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The Medtronic Total Hip Arthroplasty System is indicated for cement-less use only in the following cases:

• . Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• . Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and
• Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques

The Medtronic Total Hip Arthroplasty System Acetabular Screws are intended for supplemental fixation of the associated Medtronic Acetabular Cup.

The Medtronic Total Hip Arthroplasty System is a total hip system for the restoration of alignment, stability range of motion, and alleviation of pain, by replacing the articulating surfaces of the hip joint. The system includes femoral and acetabular components. The implants are available in a variety of sizes to accommodate varying patient anatomy.

New acetabular components including highly crosslinked UHMWPE acetabular liners and porous coated cups are the subject of this 510(k).

I am sorry, but the provided text does not contain information about an AI/ML-based medical device. The document is an FDA 510(k) clearance letter for the Medtronic Total Hip Arthroplasty System, a physical medical device (hip prosthesis).

Therefore, I cannot provide details on acceptance criteria, study methodologies, or performance related to AI/ML models as these elements are not present in the document. The document explicitly states: "Clinical Testing was not required for these products." and focuses on non-clinical (bench) testing for the hip implant's materials and wear characteristics.

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The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.

PlasmaBlade X 4.0: The PlasmaBlade™ X 4.0 is a single-use- only device designed for use with qualified Generators as a System (Surgery System). The PlasmaBlade™ X has integrated hand switch control, or alternatively, may be controlled with a qualified Footswitch, supplied as an optional accessory to the Generator. The PlasmaBlade™ X 4.0 consists of a single bendable shaft and rotatable nose piece that can be adjusted by hand. The system components are designed to be used together and operated as a single unit.

PlasmaBlade X 3.0S: The PlasmaBlade™ X 3.0S is a single-use, monopolar RF device. It is designed to be used with the qualified Generators as part of the Surgery System. It can be operated with the integrated hand switch or a qualified Footswitch. The PlasmaBlade™ X 3.0S consists of a single bendable blade and telescoping shaft that can be configured in both standard and extended length. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids.

This document is a 510(k) Premarket Notification from the FDA regarding Medtronic's PlasmaBlade X 4.0 and PlasmaBlade X 3.0S devices. It does not describe an AI/ML-driven medical device, but rather an electrosurgical cutting and coagulation device. Therefore, the requested information about acceptance criteria for an AI/ML device, including details about test sets, expert ground truth, MRMC studies, and training sets, is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis based on the provided document, addressing what information is not applicable and what little can be inferred:

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

• Not Applicable in the AI/ML sense. This document doesn't define quantitative performance metrics (like accuracy, sensitivity, specificity) for an AI/ML algorithm.
• Implied Acceptance Criteria for an Electrosurgical Device: The acceptance criteria for this device appear to be primarily related to safety and functionality, demonstrating that it performs as intended for cutting and coagulation of soft tissue and that its thermal effect is substantially equivalent to predicate devices.
• Reported Device Performance: "The thermal effect of the X series of products was found to be substantially equivalent to that of the predicate devices." This is a qualitative statement of equivalence, not a specific quantitative performance metric.

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

• Not Applicable/Not Provided. The document mentions "comparative performance testing was conducted in an in-vivo/ex-vivo animal model." It does not specify the sample size of animals or the details of the "test set" in an AI/ML context. Data provenance (country, retrospective/prospective) is also not provided.

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. "Ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant for an electrosurgical device's performance evaluation as described here. The evaluation seems to be based on physical measurements of thermal effect.

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

• Not Applicable. No human interpretation or adjudication of output is described.

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 an electrosurgical device, not an AI-assisted diagnostic tool. No MRMC study was performed or needed.

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

• Not Applicable. There is no "algorithm" in the AI/ML sense to test standalone performance. The device itself is the "standalone" item being evaluated for its physical effects.

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

• Not Applicable. The "ground truth" for this device's evaluation would be physical measurements of thermal effect in animal tissue, comparing it to predicate devices. It's not a diagnostic or prognostic tool requiring expert consensus or pathology for "ground truth."

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set for model development.

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

• Not Applicable. There is no training set mentioned or implied.

In summary, this document is a regulatory submission for a physical medical device (electrosurgical) and does not contain the information requested for evaluating an AI/ML-driven device's acceptance criteria and study data.

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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

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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.

