Search Results

The Aquamantys single-use disposable Malleable Bipolar Sealer with Light is a sterile, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys Malleable Bipolar Sealer is similar to the Aquamantys 6.0 Bipolar Sealer, cleared via K#052859, in that they are comprised of a pencil-grip handle which houses an electrode terminating at the distal tip. The Aquamantys Malleable Bipolar Sealer is constructed of the same medical device grade materials as the Aquamantys 6.0 except for the LED light circuit and over molded shaft. All biocompatibility data is on file at TissueLink Medical, Inc. A summary is included in Section 5 of this submission. The manufacture of both devices is similar, consisting of an electrode tip/shaft assembly extending out of an ergonomically designed clamshell body. Both devices have two parallel (along the axis of symmetry) electrodes stemming from the handle that are approximately 4-6 millimeters apart. Both devices are electrically insulated, leaving only the tip of each shaft electrically active. Like the Aquamantys 6.0 Bipolar Sealer, each tip of the Aquamantys Malleable is a smooth stainle cylinder with a hemispherical end. Each tip is set at a downward angle between 0° - 45° along the long axis of the device. The Aquamantys 6.0 device has a slot located on each tip oriented lateral to the handle towards the outside of the device, allowing saline to flow from the inner lumen of the hypotube to the electrode. The Aquamantys Malleable device incorporates a hole instead of a slot, similarly oriented lateral to the handle towards the outside of the device. The saline wets the outer surface of the stainless steel electrode tip in a manner identical to the Aquamantys 6.0 Bipolar Sealer. The device is not intended for use without saline. Ten (10) feet of saline tubing and electrical cord are routed distally from the handle. The distal end of the disposable electrical cord contains a standard three (3) prong paddle plug for connection to the Aquamantys Pump Generator System. The saline tubing is connected to an I.V. pump segment. The L.V. pump segment contains a 6" pump tubing portion for loading into the Aquamantys Pump portion of the Aquamantys Pump Generator System and a Drip Chamber/spike set for connection to the saline delivery source. The simultaneous application of saline irrigation and radio-frequency energy allows coagulation of bleeding tissue at much lower temperatures than conventional dry radiofrequency coagulation. This prevents the formation of surface eschar. Most conventional electrosurgical devices create a surface eschar that is hard and scab-like. The Aquamantys Malleable Bipolar Sealer has an optional illumination provided by a LED light positioned between the electrodes at the distal end of the device. It can be switched on or off with a button located on the handpiece and is used to illuminate the surgical site if needed. The Aquamantys Malleable Bipolar Sealer also incorporates a malleable shaft that can be bent by the user into various positions, while maintaining the functionality as identified in the product specifications.

The provided text describes a Special 510(k) submission for the Aquamantys Malleable Bipolar Sealer with Light. This type of submission is used when a modification is made to an existing device that has already received 510(k) clearance, and the modification does not raise new questions of safety or effectiveness. As such, the study conducted is focused on demonstrating substantial equivalence to the predicate device, rather than establishing de novo performance metrics or diagnostic accuracies typically seen in AI/reader studies.

Therefore, many of the typical acceptance criteria and study details related to diagnostic accuracy, such as AUC, sensitivity, specificity, sample size for test sets with ground truth established by experts, MRMC studies, or standalone algorithm performance, are not applicable to this type of device and submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: The "test set" in this context refers to the modifications and features of the new device that were evaluated against the predicate device's established performance and specifications. This is not a clinical test set from patient data.
• Sample Size: Not applicable in the traditional sense of a clinical trial. The evaluation involved comparing the design, materials, and functional aspects of the new device to the predicate device and internal specifications.
• Data Provenance: Not applicable in terms of patient data origin. The data provenance would be from internal engineering and material testing within TissueLink Medical, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable. Ground truth, in the sense of expert consensus on diagnostic findings, is not relevant for this engineering and equivalence testing. The "ground truth" here is the established function and safety of the predicate device and the design specifications of the new device.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring expert adjudication of findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not performed on these devices." This type of study focuses on device modifications and their impact on human interpretation or intervention, which isn't typically required for a Special 510(k) where substantial equivalence is demonstrated through engineering and performance testing.

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

• No. This is not an AI/algorithm-based device. "Standalone performance" in this context would refer to the device's functional performance according to its specifications, which was implicitly done through nonclinical testing.

