(90 days)
The TissueLink Solid Cylinder monopolar device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radio frequency current and saline for blunt dissection, hemostation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
TissueLink Solid Cylinder monopolar device
The provided document is a 510(k) Premarket Submission for a medical device (TissueLink Solid Cylinder monopolar device) and its corresponding FDA clearance letter. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through performance testing and comparison, rather than detailed clinical study results typical of drug approvals or novel high-risk device PMA submissions.
Therefore, much of the requested information regarding detailed clinical studies, AI performance metrics, and expert consensus for ground truth is not present in this document. The document describes a comparison to a predicate device (TissueLink Monopolar Floating Ball) to demonstrate substantial equivalence, which is a different regulatory pathway than proving novel clinical efficacy through extensive trials with acceptance criteria based on patient outcomes or AI accuracy.
Here's the information that can be extracted and an explanation of why other requested information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of explicit acceptance criteria with numerical targets and reported performance. Instead, the "acceptance criteria" here are implied by the demonstration of substantial equivalence to the predicate device. This typically means the new device performs similarly in terms of safety and effectiveness characteristics relevant to its intended use.
The document states: "Claim of Substantial Equivalence of the TissueLink Solid Cylinder monopolar device is made to: TissueLink Monopolar Floating Ball". This is the primary "acceptance criterion" for a 510(k) submission: demonstrating that the new device is as safe and effective as a legally marketed predicate.
Reported Device Performance (Implicit): The FDA's clearance letter ("MAR 2 7 2002") confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies that the performance (safety and effectiveness) as demonstrated in the submission was sufficient to meet the substantial equivalence standard. The specific performance parameters tested and their results are not detailed in this summary. These would typically include bench testing for electrical safety, electromagnetic compatibility, power output, tissue effects (e.g., coagulation depth, dissection speed), and biocompatibility.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. For a 510(k) submission of this type (electrosurgical device), testing would primarily involve bench testing, animal studies, and potentially limited human use data to confirm safety and performance relative to the predicate. The summary does not specify sample sizes for any tests, data provenance, or whether 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 (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The concept of "ground truth" established by experts, as typically seen in AI/diagnostic device studies, is not a primary component of a 510(k) submission for an electrosurgical device. Performance is typically assessed through objective measurements (e.g., power output, thermal spread) and potentially histology from animal models, rather than expert interpretation of images or observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically used in clinical trials and diagnostic studies where interpretations or events need to be confirmed by multiple experts. This is not relevant for the type of device and regulatory submission presented.
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 information is not applicable. This is an electrosurgical device, not an AI or diagnostic imaging device. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is an electrosurgical device, not an algorithm or AI system. Its performance is always "human-in-the-loop" as it is operated by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" as typically discussed in AI/diagnostic studies is not directly applicable. If any "ground truth" were to be considered, it would likely be based on:
- Bench Test Standards: Adherence to established engineering and electrical safety standards.
- Animal Models: Histological analysis of excised tissue from animal studies to assess coagulation depth, tissue damage, etc., compared to the predicate device.
- Performance Metrics: Objective measurements of device function (e.g., power delivery, impedance) under various conditions.
The specific details of these are not provided in the summary.
8. The sample size for the training set
This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, this is not an AI/machine learning device.
Summary of what is known from the provided text:
- Device Type: Electrosurgical Cauterizing Pen (TissueLink Solid Cylinder monopolar device).
- Predicate Device: TissueLink Monopolar Floating Ball.
- Regulatory Pathway: 510(k) Pre-Market Notification, demonstrating substantial equivalence to a predicate device.
- Indications for Use: Sterile, single use, electrosurgery device used with an electrosurgical generator for radiofrequency current and saline delivery, for blunt dissection and hemostasis of soft tissue in endoscopic and open abdominal and thoracic surgery. Not for contraceptive tubal coagulation.
- FDA Determination: Substantially equivalent to legally marketed predicate devices.
The provided document is too brief and of a different regulatory scope to contain the detailed clinical study and AI-specific information requested. It's a regulatory clearance document for a relatively mature technology where safety and performance are established through comparison to a well-understood predicate.
§ 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.