The intended use for the OSTEOSET® BVF resultant paste is to be injected, digitally packed into open bone void/gap to cure in-situ; or molded into solid pellets that are gently packed into open bone voids/gap that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

The OSTEOSET® paste cured in situ provides an open void/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 support media and is not intended to provide structural support during the healing process.

The OSTEOSET® BVF Kit is provided sterile for single use only.

Device Description

OSTEOSET® BVF Kits consist of pre-measured surgical grade calcium sulfate, premeasured mixing solution, and the tools necessary to mix the components into a paste. These products are provided sterile for single patient use. When mixed according to directions, the OSTEOSET® BVF Kit produces 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., the extremities, spine, and pelvis). These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.

The paste/beads are used to fill bone voids and may be used at an infected site.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OSTEOSET® BVF Kit, based on the provided text:

Important Note: The provided document is a 510(k) summary for a bone void filler. These types of submissions primarily demonstrate "substantial equivalence" to a predicate device rather than presenting detailed clinical trial data with acceptance criteria for a novel AI/software medical device. Therefore, many of the requested elements (like AI-specific metrics, expert adjudication, MRMC studies, training set details) are not applicable to this type of submission for a physical medical device. I will address the relevant sections and note where information is not available due to the nature of the submission.

Acceptance Criteria and Device Performance Study for OSTEOSET® BVF Kit

This 510(k) submission establishes substantial equivalence of the OSTEOSET® BVF Kit to a previously marketed predicate device, the Wright Plaster of Paris Bone Void Filler. The "acceptance criteria" in this context are primarily related to material composition, intended use, and design features demonstrating functional similarity and safety, rather than performance metrics against a specific threshold typically seen in diagnostic device studies.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description (as implied/stated in the 510(k))	Reported Device Performance / Justification
Material Composition	Powder: 98.5% surgical grade calcium sulfate (CaSO4 . 1/2 H2O) and 1.5% medical grade calcium stearate. Mixing Solution: 0.9% sterile NaCl.	Identical to the materials used for previously submitted Wright Plaster of Paris Bone Void Filler. Conforms with USP/NF Standards for calcium sulfate and calcium stearate. Saline is USP/NF for irrigation.
Intended Use	- Injection/packing into open bone voids/gaps that are not intrinsic to bony structure stability (extremities, spine, pelvis). - Filling surgically created osseous defects or those from traumatic injury. - Resorption and replacement with bone during healing. - Temporary support media to augment provisional hardware (e.g., K-Wires) during surgical procedure (not structural support during healing). - Use at infected sites (added claim).	Substantially equivalent to the predicate device's intended use, with expanded claims supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification. The device provides a bone void filler that resorbs and is replaced with bone. The paste provides an open void/gap filler that can augment provisional hardware. The paste/beads can be used to fill bone voids and at an infected site.
Design Features	- Provided sterile for single use. - Pre-measured surgical grade calcium sulfate, pre-measured mixing solution, and mixing tools. - Produces biodegradable, radiopaque paste/molded pellets.	Substantially equivalent to the predicate device. Resorbs in approximately 30-60 days when used according to labeling. Radiopaque.
Resorption Time (Explicit)	To resorb in a specific timeframe.	Resorbs in approximately 30-60 days.

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

Not Applicable (N/A) in the context of an AI/software device. This is a physical medical device. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than a test set in the conventional sense for AI performance evaluation. The "data" primarily refers to material specifications, existing regulatory approvals for similar materials, and potentially previous testing on the predicate device.
The document implies that the safety and effectiveness are supported by "substantial equivalence information, materials data, and testing results provided within this Premarket Notification," but does not explicitly detail a specific "test set" or its provenance for a study designed to meet numerical acceptance criteria for device performance in the AI sense.

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

N/A. This is a physical medical device submission, not an AI/software device requiring expert-established ground truth for a diagnostic performance test set. The "ground truth" for chemical composition would be established by analytical testing against USP/NF standards, and clinical outcomes for the predicate device would be based on historical data or general medical understanding.

