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510(k) Data Aggregation
(90 days)
Cadwell Apollo System
The Cadwell Apollo System is indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.
The Cadwell Apollo System (Apollo) is used to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages. The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K180269) with support for Apollo hardware using single or combinations of amplifiers, a photic stimulator, and interfaces with a Cadwell or 3rd party oximeter devices. Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments.
The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML powered device. The document is a 510(k) premarket notification for the Cadwell Apollo System, an electroencephalograph, and focuses on demonstrating substantial equivalence to a predicate device through engineering and software testing for safety and performance against established standards.
Therefore, the requested table and detailed information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML component cannot be extracted from this document. The document describes traditional device testing, not AI/ML model validation.
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(167 days)
Cadwell Apollo System
The Cadwell Apollo System is indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.
The Cadwell Apollo System (Apollo) is used to acquire, record, transmit, and display physiological and environmental data for ambulatory electroencephalograph (EEG) and polysomnography (PSG) and/or clinical studies of patients of all ages.
The Apollo system consists of a Recorder, a 64-channel and/or 32-channel Amplifier, a patient event button, a microphone, and various connecting cables. Optional accessories include the Arc photic stimulator, a video recording camera, and a cart for the equipment. Previously FDA cleared accessories used with the Apollo system consist of various electrodes, leads, and cables.
The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K133355) with support for Apollo hardware using single or combinations of amplifiers, and a photic stimulator.
Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments.
The provided document is a 510(k) summary for the Cadwell Apollo System, an electroencephalograph (EEG) and polysomnograph (PSG) device. It describes the device's indications for use, technological characteristics compared to a predicate device, and nonclinical testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document describes nonclinical testing for various aspects of the device, with the "reported device performance" being that the device conforms to the specified standards and its predetermined specifications.
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Software | • Predetermined specifications for Arc acquisition software (MODERATE level of concern) | Conforms to predetermined specifications and applicable software guidance documents. |
| • FDA guidance: The content of premarket submissions for software contained in medical devices, issued May 11, 2005. | ||
| • FDA guidance: Off-the-shelf software use in medical devices, issued September 09, 1999. | ||
| • FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, issued January 02, 2011. | ||
| • FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, October 02, 2014. | ||
| • IEC 62304: 2006, Medical device software - Software life cycle processes | ||
| Electrical Safety | • IEC 60601-1: 2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. | Conforms to the above standards. |
| • IEC 60601-1-11: 2010, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | ||
| • ISO 15004-2: 2007, Ophthalmic Instruments – Fundamental requirements and test methods – Part 2: Light hazard protection | ||
| Electromagnetic Compatibility | • IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests. | Conforms to the above standard. |
| Performance Testing – Bench | • Internal requirements and predetermined specifications | Conforms to its predetermined specifications and the above standards. |
| • IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs | ||
| • IEC 60601-1-6: 2010, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | ||
| • IEC 62366: 2007, Medical devices – Application of usability engineering to medical devices. |
Study Details
Based on the provided text for K180269, this submission is for a medical device (Cadwell Apollo System) to acquire, record, transmit, and display physiological and environmental data for EEG and PSG studies. The provided document details nonclinical testing to demonstrate substantial equivalence to a predicate device (K133355 Cadwell Flex EEG/PSG), rather than a clinical study evaluating diagnostic performance of an AI algorithm.
Therefore, many of the requested details related to clinical studies, AI algorithms, human readers, and ground truth establishment are not applicable or not provided in this specific 510(k) summary.
Here's an assessment based on the available information:
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Sample size used for the test set and the data provenance:
- The document describes nonclinical testing (software verification/validation, electrical safety, EMC, and bench performance testing). These tests typically involve engineered test cases, simulations, and measurements on the device itself, rather than patient data test sets.
- Not applicable / Not provided in terms of patient data test sets. The tests are focused on hardware and software functionality and compliance with engineering standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Since this is nonclinical testing against engineering standards and predetermined specifications, the concept of "ground truth" derived from expert consensus on patient data (e.g., radiologist reads) does not apply.
- Expertise would be in engineering, quality assurance, and regulatory compliance for medical devices.
- Not applicable.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical interpretation of patient data, which is not the focus of the nonclinical tests described.
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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 study was not done. This 510(k) submission is for an EEG/PSG acquisition and display system, not a device with an AI-driven diagnostic component that assists human readers in interpreting clinical cases.
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If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- No, a standalone AI algorithm performance study was not done. The Cadwell Apollo System, as described, is a hardware system with acquisition software, not a standalone diagnostic AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the nonclinical tests, the "ground truth" consists of the established engineering standards (IEC, ISO, FDA guidance) and the device's predetermined functional and performance specifications. The tests verify that the device's behavior matches these predefined requirements.
- Engineering standards and predetermined product specifications.
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The sample size for the training set:
- This question is only relevant for AI/ML-driven devices that require a training set of data. The Cadwell Apollo System is an acquisition and display system, and while its software was developed, the document does not describe it as an AI/ML device requiring a training set in the conventional sense for diagnostic performance.
- Not applicable.
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How the ground truth for the training set was established:
- Not applicable, as there is no described AI/ML training set in the document.
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