General Indication for Use: Xsorb™ 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

Xsorb™ Bicabsorbable Craniofacial Bone Fixation System & Accessories consists of single use, bioabsorbable Bone Fixation plates, meshes, fixation screws, fastners and tacks designed for use in trauma and reconstructive procedures for craniofacial skeleton, mid-face, maxilla and chin in adult and children. The single use, bioabsorbable Bone fixation plates and meshes are offered in various sizes and configurations to meet anatomical needs of the patients. The Xsorb™ - Bioabsorbable Craniofacial Bone Fixation pltaes & screws / wires 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 screws and 2.1 mm emergency screws for trauma and reconstructive procedure. The bioabsorbable screws can be tightened with 1.8mm screw driver.

AI/ML Overview

The provided text describes a 510(k) submission for the Xsorb™ Bioabsorbable Craniofacial Bone Fixation System & Accessories. This is a premarket notification for a medical device seeking clearance based on substantial equivalence to predicate devices, not typically a study proving performance against strict acceptance criteria like those for an AI/ML medical device.

Therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this type of submission.

However, I can extract information related to "performance data" as mentioned in the document for the device itself, rather than an AI/ML algorithm.

Here's a breakdown of the requested information based on the provided text, focusing on what is available and noting what is not applicable for this type of device clearance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in the way an AI/ML study would define performance thresholds (e.g., specific sensitivity/specificity targets). Instead, it refers to the device performing "as intended" and being "satisfactory" compared to predicate devices. The "performance" is based on mechanical testing.

Acceptance Criterion (Implied)	Reported Device Performance
Performs as intended when used according to instructions for use.	Laboratory product testing has indicated that the Xsorb™ Bioabsorbable Craniofacial Bone Fixation System & Accessories has demonstrated satisfactory performance for its intended applications.
Tensile strength equivalent to or greater than predicate devices.	Mechanical testing of the devices also demonstrated that the tensile strength... for the device are equal or more than the predicated devices.
Breakage force equivalent to or greater than predicate devices.	Mechanical testing of the devices also demonstrated that the ... breakage force ... for the device are equal or more than the predicated devices.
Degradation time equivalent to or greater than predicate devices.	Mechanical testing of the devices also demonstrated that the ... degradation time for the device are equal or more than the predicated devices.
Overall suitability for intended use.	...and are satisfactory for its intended use.
Substantially equivalent in design, materials, packaging, and use.	The proposed product is substantially equivalent to predicated devices in product design, materials, packaging and intended use. (This is a regulatory finding, rather than a performance metric, but it reflects the ultimate "acceptance" for 510k clearance).

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

Sample Size for Test Set: Not specified. The performance data section refers to "Preclinical testing" and "Laboratory product testing," which typically involves specific test articles (e.g., plates, screws) but doesn't quantify a "sample size" in terms of cases or patients as an AI/ML study would.
Data Provenance: Not specified. This relates to laboratory testing of the physical device, not patient data derived from a specific geographic location.
Retrospective or Prospective: Not applicable. The testing described is mechanical/laboratory testing of the device itself.

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

Not applicable. This device is a physical craniofacial fixation system, not an algorithm that requires expert ground truth labeling. Performance is assessed through mechanical properties.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML study requiring adjudication of expert opinions.

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. This is not an AI/ML device, so an MRMC study is not relevant or performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Not applicable / Mechanical Properties. The "ground truth" for this device's performance is objective mechanical measurements (tensile strength, breakage force, degradation time) compared against established standards for predicate devices or biomechanical requirements for the intended application.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. This device does not involve a "training set" or "ground truth" establishment in the context of machine learning.

Summary

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K070737

JUL 25 2007

510K Summary of Safety & Effectiveness

Xsorb™ 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: June 29, 2007

Device Name: XsorbTM Bioabsorbable Craniofacial Bone Fixation System & Accessories

Predicated Devices: Synthes Craniofacial Plate and Screw System (Ref: # K050608) Inion CPS Baby 1.5 Bioabsorbable Fixation System ( Rf: # K051341) BONAMATES Series cleared by FDA (Ref:#K040650)

Device Description:

Indications for Use:

General Indication for Use:

Xsorb™ 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. .

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K070737

Pediatric Reconstructive procedures of Cranial facial Skeleton .
Orthognathic or Reconstructive procedures of mid-face, maxilla & chin. ●
Facial Craniotomy flap fixation. ●

Comparison of technological Characteristics:

Xsorb™- Bioabsorbable Craniofacial Bone Fixation System & Accessories for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and children are substantially equivalent to the predicated devices, Synthes Craniofacial Plate and Screw System, Inion CPS Saby 1.5 Bioabsorbable Fixation System, BONAMATES Series cleared by FDA under 510k application # K050608, 1.5 DKaborousers of the FDA regulatory clearance report, 510k application and product information details regarding predicated device is attached herewith for your review and consideration. Please mornation domin rogarding 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 Data:

Preclinical testing was performed to ensure that the Xsorb™ - Bioabsorbable Craniofacial Bone Fixation System & I toomion results not performs as intended when used according to the instructions for use. Laboratory product testing has indicated that the Xsorb™ 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 equal or more than the predicated devices and are satisfactory for its intended use.

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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 stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2007

Mr. Ashvin Desai Manager, Regulatory Affairs Prosurg, Incorporated 2193 Trade Zone Boulevard San Jose, California 95131

Re: K070737

Trade/Device Name: Xsorb™- Bioabsorbable Craniofacial Bone Fixation System & Accessories Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 29, 2007 Received: July 3, 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) 276-0115. 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 vours.

Snytte Y. Michaud, Dmd.

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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K070737

Indications for Use

510(k) Number (if known). K070737

Device Name: Xsorb™ - Bioabsorbable Craniofacial Bone Fixation System & Accessories.

Indications for Use:

General Indication for Use:

Xsorb™- Bioabsorbable Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, 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. .

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Signature

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(K) Number:	K07037

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.