The intended use of PerioGlas is to provide a safe, biocompatible synthetic bone graft material for oral/maxillofacial and dental intraosseous defects use. It is to be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (DFDBA demineralized freeze dried bone) or may be mixed with each as a bone graft extender. Typical uses include:

Periodontal/Infrabony defects .
Ridge augmentation .
Extraction sites .
Cranio-facial augmentation .
Cystic cavities .
. Sinus lifts

Device Description

PerioGlas® is a synthetic osteoconductive particulate bone/void filler that is intended for oral/maxillofacial and dental intraosseous defects use. The material composed of Bioglass® (24.5 wt % CaO, 24.5 wt % Na20, 45 wt % SiO2, 6 wt % P2O5) with a particle size range of 90-710 um. It is supplied sterile in a Tyvek sealed PET-G cup that is protected by a shrink wrapped cardboard box. It is mixed with sterile water (saline) or the patient's own blood to form a wet sandy paste which is applied to the defect.

AI/ML Overview

The provided text describes the device testing and clinical data supporting the safety and efficacy of PerioGlas®. However, it does not explicitly define acceptance criteria in a structured table or directly compare performance against such criteria. Instead, it describes comparative studies and observations of equivalence or improvement.

Here's an interpretation of the implied acceptance criteria and reported performance, along with other requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria. However, based on the conclusions and device testing sections, the implied acceptance criteria revolve around substantial equivalence to predicate devices and demonstrating safe and efficacious use.

Acceptance Criterion (Implied)	Reported Device Performance
Animal Models:
Substantial equivalence in rate of bone formation to predicate devices.	PerioGlas® was substantially equivalent to hydroxylapatite predicate devices in the rate of bone formation.
Substantial equivalence in amount of bone formed to predicate devices.	PerioGlas® was substantially equivalent to hydroxylapatite predicate devices in the amount of bone formed.
Substantial equivalence in biomechanical properties (e.g., peak compressive loads, compressive stiffness) to predicate devices and normal bone.	PerioGlas® was substantially equivalent to hydroxylapatite predicate devices and normal bone in biomechanical properties including peak compressive loads and compressive stiffness.
Improved bone formation or graft site augmentation as a graft extender.	As a graft extender with autogenous bone, bone formation or graft site augmentation was greater for the mixture of bone and Bioglass® than for either alone in both rabbit calvarial and canine split-rib models.
Clinical Data:
No significant differences in clinical parameters (e.g., CAL, PDR, osseous fill) when used alone or with bone graft mixtures in periodontal applications.	Periodontal studies showed no significant differences between PerioGlas®/Bone graft mixtures and PerioGlas® alone for CAL, PDR, and osseous fill. (Note: suggested synergistic effect when combined).
Safe and efficacious use in various dental/oral/maxillofacial defects (e.g., ridge augmentation, extraction sites, sinus augmentation, cystic defects).	Ridge augmentation, extraction site, sinus augmentation, cystic defect, and general osseous reconstruction studies demonstrated safe and efficacious use of PerioGlas® alone and/or as a graft extender.
Acceptable overall implant success rate (when applicable as a graft extender for ridge augmentation, extraction sites, sinus augmentation).	A four-clinician retrospective study reported an overall implant success rate of 91%, indicating safe and efficacious use as a bone graft extender for ridge augmentation, extraction sites, and sinus augmentation.
Support for safety and efficacy from documented case reports with clinical evaluations and radiographs.	Documented case reports representing all summarized categories with clinical evaluations and radiographs support the safety and efficacy of PerioGlas® alone or as a bone graft extender in bone/void filling.
Overall conclusion of performing as well as or better than predicate devices.	The animal and/or clinical performance, safety and effectiveness data show that the device performs as well as or better than predicate hydroxylapatite devices as an osteoconductive bone void filler both alone or as a bone graft extender.

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

Animal Models:

Rabbit calvarial defect model: Sample size not specified.
Canine split-rib model: Sample size not specified.
Provenance: Not explicitly stated, but implies studies conducted in animal laboratories.

Clinical Data:

Prospective, retrospective, and case studies: Sample sizes for individual clinical studies are not specified, except for:
- Four clinician retrospective study: Focuses on implant success rate; the number of patients/cases included in this study is not specified, only the number of clinicians.
Provenance: The text indicates "Clinical Data including prospective, retrospective and case studies were reviewed and evaluated," suggesting a mix of data types from various clinical settings. Specific country of origin is not mentioned.

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

Animal Studies: Not explicitly mentioned, but typically, veterinary pathologists or researchers would evaluate outcomes in such studies.
Clinical Studies: The "four clinician retrospective study" implies four clinicians were involved in evaluating cases and determining the 91% implant success rate. Their specific qualifications (e.g., "oral/maxillofacial surgeon with X years of experience") are not specified beyond being "clinicians." For other clinical data and case reports, the number and qualifications of experts are not described.

4. Adjudication method for the test set

Not explicitly stated. For the "four clinician retrospective study," it's not described how potential disagreements among the clinicians were resolved or if there was a consensus process. For other clinical data and case reports, no specific adjudication method is mentioned.

