(26 days)
This device is to be used for bone marrow aspiration biopsy from the sternum or iliac crest.
ACRI-R Needle
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "ACRI® Needle." This letter indicates that the device has been determined to be substantially equivalent to a predicate device already on the market.
It is crucial to understand that a 510(k) clearance process does not inherently require a study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel high-risk medical device might. Instead, substantial equivalence is often demonstrated through:
- Comparison to a predicate device: Showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
- Performance testing: This typically involves bench testing, biocompatibility testing, sterilization validation, and potentially some limited clinical performance data, but not necessarily a full-fledged comparative effectiveness study or a study with pre-defined acceptance criteria for diagnostic accuracy (as would be common for AI/ML devices).
Therefore, based on the provided text, many of the requested details about acceptance criteria and a study proving their achievement cannot be extracted because they are not typically part of a 510(k) clearance document for this type of device (a biopsy needle).
However, I can extract the following information that is relevant to the device and its intended use:
Device Information:
- Trade Name: ACRI® Needle
- Regulatory Class: II
- Product Code: KNW
- Indications For Use: This device is to be used for bone marrow aspiration biopsy from the sternum or iliac crest.
- Type of Device: Bone marrow aspiration biopsy needle.
Regarding your specific questions, this document does not contain the information you are looking for related to performance studies with acceptance criteria as typically understood for AI/ML or diagnostic devices.
Let's address each point based on the absence of this information in the provided document:
-
A table of acceptance criteria and the reported device performance:
- Information not available in the provided text. The 510(k) letter does not detail specific acceptance criteria for a performance study nor report device performance against such criteria. The "performance" being assessed here is its substantial equivalence to a predicate device, which implies it performs as safely and effectively for its intended use.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information not available in the provided text. This type of detail would be found in a study report, not a 510(k) clearance letter for a mechanical device like a needle.
-
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):
- Information not available in the provided text. This is not relevant for a mechanical device like a needle and its 510(k) clearance.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information not available in the provided text.
-
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:
- Information not available in the provided text. This device is a biopsy needle, not an AI/ML diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information not available in the provided text. This is not an algorithm-based device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Information not available in the provided text. For a biopsy needle, the "ground truth" of its performance might relate to its ability to successfully obtain a biopsy or its safety (e.g., prevention of breakage). However, these specific metrics are not detailed in the FDA letter.
-
The sample size for the training set:
- Information not available in the provided text. This concept is completely inapplicable to a mechanical, non-AI device.
-
How the ground truth for the training set was established:
- Information not available in the provided text. Also inapplicable.
In summary: The provided document is an FDA 510(k) clearance letter for a medical device (a biopsy needle), demonstrating substantial equivalence rather than reporting on a study with specific performance acceptance criteria often associated with diagnostic or AI-based devices. Therefore, most of the detailed information you requested regarding study design, sample sizes, ground truth, and expert involvement is not present nor relevant for this type of FDA submission.
§ 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.