(45 days)
The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue.
The FiAPC® plus probes are sterile, single-use flexible probes intended for argon plasma coagulation (APC) and ablation of tissue. The probes have a plug on the proximal end that enables the connection to the compatible electrosurgical unit (ESU) and APC unit. The plug is ergonomically designed and contains a filter that isolates the device side from the patient side. The plug also contains an instrument recognition which ensures that the instrument can only be operated with the compatible parent devices. The connector is followed by a long tube so that the probe can be inserted into the working channel of an endoscope. At the distal end there is an opening through which the argon plasma is released. The flexible FiAPC® plus probes are available in different variants. All variants have the same outer diameter but differ in their length and distal opening, i.e. axial opening (straight fire) or lateral opening (side fire).
This document describes the Erbe Elektromedizin GmbH FiAPC plus probes, an electrosurgical device accessory. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel acceptance criteria for a new type of device or an AI/software-based system.
Therefore, the information requested in your prompt regarding acceptance criteria and studies that prove a device meets those criteria, particularly for AI/software, is not fully applicable or present in this document. This document describes a medical device accessory and its comparison to an already marketed predicate device, primarily focusing on physical and functional characteristics, and safety and effectiveness relative to that predicate.
However, I can extract the information that is relevant to your prompt based on the provided text, and explicitly state where information is not available or not applicable.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly list "acceptance criteria" in the way a software/AI device might, with specific metrics to hit. Instead, it focuses on demonstrating comparable performance and meeting design specifications through various tests.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| Intended Use Equivalence | Same intended use as the predicate device: "The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue." |
| Technological Characteristics | Largely identical to the predicate device, with minor differences in plug design, distal tip, and materials. These differences were assessed not to raise new safety/effectiveness questions. |
| Tissue Effects | Comparable tissue effects and comparable ignition distances compared to the predicate device, as demonstrated by side-by-side tissue testing. |
| Design and Performance Requirements | All design and performance requirements were successfully verified/validated, and all acceptance criteria are met, as shown by bench testing. (Specific criteria are not enumerated, but general successful verification/validation is stated). |
| Biocompatibility | Compliant with ISO 10993-1; new materials are biocompatible. |
| Electrical Safety & EMC | Compliant with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2. |
| Sterilization | Compliant with ISO 11135, achieving an SAL of 10^-6. EO residual testing and limits compliant with ISO 10993-7. |
| Packaging & Shelf-life | Compliant with ISO 11607-1 and accelerated aged devices (ASTM F 1980). |
| Safety and Effectiveness | The device does not raise new or different questions of safety and effectiveness compared to the predicate device. The device is as safe and effective as the legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance:
- Test Set Description: The "test set" for this device primarily refers to the physical units of the FiAPC plus probes and the predicate device used in bench and tissue testing.
- Sample Size:
- For tissue testing: Not explicitly stated beyond "side-by-side tissue testing."
- For other bench tests (EMC, electrical safety, sterilization, packaging): Not explicitly stated for each test, but it is implied that sufficient samples were tested to demonstrate compliance and validate performance.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were conducted internally or by contracted labs as part of the manufacturer's (Erbe Elektromedizin GmbH, Germany) verification and validation activities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided in the document. The "ground truth" for this type of medical device (argon plasma coagulation probes) is established through biophysical principles, engineering standards, and medical consensus on desired tissue effects, rather than expert annotation of data like in an AI/software context. Tissue effects are measured directly.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from expert opinions in studies involving subjective assessment (e.g., image interpretation for AI). For physical device performance, direct measurements and compliance with objective standards are used.
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 information is not applicable and not provided. MRMC studies are specific to evaluating diagnostic accuracy, particularly for imaging devices or AI tools where human interpretation is involved. This device is an electrosurgical accessory, not a diagnostic or AI-assisted system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable and not provided. This device is a physical electrosurgical probe, not an algorithm or a software-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance, as demonstrated in the document, is based on:
- Direct Physical Measurements/Bench Testing: E.g., electrical load capacity, gas flow rate, probe dimensions.
- Compliance with Industry Standards: E.g., ISO 10993-1 for biocompatibility, IEC 60601 series for electrical safety, ISO 11135 for sterilization.
- Observed Tissue Effects: "Comparable tissue effects and comparable ignition distances" to the predicate device. This is a direct physical result rather than an expert consensus or pathology report in the typical sense, though assessment of these effects would involve trained personnel.
- Comparison to Predicate Device: The overarching "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate device.
8. The sample size for the training set:
- This information is not applicable and not provided. This device is not an AI/machine learning system, so there is no "training set" in the context of AI.
9. How the ground truth for the training set was established:
- This information is not applicable and not provided for the reasons stated in point 8.
§ 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.