interpretation or multi-expert review, which is not described for this device's performance validation.

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 an "Endoscopic Camera System" for visualization and documentation. The provided information does not indicate that it includes AI or that an MRMC study was performed. The evaluation focuses on the camera system's fundamental performance characteristics, not its impact on human diagnostic accuracy with or without AI assistance.

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

• Not applicable. This device is a hardware camera system, not an algorithm, and the provided text does not indicate any standalone algorithm performance testing.

7. The Type of Ground Truth Used

• Objective Technical Measurements and Engineering Standards. The "ground truth" for an endoscopic camera system's performance would be established through:
  • Metrological standards: Measuring resolution, contrast, brightness, color accuracy, distortion, etc., using calibrated test targets and equipment.
  • Compliance with industry standards: Such as IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and AAMI TIR 12:2020 (reprocessing).
  • Design specifications: The device is tested against its predefined engineering design specifications to ensure it meets them.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware camera system, not an AI model, so there is no "training set" in the context of machine learning.

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

• Not applicable. As above, there is no "training set" for this device.

In summary, the provided 510(k) clearance letter details a regulatory approval for an endoscopic camera system based on substantial equivalence to a predicate device and compliance with applicable non-clinical safety, EMC, reprocessing, and software verification standards. It emphasizes that the device met its design specifications and passed bench tests, but it does NOT provide the granular quantitative details of "acceptance criteria" or a "study proving it meets those criteria" in the way one would expect for a diagnostic AI device requiring clinical performance validation. The specific numerical performance data would be part of the full 510(k) submission, not typically included in the public clearance letter.

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The Endoscopic Camera MC404/C3 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

The Endoscopic Camera MC404/C3 is a 1-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera MC404/C3 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 25 mm endofocus objective but may also be used with a 16 mm, 30 mmm or zoom (f = 13 to 28 mm) objective. The device is programmable by two head key bottons and offers focusing for both right-handed and left-handed users.

The provided text is a 510(k) summary for the Endoscopic Camera MC404/C3. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with specific acceptance criteria and detailed statistical analysis often seen with novel devices or AI/ML-based products.

Therefore, many of the requested categories for acceptance criteria and study details cannot be fully answered from this document. The document primarily confirms compliance with general safety and performance standards rather than specific clinical performance metrics.

Here's an analysis of what information is available from the provided text:

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)

Not applicable. The "performance data" section refers to compliance with international and European standards for electrical safety, EMC, and general medical device requirements, not a clinical test set with human or patient data.

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 was not a study requiring expert-established ground truth for a test set.

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

Not applicable. This was not a study requiring adjudication of a test set.

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. This is a 2002 submission for an endoscopic camera, not an AI-based device. No MRMC study was performed or mentioned.

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

Not applicable. This is a medical device (endoscopic camera), not an algorithm or AI. Its core function is to provide an image for human interpretation.

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

Not applicable. The performance data relates to compliance with regulatory and safety standards, not diagnostic or clinical accuracy against a ground truth. The substantial equivalence argument relies on the predicate device's established use for "visualization of body cavities," implying that if the new device can also provide adequate visualization, it meets its intended purpose.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the study that proves the device meets the acceptance criteria (based on the provided text):

The "study" in this context is the submission and review process for substantial equivalence to a predicate device, along with verification of adherence to relevant safety and performance standards.

The primary "proof" that the Endoscopic Camera MC404/C3 meets its acceptance criteria (primarily its intended use as a visualization tool for endoscopic procedures) is based on:

• Substantial Equivalence: The device is deemed substantially equivalent to the Karl Storz Endovision XL Endoscopic Camera System (K974391). The submitter argues that both devices serve the same intended use (visualization of body cavities, hollow organs, and canals during endoscopic procedures when attached to standard endoscopes and displaying images on standard video monitors). The differences are noted as "limited to picture quality and handling convenience," implying these differences do not raise new questions of safety or effectiveness.
• Compliance with Standards: The device's performance is demonstrated through its compliance with recognized international and European standards for medical devices, specifically:
  • IEC 601-1 (general medical electrical equipment safety)
  • IEC 601-1-2 (electromagnetic compatibility for medical electrical equipment)
  • EN 55011 (industrial, scientific and medical (ISM) radio-frequency equipment)
  • Medical Device Directive 93/42/EEC (European regulatory compliance)
  • UL2601-1 (Underwriters Laboratories standard for medical electrical equipment, indicated as "will be tested in accordance with").

This type of submission assumes that if the device is substantially equivalent to a legally marketed predicate and meets fundamental safety and performance standards, it is safe and effective for its stated intended use. Specific clinical performance metrics, reader studies, or AI performance validations were not required for this type of device at the time of this 2002 submission.

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The Endoscopic Camera TC804/C4 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

The Endoscopic Camera TC804/C4 is a 3-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera TC804/C4 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 30 mm endofocus objective but may also be used with a 25 mm or zoom objective. The device is programmable by two head key bottons and is equipped with a ring-focus for both right-handed and left-handed users.

