Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable, due either to the risk of associated infection or unavailability. Stimulan™ is manufactured from medical grade calcium sulfate that resorbs and is replaced with bone during the healing process. Also, as the implant is biodegradable and biocompatible, it may be used at an infected site.

Device Description

Stimulan™ Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 pans when used in accordance with the device labeling. Stimulan™ is manufactured from 98% medical grade calcium sulfate dihydrate (CaSO4 - 2H2O) and stearic acid.

AI/ML Overview

Here's an analysis of the provided text regarding the Stimulan™ Calcium Sulfate Bone Void Filler, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary and FDA clearance letter. It mainly focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed clinical study with strict acceptance criteria in the way a novel AI/software medical device might. Therefore, many of the requested fields will be marked as "Not Applicable" or explained in the context of a substantial equivalence submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Specific Metric/Benchmark)	Reported Device Performance
Chemical Composition	Equivalent to predicate device.	Stimulan™ is manufactured from 98% medical grade calcium sulfate dihydrate (CaSO4 - 2H2O) and stearic acid. This was deemed equivalent to the predicate device (Wright Medical - Osteoset Pellets, BioGeneration - ProFusion Bone Graft Substitute in terms of chemical composition).
Dissolution Rate	Equivalent to predicate device.	"Testing demonstrated that Stimulan™ has equivalent dissolution...characteristics to the predicate device." Resorbed in approximately 30-60 days.
Mechanical Characteristics	Equivalent to predicate device.	"Testing demonstrated that Stimulan™ has equivalent...mechanical...characteristics to the predicate device."
Mass to Volume Ratio	Equivalent to predicate device.	"Testing demonstrated that Stimulan™ has equivalent...mass to volume ratio characteristics to the predicate device."
Pyrogenicity	Non-pyrogenic.	"Testing indicated that the product is non-pyrogenic."
Indication for Use	Equivalent to predicate device.	Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable... Also, as the implant is biodegradable and biocompatible, it may be used at an infected site. Deemed equivalent to predicate devices.
Biocompatibility	Biocompatible.	Stated as a characteristic; implicit equivalence to predicate devices and established materials.
Biodegradability	Biodegradable.	Stated as a characteristic; implicit equivalence to predicate devices and established materials.

Study Details (Based on available 510(k) Summary)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided summary. The summary mentions "Testing demonstrated..." implying in-vitro or bench testing rather than clinical human trials with a "test set" in the context of an algorithm.
- Data Provenance: Not specified, but likely in-house lab testing, not clinical data from a specific country or setting.
- Retrospective or Prospective: Not applicable in the context of this type of testing.
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):
- Number of Experts: Not applicable. For a device like a bone void filler seeking substantial equivalence, "ground truth" is typically established via analytical chemistry, material science, and mechanical engineering testing results, rather than expert clinical consensus on a "test set."
- Qualifications of Experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This concept is relevant for clinical studies involving human interpretation or subjective endpoints, which are not described here.
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:
- MRMC Study: No. This device is a calcium sulfate bone void filler, not an AI or imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This refers to an algorithm's performance, which is not relevant for this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the "Performance Date" section, the ground truth was established through laboratory testing (material science, chemistry, and mechanical engineering tests) to assess dissolution, mechanical properties, mass to volume ratio, and pyrogenicity. The comparison was against predicate devices.
The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document describes a medical device, not a machine learning model.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.

Summary

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2/26/99

K 982663

510(k) Summary

Encore Orthopedics, Inc. Submitter's Name: 9800 Metric Blvd., Austin, TX 78758 Submitter's Address: Submitter's Telephone Number: (512) 834-6237 Debbie De Los Santos Contact Person: July 30, 1998 Submission Date: Stimulan™ Calcium Sulfate Bone Void Filler Trade Name: Calcium Sulfate Common Name: Unknown Classification Name: Wright Medical - Osteoset Pellets Legally Marketed Predicate Device: BioGeneration - ProFusion Bone Graft Substitute

Device Description:

Indications For Use:

Technological Characteristics:

Stimulan™ has the equivalent technological characteristics (i.e. chemical composition, and dissolution rate performance as the predicate device.

Performance Date:

Testing demonstrated that Stimulan™ has equivalent dissolution, mechanical and mass to volume ratio characteristics to the predicate device. Testing indicated that the product is non-pyrogenic.

Basis for Substantial Equivalence:

Stimulan™ is safe and effective because it is 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a row. The profiles are connected by a flowing line that forms the shape of a wave or ribbon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 1999

Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758

K982663 Re : Stimulan™ - Calcium Sulfate Bone Void Filler Trade Name: Unclassified Regulatory Class: MOV Product Code: January 29, 1999 Dated: February 5, 1999 Received:

Dear Ms. De Los Santos:

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 realour bood 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 be Babyers 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 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 In addition, FDA may publish further announcements action. 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 requlations.

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Page 2 - Ms. Debbie De Los Santos

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in jour can equivalence of your device to a legally rinang or edicate device results in a classification for your marketca produces of mits 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 che promotion and 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,

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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510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Stimulan™

Indications For Use

Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable, due either to the risk of associated infection or unavailability. Stimular™ is manufactured from medical grade calcium sulfate that resorbs and is replaced with bone during the healing process. Also, as the implant is biodegradable and biocompatible, it 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)

Prescription Use
(per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)_

bracello

(Divisio Divisior 510kl Nr

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.