(232 days)
The INTRACEPT Bi-Polar RF Probe and Instrument Set is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.
The Relievant INTRACEPT Bi-Polar RF Probe and Instrument Sets are used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lesions in soft tissue. The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lesions in soft tissue. The Instrument Sets are used to provide access to the target tissue and are available in a Standard Length and an Extra Length version.
The provided 510(k) summary for the INTRACEPT Bi-Polar RF Probe and Instrument Set includes limited information regarding detailed acceptance criteria and a comprehensive study report. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance validation with specific acceptance criteria.
However, based on the available information, here's a breakdown:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance/Findings |
|---|---|---|
| Lesion Creation Equivalence | The INTRACEPT system should create clinically relevant lesions that are equivalent in size. | "In vivo data demonstrated that the INTRACEPT Bi-Polar RF Probe and Instrument Set creates clinically relevant lesions that are equivalent in size to the predicate device." |
| Substantial Equivalence | The device should be substantially equivalent in design, materials, function, and intended use to listed predicate devices. | "The test data gathered demonstrate that this device is substantially equivalent to the predicate devices." |
| "No new safety or effectiveness issues have been raised." |
Note: The 510(k) summary does not specify quantitative acceptance criteria (e.g., a specific percentage deviation for lesion size or specific dimensions). The equivalence is stated qualitatively.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: Not explicitly stated. The document only mentions "In vivo data."
- Data Provenance: Not explicitly stated. Given it's "In vivo data," it implies animal or human testing. However, the country of origin and whether it was retrospective or prospective is not mentioned.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable/Not provided. The study focuses on demonstrating physical equivalence to predicate devices, primarily through lesion size, rather than diagnostic accuracy requiring expert interpretation of results.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which isn't the primary focus here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The submission does not describe any study involving human readers or comparative effectiveness with or without AI assistance. The device is a medical instrument for thermal coagulation, not an AI-powered diagnostic or assistive tool.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance assessment was done, but it's for the device's physical function, not an algorithm. The "In vivo data" on lesion creation and the comparison to predicate devices represent the standalone performance of the INTRACEPT system in achieving its intended function (thermal coagulation). This is not an algorithm in the typical AI sense, but rather the device itself performing its designated function.
7. Type of Ground Truth Used
- Physical measurement/comparison: The ground truth for the "in vivo data" regarding lesion size would most likely involve direct measurement (e.g., pathology, imaging, or gross examination) of the lesions created by both the INTRACEPT device and the predicate device. The comparison then establishes equivalence.
8. Sample Size for the Training Set
- Not applicable/Not provided. This device is not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense. The development of the device would involve engineering, bench testing, and optimization, but not typically a data training set like AI.
9. How Ground Truth for the Training Set Was Established
- Not applicable/Not provided. As stated above, there is no training set for this type of device.
§ 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.