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The ENDOCAM Flex HD Controller has been designed for video endoscopy and can be used for both diagnostic and therapeutic interventions. The camera controller has an HDMI output suitable for connecting an image output device (monitor). This product is designed exclusively for use by specialized medical personnel and may only be applied by medically qualified and adequately trained persons.

The 1-chip HD Camera Head 5521902 is used for diagnostic operations in conjunction with ENDOCAM Flex HD Controller 5521101.

This product is designed exclusively for use by specialized medical personnel and may only be applied by medically qualified and adequately trained persons.

The Richard Wolf ENDOCAM® Flex HD Camera System 5521 is an endoscopic camera system for rigid, semi-rigid, and flexible endoscopes.

The camera system consists of:

• . ENDOCAM® Flex HD Controller (5521101)
• 1-Chip ENDOCAM® Flex HD Camera Head (5521902) ●

The ENDOCAM® Flex HD Camera System is used to capture and display still and video images of endoscopic or general surgical applications. Devices are used in conjunction with other ancillary equipment such as endoscopes, light sources, and monitors.

The ENDOCAM® Flex HD Camera System 5521 does not have a graphical user interface (GUI). All available functions are controlled via two buttons on the 1-Chip ENDOCAM® Flex HD Camera Head 5521902.

Devices included in the ENDOCAM® Flex HD Camera System 5521 are reusable and do not require sterilization before use because there is no direct / in-direct patient contact. Methods of cleaning. disinfection, and sterilization are detailed in the Instruction for Use Manual.

The provided document describes a 510(k) premarket notification for the ENDOCAM® Flex HD Camera System 5521, claiming substantial equivalence to predicate devices. As such, the study design focuses on demonstrating equivalence rather than proving the device meets specific acceptance criteria through a comparative clinical study with human readers or standalone AI performance.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a table of acceptance criteria or specific performance metrics in the way one might expect for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly met by demonstrating compliance with safety standards and functional equivalence to predicate devices. The "performance" reported is related to meeting these standards and functional specifications.

• Field of application: Same as predicates.
• Basic Design and Materials: Same/equivalent to predicates.
• Ancillary Equipment Use: Used in conjunction with other video equipment and endoscopic accessories (same as predicates).
• Reusable: Yes (same as predicates).
• Camera Head Features: 1-Chip non-autoclavable Camera Head (same as predicates).
• Bench Testing: Met all requirements and demonstrated substantial equivalence to predicate devices in bench comparison testing. Minor differences in technical specifications (e.g., TV standard, power consumption, weight, dimensions, sensor type, I/O sockets, GUI absence) do not raise new safety or effectiveness issues. |
  | Reprocessing Effectiveness | Cleaning, disinfection, and sterilization methods detailed in the Instruction for Use Manual were developed using standards outlined in ANSI/AAMI ST81: 2004/ (R) 2010 and FDA's Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", issued on: March 17, 2015. (This indicates methods are established and presumably effective for reusability, but specific performance data like log reduction is not provided in this summary). |

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

The document explicitly states: "No comparison of clinical performance data was used for demonstration of substantial equivalence."

Therefore, there is no test set in the context of clinical performance evaluation (e.g., patient images or data used to evaluate diagnostic accuracy). The testing was non-clinical (bench testing) and focused on engineering specifications, safety, and functionality.

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

As there was no clinical test set, there were no experts used to establish ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring ground truth adjudication.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No comparison of clinical performance data was used for demonstration of substantial equivalence." This means there was no study comparing human readers with and without AI assistance, nor any clinical performance study.

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

This refers to a camera system, not an AI algorithm. Therefore, the concept of "standalone performance" in the context of an AI algorithm is not applicable. The device's performance was evaluated through non-clinical bench testing to ensure it met its engineering specifications and was functionally equivalent to predicate devices.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established by engineering specifications, regulatory standards, and the functional characteristics of the predicate devices. The new device's performance was measured against these predefined technical benchmarks and the behavior of the previously approved devices.

8. The Sample Size for the Training Set

This refers to an image acquisition system, not an AI model that requires a training set. Therefore, the concept of a "training set" and its sample size is not applicable here.

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

Not applicable, as there is no training set for this device.

In summary, the provided documentation focuses on demonstrating substantial equivalence through non-clinical (bench) testing, compliance with recognized safety and usability standards, and comparison of technical specifications with legally marketed predicate devices. It does not involve clinical performance studies, AI algorithms, or the extensive data-driven validation typically associated with AI-powered medical devices.

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The ICCD Endocam 5502 is designed for video endoscopy and video microscopy. It can be used for both diagnostic and therapeutic interventions. The Electronic CCD Endoscopes are used for viewing the inside of the patient via natural or surgically created passages.

Indication and Field of Application:
For use in various medical disciplines, such as urology, thorax surgery, gastroenterology, by adequately trained and qualified personnel.

The electronic CCD Endoscope is a combination of an endoscope with integrated objective lense: and CCD camera. The CCD endoscope is connected to the camera controller 5502 via a quick connector with camera cable.

