(147 days)
The device is intended to be used for drawing osteomedullary substances from the iliac crest.
A manually operated biopsy needle used for aspiration or explantation of bony substance.
This document is a Summary of Safety and Effectiveness for a medical device, the ACRI®-Iliac Crest Aspiration-Biopsy Needle. It's a regulatory submission (K962568) from 1996.
This document describes basic safety tests for a physical medical device, not an AI/software-based "device" as implied by the questions regarding AI performance, ground truth, and training sets.
Therefore, most of the requested information cannot be provided from this document because it pertains to the evaluation of AI systems, not a physical biopsy needle.
However, I can extract the information relevant to the safety and performance of this physical medical device as presented in the document.
Acceptance Criteria and Device Performance (Based on provided document):
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| Intracutaneous Reactivity | Passed |
| Acute Systemic Toxicity | Passed |
| Pyrogen Test | Passed |
| Cytotoxicity | Passed |
Explanation of Applicability to AI/Software Devices:
The questions provided are tailored for the evaluation of AI/Machine Learning-based medical devices, which typically involve assessing diagnostic accuracy, sensitivity, specificity, and other performance metrics against established ground truth. This document, being from 1996 for a physical "aspiration-biopsy needle," focuses on biocompatibility and basic safety tests.
Therefore, the following questions are not applicable to the provided document and cannot be answered:
- Sample sized used for the test set and the data provenance: Not applicable to biocompatibility testing of a physical device. There's no "data" in the AI sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set isn't relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 does not involve human readers interpreting images with or without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the AI sense isn't used for these tests. The "ground truth" for these tests is standardized biological assays.
- The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of what CAN be inferred from the document regarding the physical device:
The document indicates that the ACRI®-Iliac Crest Aspiration-Biopsy Needle was subjected to basic biocompatibility and safety tests, and it "Passed" all of them. These tests are:
- Intracutaneous Reactivity: Measures the potential for the device's material to cause irritation or sensitization when in contact with skin. "Passed" means it did not cause undue irritation.
- Acute Systemic Toxicity: Assesses the rapid, general toxic effects of leachable substances from the device on a living system. "Passed" means it did not cause acute systemic toxicity.
- Pyrogen Test: Checks for the presence of pyrogens (fever-inducing substances). "Passed" means it is free of pyrogens.
- Cytotoxicity: Evaluates the potential of the device's materials to damage cells. "Passed" means it is not cytotoxic.
The study referenced is an internal safety and efficacy testing performed by the manufacturer, Gallini s.r.I., to demonstrate compliance with regulatory requirements for a Class II medical device (indicated by the K number submission). The specific details of how these tests were performed (e.g., specific animal models, cell lines, number of replicates, statistical methods) are not included in this summary.
§ 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.