(73 days)
The Broncus™ Coagulation Electrode System is intended for coagulation or hemostasis in the tracheobronchial tree.
The Broncus Coagulation Electrode System consists of a catheter, a RF generator, and a commercially available patient return electrode. The RF generator produces RF power in a monopolar mode. The catheter delivers RF energy to the desired target site and relays temperature and other feedback to the RF generator. The patient return electrode is used to complete the return path for the electrical current.
The provided document is a 510(k) summary for the Broncus™ Coagulation Electrode System, dated January 17, 2000. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.
Specifically, this document focuses on establishing substantial equivalence to predicate devices based on intended use and non-clinical performance and biocompatibility testing. It lacks the specifics of clinical study design, sample sizes for training or test sets, expert qualifications, ground truth establishment, or specific performance metrics that would be expected for a detailed AI/ML device submission.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional testing | Passed |
| Electrical testing | Passed |
| Biocompatibility | Proven biocompatibility |
- Note: The document states that the "Coagulation Electrode System has undergone and passed functional and electrical testing designed to assess the performance of the catheter and the RF generator" and "The materials used in the Coagulation Electrode have proven biocompatibility." However, it does not specify the quantitative acceptance criteria (e.g., specific voltage ranges, tissue temperature limits, or mechanical strength thresholds) for these tests, nor does it provide detailed numerical results beyond "passed."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: The document does not mention any clinical test sets, human subject data, or data provenance. The testing described is non-clinical (functional, electrical, and biocompatibility).
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/Available: As no clinical test set or human subject data is mentioned, there is no discussion of experts establishing ground truth for such data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Available: No clinical test set is discussed.
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 device is a medical instrument (coagulation electrode system), not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance 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 medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Available: For the non-clinical tests described, the "ground truth" would be engineering specifications and standards for functional and electrical performance, and established biocompatibility standards for materials. These are not explicitly detailed in the summary.
8. The sample size for the training set
- Not Applicable/Available: This is a hardware device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable/Available: No training set is relevant for this device.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.