The provided 510(k) summary (K983279) describes a medical device, the 1 CCD Endocam (Models 5502, 4934), which is an endoscopic video camera system. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with acceptance criteria in the way a modern AI/ML device submission would.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

Based on the document, there are no specific quantitative acceptance criteria or detailed device performance metrics reported for this device in the context of diagnostic accuracy or clinical outcomes. The performance data section refers to compliance with safety standards rather than clinical performance.

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

• Test Set Sample Size: Not applicable. The submission explicitly states "No clinical tests performed."
• Data Provenance: Not applicable, as no clinical tests were performed to generate a test set.

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 clinical tests were performed and therefore no ground truth establishment for a test set was required in this submission.

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

• Not applicable, as no clinical tests were performed.

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 video camera system, not an AI-powered diagnostic tool, and the submission explicitly states "No clinical tests performed." Therefore, no assessment of human reader improvement with or without AI assistance was conducted or reported.

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 an imaging acquisition device, not an algorithm, and no clinical performance studies were conducted.

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

• Not applicable, as no clinical tests were performed. The "ground truth" for this submission was primarily related to compliance with electrical and medical device safety standards and demonstration of substantial equivalence to predicate devices based on technological characteristics and intended use.

8. The sample size for the training set

• Not applicable, as this device is a hardware imaging system and does not involve AI/ML requiring a training set.

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

• Not applicable, as no training set was used for this device.

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The 1 CCD Endocam 5502 and 3 CCD Endocam 5507 are designed for video endoscopy and video microscopy and can be used for both diagnostic and therapeutic interventions.

The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current. This permits its use for cardiac visualization procedures when used in conjuction with the proper instrumentation for entry into the cardiac system.

The endoscopic video camera systems include a camera controller and a small camera head which is connected by a camera cable to the controller. Endoscopic procedures are displayed with the objective lenses attached to the camera head and the video monitors connected to the camera controller.

The camera heads are CF Equipment (cardiac floating) according to UL2601-1 / IEC601-1.

This document is a 510(k) summary for the Richard Wolf Medical Instruments Corp. 1 CCD Endocam 5502 and 3 CCD Endocam 5507. It declares substantial equivalence and does not detail a study proving specific acceptance criteria in the manner you've requested for a medical device's performance metrics. Instead, it focuses on general safety and effectiveness through compliance with regulatory standards and comparison to predicate devices.

Therefore, many of the requested fields cannot be directly populated from the provided text. I will explain why each field cannot be filled if the information is missing.

Here's the breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance:

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

The document does not detail specific "test sets" for performance evaluation in the way requested for a clinical or AI-based device study. Instead, it refers to regulatory compliance testing performed by "Independent laboratories." Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

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

This information is not provided. The document describes compliance testing against standards, not a study involving expert-established ground truth for a test set.

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

This information is not applicable and not provided. The document refers to engineering and safety standard compliance testing, not a clinical study with image interpretation requiring adjudication.

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 applicable and not provided. The device is an endoscopic video camera 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 applicable and not provided. The device is hardware (camera system), not an algorithm.

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

The "ground truth" for the device's acceptance is based on adherence to specified international and national electrical and medical device safety standards (e.g., IEC601-1, UL2601-1) and the Medical Device Directive 93/42/EEC, rather than clinical outcomes or expert consensus on diagnostic performance.

8. The sample size for the training set:

This information is not applicable and not provided. The device is a physical camera system, not a machine learning algorithm that requires a training set.

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

This information is not applicable and not provided. As above, no training set for an algorithm is mentioned.

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Endoscopic video camera to transmit an image from an endoscope or arthroscope to a remotely located video monitor

• Power source
• Video board
• Camera head holding video chip
• Camera cable
• 628 lines resolution
• 0.9 lux minimum illumination
• ½" CCD lens
• +6 dB pre-signal conditioning
• Automatic iris 1:16000S
  100 - 240V ± 10% 0 - 440H,

Here's a breakdown of the acceptance criteria and study information for the Corin Endocam & Daycam, based on the provided text.

Note: The provided document is a 510(k) summary from 1996. It details a submission for substantial equivalence, not a robust clinical trial with detailed acceptance criteria and performance metrics as understood in modern medical device submissions for AI or diagnostic devices. Therefore, much of the requested information (like sample sizes, ground truth establishment, expert qualifications, MRMC studies) is not available in this type of document for this era of device approval. The "acceptance criteria" here are essentially the technical specifications that need to be met for substantial equivalence.

1. Table of Acceptance Criteria and 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. This submission relies on technical specifications for substantial equivalence to a legally marketed device, not a test set of data or cases in the way a modern diagnostic or AI device would.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: 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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an endoscopic video camera, and AI assistance was not relevant for its approval in 1996.

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

• Standalone Performance Study: No, a standalone performance study as described (for an algorithm) was not done. This device is a camera, and its performance is measured by its technical output specifications, not an algorithm's diagnostic accuracy.

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

• Type of Ground Truth: Not applicable. The "ground truth" for this substantial equivalence claim is the technical specifications and performance of the predicate device (Dyonics Digital video camera system). The Corin Endocam & Daycam needed to demonstrate that its technical specs and functionality were comparable.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use an algorithm that requires a training set.

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

• How Ground Truth for Training Set was Established: Not applicable.

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