Merries UNI-OSTEO pellets are used to fill bony defects which may be surgically created voids or from traumatic injury to the bone. The product is indicated to be packed into bony defects of the skeletal system which is not intrinsic to the stability of the bony structure.

Device Description

Merries UNI-OSTEO pellets are made of calcium sulfate (CaSO4). These pellets dissolve safely and completely in the body in approximately 30-60 days and resorption rate corresponds with new bone growth. The product is visible on radiographs so that the implant location can be easily identified and monitored. Merries UNI-OSTEO pellets are osteoconductive meaning that these pellets act as a scaffold and facilitate new bone growth.

AI/ML Overview

This document describes the premarket notification for the Merries UNI-OSTEO Pellets Bone Graft Substitute. The acceptance criteria and the study proving it are primarily focused on biocompatibility and equivalence to predicate devices, rather than a typical AI/software performance study.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Criteria	Acceptance Criteria	Reported Device Performance
Biocompatibility	Non-cytotoxic, non-sensitizing, non-mutagenic, and compatible with surrounding tissues	Pass (for all individual tests listed below)
Cytotoxicity	(Implicitly: non-cytotoxic)	Pass
Intracutaneous Reactivity Test	(Implicitly: non-reactive)	Pass
Maximization Sensitization Test	(Implicitly: non-sensitizing)	Pass
Genotoxicity	(Implicitly: non-mutagenic)	Pass
Implantation	(Implicitly: compatible with surrounding tissues upon implantation)	Pass
Sterility	Sterile (determined by sterilization dose auditing)	(Implied: Supports sterility)
Material Conformance	Conforms to USP/NF "Official Monograph for Calcium Sulfate"	Conforms
Mechanical Strength	Equivalent strength to predicate device	Equivalent strength
Substantial Equivalence	Equivalence in base materials, function, and intended use to predicate devices	Substantially Equivalent

2. Sample Sizes and Data Provenance

Test Set Sample Size: Not explicitly stated for each biocompatibility test. The document states "Summaries and reports of all data are contained in the Premarket Notification Submission," which is not provided here.
Data Provenance: The studies were conducted by Merries International Inc. (Taiwan, R.O.C.). The type of studies (e.g., animal models for implantation, in vitro for cytotoxicity) implies a mix of experimental data. Whether this data is considered "retrospective" or "prospective" is not applicable in the typical sense for these types of device tests; they are generally tests performed specifically for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as this submission concerns a medical device (bone graft substitute) and its biocompatibility and material properties, not an AI/software device requiring expert interpretation of outputs for ground truth.

4. Adjudication Method

Not applicable for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive tools to assess human reader improvement, which is not the nature of this device.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical bone graft substitute, not a digital algorithm. The "standalone" performance here refers to its physical and biological properties.

7. Type of Ground Truth Used

The "ground truth" for the tests performed can be characterized as:
- Biocompatibility Standards/Definitions: For tests like cytotoxicity, sensitization, and genotoxicity, the "ground truth" is defined by established scientific protocols and acceptable biological responses.
- Sterility Standards: For sterility, the "ground truth" is complete absence of viable microorganisms.
- Material Specifications: For material, the United States Pharmacopoeia (USP) National Formulary (NF) "Official Monograph for Calcium Sulfate" serves as the ground truth.
- Comparative Performance: For mechanical strength and substantial equivalence, the performance of the predicate devices (Osteoset™ Pellets and Jax™) serves as the "ground truth" or benchmark.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set was used.

Summary

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K051698 p1/2

SEF 2 9 2005

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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 UNI-OSTEO Pellets 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: Jessica Li

1. Date prepared: May 23, 2005
1. Trade name: Merries UNI-OSTEO Pellets Bone Graft Substitute
1. Product classification: Unclassified
ર. Device product code and panel code: 87MQV/Orthopedic
1. Common name: Resorbable calcium salt bone void filler device (21 CFR 888.3045)

7. Indications for use:

8. Device description:

Merries UNI-OSTEO pellets are osteoconductive meaning that these pellets act as a scaffold and facilitate new bone growth.

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i 051698 1/2

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

9. Statement of substantial equivalence:

Merries UNI-OSTEO Pellets Bone Graft Substitute is substantially equivalent in base materials, function and intended use to the following devices:

Osteoset™ Pellets (K963587, K963562) . Manufactured by Wright Medical Technology, Inc.
Jax™ (K010555) . Manufactured by Smith & Nephew, Inc.
1. Material: The raw material, calcium sulfate, conforms to the requirements of United States Pharmacopoeia(USP) National Formulary(NF) "Official Monograph for Calcium Sulfate"

11. Testing summary:

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 UNI-OSTEO is non-cytotoxic, non-sensitizing, non-mutagenic, and compatible with surrounding tissues.

Biocompatibility Tests	Results
Cytotoxicity	Pass
Intracutaneous Reactivity Test	Pass
Maximization Sensitization Test	Pass
Genotoxicity	Pass
Implantation	Pass

Merries UNI-OSTEO has been tested of sterilization dose auditing for sterility. .
The mechanical testing showed equivalent strength to the predicate device. .

Summaries and reports of all data are contained in the Premarket Notification Submission.

12. 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.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2005

Ms. Jessica Li Merries International Inc. 2F 3-1, Bau-Hung Road Shin-Tien, Taipei, Taiwan, R.O.C.

Re: K051698

Trade/Device Name: Merries UNI-OSTEO Pellets Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: September 8, 2005 Received: September 8, 2005

Dear Ms. Li:

We have reviewed your Scction 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 IDA'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.

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Page 2 -Ms. Karen L. Baker

This letter will allow you to begin marketing your device as described in your Scction 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 N-Melkison

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

Enclosure

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2.3 Statement of indication for use

510(k) Number:

Device Name: Merries UNI-OSTEO Pellets Bone Graft Substitute

ndications For Use:

Mark H. Milliman

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

K051698'

X Prescription Use (Part21 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

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.