OsSatura™ Dental is a bone filling augmentation material for used for augmentation or reconstructive treatment of alveolar ridge. This includes, filling of defects after root resection, apicoectomy and cystectomy, filling of extraction sockets to enhance preservation of the alveolar ridge and elevation of maxillary sinus floor.

Device Description

OsSatura™ Dental is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g., hydroxyapatite/tri-calcium phosphate) scaffold. The interconnected and open porous structure of OsSatura™ Dental is similar in structure to human cancellous bone. OsSatura™ Dental is available as irregular shaped chips of size 1 - 2 mm.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, OsSatura™ Dental. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full efficacy study with specified acceptance criteria in the way a clinical trial for a new drug or novel device might.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, a study that proves the device meets those criteria, or the methodology of such a study.

Here's an explanation of what an ideal response would look like if the information were available, and why it's not present in this document:

Why the requested information isn't here:

510(k) Process: The 510(k) pathway (Premarket Notification) is for devices that are "substantially equivalent" to an existing legally marketed device (a predicate). The focus is on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness profiles as the predicate. It generally does not require new clinical efficacy studies with predefined acceptance criteria and statistical power calculations like a PMA (Premarket Approval) application would for a novel, high-risk device.
"Testing" Section: The "Testing" section {1} states:
- "Pre-clinical animal data demonstrate that OsSatura™ Dental chips support bone ingrowth into a variety of bony defects."
- "Biocompatibility, extensive bench and animal testing using OsSatura Dental have successfully been performed to confirm that the device is degraded and resorbed over time and allow bone ingrowth."
- It also mentions compliance with ASTM standards (F1185-88 and F1088-87) and FDA guidance documents on bone void fillers.
- It references the long history of safe clinical use of the materials (calcium-based ceramics) and the predicate devices.
Lack of Specifics: While "testing" was done, the document does not provide:
- A table of specific quantitative acceptance criteria (e.g., "bone ingrowth percentage must be > X%")
- The raw performance data from these tests
- Details on sample sizes for these preclinical/animal studies
- Information about expert adjudication of results, ground truth methodology, or how a "test set" was defined for performance evaluation in the clinical sense.

If this were a different type of submission (e.g., a PMA or a more involved clinical study), the requested information would be structured as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (e.g., Primary Endpoint)	Level of Performance Required for Acceptance	Reported Device Performance	Outcome (Met/Not Met)
Example (Hypothetical for a similar device):
Mean percentage of bone ingrowth within defect at 6 months	≥ 25%	[Not available in document]	Not applicable
Absence of adverse events attributable to device	≤ 5% incidence of device-related infection at 1 year	[Not available in document]	Not applicable
Radiographic evidence of defect filling/osseointegration	Successful fusion in ≥ 80% of treated sites	[Not available in document]	Not applicable

(Note: The actual document does not provide such a table because it's a 510(k) summary, not a clinical trial report with specific quantifiable acceptance criteria for a primary endpoint.)

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

Test Set Sample Size: Not specified for a clinical performance evaluation in this document. The testing mentioned is preclinical (animal) and bench testing.
Data Provenance:
- Preclinical Animal Data: The document mentions "Pre-clinical animal data" {1}. Specific species, number of animals, and origin are not provided.
- Bench Testing: The document mentions "extensive bench... testing" {1}. Specifics are not provided.
- Clinical Data: The submission relies on the "long history of safe clinical use for hydroxyapatite and tri-calcium phosphate products" and the safety record of the predicate devices. No new clinical study data with a defined "test set" is presented for OsSatura™ Dental in this summary.

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

Not applicable as no specific clinical "test set" with expert-adjudicated ground truth is described in this document for the OsSatura™ Dental product itself. The preclinical and bench testing would involve researchers and scientists evaluating the results, but not in the context of expert consensus for ground truth on patient outcomes in a clinical trial.

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

Not applicable. No clinical "test set" requiring expert adjudication is described in this document.

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 synthetic bone graft material, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

Not applicable. This device is a physical biomaterial, not a standalone algorithm.

