ACRI R NEEDLE by GALLINI U.S., LLC.

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved, parallel lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul L. Hawthorne U.S. Representative Gallini U.S. 3991 Glenside Drive, Suite F Richmond, Virginia 23229

Re: K980248 Trade Name: ACRI® Needle Regulatory Class: II Product Code: KNW Dated: January 23, 1998 Received: January 23, 1998

Dear Mr. Hawthorne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with-the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

FEB 1 8 1998

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Page 2 - Mr. Hawthorne

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

fscolfe
C. Scott McWhorter, Ph.D., M.D.

M. Witten, Ph.D., M.D. Celi Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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. 1

510(k) Number (if known): K980248

Device Name: ACRI-R Needle

Indications For Use:

This device is to be used for bone marrow aspiration biopsy from the sternum or iliac crest.

(PLEASE OO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980248

Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

Regulation Number and Section

§ 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.