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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 PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).

The PEAK PlasmaBlade® TnA is a single-use, disposable, electrosurgical instrument consisting of two PlasmaBlade tips (Tonsil tip and Adenoid tip) designed to be attached to the PlasmaBlade ENT handpiece (cleared as the PEAK PlasmaBlade TnA handpiece via K083415). The device also includes a wire cleaning brush designed to remove eschar build up and maintain a clear channel for suction.

The Adenoid Tip consists of a wire electrode housed in a plastic tip with a bendable suction lumen that allows for the evacuation of tissue, fluids, and smoke. It connects to the suction shaft of the handpiece.

These device is used with PULSAR I (K073057), PULSAR II (K102029) and AEX (K143175) Electrosurgical Generators. It provides radio-frequency energy for cutting and coagulation of soft tissue. The PEAK PlasmaBlade ENT handpiece has integrated buttons for Cut and Coag, which may be used to operate the device, or it may be activated with an optional footswitch supplied with the Generators.

This FDA document is a 510(k) summary for the Medtronic PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Acceptance Criteria and Device Performance (as implied by the document):

The document does not explicitly state "acceptance criteria" in a quantitative table format with specified thresholds. Instead, it relies on demonstrating substantial equivalence to predicate devices. The implicit acceptance criteria are that the modifications to the device (specifically the Adenoid Tip) do not raise new issues of safety or effectiveness compared to the predicate devices.

The reported device performance is that it is "substantially equivalent" to predicate devices. The summary claims this equivalence based on characteristics, intended use, technology, and non-clinical testing.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document mentions "comparative performance testing conducted in an in-vivo animal model." It doesn't specify the number of animals or trials.
   • Data Provenance: The "in-vivo animal model" suggests animal data, likely pre-clinical, rather than human clinical data. The location of the testing (country of origin) is not mentioned. It is a prospective study as it was conducted to verify and validate the modified device.

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

   • Not applicable. This was an in-vivo animal model study focused on thermal effects, not an expert-based clinical review or diagnostic accuracy study which would typically involve expert consensus. The "ground truth" here would relate to measurements of thermal tissue damage, which would be objectively measured using scientific methods.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging or diagnostic studies. For an in-vivo animal study measuring thermal effects, the "ground truth" would be determined by direct physical or biological measurements.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required for this product." MRMC studies typically involve human readers interpreting cases to assess diagnostic performance or impact on clinical decision-making.

   • Effect size of human readers improvement: Not applicable, as no MRMC study was performed.

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

   • This is a medical device for surgical intervention (electrosurgical instrument). The concept of "standalone algorithm performance" typically applies to AI/software as a medical device (SaMD) for diagnostic or predictive purposes. For an electrosurgical instrument, its performance is inherently "standalone" in mechanical/electrical function, but it always operates with a surgeon (human-in-the-loop). The non-clinical and pre-clinical testing assesses the device's physical performance characteristics (e.g., cutting, coagulation, thermal effect) independent of human variability in interpretation, but not in a "standalone algorithm" sense.

6. The type of ground truth used:

   • For the in-vivo animal model, the "ground truth" for comparative thermal effect likely involved direct measurement or histological assessment of tissue damage (e.g., depth of necrosis, adjacent tissue effects) caused by the device and the predicate device. For bench testing, it would involve objective physical measurements (e.g., power output, temperature, tissue cutting characteristics).

7. The sample size for the training set:

   • Not applicable. This device is a physical electrosurgical instrument, not an AI/machine learning algorithm that requires a "training set" of data.

8. 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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