The ProFusion™ implants are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The implant is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bony cavities may be surgically created or the result of traumatic injury. The implant provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Because the implant is biodegradable and biocompatible, it may be used at an infected site.

Device Description

ProFusion™ implants are made of medical grade caloium suffate and stearic acid (as processing aid). They are provided sterile for single use. The implants are non-pyrogenic, biodegradable, radiopaque and resorbed in approximately 30-60 days, when used according to labeling.

AI/ML Overview

The provided text describes the 510(k) summary for the ProFusion™ Bone Graft Substitute. It does not present a study with acceptance criteria and device performance in the format of a table, nor does it detail a study involving human readers or AI assistance.

Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data related to material properties.

Here's an analysis based on the information provided, addressing the questions as much as possible, with recognition of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with numerical targets and corresponding device performance values as would be expected for a diagnostic or AI-driven device. Instead, it states that "Testing demonstrated that the ProFusion devices have equivalent dissolution, mechanical and mass to volume ratio characteristics to the predicate device." and "Testing indicated that the product is nonpyrogenic."

Therefore, the acceptance criteria can be inferred as "equivalence to the predicate device (Wright Plaster of Paris Pellets / Osteoset® Pellets) in dissolution, mechanical properties, and mass to volume ratio," and "non-pyrogenic."

The reported device performance is simply a statement that these equivalencies and non-pyrogenicity were "demonstrated" or "indicated."

Acceptance Criteria (Inferred)	Reported Device Performance
Equivalent dissolution characteristics to predicate device	Demonstrated to have equivalent dissolution characteristics to the predicate device.
Equivalent mechanical characteristics to predicate device	Demonstrated to have equivalent mechanical characteristics to the predicate device.
Equivalent mass to volume ratio characteristics to predicate device	Demonstrated to have equivalent mass to volume ratio characteristics to the predicate device.
Non-pyrogenic	Indicated that the product is nonpyrogenic.

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for any tests. It also does not mention a "test set" in the context of clinical data or image analysis. The "testing" referred to is for material properties. Data provenance (country, retrospective/prospective) is thus not applicable or mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the type of device and study described. This device is a bone graft substitute, and its evaluation focuses on material properties, not diagnostic accuracy requiring expert interpretation of images or other clinical data for a "ground truth."

4. Adjudication method for the test set

This information is not applicable for the reasons stated above.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone graft substitute, not an AI-assisted diagnostic tool. Therefore, effects on human reader performance with or without AI assistance are irrelevant to this submission.

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

No, a standalone algorithm performance study was not done. This device is a physical bone graft substitute, not a software algorithm.

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

The concept of "ground truth" as typically defined for diagnostic device studies (e.g., expert consensus for diagnoses, pathology for disease presence, outcomes data for treatment efficacy) is not applicable here. The "truth" for the ProFusion™ device refers to its material properties and chemical composition being equivalent to the predicate device and its non-pyrogenicity. This would have been established through standard laboratory testing methods for material science.

8. The sample size for the training set

The document does not mention a training set. This device is not an AI/ML algorithm that requires training data.

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

This question is not applicable as there is no training set for this type of device.

Summary

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K973704

160 Highway 64. Suite 12 Arlington. TN 38002 Phone: (901) 380-9411 Fax: (901) 389-8412

510(K) SUMMARY

(As required by section 21 CFR 807.92(c))

Submitter's name:	BioGeneration
Submitter's address:	9160 Highway 64, Suite 12, Arlington, TN 38002
Submitter's telephone number:	(901) 380-9411
Contact Person:	Bernard F. Grisoni, Ph.D
Submission date:	March 23, 1998
Trade Name:	ProFusion TM Bone Graft Substitute (subject to change)
Common Name:	Calcium Sulfate
Classification Name:	Unknown
Legally marketed predicate device:	Wright Plaster of Paris Pellets, also namedOsteoset ® Pellets (Wright Medical Technology)

Device description:

Indications for use:

The ProFusion™ implants are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The implant is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bony cavities may be surgically created or the result of traumatic injury. The implant provides a bone graft subsitiute that resorbs and is replaced with bone during the healing process. Because the implant is biodegradable and biocompatible, it may be used at an infected site.

Technological characteristics:

ProFusion devices have the equivalent technological characteristics (i.e. chemical composition, and dissolution rate performance) to the predicate device.

Performance data:

Testing demonstrated that the ProFusion devices have equivalent dissolution, mechanical and mass to volume ratio characteristics to the predicate device. Testing indicated that the product is nonpyrogenic.

Basis for substantial equivalence:

The ProFusion devices are safe and effective because they are equivalent to the predicate device in terms of chemical composition, indication of use, and product performances.

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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 features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 1998

Bernard Grisoni, Ph.D. ·Technical Service Director and Owner BioGeneration 9160 Highway 64, Suite 12 Arlington, Tennessee 38002

K973704 Re: ProFusion™ Bone Graft Substitute Trade Name: Regulatory Class: Unclassified Product Code: NQV Dated: January 27, 1998 Received: January 29, 1998

Dear Dr. Grisoni:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with ---the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Bernard Grisoni, Ph.D.

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) 594-4659. 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 yours,

foceleds

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

Enclosure

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Page 1 of 1

510(k) Number: K973704

Device Name: ProFusion

Indication For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

tcooo

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973704

Prescription Use
(Per 21 CFR 801.109)

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.