The provided text describes a 510(k) summary for the Endoscopic Camera TC804/C4. It outlines the device's intended use and design but does not contain information regarding specific acceptance criteria, performance data from a study, or details about ground truth establishment or sample sizes as would be expected for an AI/ML device.

The section titled "VIII. Performance Data" states: "The Endoscopic Camera TC804/C4 complies with the International Standard IEC 601-1. IEC 601-1-2. the European Standard EN 55011 and conforms to the Medical Device Directive 93/42 EEC. The device will be tested in accordance with UL2601-1." This indicates compliance with general electrical safety and EMC standards, and a plan for UL testing, but not a study evaluating its "performance" in the context of image quality or diagnostic accuracy, which would be relevant for devices that AI/ML systems typically enhance.

Therefore, I cannot populate the requested table and answer many of the questions because the document does not contain the necessary information about acceptance criteria, specific device performance metrics, study design, ground truth, or expert involvement as outlined in the prompt. The device described appears to be a standard endoscopic camera, not one incorporating AI/ML, and its regulatory submission focuses on substantial equivalence to predicate devices based on design and intended use, rather than detailed performance studies against specific acceptance criteria.

Analysis of Provided Information vs. Requested Details:

1. Table of acceptance criteria and reported device performance: Not available. The document only mentions compliance with general medical device standards (IEC, EN, UL). It does not provide specific performance metrics like resolution, sensitivity, specificity, or image quality against defined acceptance criteria.
2. Sample size for test set and data provenance: Not available. No test set or study validating specific performance claims is described.
3. Number of experts and qualifications for ground truth: Not available. No ground truth establishment is described for a performance study.
4. Adjudication method: Not available.
5. MRMC comparative effectiveness study: Not applicable/not available. The document does not describe an AI-assisted device.
6. Standalone performance study: Not available in the context of AI/ML or image quality metrics.
7. Type of ground truth used: Not available.
8. Sample size for training set: Not applicable/not available. No AI/ML model training is mentioned.
9. How ground truth for training set was established: Not applicable/not available.

In summary, the provided 510(k) summary is for a traditional endoscopic camera, and its "Performance Data" section refers to compliance with safety and electrical standards, not to clinical or image quality performance studies that would typically have acceptance criteria, ground truth, and expert evaluation described.

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The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are intended to attach to standard commercially available endoscopes for visualization of body cavities, hollow organs, and canals.

The Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are designed to provide a picture of the surgical field during endoscopic procedures. The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras take the image that would be normally seen by the naked eye, and displays it on a color monitor. The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras provide imaging through standard, commercially available, legally marketed endoscopes.

The Digital RGB and the 3-Chip Digital RGB Endoscopic Cameras both consist of a Camera head, camera control box, and camera cable, camera cable connector soaking cap and coupler accessories. A coupler couples the camera head to the commercially available endoscope.

The provided 510(k) summary for the Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras is a premarket notification for a medical device. These documents primarily focus on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting detailed "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way a clinical trial or performance standard for algorithms would.

In this context, "acceptance criteria" would relate to regulatory compliance and equivalence to predicate devices, and the "study" would be the testing performed to demonstrate that compliance.

Here's an analysis based on the provided text, addressing your points as much as possible within the limitations of a 510(k) summary:

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

The 510(k) summary does not explicitly state acceptance criteria in terms of performance metrics (like sensitivity, specificity, resolution, etc.) for image quality or clinical utility. Instead, the acceptance criteria are implicitly that the device performs similarly to the predicate devices and meets relevant safety and electromagnetic compatibility (EMC) standards.

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

This information is not provided in the 510(k) summary. The "testing" mentioned refers to compliance with electrical safety and EMC standards, not a clinical performance study involving patient data or images. For a device like an endoscopic camera from this era, clinical performance was largely assumed by its equivalence in function and image output to existing devices.

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 applicable and therefore not provided. The testing described (EMC and electrical safety) does not involve clinical "ground truth" established by experts.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies involving interpretation, which is not the type of testing described here.

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 was done. This device is a basic endoscopic camera for direct visualization, not an AI-powered image analysis tool. Therefore, discussions of "improving human readers with AI" are not relevant to this submission.

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

No standalone algorithm performance study was done. This device is hardware for image capture, not an algorithm.

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

No clinical "ground truth" was used. The testing was for compliance with electrical safety and electromagnetic compatibility standards.

8. The sample size for the training set

This information is not applicable and therefore not provided. This device is an imaging hardware component, not an AI algorithm requiring a training set.

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

This information is not applicable and therefore not provided. As per point 8, there is no AI algorithm or training set discussed in this 510(k).

In summary of the 510(k) context:

This 510(k) notification is primarily focused on demonstrating that the new endoscopic camera is substantially equivalent to legally marketed predicate devices. This means showing that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The "performance testing" referred to (EN 55011 & EN 60601-1-2) relates to electrical safety and electromagnetic compatibility, which are standard engineering tests for medical devices, rather than clinical efficacy studies often associated with AI or novel diagnostic tools. Therefore, many of the questions you asked, which are highly relevant for AI/algorithm-based devices, are not applicable to this type of medical device submission.

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