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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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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.

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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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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The Apollo System is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.

The Apollo System is designed to aid a physician in the removal of tissue and/or fluids during image-guided neurosurgery. The reusable components have three functions; vacuum generation, generation of vibrational energy, and saline irrigation. The disposable component, the Wand is a rigid cannula to remove tissue and/or fluid with the assistance of vibrational energy and aspiration. The disposable wand is designed to be image-guided, such as passing through the working channel of various neuro-endoscope trocars, allowing visualization of the procedure. To aid in tissue and/or fluid removal, the Apollo Generator provides the saline irrigation and vibrational energy to the Wand to ensure the Wand does not become clogged. Aspiration of the tissue and/or fluid is performed by the Apollo Vacuum Pump. Any tissue and/or fluid removed is collected in the Apollo Collection Canister. Activation of saline infusion and vibrational energy is controlled by the Apollo Foot Switch.

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device conformance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document is a 510(k) premarket notification decision letter from the FDA for the Apollo™ System. It primarily focuses on:

• Regulatory classification and history: K152699, Class II, Neurological Endoscope (Product Code GWG).
• Indications for Use: Controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.
• Predicate devices: K132931 (Apollo™ System) and K990572 (SONOTOME™ System).
• Device description and comparison to predicates: Outlines operating principles, system console, amplitude and frequency of vibration, irrigation flow rate, aspiration, and disposables.
• Non-clinical data summary: States a literature review was conducted to substantiate safe and effective performance and substantial equivalence, along with the appropriateness of the revised indication for use and labeling.
• Summary of Substantial Equivalence: Concludes the device has a similar safety and effectiveness profile to predicate devices.

The document does not contain details about specific performance metrics, clinical trials, or validation studies using specific datasets that would include the information you've requested.

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The Apollo™ System is used for the controlled aspiration of tissue and/or fluids during surgery of the Ventricular System. The Apollo™ disposable wand is inserted through the working channel of a neuroendoscopic trocar.

The Apollo System is a two component surgical instrument designed to aid a physician in the removal of tissue and/or fluids during endoscopic-assisted microneurosurgery. The reusable component has three functions. These functions are vacuum generation, generation of vibrational energy, and saline irrigation. The disposable component, "the Wand" is a rigid cannula to remove tissue and/or fluid with the assistance of vibrational energy and aspiration. The disposable wand is designed to pass through the working channel of various neuro-endoscope trocars allowing visualization of the procedure. The method of action of removal is first vacuum aspiration, which draws the tissue and/or fluid into the lumen of the wand. Next, a vibrational wire is agitated inside the lumen of the wand facilitating movement of any tissue and/or fluid that may otherwise clog the lumen. Saline irrigation has the purpose of providing additional fluid to transport the tissue through the cannula. The irrigation and inner vibration wire components of the disposable wand provide an improvement over existing methods of suction aspiration through a cannula in that the use of the Apollo wand can prevent clogging. Intended users for this device are physicians who have received appropriate training in endoscopicassisted microneurosurgery.

The information provided describes the Penumbra Apollo™ System, a surgical instrument for tissue and fluid removal during endoscopic-assisted microneurosurgery. The study presented focuses on non-clinical testing to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithms requiring ground truth established by experts.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents two main categories of testing: Biocompatibility and Bench-Top Testing (Design Verification). The acceptance criteria are implicitly defined by meeting established requirements and standards, and the reported performance confirms these criteria were met.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample sizes for each specific test in the biocompatibility or bench-top testing. For biocompatibility, it mentions "sample extracts," "animals," and "test article clotting times," implying plural samples were tested for each. For bench-top, it states "All testing was performed using units which were 2x sterilized." While not a precise number, this indicates multiple devices were tested after being subjected to sterilization.
• Data Provenance: The studies were conducted internally by Penumbra Inc. or by contract ISO certified facilities (for sterilization). The data is non-clinical and derived from laboratory and bench-top testing, not human patient data. Therefore, there is no country of origin for patient data or retrospective/prospective classification in the usual sense.

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

This information is not applicable to this submission. The document describes non-clinical engineering and biological testing, not a study evaluating human performance with the device or an AI algorithm requiring expert-established ground truth. The "ground truth" for these tests is based on established scientific and engineering standards (e.g., ISO 10993, IEC 60601-1, tensile strength specifications, corrosion standards).

4. Adjudication Method for the Test Set:

This information is not applicable. Since the 'test set' refers to physical devices and materials undergoing objective laboratory and bench-top measurements and observations against predefined standards, there is no need for expert adjudication in the manner of medical image interpretation or clinical outcomes. The results are quantitative measurements or qualitative observations against scientific criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, Effect Size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The submission describes the Penumbra Apollo™ System, which is a physical surgical instrument. It is not an Artificial Intelligence (AI) device, nor does the document describe any AI-assisted components or a study involving human readers with or without AI assistance.

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

This is not applicable. As stated above, the Penumbra Apollo™ System is a physical surgical instrument and not an AI algorithm. Therefore, no standalone algorithm performance study was described or performed.

7. The type of ground truth used:

The ground truth used for these tests is based on established scientific and engineering standards and specifications.

• For Biocompatibility, the ground truth refers to whether the device meets the biological safety requirements outlined in ISO 10993-1 guidelines, with conclusions drawn from standard biological assays (e.g., cytotoxic, pyrogenicity, hemolytic effects).
• For Bench-Top Testing, the ground truth refers to whether the physical and mechanical properties of the device meet predefined engineering specifications and comply with relevant standards (e.g., IEC 60601-1, tensile strength limits, corrosion resistance).
• For Sterilization, the ground truth is achieving a Sterility Assurance Level (SAL) of 10-6, validated according to EN ISO 11135.
• For Shelf-Life, the ground truth is the maintenance of device properties over a specified period, verified through accelerated and real-time aging studies against finished goods release requirements.

8. The Sample Size for the Training Set:

This information is not applicable. This is not a machine learning or AI device that requires a distinct "training set." The device development followed traditional engineering design and testing methodologies.

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

This information is not applicable for the same reason as point 8.

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