(63 days)
The Golden Tip™ Electro-Surgical Probe is an electrocautery electrode and intended for use in open surgical procedures.
The Golden Tip™ Electro-Surgical Probe is a conventional electrosurgical instrument to which is applied electrical energy in the form of a radio-frequency signal for purposes of cauterizing or cutting during a surgical procedure.
The provided text describes the submission for a 510(k) premarket notification for "The Golden Tip™ Electro-Surgical Probe." This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving performance against them in the way a clinical trial for a novel, high-risk device might.
Therefore, many of the requested categories in your prompt are not applicable or cannot be fully answered from the provided text. This device is an electrosurgical probe, which is a common, well-understood technology, and the submission emphasizes non-clinical testing and comparison to existing products.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Electrode Functional Performance: Proper function, no damage at recommended power levels during cutting and cauterizing. | Performed properly on beef steaks, chicken breasts, and beef liver steaks. No electrode damage occurred. | This is a pass/fail criterion based on observation during simulated use. The specific "power levels" are not quantified. |
| Assembly Testing: Proper assembly into common electrosurgical pencils; appropriate removal force; satisfactory force required to separate electrode tip from shaft. | Assembled properly into Valley Lab, Aspen Labs, Birtcher, Conmed, and other standard 3-terminal receiver pencils. Exhibited appropriate removal force. Met performance requirements satisfactorily for tip/shaft separation. | Criteria are qualitative ("properly," "appropriate," "satisfactorily") and indicate compliance with design intent. Specific force values are not provided. |
| Electrical Insulation: Meet ANSI/AAMI HF-18/1993, Section 4.2.5.4 requirements for insulation at low and radio frequencies. | Passed all test requirements for electrical insulation at both low frequency and radio frequency. | This is a pass/fail criterion against a recognized standard. |
| Safety and Effectiveness (General): No design characteristics violating Reviewer Guidance or resulting in safety hazards. | None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. | General compliance statement based on the sum of testing. |
| Substantial Equivalence: Equivalent in intended use, design, material, and technology to predicate device (MegaDyne). | Concluded to be substantially equivalent in intended use, design, material, and technology as the MegaDyne ElectroSurgery Electrode. | This is the overarching "acceptance criterion" for a 510(k) submission. |
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 for Functional Testing: Not specified as a numerical count of probes. It refers to "All Golden Tip™ Electro-Surgical Probes" and various "steaks" and "breasts." This suggests a qualitative, rather than large statistical, sample.
- Data Provenance: The tests were conducted "in the laboratory" and "on dogs" (pre-clinical performance). This indicates prospective testing, likely in the USA (given the submission to the FDA). No information on the country of origin of the biological samples or dogs themselves.
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)
- The document does not mention experts being used to establish a "ground truth" for the non-clinical tests described. The assessment of proper function, assembly, and insulation would have been based on engineering measurements, observations by technicians, and adherence to standards.
- The "pre-clinical performance was tested on dogs, using surgical procedures." While this implies the involvement of animal surgeons or veterinarians, their specific number or qualifications are not stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This type of formal adjudication process (e.g., for interpreting images or clinical outcomes) is not applicable to the non-clinical tests described. The results are likely direct measurements or observations against predefined technical specifications or functional requirements.
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 MRMC study was conducted. This device is a surgical instrument, not an imaging analysis AI or diagnostic tool. The concept of "human readers improving with AI" is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical electrosurgical probe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical functional tests: The "ground truth" was the physical behavior of the device (cutting, cauterizing, not sticking, not damaging) and performance against engineering specifications (assembly, electrical insulation).
- For the pre-clinical dog tests: The "ground truth" would be the observed surgical and physiological effects in the animal model, likely assessed by the veterinary surgical team against expected outcomes for electrosurgery. Specific details are not provided beyond "testing specifications were met."
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
§ 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.