(15 days)
For the simultaneous cutting and cauterization of soft tissue during surgery.
The Starion Instruments Universal Power Supply (UPS) is a reusable, AC powered unit intended for use with cautery instruments incorporating Starion technology for the simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Universal Power Supply (UPS) features an on/off switch, green power-on LED indicator, variable output and volume controls/indicators, outlet(s) for connection to Starion cautery instruments and/or optional footswitch, and audible tones to indicate activation of the instrument heating element.
The provided text is a 510(k) premarket notification summary and an FDA clearance letter for the Starion Instruments Universal Power Supply (UPS). This document type, particularly a 510(k) summary, primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the results of a dedicated study to prove it.
Here's why the requested information cannot be fully provided from the given text:
- Type of Device: The Starion Instruments Universal Power Supply (UPS) is an AC powered unit intended for use with cautery instruments for simultaneous cutting and cauterization of soft tissue. This is a hardware device, not an AI/ML-driven device or a diagnostic tool that would typically have the kind of performance metrics (sensitivity, specificity, AUC) and ground truth methodologies associated with the requested table criteria.
- 510(k) Process: The 510(k) pathway for medical devices (Class II in this case) primarily requires demonstrating "substantial equivalence" to a legally marketed predicate device. This is often achieved through performance testing that confirms the new device meets established safety and performance standards for its type, and that its technological characteristics do not raise new questions of safety or effectiveness compared to the predicate. It does not typically involve the elaborate "study" structure implied by the questions, especially those related to AI algorithm performance evaluation.
Therefore, the document does not contain information on:
- A table of acceptance criteria and reported device performance (in the context of sensitivity/specificity/accuracy for an AI algorithm).
- Sample size, data provenance, or ground truth for a test set.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study, human reader improvement with AI, or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
What the document does provide regarding "acceptance" implicitly:
- Intended Use: "For the simultaneous cutting and cauterization of soft tissue during surgery."
- Substantial Equivalence: The primary "acceptance criterion" met is demonstrating substantial equivalence to the predicate device (Starion Instruments Universal Power Supply, K043155) in terms of intended use, target population, energy output, and principles of operation.
- Device Features: The device features (on/off switch, LED, variable output/volume, outlets, audible tones) are described, implying these functionalities were tested to ensure they operate as intended and safely.
- Safety and Effectiveness: The 510(k) process is about ensuring safety and effectiveness. The FDA's clearance indicates they were satisfied that the device meets these general criteria based on the submitted information and comparison to the predicate.
In summary, the provided text describes a basic medical device (a power supply for cautery instruments) cleared through the 510(k) pathway, which focuses on substantial equivalence rather than the detailed performance study characteristics typically associated with AI/ML devices or diagnostic assays implied by your questions.
§ 886.4115 Thermal cautery unit.
(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.