(281 days)
The Aliya System is indicated for the surgical ablation of soft tissue.
The Aliva System is designed to ablate soft tissue through the delivery of pulsed electric fields (PEF) energy to target tissue. The high frequency, short duration energy delivered to the target tissue to induce programmed cell death (apoptosis) while maintaining the cellular matrix.
The Aliya System consists of an Aliya Generator, an Aliya Ablation Device and a cardiac monitor.
Generator: The Aliya Generator is a transportable non-sterile electrical device compatible for use in the operating room environment. It consists of hardware, software, a display touch screen user interface, a power supply cord and a foot switch. It features controls to initiate and stop treatment as well as indicators to monitor the treatment and provide alerts to the user.
The Aliya Generator creates high frequency short duration energy, which is delivered to the target tissue via the Aliya Ablation Device. The Generator interfaces with the commercially available Ivy Biomedical Model 7600 cardiac monitor (Cardiac Monitor), which is provided with the Aliya System and is used in accordance with its cleared indications. The Cardiac Monitor uses a 4-lead configuration, which detects the R-wave of the electrocardiogram (ECG) signal and sends a trigger signal to the Generator for precise synchronization of energy output to the patient. This ensures reliable energy delivery synchronization with the patient's cardiac cycle thereby reducing risk of cardiac rhythm disturbances.
The Generator software includes an algorithm that interprets trigger signals from the Cardiac Monitor. The algorithm will only allow the initiation and delivery of energy output when the patient's heart rate is within acceptable limits.
Aliya Ablation Device: The Aliya Ablation Device is a monopolar electrosurgical instrument comprising the Aliya Needle and the Aliya Electrode. Both the needle and electrode are designed for sterile, single use. The Aliya Needle consists of a 19 gauge, 20cm needle with a 1 cm exposed tip and a nested stylet (which is removed once the Aliya Electrode is in position). The Aliya Electrode consists of a 21 cm probe that connects with the needle, a 3-meter cable, and a plug that connects with the Aliya Generator. When connected to the Aliya Generator, the Aliya Ablation Device delivers PEF energy to the target zone at the distal 1 cm of the needle.
The provided document does not describe the acceptance criteria or a study that proves a device meets specific performance criteria related to AI or algorithm performance (as might be expected for an AI-enabled medical device). Instead, this document is a 510(k) summary for a medical device called the "Aliya™ System," which is an electrosurgical cutting and coagulation device.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the regulatory requirements for establishing substantial equivalence to a predicate device, primarily focusing on safety and performance through engineering and biological testing, rather than an AI model's diagnostic or predictive performance.
Therefore, the requested information about AI-related acceptance criteria, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details, and ground truth establishment for an AI model cannot be extracted from this document.
The document focuses on the following types of testing and their "acceptance criteria" (implied as 'Pass' for all tests):
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Verification Activity | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| System Electromechanical Safety Testing | Pass | Pass |
| System Electromagnetic Compatibility Testing | Pass | Pass |
| System Ablation Tissue Effects – Ex Vivo Testing | Pass | Pass |
| Aliya Ablation Device – Electrical Test | Pass | Pass |
| Aliya Ablation Device – Mechanical Test | Pass | Pass |
| Aliya Ablation Device – Dimensional Inspection | Pass | Pass |
| Aliya Ablation Device – Packaging and Transit Test | Pass | Pass |
| Aliya Ablation Device – Shelf Life | Pass | Pass |
| Aliya Ablation Device – Biocompatibility | Pass | Pass |
| Aliya Ablation Device – Sterilization | Pass | Pass |
| Aliya Generator – System and Software Verification | Pass | Pass |
| Aliya Generator – Hardware Verification | Pass | Pass |
| Aliya Generator – Packaging and Transit Verification | Pass | Pass |
2. Sample size used for the test set and the data provenance:
- Animal Study: The document mentions "
six healthy porcine" for an in vivo animal study. This study was conducted to evaluate "safety and performance under clinically relevant operating conditions." The tissues treated were "liver, kidney, and skeletal muscle." The provenance would be experimental animal data, likely prospective as it was a study conducted specifically for this submission. The origin (country/institution) is not specified. - Ex-vivo Tissue Ablation Performance Testing: Conducted using "liver, kidney, and muscle tissue." The "sample size" in terms of number of tissue samples is not specified. Provenance is experimental, ex-vivo.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the animal study: "
three different study physicians" were involved in applying treatment. Their qualifications are not specified beyond being "study physicians." The document does not describe experts establishing ground truth in the context of diagnostic interpretation, but rather physicians performing procedures in an experimental setting. - For engineering and biological tests, "ground truth" is typically established by engineering specifications, validated test methods, and compliance with standards. No explicit "experts" (e.g., radiologists) are mentioned for establishing ground truth in a diagnostic sense.
4. Adjudication method for the test set:
- Not applicable in the context of this type of device testing. The testing described is performance, safety, and compatibility testing, not diagnostic or interpretive tasks requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The device is not an imaging analysis or AI assistance tool for human readers. It's a surgical ablation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an AI algorithm. The device does have internal software (algorithm) in the Generator that "interprets trigger signals from the Cardiac Monitor" and "will only allow the initiation and delivery of energy output when the patient's heart rate is within acceptable limits." This is a functional safety algorithm, not an AI for diagnosis. The "standalone" performance for this is covered under "System and Software Verification" and "Hardware Verification" which passed.
7. The type of ground truth used:
- For the animal study: Visual inspection, "baseline and post procedure CB-CT (Cone Beam Computer Tomography) scanning procedure" to visualize treatment sites, and animal survival up to 28 days for endpoint evaluation. This is a form of in vivo outcome data and imaging-based assessment.
- For ex-vivo testing: Implied physical assessment of ablation zones in tissue.
- For other tests (electromechanical, EMC, etc.): Engineering specifications, compliance with recognized standards (listed in the document), and established test methodologies.
8. The sample size for the training set:
- Not applicable. This device is not an AI learning model that requires a "training set" in the machine learning sense. The software in the device is a rule-based algorithm, not a trainable AI model.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for an AI model. For the functional software, its "ground truth" (i.e., correct behavior) would be defined by its design specifications and validated through software verification processes.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.