7. The Type of Ground Truth Used

• Engineering Specifications and Predicate Device Performance: The "ground truth" against which the new device was evaluated consisted of the established performance characteristics and safety profile of the predicate device (Aquamantys 6.0 Bipolar Sealer, K#052859) and internal engineering and quality specifications of TissueLink Medical, Inc.
• The goal was to demonstrate that the changes (malleable shaft, LED light, saline delivery hole instead of slot) did not alter the fundamental safety and effectiveness or introduce new risks, thus maintaining substantial equivalence to the predicate.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. See point 8.

Ask a specific question about this device

The TissueLink SS4.0 bipolar sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein-sealling during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

Aquamantys SS4.0 Bipolar Sealer

This document is a 510(k) Summary of Safety and Effectiveness for the TissueLink Aquamantys SS4.0 Bipolar Sealer and an FDA clearance letter. It describes the device and its intended uses, and claims substantial equivalence to a predicate device.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot fulfill the request for the following information:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

This type of information is typically found in a clinical study report or a more detailed section of a 510(k) submission, not in the summary provided. The 510(k) summary focuses on demonstrating substantial equivalence based on indications for use, technological characteristics, and safety and effectiveness, often by comparison to a predicate device rather than presenting new clinical study data with acceptance criteria for a new device.

Ask a specific question about this device

The Aquamantys™ Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is intended for hemostatic sealing of soft tissue and bone at the operative site. It is intended for, but not limited to, use in orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). For use only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.

The Aquamantys Pump Generator is a shelf top unit consisting of a sheet metal housing, front control panel and side mounted pump. Within the housing resides a main circuit board, a display board and a power supply. The software integrates the flow to the desired power setting and flow level selected. The pump generator can be set from 20 to 200 watts and has high, medium and low flow rate settings.

The Aquamantys system includes the pump generator, cart and specified Aquamantys disposable devices. The Aquamantys BPS 6.0 and the Aquamantys BPS 2.3 are hand held "wand" like devices that consist of a plastic handle with two needle electrodes at one end that interface with the operative site. The other end of the handle has a cable that plugs into the pump generator and have a section of pump tubing that clamps into the peristaltic pump.

Compared to most conventional electrosurgical devices and generators, TissueLink bipolar devices are unique in that they provide simultaneous fluid delivery, as well as the treatment of tissue that is based on simultaneous irrigation and low power density RF energy delivery to tissue that is oozing blood at a slow but steady rate.

The provided text is a 510(k) summary for the TissueLink Aquamantys Pump Generator System. It focuses on demonstrating substantial equivalence to predicate devices and describes the device's function and intended use. However, it does not contain the specific information required to answer your questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what's missing:

• No Acceptance Criteria: The document does not list any specific performance acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or other quantitative measures).
• No Performance Study Results: While it mentions the device, its function, and comparisons to predicate devices for substantial equivalence, it does not present data from a study designed to measure the device's performance against any set criteria.
• No Details on Test Sets, Ground Truth, Training Sets, or Expert Adjudication: These are all elements typically found in studies evaluating the diagnostic or functional performance of a medical device, especially those involving AI or image analysis. This document is a regulatory submission for substantial equivalence based on device description and intended use, not a clinical or performance study report.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

To answer your questions, I would need a document that presents the results of a performance study for the TissueLink Aquamantys Pump Generator System, including details on its evaluation metrics and the methodology used.

Ask a specific question about this device

The TissueLink BPS bipolar sealer 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 Sealer 2.3 (Bipolar Floating Ball) device

This looks like a 510(k) summary for a medical device (TissueLink Bipolar Sealer 2.3). However, this document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or comparative effectiveness studies.

The provided text is a summary discussing:

• The application information (submitter, contacts, device name, classification).
• Claim of substantial equivalence to a predicate device.
• FDA's letter confirming substantial equivalence and market clearance.
• The indications for use statement for the device.

For a medical device like this, acceptance criteria and study details demonstrating performance would typically be found in a separate section of the 510(k) submission, often under "Performance Data," "Bench Testing," "Biocompatibility," "Sterilization," or similar headings. This summary document primarily focuses on regulatory approval and substantial equivalence.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The TissueLink Sealing Forceps (Bipolar Forceps) is a sterile, single use bipolar electrosurgical device intended to be used in general and thoracic electrosurgical applications for coagulating, sealing and transecting tissue. It is intended for, but not limited to abdominal and thoracic surgery, laparoscopic procedures, endoscopic procedures and thoracoscopic procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

TissueLink Sealing Forceps, Model 1 21-202-1

The provided document is a 510(k) summary for a device modification, focusing on regulatory approval for the TissueLink Sealing Forceps. It does not contain information about acceptance criteria, device performance testing, or study details. Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The TissueLink Solid Cylinder monopolar device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radio frequency current and saline for blunt dissection, hemostation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

TissueLink Solid Cylinder monopolar device

The provided document is a 510(k) Premarket Submission for a medical device (TissueLink Solid Cylinder monopolar device) and its corresponding FDA clearance letter. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through performance testing and comparison, rather than detailed clinical study results typical of drug approvals or novel high-risk device PMA submissions.

