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510(k) Data Aggregation
(263 days)
HybridAPC probe
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.
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(343 days)
ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
ERBEJET® 2 System - The ERBEJET 2 is intended for lifting mucosal lesions by injection into the submucosa as well as the cutting and dissection of soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) in open as well as endoscopic surgery.
HybridAPC Probe - The HybridAPC probe is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope and for HF ablation of the mucosal lesions by Argon Plasma Coagulation (APC).
The HybridAPC Probe is used with the ERBE Water Jet Model ERBEJET 2 and an ERBE Argon Plasma Coagulator (APC) Model APC 2/ElectroSurgical Unit (ESU) VIO Model System. The Water Jet delivers pressurized sterile normal saline through the Probe to provide a saline cushion beneath mucosal lesions. The induction of the saline into the submucosa is a routine practice and acts as a cushion which can reduce/limit unwanted tissue damage (penetration depth) when applying argon plasma coagulation. The APC/ESU System with the Probe supplies ionized (electrically charged) argon gas to create the HF argon plasma for the ablation of the lifted lesions. The HybridAPC Probe consists of tubing to the Water Jet, a cable with a filter integrated connector for the APC, and dual lumen tubing. The inside lumen delivers the pressurized sterile normal saline and the outer lumen delivers the electrically charged argon gas for the HF argon plasma. Clinicians would attach the Probe to the Water Jet and APC/ESU System. Then the Probe is positioned at the operative site under direct visualization endoscopically. If an operative endoscope is utilized, the working channel must be greater than 2.5 mm. Upon the setup of the Water Jet and APC/ESU System, the Probe is ready for use. The pedal of the ERBEJET 2 footswitch activates its water-jet capabilities. The tip of the Probe is placed against a lesion and the saline accumulates within the submucosal layer which cushions the lesion. Then the tip of the Probe is placed in close proximity of the raised lesion (not touching/non-contact modality). Finally, the footswitch for the APC/ESU System is depressed which delivers the ionized argon gas to create the HF argon plasma for the ablation of the lesion. The HybridAPC Probe's dimensional working parameters (tubing/tip interfacing with scope as applicable/tissue) are 2.3 mm Outer Diameter, 1.9 m Length. The device is manufactured with typical materials or agents used in the medical device industry such as tungsten, stainless steel, plastics, silicone, etc. The HybridAPC Probe is provided sterile and is single use.
The document describes a 510(k) premarket notification for the ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe. The focus is on demonstrating substantial equivalence to predicate devices, particularly regarding the new HybridAPC Probe and the added functionality of lifting mucosal lesions to the ERBEJET 2 System.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Macroscopic and histological data demonstrating that the proposed device (HybridAPC probe) is comparable or better than (substantially equivalent to) the predicate device (HybridKnife) in the mitigation of thermal tissue damage to the underlying tissue layers upon lifting the mucosa and coagulating/ablating tissue. | When the tissues were analyzed macroscopically and histologically, the HybridAPC probe and HybridKnife produced comparable thermal effect when coagulating/abating tissue. The thermal damage profile and tissue effects were substantially equivalent in protecting the proper muscle layer upon the induction of 0.9% NaCl in the submucosa. |
| Demonstrating that the lifting/cushioning for the HybridAPC probe was substantially equivalent to or better than the HybridKnife, in terms of height and area measurements of the created lift/cushion. | The results of the test showed that height and area measurements of the created cushion upon the induction of 0.9% NaCI into the submucosa of the tissue types was comparable for the proposed and predicate devices. |
| No detrimental damage to esophageal tissue (i.e., no perforation) when the ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe is used at higher pressures (Effect 70/1,015 psi) to lift the submucosa. | Performance testing with the ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe at Effect 70 (1,015 psi, near the maximum setting) to lift the submucosa of esophageal tissue showed no detrimental damage to the tissue (i.e., no perforation). |
| All changes with the proposed devices were verified or validated, and the changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness. | The ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe has been verified or validated in design control. The document states, "As a result, the changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness. In conclusion, there are no issues with the ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe that would raise additional safety or efficacy issues, when compared to the predicate devices." (This is a general statement about overall design control and verification/validation, not a specific performance metric). |
2. Sample size used for the test set and the data provenance:
- Sample Size: The study used three (3) different ex-vivo tissue types (esophagus, stomach, and rectum) from pigs.
- For coagulation/ablation testing, each tissue type was tested with and without submucosa lifting, and then with coagulation. Testing was done with minimum, default, and maximum intensity settings in triplicate (3X) for both the proposed and predicate devices.
- For submucosa lift testing, the ERBE WaterJet System settings were Effect 40, 70, and 80 to deliver 2 ml, 3 ml, and 5 ml of 0.9% NaCl at an application angle of 90° into each specified tissue type in triplicate (3X) for both the proposed and predicate devices.
- Data Provenance: The data was generated from ex-vivo animal (pig) tissue. This indicates a lab-based, pre-clinical study. The data is prospective in the sense that the experiments were conducted specifically for this submission. The country of origin of the data is not explicitly stated, but the manufacturer is ERBE USA, Inc. with the parent company ERBE Elektromedizin GmbH, suggesting European or US-based research.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study involves macroscopic and histological examination, which implies expert assessment, but the number and qualifications of the individuals performing these assessments are not specified.
4. Adjudication method for the test set:
This information is not provided. Given the nature of macroscopic and histological examination, an adjudication method (such as independent expert review or consensus) would typically be employed, but it is not described.
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:
This was not an MRMC comparative effectiveness study, nor does it involve AI. The study is a bench and ex-vivo animal study comparing a new medical device to predicate devices for its physical and functional performance, not human diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is an electrosurgical cutting and coagulation device with a waterjet and APC probe, not an algorithm, so a standalone algorithm performance study is irrelevant.
7. The type of ground truth used:
- For the coagulation/ablation and thermal damage assessment: Macroscopic and histological examination of the ex-vivo pig tissues. This is a form of expert assessment of tissue damage and morphology.
- For the lifting/cushioning assessment: Macroscopic measurements for height and area of the created lift/cushion. This is an objective measurement based on the observed physical effect on the tissue.
- For the non-perforation test: Observation of the absence of detrimental damage (perforation) to the tissue.
8. The sample size for the training set:
This is not applicable/not provided. This study describes a pre-market submission for a physical medical device, not an AI/ML algorithm that would typically have a training set. The term "training set" is generally used in the context of machine learning model development.
9. How the ground truth for the training set was established:
This is not applicable/not provided for the same reasons as #8.
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