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The Aquamantys 2.3 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, neurosurgical, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys Epidural Vein 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, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys SBS 5.0 Sheathed 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, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys Bipolar Sealer is a sterile, single-use bipolar device. The device employs radio-frequency (RF) energy and saline irrigation for hemostatic sealing and coagulation. The device is equipped with a dual electrode tip. Saline and electrical lines exit the opposite end of the handpiece from the electrodes. The handpiece is equipped with an on-off button that simultaneously activates both RF and saline flow. A saline fluid delivery line is provided with the device, and includes a section of pump tubing and drip chamber or spike. The three-pin electrical connector is designed to be plugged into the Aquamantys Pump Generator.

The provided text describes a 510(k) summary for the Aquamantys Bipolar Sealers, focusing on demonstrating substantial equivalence to a predicate device. It explicitly states that clinical studies were not required or conducted for the proposed neurosurgical expanded indications. Therefore, the information typically associated with an AI/ML device study (e.g., acceptance criteria, sample size, ground truth establishment, MRMC studies) is not present.

However, I can extract information regarding the non-clinical comparative performance data that was conducted.

Here's the breakdown of the information that can be extracted from the provided text, and the parts that state it's not applicable for this device:

Acceptance Criteria and Device Performance Study for Aquamantys® Bipolar Sealers

This document pertains to the 510(k) submission for the Aquamantys® 2.3 Bipolar Sealer, Aquamantys® EVS 4.0 Epidural Vein Sealer, Aquamantys® Mini EVS 3.4 Epidural Vein Sealer, and Aquamantys® SBS 5.0 Sheathed Bipolar Sealer. The submission aims to demonstrate substantial equivalence to a predicate device, the Codman Irrigated Bipolar Forceps.

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

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

• Sample Size: Not explicitly stated for the non-clinical test.
• Data Provenance: Ex-vivo porcine brain tissue.

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

• Not applicable. The non-clinical test involved objective measurement of thermal zone damage rather than expert interpretation of medical images.

4. Adjudication method for the test set

• Not applicable. The non-clinical test involved objective measurement of thermal zone damage.

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 device is an electrosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Clinical studies were explicitly stated as not required or conducted for the neurosurgical indications in this submission.

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

• Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

• For the non-clinical test, the "ground truth" was derived from objective measurements of thermal zone damage in ex-vivo porcine tissue, compared directly to the predicate device.

8. The sample size for the training set

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

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

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

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The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer is a single use, sterile. bipolar device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue at the operative site. It is intended for. but not limited to, abdominal, and thoracic surgery, endoscopic, laparoscopic, and thoracoscopic procedures.

The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys Endo DBS 8.7 device is a handheld "wand-like" disposable that, when connected to the Aquamantys Pump Generator, uses bipolar radio-frequency energy concurrent with saline for hemostatic sealing and coagulation. The device is equipped with dual electrodes at the distal tip. Saline and electrical lines enter from the opposite end (proximal end) of the device's hand piece from the distal electrodes. The device's hand piece is equipped with a blue button that activates bipolar RF energy concurrent with saline flow for blunt dissection and for hemostatic sealing and coagulation. The long, stainless steel shaft allows for the device to be used in laparoscopic, endoscopic and thoracoscopic procedures. A saline fluid delivery line is provided with the device, which includes a drip chamber/spike for insertion into saline bags. The proposed device connects to the Aquamantys Pump Generator using a three-pronged connector.

This document describes the Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer, a device intended for surgical hemostasis and coagulation. The provided text, a 510(k) summary, outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several bench performance tests conducted to verify and validate the Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer. However, specific quantitative acceptance criteria or detailed performance results (e.g., pass/fail thresholds, numerical outcomes) for each test are not explicitly stated in the provided text. The summary only broadly confirms that the device "has undergone bench performance testing to verify and validate the performance features and specifications."

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

The document states that the device "has undergone bench performance testing" and "animal tissue testing." However, the exact sample size used for these test sets and the data provenance (e.g., country of origin, retrospective or prospective) are not specified in this 510(k) summary.

