ReproBone is recommended for augmentation or reconstructive treatment of the alveolar ridge. Filling of infrabony periodontal defects. Filling of defects after root resection apicoectomy and cystectomy. Filling of extraction sockets to enhance preservation of the alveolar ridge. Elevation of the maxillary sinus floor. Filling of periodontal defects in conjunction with products intended for guided tissue regeneration (GTR) and guided bone regeneration (GBR). Filling of peri-implant defects in conjunction with products intended for guided bone regeneration (GBR).

Device Description

ReproBone® is a sterile, single-use, resorbable bone void filler. ReproBone® is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. ReproBone" has a highly interconnected, highly porous structure, similar to that of human cancellous bone, and is available in the form of granules of size range 0.5 - 1.0mm, and also 0.8-1.5mm. Following placement in the bony voids or gap, ReproBone® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. ReproBone® gradually resorbs and is replaced with bone during the healing process

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "ReproBone®", a resorbable calcium salt bone void filler. This document is a regulatory submission, not a scientific study report. Therefore, it focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a formalized study with detailed performance metrics.

Specifically, the document does not contain the following information typically found in a scientific study proving device performance against acceptance criteria for an AI/CAD/software device:

A table of acceptance criteria and reported device performance: The document states that "ReproBone was equivalent in terms of cell attachment and proliferation as well as bone formation and device reesorption" compared to a predicate device, but it does not provide specific quantitative acceptance criteria or reported performance values.
Sample size used for the test set and data provenance: No dedicated "test set" is mentioned for evaluating performance against acceptance criteria. The "in vivo (animal) and in vitro cell studies" are described as comparative, but no sample sizes or data provenance details are given.
Number of experts used to establish ground truth and their qualifications: This concept is not applicable as the studies described are in vivo (animal) and in vitro (cell) studies, not human image-based or clinical studies requiring expert ground truth.
Adjudication method: Not applicable for the type of studies described.
Multi-reader, Multi-case (MRMC) comparative effectiveness study: Not applicable. The device is a bone void filler, not an AI/CAD system for image interpretation.
Standalone (algorithm-only) performance: Not applicable.
Type of ground truth used: For the in vivo and in vitro studies, the "ground truth" would be the biological measurements and observations from the experiments themselves (e.g., cell counts, bone formation assessments, resorption rates).
Sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on regulatory compliance and substantial equivalence:

Acceptance Criteria and Device Performance (based on regulatory submission context):

The implied "acceptance criteria" are the demonstration of substantial equivalence to legally marketed predicate devices and compliance with relevant standards. The "performance" is reported qualitatively as equivalence.

Acceptance Criteria (Implied from Regulatory Context)	Reported Device Performance
Technological Characteristics: Same composition (60% Hydroxyapatite, 40% beta-tricalcium phosphate) as predicate, similar porous structure, sterile, single-use.	ReproBone® and the Bioactys® predicate device (K082286) share an identical composition (60% hydroxyapatite and 40% tricalcium phosphate). All predicate devices have a similar highly porous structure, promoting bone ingrowth by osteoconduction, and are gradually resorbable. Both ReproBone® and predicates are provided sterile for single-use.
Function and Intended Use: Same as substantially equivalent predicate devices.	ReproBone® and the predicate devices have the same technological characteristics, function, and intended use as "augmentation or reconstructive treatment of the alveolar ridge, filling of infrabony periodontal defects... etc."
Compliance with Standards: Meets ISO 13779-1 for hydroxyapatite (chemical analysis, trace elements, crystalline content, mechanical properties).	Tests applied are those specified in ISO 13779-1 for hydroxyapatite which include chemical analysis, trace elements, chrystalline content and mechanical properties (compressive strength). (Performance values for these tests are not explicitly stated in the summary, but compliance is asserted).
Biocompatibility/Biological Response: Equivalent cell attachment, proliferation, bone formation, and resorption compared to predicate.	"In vivo (animal) and in vitro cell studies were carried out whereby compared to a predicate device. Reprobone was equivalent in terms of cell attachment and proliferation as well as bone formation and device reesorption." (Specific quantitative data for equivalence is not provided in this summary, but the finding of equivalence is stated).

