OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.

Device Description

OSSAPLAST ORTHO is a synthetic, implantable, resorbable, radiopaque ß-tricalcium phosphate (β-ΤCP) ceramic in granulate form (particle size of 500 - 1000 µm). It consists of pure-phase ß-TCP [Ca3(PO4)2] and is osteoconductive, with high interconnecting porosity. OSSAPLAST ORTHO is supplied sterile in sealed glass vials in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.

AI/ML Overview

This document describes a 510(k) premarket notification for the "OSSAPLAST™ ORTHO" bone void filler. The information provided heavily emphasizes substantial equivalence to a predicate device and adherence to regulatory standards, rather than a clinical study with detailed performance metrics and acceptance criteria as would be expected for an AI/ML powered device.

Therefore, it is important to note that the following response is based on the information provided in the document, which does not detail a study designed to meet specific acceptance criteria in the context of device performance as one might expect for a diagnostic or therapeutic AI product. The document primarily focuses on demonstrating that the device meets safety and efficacy expectations as a resorbable calcium salt bone void filler by showing its technological characteristics are equivalent to a predicate device and that it conforms to relevant ASTM standards and FDA guidance.

Here's the breakdown of what can be extracted from the document, acknowledging the limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from regulatory context)	Reported Device Performance (from document)
Safety: Biocompatibility	OSSAPLAST ORTHO is stated to be made from pure-phase ß-TCP, the same material as the predicate device (Cerasorb® ORTHO). Explicitly stated as "biocompatibility" in the "Technological Characteristics Summary."
Efficacy: Ability to fill bony voids/gaps, gradual resorption and replacement with bone, osteoconductivity	Intended for "filling bony voids or gaps of the skeletal system...gradually resorbed and replaced with bone during the healing process." Described as "osteoconductive, with high interconnecting porosity." Stated to be "substantially equivalent in intended use to the predicate device" and to "perform in a manner substantially equivalent to that of the predicate device."
Material Composition: Pure-phase ß-Tricalcium Phosphate (ß-TCP)	Consists of "pure-phase ß-TCP [Ca3(PO4)2]."
Physical Characteristics: Granulate form, specific particle size, high interconnecting porosity	"granulate form (particle size of 500 - 1000 µm)." "high interconnecting porosity." "substantially equivalent in regard to structure, porosity, form" to the predicate device.
Sterility: Supplied sterile	"Supplied sterile in sealed glass vials in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration."
Radiopacity: Observable on medical imaging	Stated as "radiopaque ß-tricalcium phosphate (ß-TCP) ceramic."
Substantial Equivalence: To predicate device in intended use and technological characteristics	"OSSAPLAST ORTHO is substantially equivalent in intended use to the predicate device." "does not incorporate any new technological characteristics as compared to the predicate device." "OSSAPLAST ORTHO and the predicate device are made from the same material...and are substantially equivalent in regard to structure, porosity, form, packaging, sterility, and biocompatibility." "It has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate device."
Conformance to Standards/Guidance: ASTM F1088-04, FDA Special Controls Guidance	"conforms to the standard specifications of ASTM F1088-04 for a medical grade β-TCP to be used in surgical implant applications." "Performance testing was conducted in conformance with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA (FDA/ODE, 6/2/2003)." All data demonstrated that OSSAPLAST ORTHO is suitable for use as a bone void filler.

Given that this is a 510(k) submission for a medical device (bone void filler) and not an AI/ML product, many of the subsequent questions are not directly applicable. However, I will answer them based on the spirit of the questions where possible, or explicitly state when the information is not provided or applicable.

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

Sample Size: Not specified in terms of distinct "test set" or a number of patients/cases. The "performance data" section refers to conducting "performance testing" in conformance with FDA guidance, covering parameters like material characteristics, biocompatibility, and physical properties. This likely involved chemical analyses, in-vitro testing, and possibly animal studies, but the number of samples/tests is not detailed.
Data Provenance: Not explicitly stated. For material testing, it would be laboratory data. For any biological assessments, it would be from controlled lab environments or animal models.

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

Not applicable in the context of an AI/ML diagnostic device. The "ground truth" here relates to the inherent properties of the material and its biological interaction. These are established through scientific consensus, validated testing methods, and regulatory standards rather than expert consensus on diagnostic images. The "experts" would be the scientists and engineers conducting the tests and the regulatory body (FDA) reviewing the scientific evidence.

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

Not applicable. This concept typically applies to discrepancies in expert readings of medical images or other diagnostic data. The "acceptance" of the device is based on meeting pre-defined material specifications and performance characteristics, as reviewed by the FDA.

