(14 days)
The BNX™ Fine Needle Aspiration System is used to sample targeted sub-mucosal and extramural lesions of the gastrointestinal tract through the accessory channel of an ultrasound endoscope.
The BNXTM Fine Needle Aspiration System is a sterile, single patient use endoscopic ultrasound aspiration needle. The device consists of the BNXTM Aspiration Delivery System and BNXTM Fine Needle Aspiration Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The needle is used to acquire aspiration samples from lesions targeted using an ultrasound endoscope. An aspiration sample is obtained by penetrating the lesions with the needle while applying suction. The device will be offered with needle sizes of 19, 22 and 25 gauge.
The provided text describes the 510(k) summary for the BNX™ Fine Needle Aspiration System, but it is a premarket notification for a medical device that does not involve AI. Therefore, most of the requested information regarding acceptance criteria, study details for AI performance, sample sizes for training and test sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility evaluations, not through clinical efficacy studies involving diagnostic accuracy or AI performance.
Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for an AI device:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with numerical performance targets typical for AI models. Instead, it describes various verification tests and their outcomes.
| Acceptance Criteria (General Description from text) | Reported Device Performance (Summary from text) |
|---|---|
| Mechanical/Integrity Evaluations: | Adequately designed for use, conformance with pre-specified intended acceptance criteria. |
| - Handle Tensile Strength | Verified |
| - Handle Resistance to Torque | Verified |
| - Bond Strengths | Verified |
| - Needle Fracture | Verified |
| Performance Evaluations: | Functionally equivalent to predicate Cook and/or Olympus device. |
| - Device Function/Durability | Verified |
| - Aspiration Needle/Handle Locking Force | Verified |
| - Needle and Catheter Sheath Extension Locking Forces | Verified |
| - Stylette Withdrawal Force | Verified |
| - Perforation Testing | Verified |
| - Needle Echogenicity (Acoustic Reflection) | Equivalent to predicate devices |
| - Aspiration Capability | Verified |
| Biocompatibility | Demonstrated substantial equivalence |
| Packaging Integrity | Demonstrated for labeled shelf-life |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable for an AI device. The document describes bench testing performance, which involves a series of physical and mechanical tests on the device itself, not a test set of data. The number of units tested for each verification test is not specified.
- Data Provenance: Not applicable for an AI device. The testing was conducted in a laboratory/bench setting.
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. The "ground truth" for this device's performance is based on engineering specifications, material properties, and functional requirements, established by design and verified through laboratory testing (e.g., measuring forces, observing physical integrity). It does not involve expert clinical assessment of diagnostic output.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human-reviewed data for AI model evaluation. Bench testing involves direct measurement and observation against predefined engineering standards.
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. No AI component is described, and therefore no human reader assistance or MRMC study was performed. The device is a physical instrument for sample acquisition.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and effectiveness is established through adherence to engineering design specifications, biocompatibility standards, and functional performance benchmarks (e.g., a certain tensile strength, effective aspiration, visualizable echogenicity). These are verified through objective physical measurements and tests, rather than clinical outcomes or expert labels on medical data.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.