(15 days)
The Probe is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissues to produce hemostasis.
The Boston Scientific Corporation Surgical Probe is a sterile, single use electrosurgical device intended to be used to coagulate soft tissues. The surgical probe transmits radiofrequency energy from electrodes which are connected to an Electrosurgical unit (non-sterile; re-useable) through an Instrument Cable (sterile; re-useable).
The provided text describes a 510(k) summary for the Cobra® Cooled Surgical Probe, a general electrosurgical device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as one might expect for an AI/ML medical device.
Therefore, many of the requested sections about acceptance criteria, device performance, ground truth, and sample sizes for AI/ML studies are not applicable or cannot be extracted from this document. The document describes traditional medical device testing.
Here's an attempt to answer the questions based only on the provided text, noting when information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for AI/ML device performance (e.g., sensitivity, specificity thresholds). Instead, it describes general non-clinical tests designed to ensure safety and functionality. The "reported device performance" is essentially that these tests were conducted and the device performed adequately to meet the safety and effectiveness requirements for substantial equivalence.
| Requirement/Test Category | Acceptance Criteria (Not explicitly stated as numeric thresholds) | Reported Device Performance (Implied Pass) |
|---|---|---|
| Fluid Path Integrity | (Implicit: no leaks, maintains integrity) | Testing conducted, conformed to requirements. |
| Bond Joint Tensile Strength | (Implicit: meets specified strength requirements) | Testing conducted, conformed to requirements. |
| Bond Joint Torsional Strength | (Implicit: meets specified strength requirements) | Testing conducted, conformed to requirements. |
| Distal Section Fatigue | (Implicit: withstands expected fatigue) | Testing conducted, conformed to requirements. |
| Shaft to Handle Tensile Strength | (Implicit: meets specified strength requirements) | Testing conducted, conformed to requirements. |
| Biocompatibility | (Implicit: non-toxic, non-irritating) | Testing conducted, conformed to requirements. |
| In vivo performance (acute) | (Implicit: safe and effective coagulation in acute setting) | Testing conducted, conformed to requirements (for coagulation of soft tissues/hemostasis). |
| In vivo performance (chronic) | (Implicit: safe and effective coagulation in chronic setting) | Testing conducted, conformed to requirements (for coagulation of soft tissues/hemostasis). |
| Good Laboratory Practices (GLP) | Conformance to 21 CFR Part 58 | Testing conformed to 21 CFR Part 58. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided. The "non-clinical data" refers to device engineering and biological testing, not a clinical study with a "test set" of patients/samples in the AI/ML sense. The provenance of the data is that it was generated from testing within Boston Scientific Corporation or their designated labs, conforming to GLP.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. "Ground truth" in the context of expert consensus for a test set is specific to performance studies involving human interpretation or pathology, which is not the type of testing described here.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies where multiple human readers assess cases, which is not the focus of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes non-clinical engineering and biocompatibility testing, along with in vivo performance testing. It does not refer to an MRMC study comparing human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No. This device is an electrosurgical probe, which is a physical instrument, not an algorithm. Therefore, a "standalone" algorithm performance study is not applicable.
7. The Type of Ground Truth Used
For the in vivo performance testing, the "ground truth" would implicitly be the observed physiological effect (e.g., successful coagulation, hemostasis, lack of adverse tissue effects) as assessed by the researchers or histopathology following the animal studies. For engineering tests, the ground truth is against a specific engineering specification or standard. The document does not specify how this was established (e.g., specific pathology reports, outcome data, etc.) but states "In vivo performance" was tested.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (electrosurgical probe), not a machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning algorithm, this information is not relevant to this device submission.
§ 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.