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

No. The provided text describes the evaluation of a bone graft material, PerioGlas®, and its performance in animal models and clinical use. It does not describe an AI medical device or a multi-reader multi-case (MRMC) comparative effectiveness study involving AI assistance for human readers.

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

Not applicable. This question pertains to AI/algorithm performance. PerioGlas® is a medical device (bone graft particulate), not an algorithm.

7. The type of ground truth used

Animal Studies: Comparisons against "normal bone" for biomechanical properties, and direct observation of bone formation/graft site augmentation. This could be considered a combination of histological/pathological assessment and biomechanical measurements.
Clinical Studies:
- Periodontal studies: Clinical parameters (Clinical Attachment Level (CAL), Pocket Depth Reduction (PDR), osseous fill) are likely objective measurements taken directly from patients.
- Implant success rate: This typically relies on established clinical criteria for implant stability, absence of infection, and functional integration, making it an outcomes-based ground truth determined by clinicians.
- Case reports: These rely on clinical evaluations and radiographs interpreted by clinicians.

8. The sample size for the training set

Not applicable. This question typically applies to machine learning models where a training set is used to develop the algorithm. PerioGlas® is a physical medical device. The animal and clinical studies described serve as testing/validation, not "training."

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

Not applicable. As above, this pertains to machine learning models.

Summary

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

OCT 1 5 1999

Ka9q2416

510(k) Summary

General Information

Classification Name:	Endosseous Implant for Bone Filling and/or Augmentation
Common Name:	Bioglass® Synthetic Bone Graft Particulate
Trade Name:	PerioGlas®
Submitter's Name :	USBiomaterials Corporation
Address:	One Progress Boulevard, #23Alachua, FL 32615
Telephone:	(904) 462-7660
Facsimile:	(904) 462-7605
Contact:	Albert Fosmoe II, Director of Quality Assurance and Regulatory Affairs
Date of Summary:	July 1999

Device Description

Predicate Device

PerioGlas® is substantially equivalent to legally marketed osteoconductive bone filling and/or augmentation devices in the U.S. including Calcitite (K852682) and Bio-Oss (K970321). Any minor differences between PerioGlas® and the predicate devices do not raise new questions of safety or effectiveness.

Intended Use

PerioGlas® is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:

Periodontal defects ●
Ridge augmentation .
Extraction Sites ●
Cranio-facial Augmentation .
Sinus Lifts .
Cystic Defects .

Device Testing

The performance of PerioGlas® was evaluated in animal models versus hydroxylapatite predicate devices. The rate of bone formation, amount of bone formed and the biomechanical

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

properties including peak compressive loads and compressive stiffness were substantially equivalent to each other and normal bone.

PerioGlas® Bioglass® particulate was also evaluated as a graft extender with finely ground autogenous bone in a rabbit calvarial defect model and a canine split-rib model. In both of these models, bone formation or graft site augmentation was greater for the mixture of bone and Bioglass® than for either alone.

Clinical Data including prospective, retrospective and case studies were reviewed and evaluated for various dental and oral/maxillofacial intraosseous defects including a variety of ridge, periodontal, extraction sites, sinus augmentation and cystic defects using PerioGlas® alone and/or as a graft extender.

Periodontal studies showed no significant differences between PerioGlas®/Bone graft mixtures and PerioGlas® alone for a variety of clinical parameters including Clinical Attachment Level (CAL), Pocket Depth Reduction (PDR) and osseous fill. Results did suggest that there may be a synergistic effect when the two graft materials are combined.

Ridge augmentation, extraction site, sinus augmentation, cystic defect and general osseous reconstruction studies demonstrated safe and efficacious use of PerioGlas® alone and/or as a graft extender in these indications. Results from a four clinician retrospective study, as measured by the overall implant success rate (91%), indicate that the use of PerioGlas® as a bone graft extender is safe and efficacious for ridge augmentation, extraction sites and sinus augmentation.

Documented case reports representing all of the summarized categories with clinical evaluations and radiographs support the safety and efficacy of PerioGlas® alone or as a bone graft extender in bone/void filling.

Conclusions

The animal and/or clinical performance, safety and effectiveness data show that the device performs as well as or better than predicate hydroxylapatite devices as an osteoconductive bone void filler both alone or as a bone graft extender.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 image of three human profiles facing to the right, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

Mr. Albert Fosmoe II Director of Regulatory Affairs US Biomaterials Corporation One Progress Boulevard #23 Alachua, Florida 32615

K992416 Re : Perioglas - Bioglass Bone Graft Particulate Trade Name: Regulatory Class: Unclassified • Product Code: LYC Dated: July 16, 1999 Received: July 20, 1999

Dear Mr. Fosmoe II:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A . substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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

Paqe 2 - Mr. Fosmoe II

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patrucco Cacciola Hoz

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known):	K992416
Device Name:	PerioGlas®

Indications For Use:

Periodontal/Infrabony defects .
Ridge augmentation .
Extraction sites .
Cranio-facial augmentation .
Cystic cavities .
. Sinus lifts

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
------------------------------------------	----	----------------------

Signature
(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

510(k) Number	KC992416
---------------	----------

D-2

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.