(67 days)
For the simultaneous cutting and cauterization of soft tissue during surgery.
Cutting of natural or synthetic, non-metallic, sutures during surgery.
The Starion Instruments Thermal Ligating Shears are a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Thermal Ligating Shears allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. While squeezing the handle, the surgeon depresses a switch, which activates heating element(s) in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Starion Instruments Thermal Ligating Shears:
The provided text does not contain specific acceptance criteria or an analytical study report demonstrating the device meets those criteria. This document is a 510(k) summary and FDA clearance letter, which focuses on establishing substantial equivalence to a predicate device rather than detailing performance studies with specific metrics.
Therefore, many of the requested fields cannot be filled from the given information.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states the device is "substantially equivalent in terms of intended use, target population, energy source, and principles of operation to the Starion Instruments Thermal Cautery Grasper/Dissector." This implies performance is expected to be similar, but specific quantitative acceptance criteria or performance metrics are not given. | Not provided in the document. While the device is intended for "simultaneous cutting and cauterization of soft tissue," no specific performance data (e.g., cutting time, seal strength, temperature reached, tissue necrosis depth) is reported. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified. (The document is a regulatory submission, not a study report.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not specified.
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
- MRMC study: Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used
- Type of ground truth: Not applicable/Not specified. For a surgical instrument like this, "ground truth" would typically relate to objective tissue effects (e.g., proper hemostasis, clean cut, minimal thermal spread) rather than diagnostic accuracy. No such ground truth methodology is described.
8. The sample size for the training set
- Sample size: Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Ground truth establishment: Not applicable. As above, there is no training set for this type of device.
Summary of what the document does provide regarding device evaluation:
The document indicates that the Starion Instruments Thermal Ligating Shears obtained 510(k) clearance based on substantial equivalence to a predicate device, the Starion Instruments Thermal Cautery Grasper/Dissector (K002547). This means the FDA determined that the new device is as safe and effective as the legally marketed predicate device, without needing to demonstrate new performance metrics outside of comparative testing (which wouldn't be detailed in this summary). The basis for this equivalence is stated as "intended use, target population, energy source, and principles of operation."
§ 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.