7. The type of ground truth used:

For the preclinical/animal studies and bench testing, the "ground truth" would be established through direct observation, histology, material science analysis, and quantitative measurements of bone growth, degradation, and mechanical properties. This is distinct from, say, pathology or outcomes data in a human clinical trial.
The overall "ground truth" for regulatory clearance under a 510(k) is primarily the substantial equivalence to legally marketed predicate devices, which already have an established safety and effectiveness profile based on their own testing and clinical use.

8. The sample size for the training set:

Not applicable. This document describes a medical device (bone graft material), not a machine learning model that requires a training set.

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

Not applicable for the same reason as #8.

In summary, the provided 510(k) document is a regulatory submission for a device demonstrating substantial equivalence, not a detailed clinical study report. Therefore, it lacks the specific, quantifiable performance acceptance criteria and detailed study methodologies that would be found in such a report. The "proof" for this device's safety and effectiveness relies on its similarity to existing, legally marketed devices and successful preclinical and bench testing.

Summary

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AUG 2 0 2004

K031813

510(k) Summary for IsoTis NV OsSatura™ Dental

1. SPONSOR

IsoTis NV Prof. Bronkhorstlaan 10 3723 MB Bilthoven The Netherlands

Contact Person: E. Schutte
Telephone:	+31-(0) 30-2295125
Facsimile:	+31-(0) 30-2280255

Date Prepared: June 6, 2003

2. DEVICE NAME

Proprietary Name:	OsSatura™ Dental
Common/Usual Name:	Synthetic bone graft material
Classification Name:	Bone filling augmentation (Unclassified)

3. PREDICATE DEVICES

Interpore 200 porous hydroxyapatite® (K860983) BioOss Collagen (K974399)

DEVICE DESCRIPTION 4.

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5. INTENDED USE

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The OsSatura Dental and the predicate devices are all similar in design, materials of construction and function. The OsSatura™ Dental product and the predicate devices are all made of calcium salts. The proposed and predicate devices are osteoconductive. The OsSatura™ Dental product and all the predicate devices provide an interconnected, porous scaffold and an environment for new bone ingrowth. All of the devices are provided sterile and non-pyrogenic for single patient use. The only difference between the proposed device and the predicate devices is that they are composed of different forms of calcium phosphate salts. These minor differences do not affect safety or effectiveness since they all carry out the same function. The safety and biocompatibility testing performed for calcium phosphates and the long history of safe clinical use for hydroxyapatite and tri-calcium phosphate products support the safe use of OsSatura™ Dental. The hydroxyapatite and tri-calcium phosphate in the OsSatura™ Dental meet the requirements in ASTM F1185-88 and F1088-87. Additionally, testing performed on the proposed device confirmed that OsSatura™ Dental meets the applicable requirements of the FDA guidance documents on bone void fillers.

7. TESTING

Prc-clinical animal data demonstrate that OsSatura™ Dental chips support bone ingrowth into a variety of bony defects. Biocompatibility, extensive bench and animal testing using OsSatura Dental have successfully been performed to confirm that the device is degraded and resorbed over time and allow bone ingrowth.

Calcium-based ceramic materials, including hydroxyapatite and tri-calcium phosphate, have been used in clinical practice for more than 25 years with no remarkable safety issues. The devices to which OsSatura™ Dental claims substantial equivalence Interpore 200 porous hydroxyapatite and Bio-Oss Collagen have been used safely for many years in the clinical environment.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping human profiles facing to the right, representing the department's focus on people and health.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2004

Iso Tis OrthoBiologics C/O Ms. Mary McNamara-Cullinane Staff Consultant Medical Devise Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K031813

Trade/Device Name: OsSatura™ Dental Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: June 9, 2004 Received: June 14, 2004

Dear Ms. Cullinane:

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.

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Page 2 - Ms. Cullinane

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.

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) 594-4613. 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.

Chiu Lin, Ph.D.

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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K031813

510(k) Number (if known):

Device Name: OsSatura™ Dental

Indications for Use:

OsSatura™ Dental is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:

filling of defects after root resection, apicoectomy, and cystectomy ェ
filling of extraction sockets to enhance preservation of the alveolar ridge -
elevation of maxillary sinus floor -

PI.EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sivara Runga

n of Anesthesiology, General Hospi ion Control, Dental D

510(k) Number: KC31813

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

IsoTis 510(k) Premarket Notification OsSatura™ Dental

June 6, 2003

Page vii

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.