(176 days)
The NES Reprocessed RF Stylet (RFS) is intended for use in vessel and tissue coagulation including:
- Treatment of incompetent (i.e. refluxing) perforator and tributaiy veins.
The NES Reprocessed RF Stylet (RFS) is a reprocessed VNUS RFS (510(k) # K052003). The device is a high frequency electrosurgical system designed for blood vessel and tissue coagulation in general surgical procedures. This device's energy source comes from a compatible and separately cleared Radiofrequency (RF) Generator. The device has been validated to be reprocessed a maximum of one time. The NES Reprocessed RF Stylet (RFS) is provided sterile (EtO) and is a single use, disposable device. The device is used in a healthcare facility. The device's function is to deliver RF energy to the desired treatment site and relay temperature and other information to the RF Generator. The device consists of one model. The device itself consists of the stylet shaft, handle and cable. A sharp is included with the device for patient insertion. The tip of the stylet serves to deliver the RF energy to the desired treatment site while the cable plugs into the RF generator (for power and relay temperature/other feedback). The tip, inner and outer lumen are the only patient-contacting parts. The patient-contacting material is as follows: AISI 304 SST and polyimide. All patient-contacting material has proven to be biocompatible. The non patient-contacting material is as follows: poly methyl methacrylate and polypropylene. The device is compatible with the separately cleared Radiofrequency (RF) Generator. The NES Reprocessed RF Stylet (RFS) is considered an external communicating device with circulating blood contact for a duration of less than 24 hours.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, the NES Reprocessed RF Stylet (RFS), rather than an AI/ML powered device. As such, the information typically requested for AI/ML device studies (such as sample size for test/training sets, ground truth establishment with expert consensus, adjudication methods, or MRMC studies) is not applicable or provided in the document.
The acceptance criteria and the study proving the device meets these criteria are focused on demonstrating that the reprocessed device is substantially equivalent to its predicate device and maintains its safety and effectiveness.
Here's a breakdown of the provided information, framed within the context of a reprocessed medical device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Performance | No errors or warnings observed during reprocessing cycles. Device functions properly after clinical use, shipping, and reprocessing. |
| Design Validation | IFU, label, packaging, sharp, cap, pouch, and retail/shipping boxes evaluated by a user/expert to ensure user needs are met and device is capable of meeting Indications for Use. Determined to be properly designed. |
| Biocompatibility | Device passed Cyctotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, and Hemocompatibility tests. Does not elicit anatomical reactions. |
| Electromagnetic Safety & Compatibility (EMC) | Device passed both emissions and immunity testing. Determined to be electromagnetically compatible. |
| Cleaning Validation | Demonstrated proper cleaning after clinical use and reprocessing based on TOC, Protein, Hemoglobin, Bioburden (Aerobic, Yeast, Mold), and Bacterial Endotoxin levels post reprocessing. |
| Drying Validation | Demonstrated proper drying after wet cleaning processes. |
| Packaging/Shelf Life | Packaging and sealing properly maintained sterile barrier and withstood distribution, conditioning, and shelf life (based on Seal Peel Strength and Bubble Leak Test after various conditions). |
| Sterilization | Device can be properly sterilized and has an acceptable level of residual Ethylene Oxide (EtO) post sterilization. |
| Sharp Verification | NES 600053 RFS Sharp is designed similar to the OEM sharp in design, fit, strength, and function, demonstrating substantial equivalence. |
| Substantial Equivalence to Predicate | Concluded to be substantially equivalent based on similarities in indications for use, design, material, chemical composition, energy source, function, and efficacy of the reprocessing process. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes (e.g., number of devices reprocessed and tested) for each of the performance tests. The testing appears to be conducted on reprocessed devices themselves, rather than clinical patient data. The provenance of the data is implicit in that it comes from testing conducted by Northeast Scientific, Inc. as part of their 510(k) submission. No specific country of origin for the data or whether it was retrospective or prospective is mentioned, but given it's a device reprocessing validation, it would be laboratory-based testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
For the "Design Validation" section, it is stated that the evaluation was done by "a user and expert of the device." The specific number (one or more) is not definitively stated, nor are their exact qualifications beyond "user and expert." This is not a ground truth establishment in the AI/ML sense, but rather a usability and design review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No adjudication method is relevant or described, as this is laboratory testing of a reprocessed medical device's physical and functional properties, not an interpretative task requiring consensus among experts.
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 is not an AI/ML powered device, so no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI/ML powered device, so no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is its physical and functional performance, as measured against established engineering and biocompatibility standards for medical devices, as well as comparison to the original (predicate) device's specifications. For example, for biocompatibility, the "ground truth" is that the device does not cause adverse biological reactions, confirmed by passing specific biological tests. For functional performance, the "ground truth" is that the device successfully performs its intended function without errors.
8. The sample size for the training set
This is not an AI/ML powered device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML powered device and therefore there is no training set or associated ground truth establishment in that context.
§ 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.