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The Sonicision™ cordless ultrasonic dissection device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision™ cordless ultrasonic dissection device can be used to coagulate isolated vessels up to 5 mm in diameter.

The Sonicision™ 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

The Sonicision™ Cordless Ultrasonic Dissector is a component of the Sonicision™ Cordless Ultrasonic Dissection Device, which is a hand-held surgical device consisting of three interdependent components that. when assembled, enable ultra-high-frequency mechanical motion (ultrasonic energy) to transect, dissect, and coagulate tissue.

The dissector is a sterile, single-use component to which the Sonicision reusable generators and battery packs attach. This component contains features essential to the control and performance of the assembled device; such as the clamping jaw, active blade, speaker, two-stage energy button, rotation wheel, and jaw lever.

Four configurations are available, differing principally by shaft lengths are 13 cm, 26 cm, 39 cm, and 48 cm; corresponding with catalog numbers SCD13, SCD26, SCD396, and SCD48, respectively. The only difference between SCD391 and SCD396 is the packaging configuration. There is no difference in the design of the device.

The provided text describes a 510(k) premarket notification for the Sonicision™ Cordless Ultrasonic Dissector, a surgical device. While it details performance testing, it does not explicitly state specific "acceptance criteria" numerical values that the device had to meet. Instead, the performance studies aim to demonstrate comparability or non-inferiority to the predicate device.

Therefore, I cannot populate a table with explicit acceptance criteria and corresponding reported performance numerical values as they are not presented in that format in the document. The document describes the type of performance tests conducted and the finding of comparability.

However, I can extract and present the information related to the studies in the requested format, interpreting "acceptance criteria" as the goal of the test (e.g., comparable burst strength) and "reported device performance" as the outcome in relation to the predicate.

Here's the breakdown of the information based on the provided text:

Acceptance Criteria and Device Performance

As explicit numerical acceptance criteria are not provided, the "acceptance criteria" are inferred as demonstrating comparability or non-inferiority to the predicate device for various performance aspects.

Study Details

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

   • Ex-vivo Burst Testing: Specific sample size not provided, but performed on "blood vessels."
   • Ex-vivo Tissue Testing: Specific sample size not provided, but performed on "mesentery."
   • Acute In-vivo Testing: Specific sample size not provided.
   • Chronic In-vivo Testing: Specific sample size not provided.
   • Human Factors Validation: Performed in a "porcine model and a human cadaver model." Specific number of participants/cadavers not provided.
   • Data Provenance: The studies are described as "bench and animal tests" and human cadaver models, implying controlled laboratory or clinical simulation environments. The country of origin is not specified but is presumably where Covidien (Boulder, Colorado) conducts its R&D or contracted research. The studies are prospective in nature, designed specifically to test the device.

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

   • The document does not specify the number or qualifications of experts involved in establishing ground truth for any of these performance tests. For animal and cadaver studies, typically veterinarians, pathologists, and surgeons/anatomists would be involved, but this information is not provided.

3. Adjudication method for the test set:

   • The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the outcomes of these performance tests. The results seem to be presented as direct measurements or observations.

4. 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, an MRMC comparative effectiveness study involving human "readers" or AI assistance was not done. This device is a surgical instrument, not an imaging diagnostic device that would typically involve human "readers" or AI for image interpretation. The human factors validation is about user interaction with the device, not diagnostic interpretation.

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

   • This is not applicable as the device is a physical surgical instrument and does not involve an AI algorithm with standalone performance. Its performance is always integrated with human use.

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

   • Burst Strength: Likely measured mechanically (physics-based ground truth).
   • Temperatures/Cool Down Times: Measured using temperature sensors (physics-based ground truth).
   • Hemostasis/Lateral Thermal Spread: Likely assessed visually, histologically (pathology-based), or through direct measurement during animal studies (outcomes/observational ground truth).
   • Hemostasis Retention: Assessed through long-term observation in chronic animal studies (outcomes data).
   • Human Factors Validation: Established by objective task completion metrics (e.g., successful dissection, coagulation, no user errors) and subjective user feedback, compared against pre-defined user needs and FDA expectations for usability.