• "hemostatic capabilities of the Aquamantys SBS 5.0 Handpiece" (Predicate K111732, K132974)
• "cutting and coagulative capabilities of the PEAK PlasmaBlade 3.0S" (Predicate K093695).
  "The proposed PlasmaBlade T Handpiece device provides similar resection and coagulative effect to the predicate device, the PlasmaBlade 3.0S Monopolar Handpiece."
  "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." |
  | Similar Tissue Effect (Safety): The thermal damage profile imparted on tissue is comparable to predicate devices. | "The in-vivo testing determined the zone of thermal damage imparted on the tissue by the proposed devices was comparable to the predicates." |
  | Biocompatibility: Device materials are suitable for contact with tissue. | "Biocompatibility" testing was conducted and passed. (No specific performance data given, but implied acceptance by passing this test). |
  | Sterilization Efficacy: The device can be effectively sterilized. | "Sterilization" testing was conducted and passed. |
  | Electrical Safety/Electromagnetic Compatibility (EMC): The device meets electrical safety and EMC standards. | "Electrical Safety/EMC" testing was conducted and passed. |
  | Mechanical Integrity/Durability: The device maintains its mechanical integrity through transit, shelf life, and during use. | "Transit," "Shelf Life," "Mechanical Testing," and "Activation Testing" were conducted and passed. |

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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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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The PEAK PlasmaBlade UPPP is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including, uvulopalatopharyngoplasty (UPPP) and tonsillectomy (Pharyngeal, Tubal, Palatine).
The PEAK PlasmaBlade Suction Coagulator device is intended for use in surgical procedures such as general and otolaryngology (ENT) including, uvulopalatopharyngoplasty (UPPP), tonsillectomy, and adenoidectomy, where coagulation of tissue and suction of fluids are desired. It is not intended to be used as a dissection instrument.

The PEAK PlasmaBlade® UPPP and Suction Coagulator is a single-use, disposable, electrosurgical instrument consisting of two PlasmaBlade tips (UPPP tip and Suction Coagulator tip) designed to be attached to the Plasmablade ENT handpiece (cleared as the PEAK Plasmablade TnA handpiece via K083415). These devices are used with Pulsar I (K073057) and Pulsar II (K102029) Electrosurgical Generators. The devices provide radio-frequency energy for cutting (UPPP tip only) and coagulation of soft tissue and contain integrated suction for the evacuation of smoke and fluids from the surgical site. 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 Pulsar Generators.

This document, K150297, is a 510(k) premarket notification for the PEAK PlasmaBlade UPPP and Suction Coagulator. It describes the device and its intended use, and argues for its substantial equivalence to previously marketed predicate devices.

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

Based on the provided text, the acceptance criteria are primarily related to electrical safety and performance equivalence to predicate devices. The reported device performance is that these criteria were met through non-clinical testing.

• IEC 60601-1:2005 3rd Edition And A1:2012 (Medical electrical equipment-Part 1: General requirements for safety and Essential Performance)
• IEC 60601-2-2 Edition 5.0 2009-02 (Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) |
  | Performance and Thermal Effect (in-vivo) | Equivalent to that of the predicate device, demonstrated in an in-vivo animal model utilizing GLP. |
  | Device Validation for Intended Use | Further validated through cadaveric testing. |

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

• Sample Size: The document does not specify the exact sample size for the in-vivo animal model or the cadaveric testing. It only states that these tests were conducted.
• Data Provenance:
  • In-vivo animal model: Utilized GLP (Good Laboratory Practice), suggesting controlled experimental conditions. No specific country of origin is mentioned.
  • Cadaveric testing: Conducted to validate intended use. No specific country of origin is mentioned.
  • Electrical Safety testing: Performed in accordance with international standards (IEC), implying laboratory testing.

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

This section is not applicable as the document describes a medical device (electrosurgical instrument) and its safety and functional equivalence, not an AI/ML-based diagnostic or prognostic device requiring expert-established ground truth on a test set. The validation is through engineering tests and performance comparison to established predicate devices.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. There is no mention of human subjectivity or expert review in the "test set" described (animal and cadaveric performance, electrical safety).

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 section is not applicable. This submission is for an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool or an imaging device that would involve human readers.

