The Little Grafter™ Screw is intended for fixation of fractures of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articualar fractures of the tarsals, metatarsalsm carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.

Device Description

The Little Grafter™ Screw is a cannulated, sterile, single use bone fixation screw manufactured from a composite mixture of a calcium salt and a bioabsorbable polymer

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

The document is a 510(k) summary for a bone fixation screw (Little Grafter™ Screw) and the FDA's clearance letter. It primarily describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices.

Here's what can be extracted and what is missing based on your request:

Missing Information:

The document explicitly states: "Test results confirm that this composite screw has the requisite strength to provide both early and sustained fixation of the fracture site. Test results compare favourably with the predicate devices." However, it does not provide any specific acceptance criteria (numerical thresholds for strength, fatigue, etc.) nor the detailed results of the tests. It also doesn't disclose information about sample sizes used for testing, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance details, or specifics about training sets for any AI/ML component (which is not relevant for this type of device, as it's a physical medical implant).

Therefore, I cannot populate the table or answer most of your detailed questions about the study design.

Available Information (related to Performance Data):

Device Name: Little Grafter™ Screw
Performance Data Summary: "Test results confirm that this composite screw has the requisite strength to provide both early and sustained fixation of the fracture site. Test results compare favourably with the predicate devices."
Type of Ground Truth Used: Not applicable in the context of AI/ML. For a physical device like a screw, "ground truth" would relate to mechanical testing standards and potentially in vivo or ex vivo biomechanical studies. The text vaguely refers to "requisite strength" but without specific metrics.

Given the nature of the device (a bone fixation screw), the "study" referred to would be mechanical and possibly biomechanical testing, not a diagnostic or AI-driven study involving human readers or extensive data sets in the way your prompt's questions imply.

Conclusion:

The provided document, while serving as a 510(k) summary, does not offer the level of detail required to complete your request regarding specific acceptance criteria, study methodology, sample sizes, or expert involvement, as these details are typically found in the full 510(k) submission, not the public summary.

Summary

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K040265
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Exhibit VI

510(K) Summary of Safety and Effectiveness

(1) Submitter's name: Biocomposites Ltd Submitter's address: Etruscan Street, Etruria, Stoke-on-Trent, ST1 5PQ, England Submitter's telephone number: 44 (0) 1782 206500 Contact person: Stephen Bratt Date summary prepared: 27th January 2004 (2) Trade or proprietary device name: Little Grafter™ Screw Common or usual name: Bone Fixation Screw Classification name: Smooth or threaded bone fixation fastener

(3)	Legally marketed predicate device:
	Herbert Bone Screw (Zimmer Inc)	K792022
	Acutrak (Acumed Inc)	K944330
	Asnis III Screw (Howmedica Osteonics)	K000080
	Synthes Compression Screw (Synthes USA)	K021556
	Wisorb Malleolar Screw (Cambridge Scientific)	K020222

(4) Subject device description:

The Little Grafter™ Screw is a cannulated, sterile, single use bone fixation screw manufactured from a composite mixture of a calcium salt and a bioabsorbable polymer

(2) Subject device intended use:

(6) Technological characteristics:

The Little Grafter™ Screw has the same technological characteristics as the predicate devices.

(7) Performance data:

Test results confirm that this composite screw has the requisite strength to provide both early and sustained fixation of the fracture site. Test results compare favourably with the predicate devices.

(8) Basis for substantial equivalence:

The Little Grafter™ Screw is equivalent in design, performance and indications to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2004

Mr. J. Stephen Bratt Managing Director Biocomposites Ltd. Etruscan Street, Etruria, Stoke-on-Trent Staffordshire, ST1 5PQ, England

Rc: K040265

Trade/Device Name: Little Grafter™ Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 6, 2004 Received: May 10, 2004

Dear Mr. Bratt:

We have reviewed your Section 510(k) premarket notification of intent to market the device refercnced 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. J. Stephen Bratt

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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

Sincercly yours,

Sincerely, yours,

Mark N. Millican

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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Indications for Use

K040265 510(k) Number (if known):

Little Grafter™ Screw Device Name:

Indications For Use:

The Little Grafter™ Screw is indicated for fixation of fractures of small bones The Extre Grater - Odeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; mira artheamies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milken

Signivision Division of General, Restorative, and Neurological Devices

510(k) Number K040265

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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.