Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children.

Specific Indications for Use:

. Fractures of the cranium, mid-face, maxilla and chin.
. Infant craniofacial surgery ( i.e. Craniosynostosis, Congenital malformations)
. Le Forte ( I, II, III ) Osteotomies.
. Pediatric Reconstructive procedures of Cranial facial Skeleton
. Orthognathic or Reconstructive procedures of mid-face, maxilla & chin.
Facial Craniotomy flap fixation. .

Device Description

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories consists of single use, bioabsorbable, Self Compression Bone Fixation plates, meshes, fixation screws, fasteners, tacks, tenion wires and anchor pins designed for use in trauma and reconstructive procedures for craniofacial skeleton, mid-face, maxilla and chin in adult and children. The single use, bioabsorbable, self compression, Bone fixation plates are offered in various sizes and configurations to meet anatomical needs of the patients. TheAdjustable Bone Plates™- Bioabsorbable Craniofacial Bone Fixation plates, mesh, screws .tension wires, tacks and anchor pins are made from bioabsorbable co-polymer material of Poly (L -Lactide & DL-Lactide-70:30 or 85:15 ). The bone plates and meshes are designed to be used with 1.8mm and 2.1 mm screws, tacks and anchor pins for trauma and reconstructive procedure. The bioabsorbable screws can be tightened with 1.8mm conventional screw driver or deployed with endoscopic device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device and not a study that evaluated an AI/ML device. Therefore, the requested information for acceptance criteria and a study proving the device meets them, specifically in the context of AI/ML, cannot be fully extracted.

However, I can provide the information that is present concerning the device's comparison to a predicate device, which is a form of "acceptance criteria" for 510(k) submissions.

Here's a breakdown of what can be extracted, heavily acknowledging the limitations:

No AI/ML device is described in the provided text. The device is a physical craniofacial bone fixation system.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate device comparison)	Reported Device Performance
Technological Characteristics: Substantially equivalent to predicate device Xsorb™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories (K070737) in:	Met. "Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories... is substantially equivalent to the predicated device Xsorb™ Bioabsorbable, Craniofacial Bone Fixation System & Accessories cleared by FDA under 510k application #K070737."
- Product design	Identical. "the proposed product is substantially equivalent to predicated devices in product design..."
- Materials	Identical. "...materials..."
- Packaging	Identical. "...packaging..."
- Intended Use	Identical. "...and intended use."
- Material compatibility	Met. (Implied by substantial equivalence and material selection being identical)
- Product specifications	Met. (Implied by substantial equivalence)
Mechanical Performance:	Met. "Mechanical testing of the devices also demonstrated that the tensile strength, breakage force and degradation time for the device are equivalent to predicated devices & are satisfactory for its intended use."
- Tensile strength (Equivalent to predicate)	Average Tensile Strength: X= 2.5 Lb / in²
- Breakage Pull force (Equivalent to predicate)	Average Breakage Pull Force: 4.0 Lb/ in²
- Pull force during installation (Less than 1.0 Lb/in²)	Average pull force applied during Adjustable Bone plate installation, using Clamp Tool (with 2.0mm pre-set stops) is less than 1.0 Lb/in².
- Degradation time (Equivalent to predicate)	"The actual degradation time of the proposed and predicate device are practically identical."
Manufacturing Processes:	Identical. "The material selection, manufacturing process, product packaging, sterilization process and indication for use are also identical."
Sterilization Process:	Identical. "The material selection, manufacturing process, product packaging, sterilization process and indication for use are also identical."
Indications for Use:	Identical. "The material selection, manufacturing process, product packaging, sterilization process and indication for use are also identical." Note: The indications for use are explicitly listed and are deemed equivalent to the predicate.

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

Sample Size: Not specified quantitatively. The text only mentions "Preclinical testing was performed" and "Laboratory product testing has indicated that the Adjustable Bone Plates™..." It does not provide specific numbers of units tested for mechanical properties.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It is "Preclinical testing" and "Laboratory product testing", suggesting controlled lab environments rather than clinical data.

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

Not applicable. This relates to diagnostic interpretation, which is not relevant for a physical bone fixation system. The "ground truth" here is the physical measurement of mechanical properties.

