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The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.

The 1688 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.

This document, a 510(k) Summary for the Stryker 1688 4K Camera System with Advanced Imaging Modality (AIM), primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's diagnostic performance against specific clinical acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods is either not explicitly stated or not applicable in the context of this type of regulatory submission.

However, based on the provided text, I can infer and present some of the requested information related to the device's performance data that was provided in support of the substantial equivalence determination.

1. Table of Acceptance Criteria and Reported Device Performance

For regulatory purposes to demonstrate substantial equivalence, the "acceptance criteria" here relate to compliance with recognized standards and successful completion of specified tests.

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

The document does not describe a clinical "test set" in the traditional sense of a study evaluating diagnostic accuracy on patient data. The performance data provided are related to engineering and regulatory compliance testing. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable here.

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

Not applicable. This submission focuses on engineering and safety compliance, not clinical diagnostic accuracy assessed by experts against ground truth.

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

Not applicable. As above, there is no clinical test set requiring expert adjudication 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

No such study is mentioned or implied in this document. The device description explicitly states it is an "endoscopic camera system that produces live video in the surgical field," which implies it is a viewing tool for human users, not an AI-assisted diagnostic device. The "Advanced Imaging Modality" refers to visible and near-infrared imaging for fluorescence and transillumination, not AI.

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

Not applicable. This device is an imaging system intended for human-in-the-loop performance, providing visual information to a surgeon. There is no mention of a standalone algorithm for automated analysis.

7. The type of ground truth used

For the engineering and regulatory compliance tests:

• Electrical Safety, EMC, Software Verification: The "ground truth" is compliance with the specifications and requirements of the cited international standards (IEC, ANSI/AAMI).
• Performance - Bench: The "ground truth" is successful operation according to internal design specifications for CCU Timing and Video Compatibility.

There is no mention of clinical ground truth (e.g., pathology, clinical outcomes) as this submission does not present a clinical performance study.

8. The sample size for the training set

Not applicable. Since there is no mention of an algorithm based on machine learning or AI that would require a "training set," this information is not provided.

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned.

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The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.

The 1688 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.

The provided text describes a 510(k) submission for the Stryker 1688 4K Camera System with Advanced Imaging Modality (AIM). This submission focuses on administrative updates and confirms substantial equivalence to a previously cleared device (K211202).

Based on the provided information, the request for a detailed description of acceptance criteria, study details, and performance for this particular 510(k) submission (K220895) cannot be fully met because the document explicitly states:

"The 510(k) submission was not re-reviewed." (page 0)
"Please note that CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading." (page 1)
"Additionally, the device modifications to the 1688 4K Camera System do not require clinical studies to support the determination of substantial equivalence." (page 7)

Therefore, the provided document does not contain a study explicitly designed to prove that the current modified device (K220895) meets specific acceptance criteria based on human reader performance, ground truth establishment, or clinical effectiveness studies.

The document states that substantial equivalence is based on the previous 1688 4K Camera System (K211202) and that the current submission primarily addresses minor modifications and regulatory updates.

However, I can extract the information that is available about the performance data provided for this submission (K220895), which relates to software verification.

Here's the available information extracted from the provided text, recognizing the limitations mentioned above:

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 a "test set" sample size in the context of clinical or diagnostic performance evaluation, as it explicitly states that clinical studies were not required for this submission. The software verification test would likely involve testing various software modules and functionalities, but sample sizes for such engineering tests are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical or diagnostic performance study requiring expert ground truth establishment was conducted for this specific 510(k) submission.

4. Adjudication method for the test set
Not applicable, as no clinical or diagnostic performance study requiring adjudication was conducted for this specific 510(k) submission.

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 document states that the device modifications did not require clinical studies. Also, the device is an endoscopic camera system, not explicitly an AI-assisted diagnostic tool for interpretation that would typically necessitate an MRMC study comparing human readers with and without AI assistance in this context.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a camera system used by human surgeons for visualization during endoscopic procedures. While it has an "Advanced Imaging Modality," the focus of this submission is on the camera system itself, not a standalone AI algorithm for diagnosis or interpretation. The document explicitly says "clinical studies to support the determination of substantial equivalence" were not required.

7. The type of ground truth used
Not applicable for this submission in the context of clinical performance. The "ground truth" for the software verification would be the expected behavior and outcomes defined by the IEC 62304:2015 standard.

8. The sample size for the training set
Not applicable. The document does not describe the development or training of an AI model that would require a dedicated training set. The referenced "Advanced Imaging Modality" (AIM) is mentioned as part of the camera system but no details regarding specific AI model training are provided in this submission summary.

9. How the ground truth for the training set was established
Not applicable, as no AI model training specific to this submission's evaluation is described.

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The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.

The 1688 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.

The provided document does not contain information about acceptance criteria and a study that proves a device meets acceptance criteria related to performance metrics like accuracy, sensitivity, or specificity for a specific medical condition.

Instead, the document is a 510(k) Premarket Notification from the FDA for a Stryker 1688 4K Camera System with Advanced Imaging Modality. This notification focuses on demonstrating substantial equivalence to a previously cleared predicate device (K211202) for an endoscopic camera system used in various surgical procedures.

The "Performance Data" section (Page 6) describes testing completed to ensure the device meets safety, electromagnetic compatibility, cleaning, disinfection, sterilization, software integrity, usability, and general bench/animal performance standards. These are regulatory compliance tests, not a clinical study to prove the device's diagnostic or therapeutic efficacy against specific performance criteria related to a disease state.

Here's a breakdown of what is provided regarding acceptance criteria (for regulatory compliance) and the "study" (referring to the testing performed):

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• The document does not provide details on specific sample sizes for each test in the "Performance Data" section. It lists the standards followed.
• Data provenance (e.g., country of origin, retrospective/prospective) and clinical test sets are not applicable to the compliance testing described. The "Animal" performance test suggests in vivo testing, but no details on animal models, sample size, or specific outcomes are provided.

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

• This is not applicable as the tests are for regulatory compliance (e.g., electrical safety, software standards, cleaning validation) rather than evaluating performance against a diagnostic 'ground truth' established by experts.

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

• Not applicable for the types of compliance tests listed.

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, an MRMC comparative effectiveness study was not done. The device is an endoscopic camera system, not an AI-assisted diagnostic tool that would typically involve human readers.

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

• Not applicable. The device is a camera system, not an AI algorithm. Its performance is as an imaging tool used by surgeons.

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

• Not applicable. The "ground truth" for these tests are the requirements and specifications outlined in the referenced standards (e.g., electrical safety limits, sterilization efficacy, software bug-free operation).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set for an algorithm.

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

• Not applicable.

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