(25 days)
The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are intended to be used with radiofrequency (RF) generators for the thermal coagulation of soft tissues.
The Relievant INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lesions in soft tissue. The device is a modification to the Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set incorporating upgraded access and deployment instrumentation. 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.
The provided text describes a Special 510(k) Premarket Notification for the Relievant INTRACEPT Flexible RF Probe and Easy Access Instrument Set. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a comprehensive study that proves the device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance:
The document states: "The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set were tested and compared to the predicate device. Ex vivo and in vitro data demonstrated that the INTRACEPT Easy Access Instrument Set achieves RF Probe placements with less procedural complexity and improved ergonomics, which may result in reduced overall procedure time and more efficient instrument exchange. The test data gathered demonstrate that this device is substantially equivalent to the predicate device. No new safety or effectiveness issues have been raised."
Therefore, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device (Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set) in terms of:
- Design
- Materials
- Function
- Intended Use
- Safety
- Effectiveness
The reported device performance indicates that the new instrument set offers:
- Less procedural complexity
- Improved ergonomics
- Potential for reduced overall procedure time
- More efficient instrument exchange
Table of Acceptance Criteria and Reported Device Performance (based on available information):
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as stated) |
|---|---|---|
| Substantial Equivalence | Equivalent in Design to Predicate Device | "substantially equivalent in design" |
| Equivalent in Materials to Predicate Device | "substantially equivalent in materials" | |
| Equivalent in Function to Predicate Device | "substantially equivalent in function" | |
| Equivalent in Intended Use to Predicate Device | "substantially equivalent... and intended use" | |
| Safety | No new safety issues compared to Predicate Device | "No new safety or effectiveness issues have been raised." |
| Effectiveness | No new effectiveness issues compared to Predicate Device | "No new safety or effectiveness issues have been raised." |
| Procedural Efficiency | Improved or equivalent procedural complexity | "achieves RF Probe placements with less procedural complexity" |
| Ergonomics | Improved or equivalent ergonomics | "improved ergonomics" |
| Procedure Time | Potential for reduced or equivalent overall procedure time | "may result in reduced overall procedure time" |
| Instrument Exchange | Improved or equivalent instrument exchange efficiency | "more efficient instrument exchange" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states "Ex vivo and in vitro data". This indicates laboratory testing, not clinical studies involving human patients. It does not specify sample sizes, country of origin, or whether the ex vivo data was retrospective or prospective.
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. Given that the testing was ex vivo and in vitro, "ground truth" would likely be established through engineering specifications, physical measurements, and comparison to the predicate device's measured performance in controlled settings, rather than expert clinical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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 device is an RF probe and instrument set for thermal coagulation of soft tissues, not an AI or imaging device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is not an algorithm. Performance was assessed on the physical device and its components, primarily through ex vivo and in vitro testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the nature of the device and the specified testing (ex vivo, in vitro), the ground truth for this type of submission would typically be based on:
- Engineering specifications and measurements: Performance metrics like power output, lesion size, temperature control, mechanical strength, and material biocompatibility.
- Comparison to predicate device performance: Direct comparative measurements against the established predicate device in controlled laboratory settings.
- Functional testing: Demonstrating the device performs its intended mechanical and electrical functions as designed.
8. The sample size for the training set:
This refers to a training set for machine learning models, which is not applicable to a physical medical device like an RF probe.
9. How the ground truth for the training set was established:
Not applicable, as this is not a device based on machine learning.
§ 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.