(196 days)
The TissueLink Bipolar Floating Ball device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
TissueLink Bipolar Floating Ball device
This document is a 510(k) summary for the TissueLink Bipolar Floating Ball device. It primarily focuses on demonstrating substantial equivalence to a predicate device for an expanded indication of an already cleared device, rather than proving performance against specific acceptance criteria for a novel device or AI algorithm.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of regulatory submission. This is not a study focused on a diagnosis or prediction, but rather on the safety and efficacy of a medical device (an electrosurgical instrument).
Here's an attempt to address the points based on the provided document, noting where the information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or reported device performance in the way one would for a diagnostic or prognostic device. The submission is for expanded indications for an electrosurgical device. The "acceptance criteria" for a 510(k) submission generally revolve around demonstrating substantial equivalence in terms of safety and effectiveness to a legally marketed predicate device for the stated indications.
The key "performance" demonstrated here is the intended use and mechanism of action being substantially equivalent to the predicate device, but for a broader range of surgical applications.
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. This is a 510(k) submission demonstrating substantial equivalence for an electrosurgical device, not a study evaluating an AI algorithm's performance on a test set. There is no "test set" in the context of diagnostic accuracy from patient data.
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. There is no ground truth established by experts for a test set in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set for diagnostic accuracy.
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 is not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a 510(k) supporting expanded indications is typically based on design specifications, material compatibility, functional testing, and potentially clinical literature or prior device history relative to the predicate device, demonstrating that the device continues to meet its functional and safety requirements across the expanded set of indications.
8. The sample size for the training set
Not applicable. There is no training set for an AI algorithm in this context.
9. How the ground truth for the training set was established
Not applicable. No training set.
Summary based on the document:
The provided document is a 510(k) summary for the TissueLink Bipolar Floating Ball device seeking clearance for expanded indications. The core of this submission is to demonstrate substantial equivalence to an existing predicate device (the identical device, TissueLink Bipolar Floating Ball, K#020574).
- Acceptance Criteria (Implicit for a 510(k) for Expanded Indications): The device must continue to be as safe and effective as the predicate device when used for the expanded indications. This is assessed through demonstrating that the device's technological characteristics, principles of operation, and performance fall within the scope of the predicate device's cleared uses, or that any differences do not raise new questions of safety or effectiveness.
- Study Proving Acceptance Criteria: The document itself is the "study" (regulatory submission) that argues the device meets these implicit criteria. It states: "Claim of Substantial Equivalence of the TissueLink Bipolar Floating Ball device is made to: Identical device, TissueLink Bipolar Floating Ball, K#020574." The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
The expanded indications are: "The TissueLink Bipolar Floating Ball device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery." Earlier clearance (K#020574) likely covered a narrower set of these applications.
§ 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.