4. Adjudication method for the test set

N/A. Not relevant for this type of device submission.

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

N/A. This device is a bone void filler, not an AI-assisted diagnostic tool.

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

N/A. This device is a bone void filler, not an algorithm.

7. The type of ground truth used

The "ground truth" for the claims in this submission is primarily based on:
- Chemical/Material Standards: Conformance to USP/NF Standards for calcium sulfate and calcium stearate, and sterile NaCl (saline).
- Predicate Device Performance: Historical performance and regulatory acceptance of the "Wright Plaster of Paris Bone Void Filler" are the primary "ground truth" for establishing substantial equivalence in terms of intended use, safety, and general efficacy.
- Biocompatibility/Resorption: Implicitly, the understanding of calcium sulfate's biocompatibility and resorption properties in bone defects.

8. The sample size for the training set

N/A. This is a physical medical device and does not involve AI model training sets.

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

N/A. Not applicable, as there is no AI training set for this device.

Summary

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OCT 2 6 2001

K010532

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe In accelance mark of 1990 and in conformance with 21 CRF 807, this information serves as a Medical De Freeb Act of Effectiveness for the Use of the OSTEOSET® BVF Kit.

Submitted By:	Wright Medical Technology, Inc.
Date:	February 22, 2001
Contact Person:	Ehab M. EsmailManager of Regulatory AffairsPhone: 901-867-4732 Fax: 901-867 4630
Proprietary Name:	OSTEOSET® BVF Kit
Common Name:	Bone Void Filler
Classification Name and Reference:	Unclassified
Device Product Code and Panel Code:	Orthopedics/87/MOV

DEVICE INFORMATION

INTENDED USES/ INDICATIONS A.

The OSTEOSET® BVF Kit is provided sterile for single use only.

DEVICE DESCRIPTION B.

OSTEOSET® BVF Kits consist of pre-measured surgical grade calcium sulfate, premeasured mixing solution, and the tools necessary to mix the components into a These products are provided sterile for single patient use. When mixed paste. according to directions, the OSTEOSET® BVF Kit produces biodegradable,

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K01 0532
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radiopaque paste/molded pellets that resorb in approximately 30-60 days, when used according to labeling.

The paste/beads are used to fill bone voids and may be used at an infected site.

C. MATERIALS

The materials used for the OSTEOSET® BVF Kit are identical to the materials used for previously submitted Wright Plaster of Paris Bone Void Filler:

The powder supplied in the kit is 98.5% surgical grade calcium sulfate (CaSO4 . . 1/2 H2O) in conformance with USP/NF Standards for calcium Sulfate, and 1.5% medical grade calcium stearate (stearic acid) in conformance with USP/NF standards for calcium stearate (used as a molding aid). The powder will be supplied premeasured in a glass vial.
The saline is 0.9% sterile NaCl, USP/NF for irrigation. The saline will be supplied . premeasured in a glass vial.

D. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material composition, and design features of the OSTEOSET® paste cured in situ are substantially equivalent to the intended use, material composition, and design features of the previously submitted Wright Plaster of Paris Bone Void Filler Kit.

The safety and effectiveness of the OSTEOSET® BVF Kit with the expanded claims is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.

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Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.

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OCT 2 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ehab M. Esmail Manager of Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K010532

Trade/Device Name: OSTEOSET® BVF Kit Regulatory Class: unclassified Product Code: MQV Dated: July 27, 2001 Received: July 30, 2001

Dear Mr. Esmail:

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. Ehab M. Esmail

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 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

for Mark N. Millerson

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

Enclosure

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K010532

OSTEOSET® BVF Kit

INDICATIONS STATEMENT

The intended use for the OSTEOSET® BVF resultant paste is to be injected, digitally packed into The micenced id/gap to cure in-situ; or molded into solid pellets that are gently packed into open open bollo volu gap to var intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

The OSTEOSET® BVF Kit is provided sterile for single use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use (Per21 CFR 801.109) OR

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

D. Mark A. Milleson

storative

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.