(93 days)
AprioCore plus is intended for use in obtaining core biopsy specimens from soft tissue such as breast, kidney, liver, lung, thyroid, lymph nodes and various soft tissue masses performed under image guidance techniques for soft tissue biopsy.
AprioCore plus is a manually operated, sterile, single use, semi-automatic, spring-loaded biopsy needle. AprioCore plus is provided in a variety of sizes (gauge and length) and is compatible with AprioMed devices Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle.
The provided document is a 510(k) summary for the AprioCore plus, a semi-automatic, spring-loaded biopsy needle. The purpose of this summary is to demonstrate substantial equivalence to a predicate device (Quick-Core Biopsy Needle, K973565). The document primarily focuses on non-clinical and bench testing to establish this equivalence, rather than clinical studies involving human subjects or AI algorithms.
Therefore, many of the requested elements regarding acceptance criteria for AI performance, sample sizes for test sets in clinical studies, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and training set details are not applicable to this submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format alongside reported performance for each criterion. Instead, it states that "Conformity has been demonstrated" for various performance characteristics by comparing the subject device (AprioCore plus) to the predicate device (Quick-Core Biopsy Needle). The acceptance for each test appears to be that the subject device performs "equivalent to" or "equal or lower" or "equivalent or higher" than the predicate, or that it successfully meets a functional goal (e.g., "will not extend over the stylet tip", "can successfully retrieve biopsy specimen").
Table: Acceptance Criteria and Reported Device Performance (as inferred from the text)
| Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Depth projection | Subject device will not extend over the stylet tip (over-throw) during use. | Conformity has been demonstrated. |
| Penetration force | Penetration force of the subject device is equivalent to or lower than the predicate device. | Conformity has been demonstrated. |
| Loading force | Loading force of the subject device is equivalent to the predicate device and the user is able to load the device. | Conformity has been demonstrated. |
| Activation force | Force to activate the subject device is not too low, preventing unintentional activation, and is equivalent to or higher than the predicate device. | Conformity has been demonstrated. |
| Mechanical durability | Subject device withstands the forces applied during normal use. | Conformity has been demonstrated. |
| Tissue sample extraction test | Subject device can successfully retrieve biopsy specimen multiple times. | Conformity has been demonstrated. |
| Tip configuration | Subject device has a tip dead-space that is shorter compared to the predicate device, allowing biopsy closer to sensitive anatomy/structure. | Conformity has been demonstrated. |
| Visibility | Invasive part of subject device is visible in CT, Fluoroscopy, and Ultrasound. | Conformity has been demonstrated. |
| Compatibility | Device is compatible with coaxial needle standardized sizes as per ISO 9626. Compatible with AprioMed Gangi-SoftGuard and Gangi-HydroGuard. | Conformity has been demonstrated. |
| Qualification metal tubing/needle component | Stainless-steel tubing fulfills the requirement in ISO 9626. | Conformity has been demonstrated. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench testing, not a clinical study with a "test set" in the context of diagnostic accuracy. Therefore, information about human subject sample size, data provenance, retrospective/prospective nature, or country of origin is not applicable. The "test set" refers to the physical devices and materials used in the bench tests. The specific number of devices or test repetitions for each bench test is not explicitly stated in the summary, though it notes that testing confirms the device meets design requirements.
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 is not applicable as the document describes bench testing for a physical medical device, not a diagnostic device requiring expert interpretation or ground truth establishment by clinical experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes bench testing for a physical medical device, not a diagnostic study requiring adjudication of expert readings.
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 is not applicable. The device is a physical biopsy needle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical biopsy needle, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" or reference for comparison was primarily the predicate device performance and recognized consensus standards (e.g., ISO 9626, ISO 10993). For example:
- Activation force, Penetration force, Loading force, Specimen size: Comparison was directly against the predicate device.
- Sterilization, Biocompatibility, Metal tubing: Compliance with international standards (ISO 11607-1, ISO 10993, ISO 9626).
- Visibility, Depth projection, Mechanical durability, Tissue sample extraction, Compatibility: Demonstrated functional success against predefined requirements, likely derived from engineering specifications and predicate device characteristics.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. The device is a physical medical device, not an AI algorithm.
§ 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.