(23 days)
The Smith & Nephew Saphyre Bipolar Ablation Probes, in combination with the Smith & Nephew Vulcan EAS Generator, are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and and in coagulating soft tissue in joints including but not limited to the knee, shoulder, wrist, hip, etc. Arthroscopic surgery could include a variety of procedures, as listed in the table below.
Examples of Arthroscopic Surgery:
All Joints: Debridement (tendon, cartilage, fracture), Plica Removal, Resection, Synovectomy, Bursectomy, Ablation, Excision of Soft Tissue (scar tissue), Hemostasis of Blood Vessels, Coagulating Soft Tissues (ligament, articular cartilage), and Chondroplasty.
Knee: Meniscectomy, Meniscal Cystectomy, PCL/ACL Debridement, Notchplasty, Lateral Release, Labral Tear.
Shoulder: Acromioplasty, Rotator Cup Debridement, Subacromial Decompression, CA Ligament Resection, and Capsular Release.
Wrist: Triangular Fibrocartilage (TFC).
The Smith & Nephew Saphyre Bipolar Ablation Probes are single-use, bipolar, electrosurgical devices intended for coagulation of soft tissues. The Saphyre Bipolar Ablation Probes consist of an insulated shaft, an insulated power electrode, a return electrode, and a handle. Saphyre Bipolar Ablation Probes with Suction incorporate suction capability for the removal of tissue from the surgical site.
The provided text is a 510(k) pre-market notification for the Smith & Nephew Saphyre Bipolar Ablation Probes. It focuses on demonstrating substantial equivalence to predicate devices for modified indications for use, rather than presenting a performance study with acceptance criteria and results for the device itself.
Therefore, most of the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not specify performance acceptance criteria or report device performance in terms of clinical or technical metrics. The submission is for modified indications for use of an existing device, asserting that "No new risks have been introduced as a result of the modification" and that the "design are equivalent to that of the predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Available. No test set or associated data is mentioned, as this is a regulatory submission for modified indications for use, not a performance study that would typically involve a test set.
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)
- Not Applicable/Not Available. Ground truth establishment is not relevant to this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. Adjudication methods are not relevant to this type of submission.
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
- Not Applicable. This device is a surgical ablation probe, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (an electrosurgical probe), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Available. Ground truth establishment is not relevant to this type of submission.
8. The sample size for the training set
- Not Applicable/Not Available. The document does not describe a training set as it's not detailing a machine learning model or a performance study with data sets.
9. How the ground truth for the training set was established
- Not Applicable/Not Available. Ground truth establishment for a training set is not relevant to this type of submission.
Summary from the document:
The regulatory submission asserts substantial equivalence based on:
- The modified indications for use and design being equivalent to predicate devices (Vulcan Electrosurgical Probes K000691, ArthroCare ArthroWands K011083, Bipolar Ablation Probes K991218).
- No new risks being introduced due to the modification.
The FDA's review confirms this determination, stating that the device is substantially equivalent for the indications for use provided. This implies that the device, with its modified indications, is considered safe and effective to the same extent as its predicate devices, but this is a regulatory determination of equivalence rather than a report of specific performance metrics against pre-defined acceptance criteria from a clinical study.
§ 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.