Study Information (as presented in the 510(k) Summary):

A table of acceptance criteria and the reported device performance: See table above. The performance reported focuses on equivalence to a predicate device rather than meeting pre-defined numerical thresholds for new claims.
Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The summary only mentions "in vivo (animal) and in vitro cell studies."
- Data Provenance: Not specified, but given the submitter is "Ceramisys Ltd" from "Sheffield S2 1AS, England", it can be inferred the studies were likely conducted in the UK or under their oversight. No indication of retrospective or prospective nature is provided, but in vivo and in vitro studies are typically purpose-designed (prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for in vivo and in vitro studies involves direct experimental measurements and observations, not interpretations by medical experts as would be the case for diagnostic imaging algorithms.
Adjudication method: Not applicable.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance on diagnostic tasks, often with AI assistance, and is not relevant for a bone graft substitute.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a physical medical device, not a software algorithm.
The type of ground truth used: For the biological studies mentioned (in vivo and in vitro), the ground truth would be established through direct biological assays, histological analyses, and quantitative measurements of cell activity, bone formation, and material resorption.
The sample size for the training set: Not applicable. This is a physical device, not an AI algorithm.
How the ground truth for the training set was established: Not applicable.

In conclusion, this 510(k) summary is a regulatory document to establish substantial equivalence for a physical medical device, not a detailed scientific report of a study proving performance against acceptance criteria for an AI/CAD/software device. Therefore, many of the requested details specific to AI/CAD studies are not present or applicable. The "study" mentioned consists of "in vivo (animal) and in vitro cell studies" aimed at demonstrating equivalence in biological response to a predicate device.

Summary

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510(k) Summary

Ulsvis

K103820

NOV - 3 2011

ReproBone®

Preparation Date: 31st October 2011

1. Submitter's Information

Company:	Ceramisys Ltd
Address:	Alison Business CentreAlison CrescentSheffield S2 1AS, England

44 114 242 7630 Telephone: Facsimile: + 44 114 242 7631 Contact: Mr Wayne Austin (Managing Director)

2. Name of Device

Trade Name:	ReproBone®
Common Name:	Resorbable calcium salt bone void filler device
Classification name:	Bone Grafting Material, Synthetic
Product Code:	LYC
Device panel:	Oral/Dental

3. Legally Marketed Predicate'Device

The subject device is substantially equivalent to previously cleared devices. Bio-Oss® Granules (K033815) Bioactys® (K082286) MBCP® (K051885)

4. Device Description

5. Intended Use

ReproBone is recommended for augmentation or reconstructive treatment of the alveolar ridge, filling of infrabony periodontal defects, filling of defects after root resection apicoectorny and cystectomy, filling of extraction sockets to enhance preservation of the alveolar ridge, elevation of the maxillary sinus floor, filling of periodontal defects in conjunction with products intended for guided tissue regeneration (GTR) and guided bone regeneration (GBR), and filling of peri-implant defects in conjunction with products intended for guided bone regeneration (GBR).

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6. Technological characteristics

ReproBone® and the predicate devices have the same technological characteristics, function and intended use. The Bioactys® predicate device (K082286) is constructed of the ratio 60% hydroxyapatite and 40% tricalcium phosphate which is identical to the composition of ReproBone®. All have a similar highly porous structure that promotes bone ingrowth by osteoconduction, and are gradually resorbable. ReproBone® and the predicate devices are provided sterile for single-use.

K103820

7. Non clinical performance data

Tests applied are those specified in ISO 13779-1 for hydroxyapatite which include chemical analysis, trace elements, chrystalline content and mechanical properties (compressive strength).

In vivo (animal) and in vitro cell studies were carried out whereby compared to a predicate device. Reprobone was equivalent in terms of cell attachment and proliferation as well as bone formation and device reesorption.

8. Conclusion

The safety and effectiveness and performance equivalence of ReproBone® resorbable bone graft substitute for use in dental and periodontal bone voids is adequately supported by the substantial equivalence information as well as comparative biocompatibility testing, and safety and performance data provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV - 3 2011

Mr. Hillard W. Welch U.S. Representative for Ceramisys Limited Ceramisys Limited 344 Annabelle Point Road Centerville, Massachusetts 02632

Re: K103820

Trade/Device Name: ReproBone® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Il Product Code: LYC Dated: October 18, 2011 Received: October 20, 2011

Dear Mr. Welch:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. Welch

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K103820

Device Name: ReproBone

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)

Susan Kummer
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K163820

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.