a-BSM™ Bone Substitute Material is a synthetic calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.

Device Description

«-BSM™ Bone Substitute Material Kit is a synthetic, calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, to reduce alveolar bone pocket depth and increase alveolar bone thickness and height, to aid in gain in clinical attachment and for repair of cysts or other defects in the alveolar ridge or wall. &-BSM™ Bone Substitute Material Kit is provided in dry white powder form, it contains no pvrophosphates or amorphous tricalcium phosphate. The device is mixed with sterile water or saline just prior to its application to the desired periodontal defect.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device (α-BSM™ Bone Substitute Material Kit) and focuses on its substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria and a study demonstrating achievement of those criteria.

Therefore, many of the requested sections regarding detailed study design (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details) are not available in the provided document.

Here's an analysis of what is available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance/Compliance
Biocompatibility	Absence of adverse reactions to tissues/body.	Tested for: Skin Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Rabbit IM. (Results are not detailed beyond "Testing... designed to... assure the biocompatibility.")
Material Composition	Conformance to established material standards for ceramic hydroxylapatite for surgical use.	Demonstrated through: Elemental analysis, x-ray diffraction (XRD), Fourier Transform Infrared (FTIR) Spectroscopy. Conforms to ASTM Standard F 1185 for Composition of Ceramic Hydroxylapatite for Surgical Use.
Sterility	Device must be sterile.	Sterility testing (USP 23) demonstrated that the material is sterile.
Physical/Chemical Purity	Absence of pyrophosphates or amorphous tricalcium phosphate. (This is a product characteristic, not a test)	Device contains no pyrophosphates or amorphous tricalcium phosphate.
Substantial Equivalence	Similar performance and indications for use as legally marketed predicate devices.	Reviewed by FDA and deemed substantially equivalent to OsteoGen® (Impladent, Ltd.) and HAPSET® (Lifecore Biomedical). "All three products are forms of apatitic calcium phosphate with similar performance in the body." The 510(k) clearance itself is the ultimate "report" of meeting this criterion.

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

Not provided. The document mentions "Testing of x-BSM™ Bone Substitute Material was designed to characterize the finished material and assure the biocompatibility of the device," but does not detail sample sizes, study design (retrospective/prospective), or data provenance for these tests. This is typical for a 510(k) where the focus is on substantial equivalence based on material properties and basic safety, rather than clinical performance trials with controlled test sets.

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)

Not applicable/Not provided. No clinical test set requiring expert ground truth is described. The 'testing' refers to material characterization and biocompatibility assays, not diagnostic or clinical performance.

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

Not applicable/Not provided. No clinical test set 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

Not applicable. This device is a bone substitute material, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

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

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

For the material and biocompatibility testing, the "ground truth" was based on:
- Biocompatibility Standards: Established guidelines for biological response to materials.
- Material Standards: ASTM Standard F 1185 for Composition of Ceramic Hydroxylapatite for Surgical Use.
- Sterility Standards: USP 23 (United States Pharmacopeia).
For the substantial equivalence claim, the "ground truth" was the performance and properties of the predicate devices (OsteoGen® and HAPSET®) and the regulatory framework that deems devices with similar characteristics and indications as equivalent.

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" in the context of this device and testing. The device is a material, not a machine learning model.

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

Not applicable/Not provided. As there is no training set, this question is not relevant.

Summary

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K962548

AUG - 5 1997

510(K) SUMMAR for ETEX x-BSM™ Bone Substitute Material Kit

DATE PREPARED I .

June 21, 1996

2. SPONSOR INFORMATION

Address ETEX Corporation 38 Sidney Street. Suite 370 Cambridge, MA 02139

Telephone: (617)577-7270

Contact: DoSuk D. Lee, Ph.D.

3. DEVICE NAME

Proprietary Name: α-BSM™ Bone Substitute Material Kit Common/Usual_Name: Bone Graft Material Classification Name: Endosseous Implant for Bone Filling and /or Augmentation

4. DEVICE DESCRIPTION AND INTENDED USE

న్. PREDICATE DEVICES

x-BSM™ Bone Substitute Material Kit is substantially equivalent to devices currently in U.S. commercial distribution which are classified as endosseous implant for bone filling and/or augmentation. Examples of other such products include OsteoGen® (manufactured by Impladent, Ltd.) and HAPSET® (manufactured by Lifecore Biomedical). All three products are forms of apatitic calcium phosphate with similar performance in the body.

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6. DEVICE TESTING

Testing of x-BSM™ Bone Substitute Material was designed to characterize the finished material and assure the biocompatibility of the device. Biocompatibility testing included Skin Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity, and Rabbit IM. Additionally, elemental analysis, x-ray diffraction (XRD), Fourier Transform Infrared (FTIR) Spectroscopy and sterility testing (USP 23) demonstrated that the device conforms to ASTM Standard F 1185 for Composition of Ceramic Hydroxylapatite for Surgical Use and that the material is sterile.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 1997

DoSuk D. Lee, Ph.D. Etex Corporation 38 Sidney Street, Suite 370 Cambridge, Massachusetts 02139

Re: K962548 BSM Bone Substitute Material Kit Trade Name: Requlatory Class: Unclassified Product Code: LYC Dated: December 17, 1996 Received: December 23, 1996

Dear Dr. Lee:

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 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 (Premarket Approval), 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 895. substantially equivalent determination assumes compliance with the Cood Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation 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 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.

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Page 2 - Dr. Lee

This letter will allow you to beqin 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 at (301) 443-6597.

Sincerely yours,

Timothy A. Ulatowski

A. Timothy Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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PREMARKET NOTIFICATION

DEVICE NAME AND INTENDED USE STATEMENT

Device Name: α-BSM™ Bone Substitute Material Kit

510(k) Number: K962548

Indications/ Intended Uses:

PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NECESSARY

Susan Runner
Chief Division Sign-Off: CDRH, Office of Device Evaluation (ODE)
Division of Dental, Infection Control,and General Hospital Devices
510(k) Number:	K192548
Prescription Use✓	or	Over-the-Counter Use

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.