The paste made with the ProFusion® Bone Graft Substitute Kits are intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.

ProFusion® paste cured in situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.

ProFusion® Bone Graft Substitute Kits are provided sterile for single use only. Because the devices are biodegradable and biocompatible, they may be used at an infected site.

Device Description

ProFusion® Bone Graft Substitute Kits consist of pre-measured medical grade calcium sulfate powder and pre-measured mixing solution, and the tools necessary to mix the components into a paste. The device is provided sterile for single use only. When its components are mixed according to the instructions, the ProFusion Kits produce biodegradable, radiopaque paste/molded pellets that resorb in approximately 30-60 days, when used according to labeling.

After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e. long bones, extremities, spine and pelvis). These bone voids or gaps may be either surgically created or result from traumatic injury. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.

AI/ML Overview

The provided text is a 510(k) Summary for the ProFusion® Bone Graft Substitute Kits. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a standalone study with performance metrics in the way a clinical trial or AI algorithm validation would.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly answered from this document. The document states that performance data was submitted, but it does not detail the acceptance criteria or the specific numerical results of that performance data.

Here's a breakdown based on the information available and not available in the provided text:

Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for this document)

The document states: "Testing demonstrated that the performance of the ProFusion® Bone Graft Substitute Kits are substantially equivalent to the performances of the predicate devices." This is the core claim for a 510(k) submission. It does not provide specific acceptance criteria (e.g., "resorption rate must be X to Y days") and then report on the device's performance against those criteria. Instead, it asserts equivalence to predicate devices, implying that the predicate devices' established performance is the de facto "acceptance criteria."

Acceptance Criteria	Reported Device Performance
*Not explicitly stated as numerical performance criteria for this* device. Basis is substantial equivalence to predicate devices.** The implicit criteria are that the device performs comparably to the predicate devices in terms of chemical composition, indications for use, performance, and design features.	"Testing demonstrated that the performance of the ProFusion® Bone Graft Substitute Kits are substantially equivalent to the performances of the predicate devices." The device is described to resorb in approximately 30-60 days.

Detailed Study Information (Not applicable for this 510(k) Submission type)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states "Testing demonstrated...", but does not specify the sample size of any test set (e.g., number of implants, animal studies, etc.) or the provenance of the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information would be relevant for studies involving human interpretation (e.g., radiology images). This document describes a physical medical device (bone graft substitute), not an AI diagnostic tool or a device requiring expert interpretation for ground truth establishment in a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. See the explanation for point 2.
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:
- Not applicable. This device is a bone graft substitute, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated in terms of a formal "ground truth" process. For a bone graft substitute, "ground truth" for performance would likely involve histological analysis of bone ingrowth, resorption rates, biocompatibility assessments, and mechanical integrity tests in in vitro or in vivo models, typically compared against predicate devices or known biological responses. The document only states "Testing demonstrated that the performance... are substantially equivalent."
The sample size for the training set:
- Not applicable/Not provided. This would be relevant for machine learning models, which is not the case here.
How the ground truth for the training set was established:
- Not applicable/Not provided. See the explanation for point 7.

Summary of what is available:

Device Type: Resorbable calcium salt bone void filler device.
Purpose of Submission: 510(k) premarket notification to establish substantial equivalence to predicate devices.
Key Performance Claim: Substantial equivalence to predicate devices in chemical composition, indications of use, performances, and design features.
Resorption Time: Approximately 30-60 days (when used according to labeling).
Sterility: Provided sterile for single use only.
Biocompatibility/Biodegradability: Stated to be biodegradable and biocompatible, allowing use at an infected site.

In conclusion, this 510(k) summary provides a regulatory overview and basic device description, but it is not a detailed scientific study report with explicit acceptance criteria, performance metrics, and methodological details like sample sizes or ground truth establishment that would be required for a clinical trial or AI validation study. The "acceptance criteria" here are implicitly tied to the performance and characteristics of the legally marketed predicate devices.

Summary

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

OCT 3 0 2003

K031838

510(K) SUMMARY (As required by section 21 CFR 807.92(c))

Submitter's name: Submitter's address: Submitter's telephone number: Contact Person: Submission date: Trade Name: Common Name: Classification Name: Device Product Code and Panel Code: Legally marketed predicate devices:

BioGeneration®, Inc. 9160 Highway 64, Suite 12, Lakeland, TN 38002 (901) 380-9411 Bernard F. Grisoni June 12, 2003 ProFusion® Bone Graft Substitute Kits Calcium Sulfate Unclassified Orthopedics/87/MQV ProFusion® Graft Substitute Devices Wright Medical Kits

Device description:

Intended Uses/Indications:

The paste resulting from ProFusion® Bone Graft Substitute Kits is intended to be injected. digitally packed into bone voids or gaps to cure in-situ; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). These bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.

ProFusion® paste cured in situ provides an bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.

ProFusion® Bone Graft Substitute Kit s are provided sterile for single use only. Because the device is biodegradable and biocompatible, ProFusion® Bone Graft Substitute Kits may be used at an infected site.

Technological characteristics:

ProFusion® Bone Graft Substitute Kits have the equivalent chemical composition and technological characteristics to the predicate devices.

Performance data:

Testing demonstrated that the performance of the ProFusion® Bone Graft Substitute Kits are substantially equivalent to the performances of the predicate devices.

Basis for substantial equivalence:

The ProFusion® Bone Graft Substitute Kits are safe and effective because they are equivalent to the predicate devices in terms of chemical composition, indication of use, performances and design features.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is composed of three diagonal lines that curve and merge together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

OCT 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bernard Grisoni, Ph.D Technical Service Director BioGeneration, Inc. 9160 Highway 64, Suite 12 Lakeland. TN 38002

Re: K031838

Trade Name: ProFusion™ Bone Graft Substitute Kits Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 8, 2003 Received: October 9, 2003

Dear Dr. Grisoni:

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.

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

Page 2 - Bernard Grisoni, Ph.D.

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 N. Millman

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

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

Page 1 of 1

510(k) Number: K03/838

Device Name: ProFusion® Bone Graft Substitute Kits

Indications For Use:

ProFusion® Bone Graft Substitute Kits are provided sterile for single use only. Because the devices are biodegradable and biocompatible, they may be used at an infected site.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

la Mark N. Milkeson

ral. Restorative

510(k) Number K031838

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

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.