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The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices 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 Devices can be used to coagulate isolated vessels up to 5 mm diameter.

The Sonicision Cordless Ultrasonic Dissector Device, models SCD391 and SCD396, are sterile, single-use components to which the Sonicision Reusable Generator and Reusable Battery Pack attach. (The Sonicision Reusable Generator and Reusable Battery Pack are not included in this submission and will not be reprocessed by Medline ReNewal.) This component provides control for device functions such as selecting power levels, blade placement and position, grasping, coagulating and dissecting tissue. The Cordless Ultrasonic Dissection Devices can coagulate vessels up to 5 mm in diameter. Furthermore, they are designed to be inserted and extracted through a compatible 5 mm trocar when used endoscopically.

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

The document is a 510(k) premarket notification for a reprocessed medical device, specifically the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Models SCD 391 and SCD 396. The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving novel clinical effectiveness or superiority. Therefore, the testing described focuses on demonstrating that the reprocessed device performs as intended and is as safe and effective as the original, rather than establishing new performance benchmarks for all surgical devices.

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

The document doesn't provide a direct table of specific numerical acceptance criteria alongside reported performance for each test. Instead, it lists types of performance tests conducted to establish equivalence. The general acceptance criterion for all the tests is that the reprocessed device must demonstrate equivalence to the predicate device in terms of safety and effectiveness.

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

• Sample Size: The document does not specify the exact sample sizes (N numbers) used for each individual performance test. It only states that the functional characteristics "have been evaluated."
• Data Provenance: The data provenance is not explicitly stated. However, since this is a submission for a reprocessed device by Medline ReNewal, the testing would have been conducted by Medline ReNewal or their contracted testing facilities. Given the nature of performance testing for medical devices, it's generally done in a controlled laboratory environment. The origin of the reprocessed devices themselves would be from various healthcare facilities where they were originally used before being sent for reprocessing. The testing itself is prospective in the sense that Medline ReNewal performed these tests on their reprocessed devices.

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

This type of information (expert consensus, qualifications) is typically relevant for studies involving subjective interpretation, like imaging diagnostics or clinical endpoints, where human experts establish ground truth. For this submission, which is about the functional and safety equivalence of a reprocessed surgical instrument, the "ground truth" is established by direct physical and chemical testing against defined specifications or comparison to the performance of the new predicate device. Therefore, information about "experts establishing ground truth" in the clinical sense is not applicable or provided in this document.

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

Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or diagnostic accuracy studies where multiple readers interpret cases and disagreements are resolved. This document pertains to performance testing of a reprocessed surgical instrument, which involves objective laboratory measurements and comparisons to predetermined specifications or predicate device performance. Therefore, an adjudication method in this context is not applicable and not mentioned.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic aids, especially those involving AI interpretation, where human readers interact with a system to make diagnoses. The Medline ReNewal device is a surgical instrument, not an AI diagnostic tool.
• Effect Size of AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

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

• Standalone Performance: Not applicable. This is a physical surgical instrument, not an algorithm or software. Its performance is inherent to its mechanical, electrical, and material properties when used by a surgeon.

7. The type of ground truth used

The ground truth for evaluating the safety and effectiveness of the reprocessed device is established through:

• Comparison to the predicate device's known performance: The fundamental scientific technology and intended use are considered identical to the predicate.
• Pre-defined specifications and standards: Each performance test (e.g., grasping/pulling force, cutting effectiveness, cleaning, biocompatibility, sterilization) would have acceptance criteria based on established engineering standards, regulatory requirements, and the expected performance of a new device.
• Objective laboratory measurements: Physical, chemical, and biological tests are performed to directly measure different aspects of the device's function and safety.

Essentially, the "ground truth" is objective measurement against established requirements and comparison to the original device's performance.

8. The sample size for the training set

This concept of a "training set" is relevant for machine learning or AI models. Since this is a physical medical device and not an AI or software product, there is no training set in the traditional sense. The development and validation of the reprocessing procedure would involve internal process development and verification, but it's not a "training set" for an algorithm.

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 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 Ultrasonic Dissection Device that is the subject of this 510(k) is a hand-held batterypowered device used to dissect through tissues and to coagulate vessels up to 5 mm in diameter. An assembled Sonicision device includes three components: (1) The Sonicision Dissector, 13 cm; (2) the Sonicision Battery; and (3) the Sonicision Generator. The dissector is a single-use item that is provided to the user in sterile form. The generator and battery are reusable components that are sterilized by the user. The clinical intended use is achieved by the surgeon when pressure is applied to tissue placed between the clamping jaw and the exposed portion of the probe while activating ultrasonic energy with a button on the handpiece.

The provided text does not contain information about the acceptance criteria and the study that proves the device meets them in the format of a clinical study or performance goals with specific metrics for a new AI/software device. Instead, the document is a 510(k) summary for a physical medical device – the Sonicision Cordless Ultrasonic Dissection Device – seeking clearance based on substantial equivalence to a predicate device.

The "performance" section describes comparative ex vivo and in vivo testing to demonstrate that the new device performs similarly to predicate devices, particularly for its proposed use in Otorhinolaryngology (ENT) procedures.

Here's a breakdown of the available information, adapted to the requested format where possible, but highlighting that this is not a study proving an AI/software device meets acceptance criteria:

Study Type: Substantial Equivalence Evaluation for a Physical Surgical Device

1. Table of Acceptance Criteria and Reported Device Performance

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

• Vessel Burst Testing: Not specified, but involved "blood vessels."
• Ex vivo Tissue Testing (Temperatures): Not specified, but involved "mesentery."
• Acute In vivo Testing (Hemostasis): Not specified.
• Usability/Human Factors Validation: Not specified, but used a "human cadaver model."

The data provenance is from ex vivo (tissue from outside a living organism, likely animal or human cadaveric) and in vivo (within a living organism, likely animal) studies, along with human cadaver model studies. The country of origin is not specified but implicitly within the context of FDA submission, suggesting studies conducted under applicable US regulations or international standards.

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

• Usability/Human Factors Validation: Involved "practicing surgeons" who were "predominantly users of the FOCUS+ device for ENT surgeries." The exact number is not specified, nor are specific years of experience. For the other performance tests (burst strength, temperatures, hemostasis), the ground truth is objective measurement, not expert consensus.

4. Adjudication method for the test set

• Not applicable as the performance tests primarily involved objective measurements rather than subjective assessments requiring adjudication. For the usability study, the "ground truth" was the surgeon's subjective assessment of clinical acceptability, not a formally adjudicated outcome.

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 MRMC comparative effectiveness study was done. This document pertains to a physical surgical device, not an AI/software device. The usability study involved human operators using the device, but it was not an MRMC study comparing human reader performance with and without AI assistance.

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

• Not applicable. This relates to a physical surgical device, not an algorithm.

7. The type of ground truth used

• Vessel Burst Strength: Objective measurement (burst pressure).
• Max Active Blade Temperature: Objective measurement (temperature readings).
• Max Distal Shaft Temperature: Objective measurement (temperature readings).
• Hemostasis Rates: Objective observation of bleeding control.
• Clinical Acceptability (Usability/Human Factors): Expert subjective assessment/opinion from practicing surgeons.

8. The sample size for the training set

• Not applicable. This is a physical device, and the described studies are for performance validation, not for training an algorithm.

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

• Not applicable. (See point 8)

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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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