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The Smith & Nephew Dyonics® ElectroBlade™ Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The Smith & Nephew Dyonics® ElectroBlade™ Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.

The Smith & Nephew Dyonics® ElectroBlade™ Resector combines electrosurgical and shaver technology to provide hemostasis and mechanical cutting in a single instrument.

The provided text describes a 510(k) premarket notification for the Smith & Nephew Dyonics® ElectroBlade™ Resector. This submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data, rather than clinical efficacy through comparative studies with human readers or standalone AI performance.

Therefore, many of the requested categories related to clinical studies, AI performance, ground truth establishment for a training set, and expert adjudication are not applicable or cannot be extracted from this document.

Here's a breakdown of the available information:

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

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

This information is not provided in the document. The submission references adherence to established safety and performance standards for electrosurgical devices, rather than a clinical "test set" with patient data.

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)

This information is not applicable/not provided. The device is an electrosurgical tool, and its performance evaluation focused on engineering and biocompatibility standards, not on diagnostic accuracy requiring expert interpretation of a "test set."

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

This information is not applicable/not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done as this device is an electrosurgical cutting and coagulation device, not a diagnostic imaging device typically evaluated with such studies. AI assistance is also not relevant to this device's function.

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

A standalone performance study for an algorithm was not done as this is a physical medical device, not an AI algorithm.

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

The "ground truth" for this device's performance is established by adherence to recognized international and national standards for electrosurgical devices, biocompatibility, and sterilization. This involves engineering testing, material safety assessments, and validation of manufacturing processes, rather than clinical ground truth like pathology or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

This information is not applicable/not provided. The concept of a "training set" is relevant to machine learning/AI algorithms, which this device is not.

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

This information is not applicable/not provided.

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The DYONICS Electroblade Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The DYONICS EletroBlade Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.

The DYONICS ElectroBlade Resector combines the rotary cutting technology of Dyonics Arthroscopic Surgery Blades with the electrosurgical capabilities of a bipolar electrosurgery probe. The inner rotational blade is electrified by connection to a standard generator. Insulation on the outer blade isolates the electrical energy to the inner tube where it is exposed to tissue at the cutting window of the blade. The DYONICS ElectroBlade Resector operates in conjunction with the standard Dyonics shaver system and standard electrosurgical generator systems.

This 510(k) summary is for the DYONICS ElectroBlade Resector, a device combining rotary cutting technology with electrosurgical capabilities. The submission establishes substantial equivalence to the DYONICS ElectroBlade (K994365).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a table of acceptance criteria or specific quantitative performance metrics for the DYONICS ElectroBlade Resector. The submission focuses on demonstrating substantial equivalence to a predicate device (DYONICS ElectroBlade) based on intended use, materials, and method of operation rather than presenting a detailed performance study with predefined acceptance criteria.

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

The provided text does not mention any specific test set, sample size, or data provenance because the submission appears to be a substantial equivalence claim based on comparison to an existing predicate device rather than a de novo marketing application requiring extensive clinical performance data with a separate test set.

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

As there is no mention of a specific test set or a study requiring ground truth establishment, there is no information on the number or qualifications of experts.

4. Adjudication Method for the Test Set

Again, with no description of a test set, there is no mention of an adjudication method.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The submission is a 510(k) seeking substantial equivalence, not typically requiring such a study to demonstrate improvement with AI assistance (which is not relevant here as the device is not an AI diagnostic).

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

This is not applicable as the DYONICS ElectroBlade Resector is a surgical tool, not an AI algorithm. Therefore, "standalone" algorithm performance is not a concept pertinent to this device.

7. Type of Ground Truth Used

As there is no mention of a clinical study generating specific performance data that required ground truth, this information is not available. The determination of substantial equivalence relies on comparison of design, materials, and intended use, not on a detailed clinical performance study with established ground truth.

8. Sample Size for the Training Set

This is not applicable. The DYONICS ElectroBlade Resector is a physical surgical device, not a machine learning model, so there is no concept of a "training set" for an algorithm.

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

This is not applicable as the device is not an AI algorithm and therefore does not have a training set or associated ground truth.

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