Therefore, much of the requested information regarding detailed clinical studies, AI performance metrics, and expert consensus for ground truth is not present in this document. The document describes a comparison to a predicate device (TissueLink Monopolar Floating Ball) to demonstrate substantial equivalence, which is a different regulatory pathway than proving novel clinical efficacy through extensive trials with acceptance criteria based on patient outcomes or AI accuracy.

Here's the information that can be extracted and an explanation of why other requested information is not available:

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

The document does not provide a formal table of explicit acceptance criteria with numerical targets and reported performance. Instead, the "acceptance criteria" here are implied by the demonstration of substantial equivalence to the predicate device. This typically means the new device performs similarly in terms of safety and effectiveness characteristics relevant to its intended use.

The document states: "Claim of Substantial Equivalence of the TissueLink Solid Cylinder monopolar device is made to: TissueLink Monopolar Floating Ball". This is the primary "acceptance criterion" for a 510(k) submission: demonstrating that the new device is as safe and effective as a legally marketed predicate.

Reported Device Performance (Implicit): The FDA's clearance letter ("MAR 2 7 2002") confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies that the performance (safety and effectiveness) as demonstrated in the submission was sufficient to meet the substantial equivalence standard. The specific performance parameters tested and their results are not detailed in this summary. These would typically include bench testing for electrical safety, electromagnetic compatibility, power output, tissue effects (e.g., coagulation depth, dissection speed), and biocompatibility.

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

This information is not provided in the summary. For a 510(k) submission of this type (electrosurgical device), testing would primarily involve bench testing, animal studies, and potentially limited human use data to confirm safety and performance relative to the predicate. The summary does not specify sample sizes for any tests, data provenance, or whether data was retrospective or prospective.

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)

This information is not applicable/provided. The concept of "ground truth" established by experts, as typically seen in AI/diagnostic device studies, is not a primary component of a 510(k) submission for an electrosurgical device. Performance is typically assessed through objective measurements (e.g., power output, thermal spread) and potentially histology from animal models, rather than expert interpretation of images or observations.

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

This information is not applicable/provided. Adjudication methods are typically used in clinical trials and diagnostic studies where interpretations or events need to be confirmed by multiple experts. This is not relevant for the type of device and regulatory submission presented.

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

This information is not applicable. This is an electrosurgical device, not an AI or diagnostic imaging device. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this submission.

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

This information is not applicable. This is an electrosurgical device, not an algorithm or AI system. Its performance is always "human-in-the-loop" as it is operated by a surgeon.

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

As explained in point 3, the concept of "ground truth" as typically discussed in AI/diagnostic studies is not directly applicable. If any "ground truth" were to be considered, it would likely be based on:

• Bench Test Standards: Adherence to established engineering and electrical safety standards.
• Animal Models: Histological analysis of excised tissue from animal studies to assess coagulation depth, tissue damage, etc., compared to the predicate device.
• Performance Metrics: Objective measurements of device function (e.g., power delivery, impedance) under various conditions.

The specific details of these are not provided in the summary.

8. The sample size for the training set

This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable/provided. As above, this is not an AI/machine learning device.

Summary of what is known from the provided text:

• Device Type: Electrosurgical Cauterizing Pen (TissueLink Solid Cylinder monopolar device).
• Predicate Device: TissueLink Monopolar Floating Ball.
• Regulatory Pathway: 510(k) Pre-Market Notification, demonstrating substantial equivalence to a predicate device.
• Indications for Use: Sterile, single use, electrosurgery device used with an electrosurgical generator for radiofrequency current and saline delivery, for blunt dissection and hemostasis of soft tissue in endoscopic and open abdominal and thoracic surgery. Not for contraceptive tubal coagulation.
• FDA Determination: Substantially equivalent to legally marketed predicate devices.

The provided document is too brief and of a different regulatory scope to contain the detailed clinical study and AI-specific information requested. It's a regulatory clearance document for a relatively mature technology where safety and performance are established through comparison to a well-understood predicate.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device