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The Medtronic Cardioblate® System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

The Medtronic Cardioblate® Surgical Ablation System consists of a reusable radiofrequency generator which can be connected to hand-held monopolar or bipolar radiofrequency devices. The ablation devices are sterile, single-use devices operating in either monopolar or bipolar mode that deliver radiofrequency energy to the selected tissue.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This 510(k) submission (K093203) is for a Special 510(k) BP2 Saline Line Modification for the Medtronic Cardioblate® Surgical Ablation System. Crucially, Special 510(k)s are filed for modifications to a manufacturer's own legally marketed device, where the modification does not affect the device's indications for use or its fundamental scientific technology. This typically means that clinical testing is not required to establish substantial equivalence because the changes are minor and do not raise new questions of safety or effectiveness.

Therefore, the information you're asking for, which is common for new device submissions or significant modifications requiring clinical trials, is largely not applicable in this context. The study performed is a justification that the modification itself is safe and effective, not a study of the overall device's clinical performance against acceptance criteria.

Summary of Acceptance Criteria and Device Performance (Not Applicable for Clinical Performance)

Detailed Breakdown for K093203:

1. A table of acceptance criteria and the reported device performance:
   (See table above). The acceptance criteria for this specific submission relate to demonstrating that the modification (change in PVC formulation for the saline line cable assembly) does not negatively impact the device's safety or fundamental performance, and that it maintains substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   For Biocompatibility Testing and Accelerated Aging Study, the sample sizes would refer to the number of modified saline line cable assemblies or components tested. These are bench tests, not human studies. The document does not specify the exact sample sizes, but such tests are typically conducted in vitro (bench/lab-based). Data provenance would be related to the Medtronic's testing facilities (likely in the US, given the submission location). The studies are prospective in the sense that they are conducted specifically for this modification.

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):
   Not Applicable. As clinical testing was not required, there was no "ground truth" to establish through expert consensus for a clinical assessment. The "experts" involved would be Medtronic's engineers and scientists conducting the biocompatibility and accelerated aging tests, evaluating the results against established standards (e.g., ISO standards for biocompatibility).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not Applicable. Adjudication methods are typically for subjective clinical endpoints or image interpretation. These were objective bench tests.

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 surgical ablation system, not an AI-powered diagnostic device. No MRMC studies were performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not Applicable. This is a hardware modification for a medical device; there is no "algorithm" in the sense of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the biocompatibility testing, the "ground truth" is compliance with biocompatibility standards (e.g., ISO 10993 series), meaning no toxic or harmful reactions. For the accelerated aging study, the "ground truth" is the physical and functional integrity of the device components (e.g., material strength, electrical conductivity, seal integrity) after simulated aging, demonstrating it meets pre-defined engineering specifications.

8. The sample size for the training set:
   Not Applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
   Not Applicable. (As above, no training set).

Conclusion from the document:

The manufacturer concluded that the modifications to the saline line cable assembly result in a "substantially equivalent device because the fundamental scientific principle, labeling, and the intended use are unchanged as a result of these device modifications." The FDA concurred with this assessment, granting 510(k) clearance based on the provided bench test data.

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The Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System is intended to ablate soft tissue during general surgery using radiofrequency energy.

The Medtronic® Cardioblate® Bipolar Radiofrequecy Ablation System is made of bipolar Surgical Ablation Device (Model 60821 & 60822) and a Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator & accessories (Model 60890) for the application of radiofrequency energy to tissue.
The Medtronic® Cardioblate® BP (Bipolar) Surgical Ablation Device, (Model 60821 & 60822) is a hand-held, bipolar, radiofrequency surgical ablation device.
The Medtronic® Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator, (Model 60890) is capable of delivering the controlled radiofrequency energy for Bipolar or Monopolar surgical ablation. The Generator delivers in Bipolar mode up to 40 Watts, with a 20 - 350 Ohm range, and a Monopolar mode up to 50 Watts to the delivery device with a 20-500 Ohm range.

The provided text describes a 510(k) premarket submission for the Medtronic Cardioblate Bipolar Radiofrequency Ablation System. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a comprehensive study report with specific performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided document.

However, based on the available information, here's what can be inferred and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document only mentions "bench testing and non-bench analyses" for performance characteristic comparisons. These would typically involve test articles of the device but the number is not provided.
• Data Provenance: Not specified. The types of tests mentioned (bench testing) suggest laboratory-based data, but the country of origin or whether it's retrospective/prospective is not explicitly stated.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified. It is unlikely that an adjudication method in the context of human reader performance would be applicable to the "bench testing and non-bench analyses" described.

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. This device is an electrosurgical ablation system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is not applicable.

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

• Standalone Performance Study: The document describes "bench testing and non-bench analyses" which would represent standalone performance of the device itself (not an algorithm). However, detailed results or specific metrics for this standalone performance are not provided beyond the general statement of comparison to predicate devices.

7. The type of ground truth used

• Type of Ground Truth: For the "bench testing and non-bench analyses," the ground truth would likely be established through engineering specifications, physical measurements, and comparison to the documented performance of the predicate devices. For instance, if testing ablation depth, the ground truth would be the measured depth in a controlled environment. The document is not specific on the methodology.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is an electrosurgical device, not a machine learning algorithm that requires a "training set."

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for this type of device.

Summary of what the document does indicate:

• The device is intended to ablate soft tissue during general surgery using radiofrequency energy.
• The primary method for demonstrating its suitability for approval was non-clinical testing (bench testing and non-bench analyses) to show substantial equivalence to existing predicate devices (Medtronic Cardioblate Radiofrequency Ablation System K013392 and AtriCure Bipolar System K020919).
• The conclusion was that differences were "minor and not raise any concern regarding the overall safety and effectiveness."
• No human clinical trial data, AI performance metrics, or reader studies are mentioned in this 510(k) summary.

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