4. Adjudication method for the test set

Not applicable. This also pertains to expert interpretation, not physical device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is for evaluating human performance, often with or without AI assistance, in diagnostic tasks. The device described is a physical implant.

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

No. This refers to AI/ML algorithm performance. The device is a physical product.

7. The type of ground truth used

Direct physical measurement/bench testing. The "ground truth" for the mechanical properties (tensile strength, breakage force, degradation time, pull force during installation) was established through laboratory testing and measurement of the device itself.

8. The sample size for the training set

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

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

Not applicable. As above, no training set for an AI/ML model is involved.

Summary

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DEC 2 8 2007

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510K Summary of Safety & Effectiveness

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories

Company:

Contact:

Prosurg, Inc 2193 trade Zone blvd San Jose CA 95131

Ashvin Desai , Mgr Regulatory Affairs Tel: (408) 945 -4044

Date Preparaed: September 4, 2007

Device Name: Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories

Predicated Devices: XSorb™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories

Device Description:

Indications for Use:

General Indication for Use:

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2 7 2

K072528

Specific Indications for Use:

. Fractures of the cranium, mid-face, maxilla and chin.
. Infant craniofacial surgery ( i.e. Craniosynostosis, Congenital malformations)
. Le Forte ( I, II, III ) Osteotomies.
. Pediatric Reconstructive procedures of Cranial facial Skeleton
. Orthognathic or Reconstructive procedures of mid-face, maxilla & chin.
Facial Craniotomy flap fixation. .

Product Comparision with Predicate Device:

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories

Comparison of Technological Characteristics:

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children is substantially equivalent to the predicated device Xsorb™ Bioabsorbable, Craniofacial Bone Fixation System & Accessories cleared by FDA under 510k application #K070737. The FDA regulatory clearance report, 510k application and product information details regarding predicated device is attached herewith for your review and consideration. Please review the comparison matrix ( Attachment I ) outlining the Product specifications, Material compatibility and Indications for Use for the proposed device with predicated device. Please note that the proposed product is substantially equivalent to predicated devices in product design, materials, packaging and intended use.

Performance Testing Data:

Preclinical testing was performed to ensure that the Adjutable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories products performs as intended when used according to the instructions for use. Laboratory product testing has indicated that the Adjustable Bone Plates™- Bioabsorbable Craniofacial Bone Fixation System & Accessories has demonstrated satisfactory performance for its intended applications. Mechanical testing of the devices also demonstrated that the tensile strength, breakage force and degradation time for the device are equivalent to predicated devices & are satisfactory for its intended use. The average tensile strength and breakage Pull force value for Adjustable Bone Plates™ ( X= 2.5 Lb / in2 and 4.0 Lb/ in2 respectively), The average pull force applied during Adjustable Bone plate installation, using Clamp Tool (with 2.0mm pre-set stops) is less than 1.0 Lb/ in2 The actual degradation time of the proposed and predicate device are practically identical. The material selection, manufacturing process, product packaging , sterilization process and indication for use are also identical. Based on the product test data, we have determined that the proposed device, Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories is substantially equivalent to predicate device Xsorb™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories cleared by FDA under 510k application #K070737.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2007

Mr. Ashvin Desai Manager, Regulatory Affairs Prosurg, Incorporated 2195 Trade Zone Boulevard San Jose, California 95131

Re: K072528

Trade/Device Name: Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: December 4, 2007 Received: December 10, 2007

Dear Mr. Desai:

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 - Mr. Desai

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 (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/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Sheela H. Mccaughey, D.O. for Colleen Van Kirk

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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K072528

CENTER FOR DEMOGRAPHIC AND POPULATION HEALTH

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Indications for Use

510(k) Number (if known): K0772528

Device Name: Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories

Indications for Use:

General Indication for Use:

Specific Indications for Use:

Fractures of the cranium, mid-face, maxilla and chin. ●
Infant craniofacial surgery ( i.e. Craniosynostosis, Congenital malformations) .
Le Forte ( I, II, III ) Osteotomies. .
Pediatric Reconstructive procedures of Cranial facial Skeleton.
Orthognathic or Reconstructive procedures of mid-face, maxilla & chin.
Facial Craniotomy flap fixation.

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)
Emily Murphy

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072528

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.