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The Aquamantys™ Minimally Invasive Sealer (MIS) FLEX and Aquamantys™ Minimally Invasive Sealer (MIS) Flex Mini are sterile, single-use bipolar electrosurgical devices intended to be used in conjunction with a qualified Pump Generator for delivery of Radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. They are intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. These devices are not intended for contraceptive tubal coagulation (permanent female sterilization).

MIS FLEX and MIS FLEX Mini are single-use, disposable, bipolar devices. The MIS FLEX and MIS FLEX Mini employ radio-frequency (RF) energy and saline irrigation (termed Transcollation Technology™) for hemostatic sealing and coagulation. The devices are equipped with dual electrode tips while 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 either of the FDA cleared AEX (K143175) or Aquamantys (K052859) Pump Generators. The MIS FLEX devices feature a fully malleable shaft, altered saline delivery and dual ports for saline delivery (two for each electrode). The distal end of the device features small, rounded electrode geometry. The MIS FLEX and MIS FLEX Mini differ by the length of the shaft. The MIS FLEX is designed for transsphenoidal and MIS Spine procedures while the MIS FLEX Mini is designed for craniotomies with application in posterial cervical and other spinal procedures.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the manner typically seen for performance claims like accuracy, sensitivity, or specificity. This document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel performance against acceptance criteria.

However, based on the information provided, I can infer the "acceptance criteria" were primarily related to safety, electrical performance, biocompatibility, and functional access. The "study" refers to the non-clinical testing performed to demonstrate these aspects.

Here's an interpretation based on the document's content:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

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

The document does not specify exact sample sizes for most tests.

• Cadaver Study (Anatomical Access): "The access study was conducted to ensure that the MIS FELX will be able to access key anatomy..." No sample size (number of cadavers) is given. Data provenance is not specified beyond being an "access study."
• In-vivo Porcine Model (Comparative Performance): "The second study was a comparative performance test, which was conducted in an in-vivo porcine model." No specific number of animals is given. Data provenance is "in-vivo porcine model."
• Ex-vivo Tissue Testing (Comparative Performance): "Ex-vivo tissue testing was also completed." No sample size (number of tissue samples) is given. Data provenance is "ex-vivo tissue."
• Biocompatibility, Sterilization, Shelf Life, Electrical Safety, EMC, Mechanical Testing: These are generally performed on device units. The specific number of units tested is not provided, which is typical for a 510(k) summary. Data provenance would be laboratory testing.

All testing described appears to be prospective, laboratory-based, or animal-based, as part of the device development and validation process. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities or contract labs.

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

• Cadaver Study (Anatomical Access): The document mentions ensuring access to "key anatomy and meet customer needs for neurosurgical and spine procedures." This implies involvement of medical experts (e.g., neurosurgeons, spine surgeons). However, the number of experts, their qualifications, or how they established "ground truth" for access (e.g., by subjective evaluation, objective measurement of reach) is not specified.
• For other tests (biocompatibility, electrical safety, thermal effect), "ground truth" is typically defined by adherence to recognized standards and objective measurements, rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for a device of this type, especially for performance studies described. The "acceptance" was based on meeting pre-defined requirements or demonstrating substantial equivalence to a predicate, not on a human-expert adjudication of results. For the access study, evaluation criteria for "meeting needs" would have been set by the manufacturer, possibly in consultation with clinicians, but an adjudication method is not described.

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

• No, an MRMC comparative effectiveness study was not done. The document describes a "comparative performance test" for thermal effect, but this was a technical comparison of the device against a predicate in animal and ex-vivo models, not a study evaluating human readers' performance with and without AI assistance. This device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system that would typically warrant an MRMC study.

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

• This question is not applicable as the device is not an algorithm or AI system. It is a physical electrosurgical device. The "standalone" performance refers to its direct functional capabilities (e.g., thermal effect, access).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Biocompatibility: Adherence to ISO standards, measured biological responses (e.g., cytotoxicity, irritation, sensitization).
• Electrical Safety & EMC: Adherence to IEC standards, objective electrical measurements.
• Performance (Thermal Effect): Objective measurements of thermal effect (e.g., temperature, tissue charring, coagulation depth) in animal and ex-vivo models, compared against the predicate and potentially against defined specifications derived from predicate performance. The "ground truth" is primarily the measured physical effect relative to established benchmarks and predicate performance.
• Performance (Anatomical Access): Likely subjective or objective assessment of the device's ability to reach target anatomical locations in cadavers, possibly based on expert opinion/feedback from surgeons.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical electrosurgical instrument, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Not applicable, as there is no training set for this type of device.

