(23 days)
The APC Integrated Filter Probes are intended for use in Argon Plasma Coagulation (APC). The devices are used to treat many conditions in endoscopy for various surgical procedures.
The APC Integrated Filter Probes incorporate a filter similar to the APC Membrane Filter and the hose (specifically the length) of an APC Connector Hose into one device. The Probes are flexible. They are provided in various lengths, diameter sizes, and tip configurations to accommodate the various size/types of endoscopes for a variety of applications (i.e., the treatment of various target tissues inside a patient). The working lengths of the APC Integrated Filter Probes are 4.9ft. (1.5m) to 9.8ft. (3m). The working diameters of the Probes are 4.5 French (1.5mm) to 9.6 French (3.2mm). The Probes have either an axial (straight fire), lateral (side fire), or circumferential opening allowing the energy to be delivered straight, at a 45 to 90 degree angle, or directly to target tissue regardless of the probe's position. The three types of openings for the APC Integrated Filter Probes allow the physician a choice in the direction or the option not to have to consider the direction (just proximity) of delivering the argon plasma to the treatment site which is based upon tissue resistance.
The APC Integrated Filter Probe Adapter is a flexible connecting cable. It connects the APC Integrated Filter Probe to an ERBE Argon Plasma Coagulator. The Adapter is a conduit for both electrosurgical current and argon gas. It is approximately 13-1/2" in length.
The provided document is a 510(k) premarket notification for a medical device (ERBE APC Integrated Filter Probes and Adapter). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a novel device meets specific acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding acceptance criteria, extensive studies, sample sizes, expert ground truth, MRMC studies, and standalone performance is not typically found or required in a 510(k) submission of this nature.
However, based on the document, I can provide information on what was verified/validated to show the device is safe and effective and substantially equivalent to its predicate.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical trial or performance study. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device. The performance is assessed by confirming that the modified device functions similarly to the predicate and that modifications do not raise new safety or efficacy concerns.
The core "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Implicit Acceptance Criteria and Reported Device Performance (based on substantial equivalence claims):
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (from the 510(k)) |
|---|---|
| Functional Equivalence: Performs like the predicate. | Probes: "The APC Integrated Filter Probes have the same performance, working dimensional and tip specifications... as the predicate APC Probes. The Integrated Filter Probes incorporate a filter similar to and performs like the predicate APC Membrane Filter." |
| Adapter: "The [Adapter's] performance was validated via Recognized Standards." | |
| Material Biocompatibility: No new biocompatibility issues. | Probes: "All added or modified materials... were evaluated for biocompatibility with no problem found." "The materials were found via validation testing and the materials are biocompatible." |
| Adapter: "Biocompatibility testing was not necessary because the Adapter doesn't come in contact with the patient." | |
| Sterilization Efficacy: Maintains sterility. | Probes: "The sterilization cycle has been validated." |
| Structural Integrity & Safety: No new safety/efficacy concerns from modifications. | Probes: "The structural modifications of changing the connector end didn't raise any safety or efficacy issues." "No negative impact was found with the dimensional modification of installing a filter." "The filter... was found to be sufficient in keeping backflow fluid from reaching the Adapter or Coagulator." |
| Adapter: "No safety or efficacy concerns for the Adapter." "Found to function properly through validated testing and using Recognized Standards." | |
| Instrument Recognition System Functionality: Correctly communicates with coagulator. | Probes: "Instrument recognition system. If attached directly... Coagulator recognizes the Probe diameter size and automatically sets conservative default settings." (EPROM-based is more specific and recognized "in real-time"). |
| Adapter: "The Adapter has a resistor instrument recognition system. If the Adapter is used, it overrides specific probe recognition... no safety or efficacy issues are expected because the Adapter's resistor sets the lowest/most conservative default settings." |
Study Details Not Provided (typical for 510(k) premarket notifications)
The document is a 510(k) summary, not a clinical study report. Therefore, it does not contain the following information as these are generally not required for substantial equivalence claims of this nature, especially for Class II accessories to an existing system:
- Sample size used for the test set and the data provenance: Not applicable or provided. Performance was demonstrated through "validation testing" and adherence to "Recognized Standards," but specific sample sizes for these tests are not detailed. These are likely internal engineering and bench tests, not large-scale clinical studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context would relate to clinical outcomes, which were not directly assessed through clinical trials for this 510(k).
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrosurgical accessory, not an AI-driven diagnostic or treatment planning tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device accessory.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and effectiveness relies on its performance against engineering specifications, biocompatibility standards, and functional equivalence to its predicate, rather than clinical outcomes data from a de novo study.
- The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Approach in the 510(k):
The manufacturer relied on the following to demonstrate substantial equivalence:
- Bench Testing and Validation: "Functionality and reliability of the Probes were demonstrated through validation testing using Recognized Standards."
- Biocompatibility Testing: "All added or modified materials... were evaluated for biocompatibility with no problem found."
- Sterilization Validation: "The sterilization cycle has been validated."
- Predicate Comparison: Detailed comparison of materials, dimensions, intended use, performance specifications, and other characteristics to legally marketed predicate devices, highlighting similarities and explaining differences.
- Risk Analysis: Stating that modifications "didn't raise any safety or efficacy issues" and "no negative impact was found."
- Design Controls: Stating, "All the changes have been verified or validated in design control."
In essence, the "study" for this 510(k) involved engineering verification and validation, materials testing, and a comprehensive comparison to established predicate devices, rather than a clinical trial with acceptance criteria for patient outcomes.
§ 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.