(48 days)
The Microline reusable 3 mm and 5 mm diameter Electrosurgical Cautery Probes are intended to deliver energy from an independent monopolar electrosurgical generator to cauterize tissues during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
The Microline Electrosurgical Cautery Probes are a line of non-sterile, reusable 3 mm and 5 mm diameter instruments used to deliver energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
The provided text is a 510(k) summary for a medical device (Electrosurgical Cautery Probes). It focuses on establishing substantial equivalence to a predicate device rather than presenting extensive performance studies or acceptance criteria for the new device.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in the provided text.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document primarily focuses on establishing substantial equivalence based on device description and comparison to a predicate, not on specific performance criteria or a study demonstrating meeting those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. No specific test set or study data is presented.
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)
This information is not provided in the document. No ground truth establishment for a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No test set or adjudication method is described.
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
This information is not provided in the document. An MRMC study is not mentioned, and AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. As this is an electrosurgical probe, it's a physical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. No ground truth is discussed in the context of device performance testing.
8. The sample size for the training set
This information is not provided in the document. No training set is mentioned as this is a physical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not provided in the document. No training set or ground truth establishment for it is discussed.
Summary of available information relevant to "proving the device meets acceptance criteria":
The document primarily states that the Microline Electrosurgical Cautery Probes are "substantially equivalent" to the Olsen Electrosurgical reusable laparoscopic electrodes (K913108). This is the core "proof" presented in a 510(k) submission, meaning that the new device is as safe and effective as a legally marketed predicate device.
Specifically:
- Substantial Equivalence Statement: "The Microline Electrosurgical Cautery Probes are substantially equivalent to the Olsen Electrosurgical reusable lapasocopic electrodes (K913108)."
- Basis for Equivalence: "Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Microline Electrosurgical Cautery Probes relative to its predicate."
- Indications For Use: The new device shares the same intended use: "to deliver energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula."
In essence, the "acceptance criteria" here are met by demonstrating that the device is fundamentally similar in function, materials, and safety/effectiveness profile to a previously approved device. The "study" proving this is the detailed comparison and justification presented in the 510(k) submission itself, stating that any differences do not impact safety or effectiveness.
§ 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.