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The PlasmaBlade T is a monopolar, single use, sterile, disposable device intended for use with the AEX Generator. The device delivers RF energy concurrent with saling and coagulation of soft tissue and bone and RF energy for cutting and coagulation of soft tissue. It is intended for, but not limited to. General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal, Thoracic, and Open abdominal surgery procedures.

The PlasmaBlade T should not be used on small appendages or body parts, as in circumcision. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The proposed single-use disposable accessory device, the PlasmaBlade T monopolar handpiece, provides the hemostatic capabilities of the Aquamantys SBS 5.0 Handpiece (Cleared under K111732, K132974) and the cutting and coagulative capabilities of the PEAK PlasmaBlade 3.0S (Previously cleared under K093695).

The proposed PlasmaBlade T Handpiece device is a monopolar, single use, disposable device and is provided sterile. The devices are not intended for reuse or resterilization. The PlasmaBlade T handpiece consists of an enamel coated insulated blade electrode with an uncoated circular electrode, an insulated telescoping shaft, handle with three integrated controls, and a co-extruded cable assembly to provide both power and saline. The seven-pin electrical connector is designed to be plugged into the AEx Generator (Cleared under K143175).

The proposed PlasmaBlade T Handpiece is a disposable device, that when connected to the AEX Generator (K143175), uses monopolar RF energy for the resection and coagulation of soft tissue and bone. The proposed PlasmaBlade T Handpiece device provides similar resection and coagulative effect to the predicate device, the PlasmaBlade 3.0S Monopolar Handpiece (Cleared under K093695).

In addition to the monopolar cutting and coagulation capabilities the proposed PlasmaBlade T Handpiece device also uses monopolar RF energy concurrent with saline delivery to provide a broader coagulative effect; similar to the predicate Aquamantys SBS 5.0 Handpiece (Cleared under K111732, K132974), this result is trademarked as Transcollation® Technology by Medtronic. The proposed PlasmaBlade T Handpiece device also has a pump header tubing segment and saline bag spike tubing allowing the user to manually connect the device to saline source in the OR as well as the AEX Generator's peristaltic pump. This ensures the device is connected for saline delivery at the same time as the device is connected electrically to the proposed AEX Generator.

This document describes a 510(k) premarket notification for the PlasmaBlade T device, an electrosurgical cutting and coagulation device. The information provided focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

Key Takeaway: The provided document is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving a novel device meets specific (and often more stringent) acceptance criteria through exhaustive clinical trials typically associated with a "new" device. For 510(k)s, "acceptance criteria" are generally tied to showing that the new device performs as safely and effectively as the predicate, often through a combination of bench testing and, sometimes, animal studies. Clinical trials (human studies) are usually not required for 510(k)s unless there are significant differences in technology or indications from the predicate that raise new questions of safety or effectiveness.

Based on the information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a formal table of quantitative acceptance criteria with corresponding performance metrics like one might see for an AI-driven diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices through various non-clinical tests.

Study Type: Non-Clinical Performance Testing (Bench and Animal) to demonstrate substantial equivalence.

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

• Sample Size: The document does not specify exact sample sizes for each type of bench testing (e.g., number of devices tested for sterilization, number of cycles for activation testing). For the in-vivo animal model, it states that testing was "completed" but does not give the number of animals or trials.
• Data Provenance: Not explicitly stated, but typically, these tests are conducted in a laboratory setting (e.g., Medtronic's R&D facilities or contracted labs) within the country of manufacture or testing. The document implies these were conducted specifically for this submission, making them prospective data for the purpose of this regulatory filing. There is no mention of country of origin for the data specifically.

3. Number of Experts and Qualifications for Ground Truth Establishment:

This question is largely not applicable to this type of device and study.

• This is not an AI/diagnostic device where human expert labels establish ground truth on patient data.
• Ground truth for functional performance (e.g., cutting, coagulation, thermal spread) in bench and animal studies is established through direct physical/physiological measurement and observation, not through expert consensus on interpretation. For instance, the "zone of thermal damage" is a measurable characteristic of tissue effect.
• The FDA guidance document mentioned ("Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff") served as the standard against which the tests were designed and evaluated by the manufacturer's engineers and scientists.

