(113 days)
Product Number (P/N) 20132-250, 20132-251, 20132-253, 20132-254 and 20132-255: The Rigid Argon Plasma Coagulation Applicators are intended for monopolar cutting and coagulation of tissue with and without argon gas or for coagulation and ablation using argon plasma. They are used in open and in laparoscopic surgery.
P/N 20132-256: The Rigid Argon Plasma Coagulation Applicator is intended for monopolar coagulation of tissue using argon plasma. It is used in open surgical procedures.
The Erbe APCapplicators are sterile, single-use electrosurgical instruments for monopolar cutting and coagulation with and without argon gas and/or for coagulation and ablation of tissue using argon plasma. They are used in open and/or laparoscopic surgical procedures. The APCapplicators are intended for use with an Erbe Argon Plasma Coagulator Unit Model APC 2 in combination with a compatible Erbe V/O® electrosurgical unit. Note that the APC 2 must be equipped with an APC receptacle with finger switch activation. Activation may either be done via finger switch on the handle of the Erbe APCapplicator or via footswitch.
The applicators are provided in various shaft lengths either with an adjustable spatula/needle electrode or a malleable tip. Adjustable means that by using the rotary wheel the spatula/needle electrode may either be fully withdrawn inside the instrument shaft or extended up to 14mm outside of the shaft. With an extended electrode the user may cut and coagulate tissue with or without argon gas.
The provided text describes a 510(k) premarket notification for electrosurgical accessories (Erbe APCapplicators). This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that a device meets specific, quantitative acceptance criteria through rigorous clinical trials or AI performance evaluations.
Therefore, the information requested in your prompt (acceptance criteria table, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance with effect sizes, adjudication methods) is not applicable to this document.
Here's why and what information IS available:
Why the requested information is not applicable:
- Medical Device Type: The Erbe APCapplicators are electrosurgical accessories. Their clearance hinges on demonstrating they perform as intended and are as safe and effective as a known predicate device. This is primarily established through bench testing, performance testing (e.g., tissue testing), material characterization, and adherence to recognized standards for electrical safety, biocompatibility, and sterilization, rather than through complex clinical studies evaluating diagnostic accuracy or human-AI interaction.
- 510(k) Pathway: The 510(k) pathway is for devices that are substantially equivalent to a legally marketed predicate device. It does not require proof of clinical superiority or a deep dive into AI performance metrics, as would be expected for a novel AI/ML-based diagnostic device.
- Nature of "Performance": The "performance" mentioned in this document refers to the device's ability to safely and effectively cut, coagulate, or ablate tissue, and its compatibility with the intended electrosurgical units. It doesn't involve "accuracy" or "detection" rates in the way an AI diagnostic algorithm would be evaluated.
Information Available from the Document (related to device "performance" and "studies"):
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Acceptance Criteria/Reported Device Performance:
- Implicit Acceptance Criteria: The device is deemed acceptable if it demonstrates substantial equivalence to the predicate, meaning it performs its intended functions (monopolar cutting, coagulation, ablation using argon plasma) safely and effectively. This is demonstrated through adherence to various standards and performance tests.
- Reported Performance: The document states:
- "Validation activities in design control that include testing/certification to designated standards and performance testing of the proposed devices has demonstrated substantial equivalence to the predicate device."
- "The functionality of both groups has been found to be the same." (Referencing reusable predicate vs. single-use proposed device)
- No Quantitative Performance Table: There is no table of quantitative acceptance criteria like sensitivity/specificity or AUC, because this is not an AI diagnostic device.
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Sample Sizes and Data Provenance:
- Not Applicable: There are no "test sets" or "training sets" in the context of AI models. The document refers to "Performance Evaluations/Testing" including "Tissue Testing." The sample sizes for these bench and tissue tests are not specified, nor is the origin of the "data" in a geographical or prospective/retrospective sense.
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Number of Experts and Qualifications for Ground Truth:
- Not Applicable: There's no "ground truth" to be established by experts in the context of diagnostic agreement, as this is a surgical accessory. "Ground truth" for its performance would implicitly be its ability to physically cut/coagulate tissue in a controlled environment, and its adherence to electrical safety and biocompatibility standards.
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Adjudication Method:
- Not Applicable: No adjudication method is described, as there are no expert readings or interpretations to adjudicate.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable: No MRMC study was done, as this is not an AI-assisted diagnostic device where human reader improvement is a relevant metric.
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Standalone Performance (Algorithm Only):
- Not Applicable: There is no "algorithm" in the sense of an AI model. The device's "standalone" performance refers to its physical and electrical characteristics conforming to safety and performance standards.
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Type of Ground Truth Used:
- Implied through Standards and Bench Testing: The "ground truth" for this device's performance is implicit in its ability to meet engineering specifications, fulfill its intended function (cutting/coagulating tissue) in lab settings, and comply with recognized consensus standards (e.g., IEC 60601 series for electrical safety, ISO 10993 for biocompatibility, ISO 11135 for sterilization). It's based on objective physical/electrical measurements and material properties, not clinical outcomes or expert consensus on medical images.
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Sample Size for Training Set:
- Not Applicable: No training set in the AI context.
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How Ground Truth for Training Set was Established:
- Not Applicable: No training set.
In summary, the provided document is for a traditional medical device (electrosurgical accessory) seeking 510(k) clearance via a substantial equivalence pathway. The framework you've provided for AI/ML diagnostic devices is not applicable to this example.
§ 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.