I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets the acceptance criteria. The document is a 510(k) summary for a "BMN 'I' Type Marrow Biopsy Needle," which is a premarket notification to the FDA. It includes:

Applicant and contact information.
Device name, common name, and classification.
Indication for use.
FDA's determination of substantial equivalence to a predicate device.
Regulatory information regarding marketing, general controls, and compliance.

There is no mention of performance metrics, acceptance criteria, study design, results, or ground truth establishment. Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about a study.

Summary

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BMN "I" TYPE

510 (k) SUMMARY

K0209f7

JUN 2 5 2002

> Applicant	: H.S. Hospital Service S.p.A.Via Naro, 81 - 00040 Pomezia (Roma) Italy
> Contact Person	: MMC International, LLCMr. Lucio Improta10147 Umberland Place - Boca Raton, FL 33428Tel. (561) 477-1671e-mail : mmcintern@aol.com
> Submission Date	: February 28, 2001
> Trade Name	: BMN “I” Type Marrow Biopsy Needle
> Common Name	: Bone Marrow Biopsy Needle
> Classification Name	: 876.1075 - Biopsy instrument

❖ Indication for use :

This biopsy instrument is used for drawing of osteomedullary substance and or for Explantation of bone marrow

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

H.S. Hospital Service S.R.L. c/o Mr. Lucio Improta MMC International LLC 10147 Umberland Place Boca Raton, FL 33428

JUN 2 5 2002

Re: K020987

Trade/Device Name: BMN "I" Type Marrow Biopsy Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: February 28, 2002 Received: March 27, 2002

Dear Mr. Improta:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Lucio Improta

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark A. Millikens

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

Enclosure

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PREMARKET NOTIFICATION SUBMISSION - 510 (k)

BMN "I" TYPE

ATTACHMENT "B"

510 (k) # K020981

DEVICE NAME

BMN "I" Type Biopsy Needle

INDICATION FOR USE

This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Melkerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020987

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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.