4. Adjudication Method for the Test Set:

Not applicable in the context of expert adjudication for diagnostic labeling. Performance testing involves direct measurement and comparison to predefined criteria or predicate device performance. Engineer/scientist review of test results would be the "adjudication" (verification) method for non-clinical studies.

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

• No, an MRMC study was NOT done.
• The device is an electrosurgical instrument, not an imaging or diagnostic AI device where human readers interpret cases. The human "user" is a surgeon performing a procedure, not "reading" data.
• The study focuses on the device's physical and functional performance, not on improving human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Technically, all the studies described (bench and animal) are "standalone" in the sense that they are evaluating the device's intrinsic performance characteristics without a human user's interpretive decision-making being part of the primary endpoint.
• The "human-in-the-loop" for this device is the surgeon using it during a procedure for its intended purpose (cutting, coagulating, sealing), not interpreting data generated by the device. The non-clinical studies assess the device's ability to perform these actions comparably to predicates.

7. Type of Ground Truth Used:

The ground truth for the performance claims in this submission is established through:

• Physical/Chemical Measurements: For sterilization, electrical safety, mechanical integrity, shelf-life.
• Direct Observation/Measurement on Animal Tissue: For functional performance related to cutting, coagulation, and critically, the "zone of thermal damage imparted on the tissue." This is akin to a pathological/physiological ground truth as it directly measures the device's effect on biological tissue.
• Comparison to Predicate Device Performance: The primary "ground truth" for substantial equivalence is the established safe and effective performance of the predicate devices. The new device must demonstrate comparable performance across the relevant tests.

8. Sample Size for the Training Set:

Not applicable. This device is hardware (an electrosurgical instrument), not an algorithm that requires a "training set" of data in the machine learning sense.

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

Not applicable. (See point 8).

In summary, the 510(k) submission for the PlasmaBlade T device relies on comprehensive non-clinical testing (bench and animal studies) to demonstrate substantial equivalence to its predicate devices. The "acceptance criteria" are implicitly met by showing that the new device performs comparably to the predicates in terms of safety and effectiveness across various functional and physical tests, including the critical aspect of tissue effect (thermal damage). Clinical human studies were not required for this type of device and submission pathway.

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The CoreCath 2.7S 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, providing electrosurgical hemostasis, and evacuation of surgical smoke during such procedures.

The CoreCath 2.7S is a disposable, single-use monopolar RF (radiofrequency) surgical device intended to be use for ablation and hemostasis of soft tissue obstructions in upper airways and tracheobronchialtree. The CoreCath 2.7S is terminally sterilized via ETO. It is comprised of a cylindrically shaped, disposable monopolar cutting and coagulation electrode affixed to the distal end of a polymeric. flexible multi lumen shaft and cabling, intended for connection to the monopolar output port of the Medtronic Advanced Energy AEX Generator (K143175). The CoreCath 2.7S is intended to be energized for use by the footswitch accessory supplied with the AEX Generator. It has an active length of approximately 750 mm and a maximum diameter crossing profile of 2.68 mm. It is sized such that may be delivered through the working channel of a flexible bronchoscope 2.8 mm diameter working channel and working length of 600 mm.

The provided text describes a medical device, the CoreCath 2.7S, and its regulatory submission (510(k)). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML device.

The document is a 510(k) premarket notification decision letter from the FDA, along with the device's Indications for Use and a 510(k) Summary. It focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than what would be required for an AI/ML-powered diagnostic or treatment device with specific performance metrics.

Specifically, the document states:

• "Summary of Clinical Tests: Clinical testing was not required for this product." This indicates that no human clinical efficacy study was performed or required for this device to gain market clearance.
• "Summary of Non-Clinical Testing: The design and performance of the modified CoreCath 2.7S were verified and validated through bench testing." This refers to engineering and safety bench tests, not performance against specific clinical or diagnostic metrics as one would find for an AI/ML device.
• "Comparative performance testing was conducted in an in-vivo animal model. Ex-vivo tissue testing was also completed. Thermal effect of the CoreCath 2.7S in both the in-vivo and ex-vivo model was substantially equivalent to that of the predicate device." This confirms substantial equivalence primarily on thermal effects and other aspects related to an electrosurgical instrument, not AI/ML performance.

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document describes a traditional electrosurgical device, not an AI/ML product.

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