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

This section is not applicable. The device is an electrosurgical instrument, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context refers to established standards and observable physical outcomes:

• Electrical Safety: Defined by compliance with international consensus standards (IEC 60601-1 and IEC 60601-2-2).
• Performance and Thermal Effect: Demonstrated by equivalence to the predefined performance characteristics and thermal effects of the predicate device in a biological model (in-vivo animal model).
• Intended Use Validation: Confirmed through cadaveric testing, ensuring the device functions as expected in a simulated surgical environment.

8. The sample size for the training set

This section is not applicable. The PEAK PlasmaBlade UPPP and Suction Coagulator is a physical medical device, not an AI/ML model that requires a training set.

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

This section is not applicable for the same reasons as point 8.

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AEx Generator:
The AEx Generator is a radio frequency (RF) electrosurgical generator capable of simultaneously powering specified monopolar and bipolar electrosurgical instruments. It is intended to be used for delivery of RF energy to instruments indicated for cutting and coagulation of soft tissue and for delivery of RF encrgy concurrent with saline to instruments indicated for hemostatic sealing and coagulation of soft tissue and bone. 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, Gyneologic, Orthopaedic. Arthroscopic, Spinal and Neurological, Thoracic, and Open Abdominal Surgery procedures. The device is not intended for contraceptive tubal coagulation (Permanent Female Sterilization).

PlasmaBlade T:
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 device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Currently included as part of the system in this 510(k) submission are the AEX Generator, and the PlasmaBlade T Handpiece which is a one hand-held disposable, sterile, single use disposable electrosurgical device that is compatible only with the AEX Generator.

The AEX Generator is a line powered, electrosurgical generator with monopolar and bipolar RF that is intended for use only with specific compatible Medtronic electrosurgical Handpieces. The AEX Generator is a shelf-top unit consisting of a plastic, metal housing and a front LCD control panel. The Generator has a peristaltic pump outside the generator's housing, which is capable of transferring saline through the disposable accessory device concurrent with the generator's provision of RF energy. The LCD control panel is a touchscreen and serves as the user interface for power and saline settings. The AEX Generator has three-pin and seven-pin receptacles in its front panel that provides for the monopolar PlasmaBlade and bipolar Aquamantys disposable Handpieces connection to the Generator's RF power.

The proposed PlasmaBlade T Handpiece connection to the AEX Generator pump is configured to interface with the AEX Generator peristaltic pump. The AEX Generator accepts designated, commercially available, split-pad and single foil patient return electrode pads (neutral electrodes), non-REM neutral electrodes for monopolar applications

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a structured table or numerical values for performance metrics. Instead, it relies on a comparison of the proposed device's performance to that of predicate devices, stating it is "comparable" or shows "no clinically significant difference."

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

• Sample Size: The document mentions "in-vivo, ex-vivo animal (porcine) studies" for thermal effects on tissue. However, it does not specify the number of animals or specific samples used in these studies.
• Data Provenance: The studies were animal (porcine) studies and were conducted as non-clinical testing. The document does not specify the country of origin.

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

The document does not mention the use of experts to establish ground truth for the animal studies in the context of human diagnosis or interpretation. The "ground truth" for the thermal effects appears to be directly measured or observed in the porcine tissue. For compliance with standards, the "ground truth" is adherence to the standard's requirements, which would typically be assessed by qualified engineers/testers, but no specific number or qualifications are provided.

4. Adjudication Method for the Test Set

Not applicable. The non-clinical testing and comparison against predicate devices do not involve an adjudication method in the context of human interpretation or diagnosis.

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

No. The document describes non-clinical testing (animal studies, software verification, EMC, electrical safety, bench-top performance) that compares the proposed device to predicate devices. It does not mention any clinical studies involving human readers or cases, nor a multi-reader multi-case (MRMC) comparative effectiveness study to assess human reader improvement with or without AI assistance. The device in question is an electrosurgical generator and handpiece, not an AI diagnostic tool.

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

Not applicable. The device is a physical electrosurgical system, not an algorithm or AI. The performance studies focus on the hardware's functional capabilities.

7. Type of Ground Truth Used

For the "Thermal Effects on Tissue" studies, the ground truth appears to be direct measurement or observation of thermal damage in porcine tissue. For the other tests (Software, EMC, Electrical Safety, Bench-top), the ground truth is compliance with recognized consensus standards and verification of output characteristics.

8. Sample Size for the Training Set

Not applicable. The device is an electrosurgical generator and handpiece, not a machine learning model that requires a training set.

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

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

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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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