MERRIES K-PHATE BONE GRAFT SUBSTITUTE by MERRIES INTERNATIONAL INC.

Merries K-PHATE is intended to be packed into bony defects of the skeletal system ( extremities, spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

Device Description

Merries K-PHATE bone graft substitute is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite and 40% ß-tricalcium phosphate. Merries K-PHATE is supplied sterile in various shapes and sizes. The choice of different form or size of the product depends on the type and size of the recipient site. Blocks and wedges are used for large bony defect while granules are used as bone filler for small area.

AI/ML Overview

The provided text describes the 510(k) Premarket Notification Summary for the "Merries K-PHATE Bone graft substitute" (K063157). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, performance metrics, and study design for a clinical effectiveness study is not explicitly present in the provided text.

Specifically, this submission relies on:

Material characteristics: The device is a biphasic calcium phosphate ceramic, similar to predicate devices.
Function and intended use: It's designed as a resorbable bone void filler, the same as predicate devices.
Biocompatibility testing: To ensure safety.
Sterilization dose auditing: To ensure sterility.
Chemical requirements: Conformance to ASTM standards for ceramic hydroxyapatite and beta-tricalcium phosphate.

Here's an attempt to answer your questions based on the provided text, recognizing that a full clinical study with acceptance criteria for effectiveness is not detailed:

Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)

Since this is a 510(k) submission for a bone graft substitute, the primary "acceptance criteria" discussed are related to substantial equivalence to legally marketed predicate devices, and the device's safety through biocompatibility and material testing. Performance in terms of clinical outcomes (e.g., rate of bone fusion, strength of new bone) is inferred from the predicate devices rather than directly proven through a new comparative clinical study for this specific device in this submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion	Reported Device Performance
Substantial Equivalence	Similarity in base materials, function, and intended use to listed predicate devices.	Stated as "substantially equivalent" in base materials, function, and intended use to MBCP™, Pro Osteon® 500R, Vitoss® Scaffold, and BoneSave™ Bone void Filler.
Material Composition	Conformance to ASTM F1185-88 (ceramic hydroxyapatite)	Implicitly stated as conforming to ASTM F1185-88.
	Conformance to ASTM F1088-87 (beta-tricalcium phosphate)	Implicitly stated as conforming to ASTM F1088-87.
Biocompatibility (ISO 10993 equivalent)	Non-cytotoxic	Pass (Cytotoxicity Test)
	Non-irritant	Pass (Subcutaneous Irritation Test)
	Non-sensitizing	Pass (Guinea Pig Skin Sensitization Study)
	Compatible with surrounding tissues	Pass (Implantation Test)
	Non-mutagenic	Pass (Sister Chromatid Exchange Test)
Sterility	Sterilization dose auditing for sterility.	Stated as "Merries K-PHATE has been tested of sterilization dose auditing for sterility."
Manufacturing & Quality	Good Manufacturing Practice (GMP)	Required by Act (implied by 510(k) clearance)
Labeling	Conformance to labeling regulations (21 CFR Part 801)	Required by Act (implied by 510(k) clearance)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided summary does not detail a clinical "test set" for performance evaluation in the way a clinical trial would. The "tests" reported are primarily bench/laboratory tests for material properties and biocompatibility.

Sample Size for Bench/Biocompatibility Tests: Not specified in the summary. These tests typically involve a relevant number of samples for each specific test (e.g., cell cultures for cytotoxicity, animal models for irritation/sensitization/implantation).
Data Provenance: The manufacturing company is based in Taipei, Taiwan (Merries International Inc.). The specific locations where the individual biocompatibility tests were conducted are not stated, but given the company's location, they were likely performed in a certified lab, potentially in Taiwan or another country as required for international standards. These tests are prospective in nature, conducted specifically for this submission.

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 as there is no human-read clinical test set described in this summary to establish a "ground truth" for diagnostic or prognostic performance. The "ground truth" for the material and biocompatibility tests is based on objective scientific measurements and established standards (e.g., cell viability, tissue response, chemical composition as per ASTM).

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

This is not applicable. No clinical test set with human assessment requiring adjudication 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

This is not applicable. This device is a bone graft substitute, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant to this type of device.

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

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

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

For the tests conducted:

Material Composition: Ground truth is based on physical and chemical analysis techniques confirming compliance with ASTM standards.
Biocompatibility: Ground truth is based on biological assays and histological examination in animal models, evaluated against established criteria for cytotoxicity, irritation, sensitization, and tissue compatibility.
Sterility: Ground truth is based on microbiological testing (sterilization dose auditing).

