(66 days)
Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.
Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.
The provided text describes a 510(k) premarket notification for Aaron Reusable Electrosurgical Electrodes. The submission focuses on demonstrating substantial equivalence to predicate devices and validating cleaning and resterilization processes for reuse.
Based on the provided information, the device is an electrosurgical electrode, not an AI or imaging device, and therefore the standard AI/Imaging study characteristics are not applicable. The provided text addresses traditional medical device performance and safety.
Here's an interpretation of the "acceptance criteria" and "study" based on the context of a 510(k) submission for this type of device:
Acceptance Criteria and Device Performance (Interpreted from 510(k) Summary)
The primary acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices and validating the reusability claims through cleaning and sterilization processes.
| Acceptance Criteria Category | Specific Criteria (Interpreted) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Substantial Equivalence - Method of Operation | Device operates in the same fundamental way as predicate devices. | "substantially equivalent to Aaron Reusable Electrosurgical Electrodes (K931338 and K942986) in operation" |
| Substantial Equivalence - Intended Use | Device's intended medical application is the same as predicate devices. | "substantially equivalent to ... in ... intended use" |
| Substantial Equivalence - Energy Source | Device uses the same type of energy source as predicate devices. | "substantially equivalent to ... in ... energy source" |
| Substantial Equivalence - Method of Preparation (Initial State) | Device's initial manufacturing/packaging state is similar (specifically, not sold sterile here, which is a key difference being addressed). | "Performance claims for the reusable electrodes differ from the predicate device in that they are not sold sterile." |
| Reusability - Cleaning Efficacy | Device can be effectively cleaned to remove biological material as per established standards. | "Cleaning and resterilization processes are validated in accordance with Good Hospital Practice: Steam Sterilization and Sterility Assurance (ANSI/AAMI ST46: 1993) and Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: A Guide for Device Manufacturers (AAMI TIR 12: 1994)." |
| Reusability - Sterilization Efficacy | Device can be effectively sterilized by steam under pressure as per established standards. | "Cleaning and resterilization processes are validated in accordance with Good Hospital Practice: Steam Sterilization and Sterility Assurance (ANSI/AAMI ST46: 1993)..." |
| Durability - Loop Configuration | Loop electrodes maintain safety and performance after repeated cleaning and sterilization cycles. | "Aaron Reusable Electrosurgical Electrodes in the loop configuration may be cleaned and sterilized up to 5 times." |
| Durability - Blade, Needle, Ball Configurations | Blade, needle, and ball electrodes maintain safety and performance after repeated cleaning and sterilization cycles. | "Aaron Reusable Electrosurgical Electrodes in the blade, needle, and ball configurations may be cleaned and sterilized up to 25 times." |
| Overall Safety and Performance | Testing indicates equivalent safety and performance compared to predicate devices. | "Testing performed on Aaron Reusable Electrosurgical Electrodes indicate that the devices are substantially equivalent in method of operation, safety, and performance." |
Study Information (Based on a Traditional Medical Device 510(k))
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Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for the "testing performed" to demonstrate substantial equivalence or for the cleaning/sterilization validation. This level of detail is typically found in the full 510(k) submission, not the summary.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would be internal testing performed by the manufacturer to support their claims.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and submission. "Ground truth" with expert consensus is typically relevant for diagnostic devices (e.g., imaging devices) where expert interpretation is compared. For this electrosurgical electrode, "ground truth" would be established by objective measurements (e.g., material degradation tests, sterility tests, electrical performance tests) against established engineering and medical device standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods are relevant for subjective assessments (like image interpretation) where multiple readers disagree. This submission focuses on objective performance characteristics validated against standards.
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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 device. MRMC studies are not applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is an electrosurgical device, not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the reusability claims: The "ground truth" would be objective testing results comparing the device's performance (e.g., electrical impedance, material integrity, sterility assurance levels) against established engineering standards (e.g., ANSI/AAMI ST46:1993, AAMI TIR 12:1994) after specified numbers of sterilization cycles.
- For substantial equivalence: Comparison against the predicate device's known performance specifications and general safety/effectiveness requirements for electrosurgical electrodes.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. No training set exists.
§ 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.