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. This is a bone void filler, not a diagnostic AI device. MRMC studies are not relevant for this type of product.

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

No. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device is based on:
- Material Science Specifications: Chemical composition (pure-phase ß-TCP), particle size, porosity, radiopacity confirmed through analytical chemistry and physical characterization tests.
- Biocompatibility Standards: Established through in-vitro and potentially in-vivo (animal) studies against recognized international standards.
- Performance Benchmarks: Demonstrated through adherence to ASTM F1088-04 and consistency with the known performance characteristics of the predicate device.
- Regulatory Guidance: Conformance with the FDA's "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device."

8. The sample size for the training set

Not applicable. This product does not involve a training set for an AI/ML algorithm. The "development" and "formulation" of the material would be based on scientific literature, material science principles, and previous research on ß-TCP bone void fillers.

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

Not applicable. As a non-AI/ML device, there is no "training set." The understanding of the material's properties (its "ground truth") is derived from fundamental scientific knowledge, established material characterization techniques, and biological studies, which inform the design and manufacturing of the device to meet its intended purpose.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K042305" at the top, followed by the word "OSSACUR" in a stylized font. The word "OSSACUR" is enclosed within two curved lines, one above and one below, forming a circular shape around the word. The text and graphic appear to be part of a logo or branding element.

OCT 2 1 2004

510(K) Summary

A. Submitter Information

Submitter's Name:	OSSACUR® AG
Address:	Benzstrasse 2
	D-71720
	Oberstenfeld, Germany
Phone Number:	(+49) 70629404-0
Fax Number:	(+49) 7062 9404-20
Contact Person:	Arne Briest
Date of Preparation:	August 23, 2004

B. Device Name

Trade Name:	OSSAPLAST™ ORTHO
Common/Usual Name:	Bone Void Filler
Classification Name:	Resorbable calcium salt bone void filler device§888.3045 (Product Code: MQV)

C. Predicate Device
Trade Name:

Cerasorb® ORTHO (K014156)

D. Device Description

OSSAPLAST ORTHO is supplied sterile in sealed glass vials in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.

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E. Intended Use

OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, illum, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process. OSSAPLAST ORTHO is substantially equivalent in intended use to the predicate device.

F. Technological Characteristics Summary

OSSAPLAST ORTHO does not incorporate any new technological characteristics as compared to the predicate device. OSSAPLAST ORTHO and the predicate device are made from the same material (pure-phase ß-TCP) and are substantially equivalent in regard to structure, porosity, form, packaging, sterility, and biocompatibility. OSSAPLAST ORTHO conforms to the standard specifications of ASTM F1088-04 for a medical grade β-TCP to be used in surgical implant applications.

G. Performance Data

Performance testing was conducted in conformance with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA (FDA/ODE, 6/2/2003). All data demonstrated that OSSAPLAST ORTHO is suitable for use as a bone void filler. It has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its body, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 2004

Ossacur AG c/o Ms. Kristi M. Kistner, RAC President Pacific OtterWorks, Inc. 975 Veronica Springs Road Santa Barbara, CA 93105

Re: K042305

OSSAPLAST® ORTHO Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: August 23, 2004 Received: August 25, 2004

Dear Ms. Kistner:

We have reviewed your Section 510(k) premarket notification of intent to market the we have feviewed your bootion o re(s) pinned the device is substantially equivalent (for device for use stated in the enclosure) to legally marketed predicate devices the indications for abo subscription to May 28, 1976, the enactment date of the marketed in morisiate commits, 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 with the provisions of the Pecial a pplication (PMA). You may, therefore, market the approval of a promance apple on well provisions of the Act. The general controls device, subject to the general requirements for annual registration, listing of devices, provisions of the ing 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 (I MF), It may be babyer to saving in the Code of Federal Regulations, Title 21, Parts affecting your de ross on 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 r lease be advised anas made a determination that your device complies with other not mean that I Drivinar of I mac or any Federal statutes and regulations administered by other requirements on the Her of at comply with all the Act's requirements, including, but not I cadelar agencies: " on and listing (21 CFR Part 807); labeling (21 CFR Part 801); good

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Page 2 - Ms. Kristi M. Kistner, RAC

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.

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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 A. Milkers

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

510(k) Number (if known): 1042305

Device Name: OSSAPLAST® ORTHO Bone Void Filler

Indications for Use:

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mark A. Millham

Division of General, Restorative, and Neurological Devices

510(k) Number K042305

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.