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The Eblator Device is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution.

The application device, the Eblator Device, is an electrosurgical ablator for general arthroscopic applications. In conjunction with a general purpose electrosurgical generator, the Eblator Device provides cutting, vaporization and coagulation of target tissue by radio frequency electrosurgical energy. As with most hand-controlled surgical pencils, the Eblator Device can also be used with footswitch control when a footswitch is connected to a generator designed for footswitch control. The Eblator Device is requesting clearance for 4 models of Eblator Device, representing different combinations of electrode configurations and aspiration design. The Eblator Device models include 2 different electrode angles, 90° and 50°, as well as with or without aspiration design. Except for these characteristics, these 4 models are all identical. The Eblator Device is designed to be used with a compatible electrosurgical generator and aspiration system (aspiration model only). These devices are single use and are sold sterile.

The acceptance criteria and study proving the device meets them are summarized below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

• Snap Fit Strength
• Weld Integrity Test
• Probe Flexural Test
• Probe Axial Pull Force | All test requirements were met as specified by applicable standards and the test protocols. (Compliance with IEC-60601-1, Ed 3.2, 2005 + AM1:2012 + AM2:2020; IEC 60601-2-2, Ed 6.0: 2017, and E Surgical self-enforced requirements) |
  | Electrical Testing | - Bench-top validation testing for relevant components (HF Leakage Current, HF Dielectric Strength Test, Mains Frequency Dielectric Strength Test, Housing Temperature Verification, Continuity & Activation Switch Resistance) | All test requirements were met as specified by applicable standards and the test protocols. (Compliance with IEC 60601-1: 2005 + AM1:2012; IEC 60601-1-2: 2014; IEC 60601-2-2: 2017) |
  | Electromagnetic Compatibility (EMC) | - Compliance with IEC 60601-1-2, Ed 4.1: 2017 + AM1:2020 | The results demonstrated compliance of the application device to current IEC 60601-1-2, Ed 4.1: 2017 + AM1:2020 standard requirements. |
  | Biocompatibility | - Compliance with ISO 10993-1 and FDA's modified ISO guidelines | Biocompatibility verification was performed in accordance with requirements of ISO 10993-1 and FDA's modified ISO guidelines. |
  | Bench-top Validation Testing (General) | - Cable Dynamic Strain Relief
• Cable Static Strain Relief
• Anchorage Test
• Fluid Ingress Test
• Visual Inspection
• Function Test
• Activation Force
• Activation Over Time
• Aspiration Tube Dynamic Strain Relief
• Aspiration Tube Static Strain Relief
• Distal Fluid Ingress Test
• Active Electrode to Inner Tube Torque Test
• Fluid Leak Test | All test requirements were met as specified by applicable standards and the test protocols. |
  | Thermal Performance (Tissue Effect) | - Measurement of thermal damage zone in ex vivo tissue compared to predicate device under same generator mode and power settings. | The thermal effects of the Eblator Device on ex vivo tissue was evaluated by measuring the size of the thermal damage zone caused by the Eblator Device compared to the size of thermal damage zone caused by the predicate device under the same generator mode and power settings. In all cases there was no clinical difference between the thermal damage caused by the Eblator Device and the predicate. Validation was conducted in three different tissues (porcine muscle, liver, and kidney). |
  | Packaging Tests | - Burst Test
• Seal Strength Test
• Bubble Leak Test
• Dye Leak Test | All test requirements were met as specified by applicable standards and the test protocols. (Compliance with ISO 11607-1, ISO 11607-2) |
  | Shelf Life/Aging | - Accelerated Aging Evaluation Test (2-year storage) | An accelerated aging evaluation test demonstrated compliance of the Eblator Device to meet the defined product specifications after 2 year storage. (Compliance with ASTM F1980) |
  | Regulatory Guidance Compliance | - FDA guideline Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020). | The Eblator Device was fully tested and found to be in compliance with the FDA guideline Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020). |

Missing Information from the Provided Text:

The provided text describes a 510(k) premarket notification for a medical device (Eblator Device). Such submissions primarily focus on demonstrating substantial equivalence to a predicate device through various engineering and performance tests, rather than clinical trials or AI performance evaluations with human readers. Therefore, several points from the request are not applicable or not present in this type of document.

The document does not describe a study involving humans, AI, or ground truth developed by experts in the context of diagnostic performance. It focuses on the physical and electrical performance of an electrosurgical device.

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

• Sample Size for Test Set: Not applicable in the context of device performance testing described. The tests involve multiple units of the Eblator Device for various mechanical, electrical, and functional evaluations. For the thermal performance test, three different ex vivo tissues (porcine muscle, liver, and kidney) were used, but the number of samples or repetitions for each tissue type is not specified.
• Data Provenance: The study was a bench-top validation and ex vivo tissue study. The specific country of origin of the data is not mentioned, but it's an industry-sponsored submission to the FDA (U.S.). It is retrospective in the sense that the tests were conducted prior to submission.

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

• Number of Experts & Qualifications: Not applicable. The ground truth for the performance tests (e.g., proper function, electrical compliance, thermal damage size) is established by adherence to engineering specifications and recognized standards, not by expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no expert review or adjudication process for the type of engineering and bench-top performance tests described. Test results are compared against predefined numerical and qualitative specifications outlined in standards and internal protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., imaging AI) and involves human readers interpreting cases. The Eblator Device is an electrosurgical tool, not a diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Standalone Study: Not applicable. The device is a surgical instrument; there is no embedded algorithm in the diagnostic sense that would perform "standalone" without human interaction. Its performance is measured as a direct physical and electrical output.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth is defined by engineering specifications, international and recognized consensus standards (e.g., IEC 60601 series, ISO 10993-1, ISO 11135, ISO 11607, ASTM F1980), and the FDA's specific guidance for electrosurgical devices. For the thermal performance, the ground truth was the comparative thermal damage zone to the predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI-driven device requiring a training set. The "training" in this context refers to the development and iterative testing of the device during its design phase, which is not quantified by a "training set" in the sense of data science.

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

• Establishing Ground Truth for Training Set: Not applicable. As there is no training set in the AI sense, there's no ground truth established for it. The device design and performance targets are driven by engineering principles, clinical needs, and regulatory requirements.

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