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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 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13 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 diameter.
The Sonicision 13-cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13, is a sterile, single-use component 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 Device can coagulate vessels up to 5 mm in diameter. Furthermore, it is designed to be inserted and extracted through a compatible 5 mm trocar, when used endoscopically.

The provided FDA 510(k) summary for the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, model SCD13 (K173627), does not contain information about acceptance criteria and the study that proves the device meets those criteria in the format requested, particularly for AI/ML-based devices. This submission is for a reprocessed surgical instrument and focuses on demonstrating substantial equivalence to a predicate device through functional, performance, and biocompatibility testing, rather than presenting clinical study results with acceptance criteria typical for diagnostic or AI-powered devices.

However, I can extract information related to performance testing and the type of evidence used to support the substantial equivalence claim. Since this is not an AI/ML device, many of the requested fields (like effect size with/without AI, sample size for test set/training set for AI, number of experts for ground truth, adjudication method, etc.) are not applicable.

Here's an adaptation of the requested table and information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a reprocessed device demonstrating substantial equivalence to a predicate, the "acceptance criteria" are implicitly that the reprocessed device performs comparably to the original predicate device across various functional and safety aspects. The reported performance aims to show this comparability.

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

The document does not specify a "sample size" in the context of a "test set" for diagnostic performance, as this is a surgical instrument.
For the performance testing:

• Bench tests: The number of devices or trials tested for each bench criterion (e.g., simulated use, grasping force, cutting effectiveness, cleaning, drop test, device integrity, tissue sticking, prolonged cutting/coagulation evaluation, thermal spread) is not explicitly stated in the summary.
• Acute ex vivo: Tissue types and vessel sizes evaluated are listed (Hypogastric, Short Gastric, Gastrosplenic, Ovarian Pedicle for A/V Bundle, Splenic, Renal for Isolated Arteries or Veins, all up to 5mm diameter), but the number of vessels or tissue samples tested is not provided.
• Chronic in vivo: A single 21-day chronic in vivo study was conducted using a porcine model. The number of animals used is not specified.

Data Provenance: The studies are described as bench tests, ex vivo (tissue samples, likely animal or cadaveric), and in vivo (porcine model). The country of origin for these studies is not specified in the provided summary.

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

There is no mention of "experts" establish a "ground truth" for a diagnostic test set, as this is related to a surgical instrument's functional performance and reprocessing safety. The evaluation would have been performed by qualified laboratory personnel and veterinary surgeons (for in vivo studies), but not "experts" in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic test requiring adjudication of interpretations.

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 a reprocessed surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device. The device's performance is standalone in the sense that its functional capabilities are evaluated independently, but it is ultimately used by a human surgeon.

7. The type of ground truth used

The "ground truth" for this type of device is established through:

• Direct measurement: For physical properties (e.g., grasping force, cutting effectiveness, device integrity, cleaning efficacy).
• Histopathology/Morphometry: For tissue effects like thermal spread and absence of injury in collateral structures.
• Direct observation and assessment: For simulated use and in vivo studies (e.g., visual assessment of vessel sealing, absence of hemorrhage).
• Laboratory assays: For biocompatibility (cytotoxicity, endotoxins).
• Comparison to predicate device: The ultimate "ground truth" for substantial equivalence is demonstrating that the reprocessed device performs as safely and effectively as the original, legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore has no "training set."

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

Not applicable, as there is no training set for an AI/ML model for this device.

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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.

Ask a specific question about this device

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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