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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, outlet(s) for connection to Starion cautery instruments and/or optional footswitch, and an audible tone to indicate activation of the instrument heating element.

The provided text is a 510(k) summary and FDA clearance letter for the Starion Instruments Universal Power Supply (UPS). It indicates that the device is a Class II medical device (thermal cautery unit) and has been found substantially equivalent to a legally marketed predicate device (Starion Instruments Surgical Power Supply, K000893).

The details requested in your prompt (acceptance criteria, study results, sample sizes, ground truth establishment, expert qualifications, etc.) are typically found in a 510(k) submission's detailed safety and effectiveness section, sometimes within a "Special Controls" document, or in the Design History File of the device manufacturer. The provided public summary and clearance letter do not contain this level of detail regarding specific performance studies or acceptance criteria beyond stating substantial equivalence.

Therefore, based only on the provided text, I cannot fill in most of the requested table and study details.

Here's what can be inferred from the provided text, and what cannot:

Information Available from the Text:

• Device Name: Starion Instruments Universal Power Supply (UPS)
• Intended Use: Simultaneous cutting and cauterization of soft tissue during surgery.
• Predicate Device: Starion Instruments Surgical Power Supply (K000893)
• Regulatory Classification: Class II, Product Code HOO, Regulation Number 21 CFR 886.4115 (Thermal cautery unit)
• Basis for Clearance: Substantial Equivalence to a predicate device.

Information NOT Available from the Text:

• Specific quantitative acceptance criteria for performance.
• Results of concrete performance tests to demonstrate these criteria are met.
• Details of any specific studies (other than the implicit substantial equivalence comparison).
• Sample sizes for test sets or training sets.
• Data provenance for any hypothetical test sets.
• Number/qualifications of experts, adjudication methods.
• Whether MRMC or standalone studies were performed.
• Type of ground truth used or how it was established for any test/training data.

Why this information is not present in the provided text:

For a 510(k) submission relying on substantial equivalence to a predicate device, the primary "study" is often a comparison to the predicate device demonstrating that the new device has the same technological characteristics, intended use, and performs as safely and effectively as the predicate. While internal testing (e.g., electrical safety, EMC, functional performance) is conducted by the manufacturer, the detailed summary provided to the FDA and then released publicly for a simple Class II device like a power supply often focuses on the comparison to the predicate rather than extensive new clinical or performance studies with defined acceptance criteria in the same way a novel, high-risk device might.

The FDA's finding of "substantial equivalence" means they deemed the device to be as safe and effective as the predicate based on the information provided by the manufacturer, which would have included performance data, but this data is not detailed in the publicly available summary you've provided.

Therefore, the table and study description will largely be empty or state "Not specified in the provided document."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified in the provided document.
• Data Provenance: Not specified regarding any specific test sets. The clearance is based on comparison to a predicate device and likely internal design verification/validation testing conducted by the manufacturer (Starion Instruments Corporation, Saratoga, CA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not specified. The 510(k) summary focuses on substantial equivalence to a predicate device for an electrical medical device power supply. This type of device typically relies on engineering and electrical safety testing against recognized standards rather than expert consensus on a "test set" of clinical data in the way an AI diagnostic device would.

4. Adjudication method for the test set

• Not applicable/Not specified. See point 3.

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

• No. This is not applicable to a universal power supply for cautery instruments. MRMC studies are specific to diagnostic devices, particularly those involving image interpretation by human readers, often comparing human performance with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a power supply, not an algorithm or an AI system. Its function is to power cautery instruments used by a surgeon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not specified in the context of clinical "ground truth." For a power supply, "ground truth" would relate to its electrical and functional performance meeting engineering specifications and safety standards, as compared to the predicate.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

In summary: The provided 510(k) content is for an electrical power supply device cleared via substantial equivalence. It does not involve the types of studies (MRMC, standalone algorithm performance, AI training sets with expert-established ground truth) that your questions are designed to uncover for more complex diagnostic or AI-enabled medical devices. The "study" here is the manufacturer's demonstration to the FDA that their new UPS is as safe and effective as their previously cleared predicate device.

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