7. The sample size for the training set:

   • This concept (training set) is not applicable as the device is a physical surgical instrument, not a machine learning/AI model. Therefore, there is no "training set" in the conventional sense. The development of the device would involve engineering, design, and iterative testing, but not data-driven "training" like an AI.

8. How the ground truth for the training set was established:

   • As there is no "training set" for an AI model, this question is not applicable to this device submission.

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The Sonicision™ Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm in diameter.

The Sonicision™ Cordless Ultrasonic Dissector is a component of the Sonicision™ Cordless Ultrasonic Dissection Device, which is a hand-held surgical device consisting of three interdependent components that, when assembled, enable ultra high-frequency mechanical motion (ultrasonic energy) to transect, dissect, and coagulate tissue.

The dissector is a sterile, single-use component to which the Sonicision reusable generators and battery packs attach. This component contains features essential to the control and performance of the assembled device; such as the clamping jaw, active blade, speaker, two-stage energy button, rotation wheel, and jaw lever.

Four configurations are available, differing principally by shaft length. The lengths are 13 cm, 26 cm, 39 cm (cleared through K101797), and 48 cm; corresponding with catalog numbers SCD13, SCD26, SCD391/6, and SCD48, respectively.

The provided text describes a 510(k) premarket notification for the "Sonicision™ Cordless Ultrasonic Dissection Device" (K141371). This submission aims to demonstrate substantial equivalence to a predicate device, not to prove that the device meets specific acceptance criteria through a standalone study with clinical outcomes.

Therefore, much of the requested information regarding acceptance criteria, device performance, ground truth, and study design elements like MRMC studies, sample sizes for test/training sets, and expert qualifications/adjudication methods typically associated with clinical performance studies validating a new AI/diagnostic device, cannot be found in this document.

This document focuses on bench testing and preclinical testing to demonstrate that the proposed device, despite having different shaft lengths, maintains the same safety and performance characteristics as its predicate device.

However, I can extract information related to the types of tests performed and what was demonstrated, which implicitly serve as a form of "acceptance criteria" for demonstrating substantial equivalence in this context.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria or performance values in a table format. Instead, it states that "All aspects were found to be identical" to the predicate device, implying that the performance of the new device (SCD13, SCD26, SCD48) matched that of the predicate (SCD391, SCD396) for the tested characteristics. The list below represents the areas of performance that were evaluated.

Key statement from the document: "All aspects were found to be identical, with the exception of the shaft length and measurement marks." And "The shaft-length differences were found to not affect safety or performance through design verification and validation testing..."

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

• Sample Size for Test Set: Not specified in terms of numerical count for tissues or animals. The text mentions "excised porcine tissue" and "porcine" for preclinical testing, indicating animal tissue was used. No human data or specific number of tissue samples is provided.
• Data Provenance: Porcine (animal) tissue. The testing was described as "Bench testing" and "Preclinical testing." Given the context of a 510(k) submission, this would be prospective testing conducted by the manufacturer.

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

Not applicable to this type of submission. This document does not concern an AI/diagnostic device requiring expert consensus for ground truth. The "ground truth" for the performance evaluations would be objective measurements from the bench and preclinical tests (e.g., actual burst pressure, measured temperature, observed hemostasis).

4. Adjudication method for the test set

Not applicable. There's no indication of human expert adjudication for the performance results. The evaluations would rely on direct measurements and observations during testing.

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. This device is a surgical dissection device, not an imaging/diagnostic device that would involve human "readers" or an AI component in that capacity.

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

Not applicable. This is a medical device (surgical instrument), not an algorithm or AI.

7. The type of ground truth used

The ground truth for the performance characteristics was derived from objective measurements during bench testing (e.g., active blade displacement, frequency, force, temperature, burst pressures) and observed physiological responses during preclinical testing on porcine tissue (e.g., hemostasis, thermal spread).

8. The sample size for the training set

Not applicable. The device is not an AI/ML model that requires a training set.

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

Not applicable. No training set was used.

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