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 days when used in accordance with the device labelling. Stimulan™ is manufactured from 98% medical grade calcium sulfate dihydrate (CaSO4 . 2H2O) and stearic acid.

AI/ML Overview

This document is a 510(k) summary for the Stimulan™ Calcium Sulfate Bone Void Filler. It describes the device, its intended use, and its comparability to predicate devices. However, this document does not contain the detailed study information, acceptance criteria, test set, ground truth methods, or other specific performance data typically found in a clinical study report or a more comprehensive premarket notification submission.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be extracted or inferred based on the nature of a 510(k) submission:

A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states that Stimulan™ is "comparable" to predicate devices, referencing "equivalent design, materials and indications." A 510(k) primarily demonstrates substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness criteria. Specific quantitative performance acceptance criteria and results are not detailed in this summary.
Sample size used for the test set and the data provenance:
- Cannot be provided. This document does not describe a specific clinical study with a test set. It is a summary for a 510(k) application, which often relies on performance data from predicate devices, bench testing, or non-clinical studies rather than a prospective clinical trial with a defined "test set" in the context of device performance metrics like sensitivity/specificity.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Cannot be provided. As no specific "test set" or clinical study with adjudicated outcomes is detailed, there's no mention of experts establishing ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Cannot be provided. No adjudication method is described.
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. This device is a calcium sulfate bone void filler, not an AI-powered diagnostic or imaging device. Therefore, an MRMC study related to AI assistance for human readers is irrelevant and not mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided directly related to a "test set" for performance metrics like sensitivity/specificity. The 510(k) process for this type of device typically relies on demonstrating biocompatibility, mechanical properties, and resorption characteristics through pre-clinical testing (e.g., in vitro, animal studies) and comparing these to predicate devices, rather than establishing a ground truth for diagnostic accuracy.
The sample size for the training set:
- Not applicable/Cannot be provided. This document pertains to a physical medical device, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable/Cannot be provided. As there is no training set mentioned.

Summary

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AUG 4 2000

Summary of Safety and Effectiveness

Koo/24

Biocomposites Ltd Etruscan Street Etruria Stoke-on-Trent ST1 SPO England 44 01782 206500

Trade Name: Stimulan™ Calcium Sulfate Bone Void Filler

Common Name: Calcium Sulfate

Classification Name: Unknown

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

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 biodegrable and biocompatible, it may be used at an infected site.

Comparable Features to Predicate Device(s): Features comparable to predicate devices include equivalent design, materials and indications.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 2000

Mr. J Stephen Bratt Managing Director Biocomposites Ltd. Etruscan Street, Ethuria, Stoke-on-Trent Staffordshire, ST1 5PQ, England

Re: K001724

Trade Name: Stimulan Calcium Sulfate Pellets Regulatory Class: Unclassified Product Code: MQV Dated: May 22, 2000 Received: May 26, 2000

Dear Mr. Bratt:

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 stired in the energence, to 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 control Coonisions of the Act. The general control provisions of the Act include requirements for annual provisions of ani-1994 - 1997 - 1997 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 (Fremances I pprovide 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 mopolwaiith 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.

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.

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Page 2 - Mr. J Stephen Bratt

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) 594-4639. 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,

Dmne R. lochner

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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Stimulan™

Indications For Use

e R. bochner.

(Division Sign-Off) Division of General Restorative Devices K001724 510(k) Number

Regulation Number and Section

N/A