Synthes Calcium Sulfate Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Pellets are to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the Pellets are biodegradable and biocompatible, they may be used at an infected site.

Device Description

Synthes Calcium Sulfate Pellets are composed of a porous, osteoconductive, bone void filler material consisting of calcium sulfate dihydrate and stearic acid. When used according to directions, the biodegradable, radiopaque pellets are resorbed in approximately 30 - 60 days and replaced by natural bone.

The cylindrical pellets weigh approximately 100 mg and are supplied in capped, glass vials in sizes of 50, 100 and 200 pellets per vial. The product is pre-sterilized by gamma radiation and is not intended to be resterilized. It is for single use only.

Synthes Calcium Sulfate Pellets have the same dissolution rate, compression strength and mass to volume ratio characteristics as the predicate device.

AI/ML Overview

The provided text is a 510(k) summary for the Synthes (USA) Calcium Sulfate Bone Void Filler Pellets. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a clinical study or acceptance criteria for device performance as would be found in a typical study report. Therefore, I cannot fully complete all sections of your request.

Here's what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Dissolution rate	Same as predicate device
Compression strength	Same as predicate device
Mass to volume ratio	Same as predicate device
Resorption time	Approximately 30-60 days

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 provided in the document. The 510(k) summary indicates that the device has the "same dissolution rate, compression strength and mass to volume ratio characteristics as the predicate device," implying a comparison or testing was done, but details of the test set are absent.

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 provided in the document. This type of information is typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

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

This information is not provided in the document.

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 type of study is not mentioned in the document. The device is a bone void filler, not an imaging or diagnostic AI system, so an MRMC study would not be applicable.

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

This concept is not applicable as the device is a physical bone void filler, not an algorithm.

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

For the physical characteristics mentioned (dissolution rate, compression strength, mass to volume ratio), the ground truth would likely be established through laboratory testing and measurements based on established engineering and materials science standards. For the resorption time, it would likely be based on animal studies or historical data from similar calcium sulfate products. However, the specific type of ground truth and how it was established for this specific device's tests is not explicitly detailed beyond stating it matches the predicate.

8. The sample size for the training set

This information is not provided in the document. The concept of a "training set" is typically for machine learning or AI models, which is not what this device is.

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

This information is not provided in the document and is not applicable for this device type.

Summary

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K002362

NOV = 1 2000

510(k) Summary

Sponsor

Device Name

Classification

Predicate Device

Device Description

Intended Use

Material

Synthes (USA) 1690 Russell Road Paoli, PA 19301 Bonnie Smith (610) 647-9700

Synthes (USA) Calcium Sulfate Bone Void Filler Pellets

Unclassified. The Device Product Code is 87 MQV.

Wright Medical Technology's OsteoSet® Pellets

Synthes Calcium Sulfate Pellets have the same dissolution rate, compression strength and mass to volume ratio characteristics as the predicate device.

Synthes Calcium Sulfate Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The pellets are to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the pellets are biodegradable and biocompatible, they may be used at an infected site.

Calcium Sulfate

Synthes (USA) Calcium Sulfate Bone Void Filler Pellets

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, graphic style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV = 1 2000

Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, PA 19301

Re: K002362

Synthes Calcium Sulfate Pellets Regulatory Class: unclassified Product Code: MQV Dated: August 2, 2000 Received: August 3, 2000

Dear Ms. Smith:

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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 - Ms. Bonnie J. Smith

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) 594-4595. 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,

Mark N. Mullens

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 Statement 2.

Page ot

510(k) Number (if known):

Device Name:

Indications:

K002362

Synthes (USA) Calcium Sulfate Bone Void Filler Pellets

Contraindications:

This product is not intended to provide structural support during the healing process; therefore, Synthes Pellets are contraindicated in cases where structural support of the skeletal system is required.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use
for Mark N Milburn
(Division Sign-Off)

Division of General Restorative Devices 510(k) Number.

CONFIDENTIAL

Synthes (USA) Calcium Sulfate Bone Void Filler Pellets

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.