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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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