(59 days)
The Ellusa Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures.
The Ellusa Generators are radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device is designed to enable the performance of monopolar and bipolar functions for cutting, coagulation, and hemostasis in conjunction with separately-marketed electrosurgical accessories and ancillary equipment which have been developed for mutually- exclusive use with the Ellusa line of generators.
All selections are effected through push buttons and lamps, which give the operator feedback of status. The power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and /or hand switches.
Ellusa Electrodes are used with the Ellusa Generator. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Ellusa family of electrodes is available in various shapes and sizes depending on the need of the surgeon. The devices are available in classic alloys (Tungsten, brass, stainless steel).
These devices are designed to comply with international safety standards including applicable IEC series electrical safety standards.
The provided text is an FDA 510(k) summary for a medical device (Ellusa Generator and Monopolar Tips). It demonstrates substantial equivalence to a predicate device rather than presenting a study of its own for novel acceptance criteria.
Therefore, the information required to directly answer the request (acceptance criteria and a study proving the device meets them, especially in the context of AI/human reader performance) is not present in the provided document.
The document states that:
- The device is "substantially equivalent" to a predicate device (Soniquence RF Generator & Monopolar Electrodes, K183611).
- "There are no technological differences between the subject device as compared to the predicate devices, and the indications for use are identical to the predicate devices."
- "The only difference between the subject devices of this 510k and the predicate devices is a rebranding with the Ellusa name. The technology remains the same."
This type of submission focuses on demonstrating that the new device operates fundamentally the same as a device already on the market, by comparing technological characteristics and showing compliance with relevant safety and performance standards. It does not involve AI or human reader studies.
However, I can extract information regarding the non-clinical testing performed to demonstrate safety and performance equivalence, which acts as the "proof" for this type of submission.
Here's an interpretation of the "acceptance criteria" and "study" based on the provided document, framed within the context of a 510(k) submission for substantial equivalence:
Acceptance Criteria and Demonstrating Equivalence (as per a 510(k) submission):
The acceptance criteria for a 510(k) are not typically expressed as specific performance metrics of a novel AI algorithm or human reader improvement. Instead, they revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. For this device (an electrosurgical generator and tips), the "acceptance criteria" are implicitly met by:
- Identical Intended Use: The device performs the same functions for the same purposes as the predicate.
- Substantially Equivalent Technological Characteristics: No new questions of safety or effectiveness are raised compared to the predicate. Minor differences are shown not to affect safety or performance.
- Compliance with Recognized Standards: The device meets relevant international safety, performance, biocompatibility, and sterilization standards.
- Successful Non-Clinical Testing: Specific tests confirm the device's electrical output, thermal effects, and general functionality are comparable and within acceptable limits.
The "Study" Proving the Device Meets Acceptance Criteria (Non-Clinical Testing):
The "study" in this context is the Non-Clinical Testing section, which provides the technical evidence for substantial equivalence.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance (Summary from Non-Clinical Testing Section) |
|---|---|
| Identical Intended Use | The Ellusa Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures... The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures. (Identical to Predicate). |
| Technological Equivalence (Generators) | Principle of Operation: Identical to predicate (Conversion of electrical energy to high-frequency RF energy). |
| Modes of Operation/Mechanism of Action: Predominantly identical; minor nomenclature changes (e.g., "Cut/Coag" vs. "Blend") and some models with reduced max output (e.g., 120W vs. 170W) which are stated not to introduce new risks or affect safety/effectiveness. | |
| Output Frequency: Identical (4 MHz monopolar, 1.7 MHz bipolar). | |
| Maximum Power Output: Predominantly identical; some models 120W (vs. 170W for predicate). | |
| Peak-to-Peak Voltage: Identical (1,200V). | |
| Power Activation Control: Identical (Footswitch and/or fingerswitch). | |
| Applied Part Type: Predominantly identical CF; some models BF (stated not to affect equivalence). | |
| Technological Equivalence (Monopolar Tips) | Intended Use: Identical to predicate. |
| Product Code/Classification: Identical. | |
| Functions/Energy Type: Identical (Cutting/coagulation, Monopolar). | |
| Design Specifications/Shaft Forms/Malleability/Lengths/Diameter/Tip Configurations/Material Composition/Biocompatibility/Sterilization/Packaging/Activation Method/Cable Length/Temperature Probe/Cooling Function: All identical to predicate. | |
| Electrical Safety & EMC Testing | Successfully performed: AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2. |
| Usability Engineering | Successfully performed: IEC 62366. |
| Sterilization Validation | Successfully performed: ISO 11135, ISO 11737-1, ISO 11737-2, ISO 11138-1. |
| Biocompatibility | Successfully performed: ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11. |
| Shelf Life Testing | Successfully performed: ASTM F1980-07. |
| Performance Testing (Generator & Tips) | Successfully performed: Software V&V (IEC 62304, FDA Guidance), Energy Output Verification (all five modes, compared to predicate), Thermal Effect Comparison (representative modes on ex-vivo bovine tissue), Design Verification/Validation (output power, Hipot test, pull test, lateral heat spread in tissue, temperature profile, final test). All passed applicable acceptance criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "ex-vivo bovine tissue" for thermal effect comparison, but does not specify a quantitative sample size (e.g., number of tissue samples or test runs). For electrical safety and other standard compliance tests, the "sample" would be the device units tested, but a specific number is not provided, though it would be standard practice to test a representative number of units.
- Data Provenance: The tests are "non-clinical verification and validation activities" conducted by the submitter (Ellusa, LLC). The data provenance would be internal laboratory testing.
- Retrospective or Prospective: These tests are prospective, conducted specifically to support the 510(k) submission.
- Country of Origin of Data: Not explicitly stated, but assumed to be the testing facilities used by Ellusa, LLC (US-based).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and submission. "Ground truth" in the context of AI or diagnostic imaging usually refers to clinical diagnoses or pathology results established by medical experts used to train and validate algorithms. For an electrosurgical device, performance is evaluated against engineering specifications and physical measurements, not expert clinical interpretations of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in studies involving human readers or AI output where there might be disagreements in interpretation (e.g., diagnosis from medical images). This document describes engineering validation and verification 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:
- No. This is an electrosurgical device, not an AI or diagnostic imaging product designed to assist human readers. Therefore, an MRMC study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is hardware (generator and tips) for surgical procedures. It does not have an AI algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the performance tests (e.g., energy output, thermal effect), the "ground truth" is established by physical measurements and engineering specifications, often compared against the predicate device's known performance or against established scientific principles of energy delivery and tissue interaction. For example, for "Energy output verification," the ground truth is the expected power output for a given setting, measured by calibrated equipment. For "Thermal effect comparison," the ground truth involves measuring the actual thermal spread in tissue and comparing it to expected or predicate device behavior.
8. The sample size for the training set:
- Not applicable. This device is not an AI system that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no AI training set is involved.
In summary, the provided document details a 510(k) submission for substantial equivalence of an electrosurgical device based on engineering and safety testing, not on AI or human-in-the-loop performance studies.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.