PORE-SI BONE GRAFT SUBSTITUTE by APATECH LTD.

Pore-Si is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Pore-Si 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.

Device Description

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

AI/ML Overview

The provided text describes a medical device, Pore-Si Bone Graft Substitute, and its clearance through the 510(k) pathway. However, it does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or any of the detailed aspects requested in the prompt (e.g., sample sizes, expert qualifications, MLMC studies, specific performance metrics like sensitivity/specificity, or training set details for an AI/algorithm).

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results against predefined acceptance criteria in the way an AI/algorithm performance study would.

Here's how the provided information relates to the requested points, and where information is missing:

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

Missing Information: The document states, "Extensive bench testing has shown Pore-Si to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive preclinical testing has confirmed Pore-Si to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffolds." However, it does not specify what those requirements/standards are (i.e., the acceptance criteria) nor does it provide a table with reported quantitative performance metrics against those criteria.
Implied Acceptance Criteria: The clearance is based on substantial equivalence to predicate devices, implying that the acceptance criteria are largely met by demonstrating similar technological characteristics, indications, contraindications, risks, and potential adverse events as the predicate devices. The "relevant standards" for "Calcium Salt Bone Void Fillers" would also constitute acceptance criteria, but they are not detailed here.

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

Missing Information: No details about a specific "test set" are provided. The "preclinical testing" mentioned would have involved animal or in vitro models, but the sample sizes, study design, or data provenance (e.g., country of origin, retrospective/prospective) are not disclosed in this summary.

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

Missing Information: Since details of a specific test set and ground truth establishment (as would be relevant for an AI/algorithm study) are not provided, this information is absent. The "ground truth" for a bone void filler would typically be histological analysis from preclinical studies or clinical outcomes in human trials, not expert consensus on images.

4. Adjudication method for the test set

Missing Information: Not applicable as no specific test set requiring adjudication in the context of diagnostic performance is described.

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

Not Applicable: This device is a bone graft substitute, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.

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

Not Applicable: This device is a physical medical implant, not an algorithm or AI.

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

Implied Ground Truth: For a bone graft substitute, the "ground truth" for effectiveness would typically involve histological evidence of bone formation and integration in preclinical animal models, and potentially clinical outcomes (e.g., fusion rates, successful healing) in human trials. For safety, it would involve biocompatibility studies and adverse event tracking. The document vaguely refers to "bony infiltration of the porous scaffolds" from preclinical testing, suggesting histological evaluation.

8. The sample size for the training set

Not Applicable: This device is not an AI/algorithm, so there is no "training set."

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

Not Applicable: As above.

Summary:

The provided document details the 510(k) clearance process for a bone graft substitute, emphasizing its substantial equivalence to previously cleared devices. It confirms that the device underwent "extensive bench testing" and "extensive preclinical testing" to confirm safety and effectiveness, meeting "relevant standards." However, it does not delve into the granular details of study designs, specific quantitative acceptance criteria, performance metrics, sample sizes, or ground truth methodologies that would be expected when evaluating an AI/algorithm's performance. The information requested in the prompt is specific to AI/algorithm performance studies, which is not what this document describes.

Summary

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	510(k) Summary	K040082
AUG - 4 2004
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:	[Date]
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:	Pore-Si Bone Graft Substitute
Common Name:	Synthetic, porous hydroxylapatite
Predicate Devices:	Isotis NV OsSatura™ BCP Bone Void FillerIsotis S.A. K030131 - cleared May 20, 2003Skelite™ Synthetic Resorbable Bone VoidFiller (K011726), Millenium Biologix, Inc. -

Intended use:

Device Description:

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Technological Characteristics and Substantial Equivalence

Pore-Si 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 Pore-Si and both of its predicate devices is therefore substantially equivalent. Pore-Si is presented in irregular granules or chips in the same manner as its predicate devices. Its indications, contraindications, risks and potential adverse events are the same and thus substantial equivalence is claimed for the device.

Testing

Extensive bench testing has shown Pore-Si to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive preclinical testing has confirmed Pore-Si to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffolds.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2004

ApaTech Limited C/o Mr. Barry Sall, RAC Senior Regulatory Consultant PAREXEL International 195 West Street Waltham, Massachusetts 02451-1163

Re: K040082

Trade Name: Pore-Si Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: July 14, 2004 Received: July 14, 2004

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren or (a) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered proc to they 20, 1978, as occordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dererere, mains 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 If your de rise 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 r lease be actives a adetermination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or uny I vith 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 - Mr. Barry Sall, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and no yourse FDA finding of substantial equivalence of your device to a legally prematics modicate 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 11 you attire 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 other general 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. Willcox

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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510(k) Number (if known): _ KOG 0 0 82

Device Name: Pore-Si Bone Graft Substitute

Indications for Use:

Pore-Si 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. Pore-Si 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.

× Prescription Use_ (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Mark A. Milburn

Restorative. Division of Ge and Neurological Devices

510(k) Number K040082

Confidential

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.