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

The summary does not mention using experts to establish ground truth for the test set. The testing described appears to be primarily engineering and physical performance testing, and animal tissue testing, rather than human-expert-reviewed clinical or image-based evaluations.

4. Adjudication Method for the Test Set:

Given that expert-established ground truth is not mentioned, an adjudication method is not applicable and not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it discussed in the document. The submission explicitly states: "Clinical testing was not required to establish substantial equivalence between the proposed and predicate devices." This device is a surgical instrument, not an AI or diagnostic imaging device that would typically undergo MRMC studies.

6. Standalone Performance Study:

A standalone performance study (algorithm only without human-in-the-loop) was not applicable and not performed. The device is a surgical instrument and not an AI algorithm. The performance testing conducted was on the device itself (bench and animal tissue).

7. Type of Ground Truth Used:

For the bench performance tests, the "ground truth" would be established by engineering specifications and validated test methods. For the animal tissue testing, the "ground truth" for hemostatic sealing and coagulation would be assessed through direct observation and measurement of the tissue response during and after device application. The document does not specify if these assessments were quantitative or qualitative, or who performed them.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable as this is a physical medical device (electrosurgical accessory), not an AI algorithm requiring training data.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no training set mentioned for this device.

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The EC 2.7 Endoscopic Cutter is a single use electrosurgical instrument designed to be used with flexible bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in upper airways and tracheobronchial tree, and provision of electrosurgical hemostasis during such procedures.

The EC 2.7 Endoscopic Cutter is a disposable, single-patient-use monopolar RF (radio-frequency) surgical endotherapy device intended to be inserted through the working channel of a flexible bronchoscope. The EC 2.7 Endoscopic Cutter is terminally sterilized via ETO. It is comprised of a separately packaged, cylindrically shaped, disposable monopolar cutting and coagulation electrode affixed to the distal end of a polymeric, flexible multi lumen shaft , and a separately packaged, single-patient-use, electrical adaptor with cabling, intended for connection to the monopolar output port of a Covidien® Corporation, ValleyLab™ Force FX™ or FX-C Electrosurgical Generator. The ValleyLab™ Force FX™ was cleared to market via 510(k) K944602.

The provided text describes a 510(k) premarket notification for the Medtronic Advanced Energy LLC EC 2.7 Endoscopic Cutter. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the typical format of a performance study with specific metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and adherence to recognized standards.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document does not present a table of specific quantitative acceptance criteria or reported device performance in the manner requested (e.g., sensitivity, specificity, accuracy).

Instead, it lists performance testing methods as evidence of compliance and substantial equivalence:

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

The document mentions "bench testing, human cadaveric studies and in vivo animal data collection." However, specific sample sizes for these tests are not provided. The provenance (country of origin, retrospective/prospective) of these studies is also not specified.

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 device is an electrosurgical cutting tool, not an AI/imaging device requiring expert ground truth for classification. Therefore, this information is not applicable and not present in the document.

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

Not applicable to this type of device and submission. The performance testing focuses on functional parameters, material compatibility, and adherence to standards, rather than diagnostic accuracy requiring adjudication.

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 MRMC study was conducted or is relevant to this electrosurgical device. This type of study is specific to AI-powered diagnostic tools.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the non-clinical performance data (bench, cadaveric, animal studies), the "ground truth" would be related to the observed physical effects and measurements, such as:

• Bench Testing: Direct physical measurements (e.g., cutting depth, coagulation area, power output, electrode integrity), functional evaluations (e.g., ability to cut specific tissue analogs), and material science tests.
• Human Cadaveric Studies: Observation of tissue cutting and coagulation characteristics on post-mortem human tissue.
• In Vivo Animal Studies: Direct observation of the device's effects on live animal tissue (e.g., cutting, coagulation, hemostasis, tissue response) under simulated surgical conditions.

These "ground truths" are based on direct physical and biological interaction observations and measurements, often compared to the known effects of the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/machine learning algorithm.

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

Not applicable for the same reason as point 8.

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