(88 days)
The TissueLink Bipolar Floating Ball device is a sterile, single use bipolar electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of mention to be asou in colligation for hemostatio sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, general and operaire surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
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Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study proving device performance:
Crucial Note: The provided 510(k) summary (K020574) for the TissueLink Bipolar Floating Ball device does not contain the information requested in points 1-9 regarding performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement. The document is primarily a notification of intent to market, a summary of safety and effectiveness, and an FDA letter confirming substantial equivalence to a predicate device.
It explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that substantial equivalence was established, likely based on design, materials, and intended use comparison to the predicate, rather than new, extensive clinical performance studies with acceptance criteria as one might expect for a novel or high-risk device.
Therefore, many of the requested details cannot be extracted from this document. However, I can explain why they are not present based on the nature of a 510(k) submission focusing on substantial equivalence.
Detailed Response based on provided document:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Not specified Not specified Explanation: The 510(k) summary does not list specific acceptance criteria or report detailed device performance data from a dedicated study. For devices seeking substantial equivalence, performance is typically inferred through comparison to the predicate device's known performance characteristics (e.g., power output, temperature profiling, safety features) rather than novel clinical endpoints with predefined acceptance thresholds.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The document does not describe a "test set" in the context of a performance study.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable.
- Qualifications: Not applicable.
Explanation: Since no specific performance test set or ground truth establishment is described, neither the number nor the qualifications of experts are mentioned.
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Adjudication Method for the Test Set:
- Adjudication Method: Not applicable.
Explanation: No test set or ground truth adjudication process is outlined in the submission.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done? No.
- Effect Size of Human Readers Improvement: Not applicable.
Explanation: This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a key aspect. The TissueLink Bipolar Floating Ball device is an electrosurgical tool, and an MRMC study for improved human reader performance with AI assistance would not be relevant in this context.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study Done? No.
Explanation: This device is a surgical instrument operated by a human, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable.
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Type of Ground Truth Used:
- Type of Ground Truth: Not applicable.
Explanation: The document does not describe a performance study requiring a "ground truth" to evaluate the device's output or diagnostic accuracy. Instead, substantial equivalence to the predicate is the primary basis for clearance.
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Sample Size for the Training Set:
- Sample Size: Not applicable.
Explanation: As there's no mention of a machine learning component or an AI algorithm, a "training set" in this context is irrelevant.
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How the Ground Truth for the Training Set Was Established:
- How Established: Not applicable.
Explanation: Similar to point 8, the concept of a training set ground truth does not apply to this type of medical device submission.
Summary of what the document DOES demonstrate:
The provided 510(k) summary (K020574) focuses on demonstrating substantial equivalence to a predicate device (TissueLink Monopolar Floating Ball). This means the manufacturer presented evidence that the new Bipolar Floating Ball device is as safe and effective as the previously cleared predicate device, based on similarities in:
- Intended Use: "hemostatic sealing and coagulation of soft tissue at the operative site."
- Operating Principles: Bipolar electrosurgery.
- Materials and Design: (Though not detailed in this summary, these would be compared in the full submission).
- Performance Characteristics: (Again, usually compared against the predicate's known performance limits rather than generating new clinical data with acceptance criteria for a 510(k) unless there are significant technological differences).
The FDA's letter confirms they found the device "substantially equivalent" for the stated indications for use. This regulatory pathway typically relies on comparison to existing devices rather than extensive novel clinical trials with predefined acceptance criteria for performance, especially for devices considered Class II where general controls and special controls are deemed sufficient.
§ 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.