(144 days)
The Electrocautery Dilation Balloon is intended for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.
The Electrocautery Dilation Balloon is indicated for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. Using either endoscopic or fluoroscopic means, the balloon is placed at the physician selected site. Once in place, the clinician inflates the balloon to dilate the stricture. The electrocautery needle knife may be used for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The needle knife is advanced and retracted with the proximal handle.
The provided text describes a 510(k) summary for the Electrocautery Dilation Balloon. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific performance metrics akin to a novel AI device.
Therefore, many of the typical "acceptance criteria" and "study" details requested for an AI device (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, and types of ground truth) are not applicable to this traditional medical device submission.
Here's a breakdown based on the provided text, highlighting what is and isn't available:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission focuses on "Product testing" to ensure the device performs as intended and is safe. The acceptance criteria are largely based on engineering performance specifications rather than clinical accuracy for diagnostic or prognostic purposes, which would involve concepts like sensitivity, specificity, etc.
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Functional Performance | Inflation/Deflation/Burst integrity | Met specification |
| Mechanical Performance | Atraumatic tip | Met specification |
| Electrocautery Function | Electrocautery extension/retraction | Met specification |
| Material Durability | Corrosion resistance | Met specification |
| Overall Equivalence | Equivalent to predicate devices in: | Substantially equivalent |
| - Indications for use | ||
| - Basic overall function | ||
| - Methods of manufacturing | ||
| - Materials used |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This submission does not describe a clinical "test set" in the context of evaluating diagnostic accuracy or a similar performance claim requiring patient data. The testing mentioned (
inflation/deflation/burst, atraumatic tip, electrocautery extension/retraction, and corrosion testing) refers to bench testing of the device itself, likely using a sample of manufactured devices, but the specific number is not provided. Data provenance (country of origin, retrospective/prospective) is also not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. There is no "ground truth" to establish in the context of diagnostic performance for this type of device submission. The device is a tool for a medical procedure, and its performance is assessed against engineering and functional specifications, not against a diagnostic gold standard in patient cases.
4. Adjudication Method for the Test Set:
- Not Applicable. As there's no clinical test set requiring expert interpretation or labeling, there's no adjudication method 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:
- Not Applicable. An MRMC study is relevant for evaluating the clinical impact of an AI diagnostic aid on human readers. This device is a surgical/interventional tool, not an AI diagnostic system, so such a study would not be performed for this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical medical instrument, not an algorithm. Standalone performance as typically described for AI devices is irrelevant.
7. The Type of Ground Truth Used:
- Not Applicable (in the AI/diagnostic sense). The "ground truth" for this device's performance would be engineering specifications and functional requirements (e.g., "the balloon must inflate to X pressure without bursting," "the knife must extend and retract smoothly"). These are verified through direct measurement and observation during bench testing.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there's no training set, this question is not relevant.
In summary: The provided 510(k) pertains to a traditional device (electrocautery dilation balloon) demonstrating substantial equivalence to predicates through bench testing and material compatibility. The performance criteria are therefore engineering and functional, not clinical diagnostic accuracy, which is why many of the requested AI-centric details are not present in the document.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).