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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, 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:

1. A table of acceptance criteria and reported device performance (in the context of sensitivity/specificity/accuracy for an AI algorithm).
2. Sample size, data provenance, or ground truth for a test set.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, human reader improvement with AI, or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. 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.

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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

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."

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For the simultaneous cutting and cauterization of soft tissue during surgery.

The Starion Instruments Thermal Cautery Probe is a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Thermal Cautery Probe allows the surgeon to position the probe in the region of tissue to be cauterized. The Thermal Cautery Probe features a handle, a finger/footswitch control and power cord for connection to a Starion Instruments power supply.

The provided text is a 510(k) summary for the Starion Instruments Thermal Cautery Probe, which describes its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table and details because the information is not present in the given document.

The document primarily focuses on the regulatory submission process and the FDA's determination of substantial equivalence based on the device's intended use, target population, energy source, and principles of operation being similar to the predicate device. It does not include a technical performance study with quantitative results against specific acceptance criteria.

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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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Ask a specific question about this device