(81 days)
Aaron Arthroscopy Electrodes are sterile, single-use 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 arthroscopic surgical procedures.
Aaron Arthroscopy Electrodes sterile, single-use electrodes that 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 arthroscopic surgical procedures.
The provided text describes a 510(k) premarket notification for the Aaron Arthroscopy Electrode. The document states that "Testing performed on Aaron Arthroscopy Electrodes indicate that the devices are substantially equivalent in method of operation, safety, and performance" to the Unimed Arthroscopy Electrode (K970066).
However, the 510(k) summary does not provide specific acceptance criteria or detailed study results in the format requested. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than performing a de novo study against explicit, quantitative acceptance criteria for device performance.
Therefore, many of the requested categories about acceptance criteria, detailed study design, sample sizes, and ground truth establishment cannot be extracted from this document because they are either not publicly available or not part of the standard 510(k) summary provided.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate in method of operation. | "substantially equivalent in method of operation" |
| Substantial equivalence to predicate in safety. | "substantially equivalent in... safety" |
| Substantial equivalence to predicate in performance. | "substantially equivalent in... performance" |
| Substantial equivalence to predicate in intended use. | "substantially equivalent to the Unimed Arthroscopy Electrode (K970066) in... intended use" |
| Substantial equivalence to predicate in energy source. | "substantially equivalent to the Unimed Arthroscopy Electrode (K970066) in... energy source" |
| Substantial equivalence to predicate in method of preparation. | "substantially equivalent to the Unimed Arthroscopy Electrode (K970066) in... method of preparation" |
| Device functions as intended for cutting, excising tissue, and coagulating blood vessels during arthroscopic procedures. | Implied by substantial equivalence to predicate which performs these functions. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The testing is internal to Aaron Medical Industries.
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/Not specified. This document pertains to a medical device's functional equivalence, not an AI or diagnostic tool requiring expert ground truth for image interpretation or disease diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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 is not an AI or diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI or diagnostic imaging device. The device is used by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of diagnostic ground truth. The "ground truth" for this device would be its ability to perform its intended functions (cutting, coagulation) reliably and safely, analogous to the predicate device, likely assessed through engineering tests, biocompatibility tests, and performance testing. The specifics are not detailed in this summary.
8. The sample size for the training set
- Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning device.
§ 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.