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510(k) Data Aggregation
(293 days)
The Karl Storz AIDA HD Connect is intended for use by qualified personnel in the Doctor's Office, Operating Room and Nurses Station. The Advanced Image and Data Archiving (AIDA) HD Connect is a Windows based archiving and documentation software for still images, video and audio sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation of the surgical procedure in both SD and HD for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis.
The Karl Storz AIDA HD Connect is a Windows based archiving and documentation software. The unit may include a DVD drive or Blu-Ray drive and an optional integrated SmartScreen. The unit has several types of inputs and outputs to accommodate SD and HD still image capture and video recording, audio recording, image and video display, and peripherals.
The Karl Storz AIDA HD Connect is an archiving and documentation software intended for capturing and annotating still images, video, and audio sequences, and patient data during diagnostic or therapeutic procedures. It is explicitly stated that "Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis."
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device meets electrical safety standards. | Electrical safety testing performed in accordance with IEC 60601-1. |
| EMC: Device meets electromagnetic compatibility standards. | EMC testing performed in accordance with IEC 60601-1-2. |
| Performance: Device meets product requirement specifications and is fit for its intended use. | "Performance testing was conducted to verify that the device meets the product requirement specifications and is fit for its intended use." The results demonstrated "that the characteristics of the Karl Storz AIDA HD Connect are substantially equivalent to the predicates in terms of performance." |
| Substantial Equivalence: Differences from predicate device do not raise new issues of safety and effectiveness. | "Design control activities, including risk analysis and verification testing, demonstrate that the differences between AIDA HD Connect and the predicate do not raise any new issues of safety and effectiveness." The device is "substantially equivalent to the unmodified predicate device as it has the same intended use and utilizes the same fundamental scientific technology to perform that intended use." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The provided text does not contain information about a specific test set of medical data (e.g., patient images, videos). The performance testing described refers to verification testing against product requirements and substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic accuracy from a specific dataset.
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 or not provided. Since the device is not intended for primary diagnosis and the testing described focuses on engineering and regulatory compliance (electrical safety, EMC, functional performance), there wouldn't be a need for experts to establish diagnostic ground truth in the context of this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable or not provided for the same reasons as 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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an archiving and documentation system, not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its intended use or regulatory submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A standalone performance study as typically understood for diagnostic AI algorithms was not done. The performance testing focused on verifying the device's technical specifications and its functional equivalence to a predicate device, not on standalone diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The type of "ground truth" for the performance testing described was primarily product requirement specifications and compliance with established engineering and regulatory standards (e.g., IEC 60601-1 for electrical safety). There was no "ground truth" related to medical disease states or patient outcomes, as the device is not for diagnosis.
8. The sample size for the training set:
This information is not applicable or not provided. The device is described as software for archiving and documentation, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable or not provided for the same reasons as point 8.
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