There is no "expert consensus" or "pathology" in the sense of a clinical diagnostic study. Outcomes data (e.g., long-term bone healing) would typically be part of a full clinical trial, which is not detailed here for this 510(k) submission.

8. The sample size for the training set

This is not applicable. This device is a medical implant, not a machine learning model, and therefore does not have a "training set."

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

This is not applicable as there is no training set for this device.

Summary

{0}------------------------------------------------

K063157

Image /page/0/Picture/1 description: The image shows the word "Messies" in a stylized, handwritten font. The text is white against a black background, creating a high contrast. The font has a flowing, cursive style, with elongated strokes and unique letterforms. The overall impression is casual and playful.

MAR 1 0 2008 Merries International Inc. 2F 3-1, Bau-Hung Rd., Shin-Tien Taipei, Taiwan,

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of 21CFR 807.92

Merries K-PHATE Bone graft substitute

1. Submitted by:
  Merries International Inc. 2F 3-1, Bau-Hung Rd., Shin-Tien Taipei, Taiwan, R.O.C. Tel: 886-2-89117712 Fax: 886-2-29179241 Contact person: Sophia Lee
Date prepared: Sep. 20, 2006 2.
1. Trade name: Merries K-PHATE Bone graft substitute
1. Product classification: Class II
Device product code and panel code: 87MQV/Orthopedic న్.
1. Common name: Resorbable calcium salt bone void filler device (21 CFR 888.3045)
1. Indications of use:

1. Device description:
  Merries K-PHATE bone graft substitute is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite and 40% ß-tricalcium phosphate. Merries K-PHATE is supplied sterile in various shapes and sizes. The choice of different form or size of the product depends on the type and size of the recipient site. Blocks and wedges are used for large bony defect while granules are used as bone filler for small area.

1-2
pg 1 of 3

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "Messies" in a stylized, handwritten font. The word is white against a black background, creating a strong contrast. The font has thick strokes and a flowing, cursive style, giving it a dynamic and informal appearance.

Merries International Inc. 2F 3-1, Bau-Hung Rd., Shin-Tien Taipei, Taiwan,

1. Statement of substantial equivalence: Merries K-PHATE Bone graft substitute is substantially equivalent in base materials, function and intended use to the following devices:
- MBCPTM (K032268, K043005, and K051774) . Manufactured by Biomatlante
- Pro Osteon® 500R Resorbable Bone Graft Substitute (K990131) Manufactured by Interpore Cross INTL.
- . Vitoss® Scaffold Synthetic Cancellous Bone Void Filler (K032409) Manufactured by Orthovita, Inc.
- BoneSave™ Bone void Filler(K033258) Manufactured by Howmedica Osteonics Corp.
Testing summary: 10.
- Chemical requirements conform to the ASTM F1185-88 "Standard specification for composition of ceramic hydroxylapatite for surgical implants" and ASTM F 1088-87 "Standard specification for beta-tricalcium phosphate for surgical implantation".
- After taking into account the intended use and the device contact duration ● (>30days), the following biocompatibility tests have been completed and results support that Merries K-PHATE is non-cytotoxic, non-sensitizing, non-mutagenic, and compatible with surrounding tissues.

Biocompatibility Tests	Results
Cytotoxicity	Pass
Subcutaneous Irritation Test	Pass
Guinea Pig Skin Sensitization Study(Maximization Test)	Pass
Implantation Test	Pass
Sister Chromatid Exchange Test	Pass

. Merries K-PHATE has been tested of sterilization dose auditing for sterility.
Summaries and reports of all data are contained in the Premarket Notification Submission.

1-3

pg 2 of 3

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "Messies" in a stylized, handwritten font. The text is white against a black background, creating a high contrast. The font has a flowing, cursive style, with each letter connected to the next. The overall impression is casual and informal.

Merries International Inc. 2F 3-1, Bau-Hung Rd., Shin-Tien Taipei, Taiwan,

363

1. Summary of technological characteristics:
  The device is substantial equivalence to the predicate devices based on the same material characteristics and intended use. In additional, biocompatibility tests and well documented material support its safety and effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

Merries International Inc. % Ms. Sophia Lee 2F 3-1, Bau-Hung Road Shin-Tien, Taipei China

MAR 1 0 2008

Re: K063157

Trade/Device Name: Merries K-PHATE Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: January 15, 2008 Received: January 15, 2008

Dear Ms. Lee:

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 complies 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.

{4}------------------------------------------------

Page 2 - Ms. Sophia Lee

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

2.3 Statement of indication for use

510(k) Number (if known): _Ko63)57

Device Name:

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

Page 1 of 1

510(k) Number_

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.