(263 days)
The HybridAPC probe is intended for the submucosal injection of sterile normal saline to lift mucosa using direct visualization through an endoscope and for HF ablation of the mucosa, with or without lesions, by Argon Plasma Coagulation (APC).
Indications include but are not limited to:
- Barrett's esophagus
- Ulcers
- Arteriovenous Malformations
- Angioma
- Angiodysplasia
- Gastric Antral Vascular Ectasia (GAVE)
- Radiation Proctitis
- Gastroesophageal reflux disease (GERD)
- Post-polypectomy ablation/Post-EMR ablation
The HybridAPC probe is a flexible, sterile, single use monopolar probe that combines the technologies of hydrosurgery and argon plasma coagulation (APC) in one instrument. Each function can be activated independently without the need to change instruments. It is used with the hydrosurgical unit Model ERBEJET® 2 and an Erbe APC unit in combination with an electrosurgical unit (ESU) VIO Model. The probe is used with endoscopes with a working channel diameter larger than 2.5mm.
The hydrosurgical function is intended to deliver a pressurized fluid to create a fluid cushion beneath the mucosa/mucosal lesion to be ablated which serves as a mechanical and thermal protection layer for the underlying tissue and to reduce the risk of perforations. The electrosurgical (i.e. APC) function is intended for ablation of the lifted mucosa/mucosal lesion. The Hybrid APC probe has a length of 1.9 meters and an outer diameter (OD) of 2.3mm.
The HybridAPC probe is connected to the units via respective cables/tubings. The settings or adjustment of application parameters is performed via the units. Activation of the instrument is done using a footswitch.
The provided FDA 510(k) clearance letter and summary for the HybridAPC probe primarily focus on demonstrating substantial equivalence to predicate devices, particularly regarding indications for use and technological characteristics. It does not present a detailed study with specific acceptance criteria and performance metrics for an AI/algorithm-driven device, nor does it mention a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
The document highlights the device's mechanism (hydrosurgery and argon plasma coagulation) and its expanded indications based on real-world evidence from peer-reviewed literature. It details non-clinical bench performance testing for safety and functional aspects (tissue lifting and thermal effect), but these are not presented as acceptance criteria for an AI model's performance.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance of an AI model from this document. The document describes a medical device, not an AI/algorithm.
However, I can extract information relevant to the device's overall performance validation, which is different from an AI's performance.
Based on the provided document, here's what can be extracted about the device's validation:
1. A table of acceptance criteria and the reported device performance:
The document describes various non-clinical bench tests to demonstrate safety and performance, but it does not list quantitative acceptance criteria or specific reported device performance metrics in a table format for an AI/algorithm. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Testing | "Performed as intended and meets design specifications for both safety and performance." Specifically: "Tissue testing to validate the lifting function and the thermal effect." |
| EMC and Electrical Safety | "Tested in compliance with FDA recognized versions of IEC 60601-1; IEC 60601-2-2; IEC 60601-2-18: and IEC 60601-1-2, as applicable." (Implies compliance was met, but no specific performance values). |
| Biocompatibility | "Performed in compliance with ISO 10993-1 and FDA Guidance 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to demonstrate biocompatibility of the used materials." (Implies compliance was met). |
| Sterilization Validation | "Performed in compliance with ISO 11135 and documentation was provided according to FDA Guidance 'Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile' showing an SAL of 10⁻⁶. EO residual testing and limits are in compliance with ISO 10993-7." (Implies compliance was met, with specific SAL). |
| Packaging and Shelf-life | "Validation was performed in compliance with ISO 11607-1 and accelerated aged (ASTM F 1980) + real-time aged devices." (Implies compliance was met). |
2. Sample size used for the test set and the data provenance:
- Test Set (for clinical evidence, specifically for expanded indications): "Data from various studies, involving more than 1,900 patients for safety and more than 1,200 patients/lesions for performance outcomes..."
- Data Provenance: "Real-world evidence in form of clinical data (peer-reviewed literature)." The country of origin is not specified but it's peer-reviewed literature, implying a broad range. The data is retrospective, as it's from existing literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/mentioned. The clinical evidence for expanded indications relies on peer-reviewed literature and a systematic literature review/meta-analysis, not an expert panel establishing ground truth for a specific test set.
4. Adjudication method for the test set:
- Not applicable/mentioned. The document does not describe an adjudication process for a test set. The clinical evidence is based on published literature.
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. The document does not describe a MRMC study, as it is reviewing a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. Not applicable, as this is a medical device, not an AI/algorithm.
7. The type of ground truth used:
- For the expanded indications, the "ground truth" or substantiation for safety and effectiveness is derived from real-world evidence in the form of peer-reviewed clinical literature (outcomes data, safety analysis reported in studies).
- For the device's functional performance, it relies on bench testing and validated engineering specifications.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device.
Summary of AI-related information:
The provided document is a 510(k) clearance for a physical medical device (HybridAPC probe), not an AI/algorithm product. Therefore, it does not contain the specific information requested regarding acceptance criteria, study design, and performance metrics for an AI-driven device, MRMC studies, or training/test sets for AI models. The "study" mentioned is a systematic literature review and meta-analysis to support expanded indications for the device based on existing clinical evidence.
§ 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.