Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure. Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect. The bony defects or cavities may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

Device Description

Genex® Bone Graft Substitute consists of synthetic bioabsorbable calcium salts, premeasured mixing solution and tools necessary to mix the components into a paste. These products are provided sterile for singe patient use. When mixed according to directions, the Gonex® Bone Graft Substitute produces biodegradable, radiopaque paste/moulded blocks that resorb in approximately 6 -- 9 months when used according to labelling. After the granular powder is hydrated using all of the mixing solution supplied in each pack, the resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are gently paced into non-load bearing voids or gaps of the skeletal system (i.c. the extremitics, spinc and pelvis). These bone voids may be surgically created osseous defects or osscous defects created from traumatic injury to the hone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.

AI/ML Overview

The provided document is a 510(k) summary for the Genex® Bone Graft Substitute. It does not contain acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, and direct performance data either cannot be answered or would be speculative based on this document.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not provided in the document. 510(k) summaries primarily demonstrate substantial equivalence, not the fulfillment of specific performance acceptance criteria from a pre-defined study protocol for a novel device.

Reported Device Performance:

Performance Aspect	Reported Statement
Resorption	"resorbs in approximately 6 – 9 months when used according to labelling."
Replacement	"resorbs and is replaced with bone during the healing process."
Bone Void Filler	"provides a bone void filler"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided 510(k) summary. The document states "Test results confirm that Genex® Bone Graft Substitute provides a bone void filler which, when placed in contact with healthy bone, resorbs and is replaced with bone during the healing process," but it does not detail the nature, size, or provenance of these "test results."

3. 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)

This information is not available in the provided 510(k) summary. Given that it's a bone graft substitute, ground truth would likely be established by histological analysis or imaging read by clinical experts, but no details are given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided 510(k) summary.

5. 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

This is not applicable. The device is a bone graft substitute, not an AI-powered diagnostic or imaging interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a physical bone graft substitute, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document implies that "test results" confirmed the device's performance, specifically its resorption and replacement by bone. For a bone graft substitute, ground truth would typically involve histological evaluation (pathology) from tissue samples over time to confirm bone ingrowth and material resorption, potentially combined with imaging (radiological) assessment of defect filling and healing. However, the document does not explicitly state the type of ground truth used for its "test results."

8. The sample size for the training set

This information is not available in the provided 510(k) summary. The document does not describe a "training set" as it would for a machine learning model; the "test results" mentioned are likely from a traditional preclinical or clinical study, but details are not given.

9. How the ground truth for the training set was established

Not applicable as no training set is described. If referring to the "test results" in general, please refer to the answer for question 7.

Summary

{0}------------------------------------------------

K040600

MAY - 7 2004

Exhibit V

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:	12th February 2004
(2)	Trade or proprietary device name:	Genex® Bone Graft Substitute
	Common or usual name:	Bone Void Filler, Bone Graft Substitute
	Classification name:	Resorbable Calcium Salt Bone Void Filler
		Device, Calcium Sulphate Preformed Pellet

Legally marketed predicate device:
Stimulan® Bone Void Filler Kit	Biocomposites Ltd	K021551
Vitoss™ Scaffold	Orthovita Inc	K994337
Therifil™ Bone Void Filler	Therics Inc	K031040
Cem-Ostetic Bone Void Filler	Berkeley Advanced Biomaterials Inc	K022622

(4) Subject device description:

After the granular powder is hydrated using all of the mixing solution supplied in each pack, the resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are gently paced into non-load bearing voids or gaps of the skeletal system (i.c. the extremitics, spinc and pelvis). These bone voids may be surgically created osseous defects or osscous defects created from traumatic injury to the hone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.

(5) Subject device intended use:

(6) Technological characteristics:

Genex® has the same technological characteristics as the predicate devices.

{1}------------------------------------------------

Performance data: (7)

Test results confirm that Genex® Bone Graft Substitute provides a bone void filler which, when placed in contact with healthy bone, resorbs and is replaced with bone during the healing process.

Basis for substantial equivalence: (8)

Genex® is equivalent in design, materials, intended use, performance indications and contraindications to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2004

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

Re: K040600

Trade/Device Name: Genex® Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: March 2, 2004 Received: M arch 8, 2004

Dear Mr. Bratt:

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.

{3}------------------------------------------------

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

Sincerely yours,

Mark A. Melkers

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K040600

Device Name:

Genex Bone Graft Substitute

Indications For Use:

Indications For Use:
Genexe is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure.

Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect.

The bony defects or cavities may be surgically created or the result of traumatic injury. Genex provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

Genex® is provided sterile for single use only.

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 N. Wilkerson

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

510(k) Number K040600

Page 1 of _ 1

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.