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The TissueLink Bipolar Floating Ball device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

TissueLink Bipolar Floating Ball device

This document is a 510(k) summary for the TissueLink Bipolar Floating Ball device. It primarily focuses on demonstrating substantial equivalence to a predicate device for an expanded indication of an already cleared device, rather than proving performance against specific acceptance criteria for a novel device or AI algorithm.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of regulatory submission. This is not a study focused on a diagnosis or prediction, but rather on the safety and efficacy of a medical device (an electrosurgical instrument).

Here's an attempt to address the points based on the provided document, noting where the information is not available or not applicable:

1. A table of acceptance criteria and the reported device performance

This document does not contain a table of acceptance criteria or reported device performance in the way one would for a diagnostic or prognostic device. The submission is for expanded indications for an electrosurgical device. The "acceptance criteria" for a 510(k) submission generally revolve around demonstrating substantial equivalence in terms of safety and effectiveness to a legally marketed predicate device for the stated indications.

The key "performance" demonstrated here is the intended use and mechanism of action being substantially equivalent to the predicate device, but for a broader range of surgical applications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission demonstrating substantial equivalence for an electrosurgical device, not a study evaluating an AI algorithm's performance on a test set. There is no "test set" in the context of diagnostic accuracy from patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no ground truth established by experts for a test set in this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set for diagnostic accuracy.

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

Not applicable. This is not an AI-assisted diagnostic or imaging device.

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

Not applicable. This device is not an algorithm.

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

Not applicable. The "ground truth" for a 510(k) supporting expanded indications is typically based on design specifications, material compatibility, functional testing, and potentially clinical literature or prior device history relative to the predicate device, demonstrating that the device continues to meet its functional and safety requirements across the expanded set of indications.

8. The sample size for the training set

Not applicable. There is no training set for an AI algorithm in this context.

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

Not applicable. No training set.

Summary based on the document:

The provided document is a 510(k) summary for the TissueLink Bipolar Floating Ball device seeking clearance for expanded indications. The core of this submission is to demonstrate substantial equivalence to an existing predicate device (the identical device, TissueLink Bipolar Floating Ball, K#020574).

• Acceptance Criteria (Implicit for a 510(k) for Expanded Indications): The device must continue to be as safe and effective as the predicate device when used for the expanded indications. This is assessed through demonstrating that the device's technological characteristics, principles of operation, and performance fall within the scope of the predicate device's cleared uses, or that any differences do not raise new questions of safety or effectiveness.
• Study Proving Acceptance Criteria: The document itself is the "study" (regulatory submission) that argues the device meets these implicit criteria. It states: "Claim of Substantial Equivalence of the TissueLink Bipolar Floating Ball device is made to: Identical device, TissueLink Bipolar Floating Ball, K#020574." The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

The expanded indications are: "The TissueLink Bipolar Floating Ball device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery." Earlier clearance (K#020574) likely covered a narrower set of these applications.

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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).

Not Found

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:

1. 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.

2. 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.

3. 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.

4. Adjudication Method for the Test Set:

   • Adjudication Method: Not applicable.

   Explanation: No test set or ground truth adjudication process is outlined in the submission.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

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