ApaPore® is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. ApaPore® is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, spine and pelvis. These defects may be surgically created osseous defect or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

ApaPore® is used in open bone voids that may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ApaPore® is intended for use on bone voids/gaps that are not intrinsic to the stability of the bony structure of the skeletal system, i.e., in the extremities, spine and pelvis.

ApaPore® is intended to be carefully packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine or pelvis). Following placement in the bony void. the synthetic bone void filler ApaPore® provides a scaffold for new mature host bone growth.

Device Description

ApaPore® is phase-pure hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold. The interconnected and open porous structure of ApaPore® is similar to human cancellous bone. ApaPore® is available as irregularly shaped chips of 2 different sizes, in a choice of 3 porosities to suit surgeon preference.

AI/ML Overview

The provided text is related to a 510(k) summary for a medical device called ApaPore® Bone Graft Substitute. It mainly focuses on asserting substantial equivalence to predicate devices and does not describe a study involving detailed acceptance criteria and reported device performance in the way one would expect for a diagnostic or AI-driven device.

Based on the provided text, here's a breakdown of the requested information, noting where details are unavailable:

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

The document does not specify quantitative "acceptance criteria" or "reported device performance" in terms of specific metrics like sensitivity, specificity, accuracy, or other performance characteristics. Instead, it relies on demonstrating compliance with relevant standards and clinical use.

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. The document states, "ApaPore® has been regularly used clinically for the past 16 months and no adverse events have been reported," but this is a general statement about clinical use, not a structured test set with a defined sample size or detailed data provenance.

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 applicable and not provided. The device is a bone graft substitute, and its evaluation relies on bench testing and clinical safety observations, not on expert ground truth for interpretation like a diagnostic imaging device.

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

This information is not applicable and not provided. There is no mention of an adjudication method as there is no diagnostic test set being interpreted.

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 is not applicable as the device is a bone graft substitute, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

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

This is not applicable as the device is a physical bone graft substitute, not an algorithm.

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

For the safety and effectiveness claims, the "ground truth" seems to be established through:

Bench Testing: "Extensive bench testing has shown ApaPore® to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers." This implies compliance with physical, chemical, and biological standards.
Clinical Observation: "ApaPore® has been regularly used clinically for the past 16 months and no adverse events have been reported." This serves as real-world safety data.
Biological/Physiological Outcome: The intended outcome is that the device "resorbs and is replaced by bone during the healing process" and "provides a scaffold for rapid bone repair via bony infiltration of the porous scaffolds." While detailed outcomes data from a specific study are not presented, these are the biological ground truths it aims to achieve.

8. The sample size for the training set

This is not applicable and not provided. The device is not an AI algorithm that requires a training set.

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

This is not applicable and not provided. The device is not an AI algorithm that requires a training set with established ground truth.

Summary of Device Evaluation in the Document:

The provided 510(k) summary for ApaPore® Bone Graft Substitute primarily relies on:

Substantial Equivalence: It claims substantial equivalence to predicate devices (Isotis NV OsSatura™ BCP Bone Void Filler) based on shared materials (porous calcium salt, hydroxylapatite), similar physical presentation (irregular granules/chips), and identical indications, contraindications, risks, and potential adverse events.
Bench Testing: The document states that "Extensive bench testing has shown ApaPore® to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers." While the specific standards and outcomes aren't detailed, this forms a basis for safety and performance claims.
Clinical Experience (No Adverse Events): "ApaPore® has been regularly used clinically for the past 16 months and no adverse events have been reported." This provides real-world safety data, albeit not from a controlled clinical trial described here.

The document does not describe a clinical study with a defined test set, ground truth acquisition, expert involvement, or statistical analysis of performance metrics typically associated with diagnostic or AI-based devices. Its focus is on demonstrating safety and effectiveness for a Class II resorbable bone void filler through equivalence and compliance with established standards and observed clinical safety.

Summary

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MAY - 7 2004	510(k) Summary	K033722
Submitter:	ApaTech LimitedQueen MaryUniversity of LondonMile End RoadLondon, United KingdomE1 4NS
Contact Person:	Thomas Buckland Ph.D+44 (0) 20 7882 5507/7690 (phone)+44 (0) 20 7882 7503 (fax)
Date Prepared:	November 19th, 2003
Classification:	Resorbable calcium salt bone void fillerdevices have been classified by theOrthopedics Device Panel as Class IISpecial Controls per 21 CFR 888.3045
Trade Name:	ApaPore® Bone Graft Substitute
Common Name:	Synthetic, porous hydroxylapatite
Predicate Devices:	Isotis NV OsSatura™ BCP Bone Void FillerIsotis S.A.K030131 - cleared May 20, 2003

Intended use:

Device Description:

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Technological Characteristics and Substantial Equivalence

ApaPore® is composed of a porous calcium salt, hydroxylapatite, equivalent to that contained in both predicate devices and to that in routine clinical use. The technologies employed in ApaPore® and both of its predicate devices is therefore substantially equivalent. ApaPore® is presented in irregular granules or chips in the same manner as its predicate devices. Its indications, contraindications, risks and potential nd verse events are the same and thus substantial equivalence is claimed for the device.

Testing

Extensive bench testing has shown ApaPore® to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive precision of an receant ApaPore® to be safe and effective in providing a scaffold for rapid bone repair via bonny infiltration of the porous scaffolds. ApaPore® has been regularly used clinically for the past 16 months and no adverse events have been reported.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2004

Apatech Ltd. C/o Barry Sall, RAC Senior Regulatory Consultant Parexel 195 West Street Waltham, Massachusetts 02451-1163

Re: K033722

Trade/Device Name: ApaPore® Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: April 2, 2004 Received: April 2, 2004

Dear Mr. Sall:

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 complics 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 -- Barry Sall, RAC

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 (301) 594-4659. 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 vours,

Sincerely yours,

Mark A. Millburn

Celia M. Witten, PhD, MD 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):

Device Name: ApaPore® Bone Graft Substitute

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

510/\ K033722

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.