(13 days)
The Medtronic Cardioblate® System is intended to ablate soft tissue during general surgery using radiofrequency energy.
The Medtronic Cardioblate® 68000 Generator is a reusable, non-sterile radiofrequency generator. In bipolar mode, the generator is attached to a bipolar Surgical Ablation Device (e.g. Model 60831 or 60841), which is the hand-held, sterile, single-use device that applies radiofrequency energy to the selected tissue. The Cardioblate® 68000 Generator is capable of delivering a controlled amount of radiofrequency energy for both Monopolar and Bipolar surgical ablation techniques. The generator delivers up to 50 Watts energy in either the bipolar or monopolar mode.
The provided text is a 510(k) summary for the Medtronic Cardioblate® 68000 Generator. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report with specific performance metrics typically found in clinical efficacy or standalone performance studies for new technologies.
Therefore, much of the requested information regarding acceptance criteria, specific performance statistics, sample sizes for test and training sets, expert qualifications, and adjudication methods is not explicitly available in this summary. The summary focuses on the comparison to a predicate device and the verification and validation (V&V) of the new generator.
Here's an attempt to extract and infer information based on the provided text, while also explicitly stating what is not available:
Acceptance Criteria and Study for Medtronic Cardioblate® 68000 Generator
The Medtronic Cardioblate® 68000 Generator is presented as substantially equivalent to its predicate device, the Cardioblate® Bipolar Radiofrequency Ablation System (K031247). The primary "acceptance criteria" presented here revolve around demonstrating this substantial equivalence through verification and validation testing, ensuring the new generator performs comparably to the predicate and meets general safety and performance standards for electrosurgical devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence: The Cardioblate® 68000 Generator delivers the same amount of radiofrequency energy and uses the same algorithms as the predicate device. Ensures comparable energy output for ablation. | "The Generator uses the same energy source to deliver the same amount of radiofrequency energy to ablate tissues, and uses the same surgical ablation devices." |
| "Although both generators use the same algorithms to operate, the Model 68000 Generator is updated to include a touchscreen interface, an updated microprocessor and a molded, ergonomic case." | |
| Lesion Equivalence: The device, when used with specified ablation devices, produces equivalent lesions to the predicate system in tissue. | "lesion equivalence...tests on tissue with the entire system." (Implies successful demonstration but no specific metrics are provided.) |
| Transmurality Equivalence: The device achieves equivalent transmurality (penetration through tissue layers) compared to the predicate system. | "transmurality equivalence tests on tissue with the entire system." (Implies successful demonstration but no specific metrics are provided.) |
| Software Validation: The updated software for the touchscreen interface and microprocessor functions correctly and safely. | "software validation" |
| Hardware Qualification: The updated hardware components (microprocessor, molded case) meet design specifications and safety requirements. | "hardware qualification" |
| Electromagnetic Compatibility (EMC): The device operates without causing or being susceptible to electromagnetic interference. | "electromagnetic compatibility" |
| Safety Testing: The device meets all relevant electrical and patient safety standards. | "safety testing on the generator" |
| Intended Use: The device is suitable for its intended use of ablating soft tissue during general surgery using radiofrequency energy. | The "Intended Use" statement is identical to the predicate device. |
Missing Information: Specific quantitative thresholds or statistical metrics for "equivalence" (e.g., within X% of predicate) are not provided in this summary. The summary confirms that testing was done and confirmed equivalence, but not the detailed results.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "lesion equivalence and transmurality equivalence tests on tissue," implying an in vitro or ex vivo test environment.
- Data Provenance: The tests were conducted as "Verification and validation testing" by the manufacturer (Medtronic). There's no mention of country of origin for data beyond the implied in-house testing. The nature of these tests (lesion and transmurality equivalence) suggests in vitro or ex vivo lab studies rather than clinical trials. Therefore, it is retrospective as it refers to performance specifications to be met rather than clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For lesion and transmurality equivalence in tissue, "ground truth" would likely be established through histological analysis by pathologists or specialized technicians, or by direct physical measurement by engineering or medical staff. However, no details are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. This type of performance testing (lesion size, transmurality) usually involves direct physical measurement or objective histological assessment rather than subjective expert review requiring adjudication in the way clinical image interpretation studies do.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI, where human readers interpret medical images with and without AI assistance. This device is an electrosurgical generator, and its performance is evaluated through physical characteristics (power output, lesion size) and safety parameters, not through human interpretation of cases.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Standalone Study: Yes, in a sense. The "Verification and validation testing" on the generator and "lesion equivalence and transmurality equivalence tests on tissue with the entire system" constitute a standalone evaluation of the device's functional performance against established parameters (likely derived from the predicate device). The performance discussed relates to the device's physical output and effect on tissue, not an AI algorithm's interpretive ability.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the "lesion equivalence and transmurality equivalence tests on tissue" would likely be:
- Direct Measurement: Physical dimensions (length, width, depth) of the lesions created in tissue.
- Histopathology: Microscopic examination of tissue samples to confirm lesion characteristics, cellular damage, and transmurality.
- Known Electrical Output: Verification of the generator's energy delivery based on established electrical engineering principles.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not specified. This device is an electrosurgical generator, not an AI algorithm that "learns" from a training set. The "algorithms" mentioned refer to the control logic within the generator for delivering radiofrequency energy, which are programmed, not trained with data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As noted above, this device does not use a training set in the context of machine learning. The algorithms are programmed based on engineering principles and knowledge of radiofrequency energy delivery in biological tissue, reflecting established medical device design practices.
§ 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.