In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and, maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft subsitives, or bone fragments from comminuted fractures), in trauma and reconstructive procedures.

Specific indications include: I. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible, 2. Metacarpus, proximal and middle phalangeal bones, 3. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax.

Device Description

The Re-Zorb™ Plating System consists of plates, fixation devices, and associated instrumentation. The plates are offered in lengths of 60 and 110mm, and widths of 14 and 20mm. All plates are 1.6mm thick with uniformly distributed fixation holes and a polished finished. Fixation devices included in the system consist of screws and tacks. The screws and tacks are offered in 2.7mm diameters and lengths ranging from 8 to 40mm. The plates, screws, and tacks are injection molded from poly (1-lactide-co-D, L-lactide) 70:30, which gradually lose strength in vivo and are provided sterile. Suture can also be used in conjunction with the plates.

AI/ML Overview

The provided text describes a 510(k) summary for the ACUTE Innovations® LLC Re-Zorb™ Plating System. This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and mechanical properties, rather than presenting a study involving AI or human reader performance. Therefore, many of the requested criteria related to AI device performance evaluation, human reader studies, and ground truth establishment are not applicable or detailed in this submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI device. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (from text)	Reported Device Performance (from text)
Substantially equivalent intended use	Identical to predicate device (Inion FreedomPlate™ K063410)
Substantially equivalent scientific technology	Uses poly (1-lactide-co-D, L-lactide) 70:30, shown not to raise new safety/effectiveness questions compared to predicate's degradable material.
Substantially equivalent degradation profile	Shown through performance data and specifications.
Substantially equivalent mechanical properties	Shown through performance data and specifications.
Compliance to voluntary consensus standards	Listed in the application (details not provided in this extract).

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The submission describes a medical device (plating system) cleared through the 510(k) pathway, which primarily relies on technological comparison and non-clinical testing rather than clinical study data from a test set of patient cases. No test set in the context of diagnostic performance or AI evaluation is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There is no mention of a test set requiring expert ground truth establishment for a diagnostic or AI performance evaluation. The safety and effectiveness are established through comparison to a predicate and performance data on the device's material and mechanical properties.

4. Adjudication Method for the Test Set

Not applicable. No test set 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

No, an MRMC comparative effectiveness study was not done. The device is a bone plating system, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. The device is a physical medical implant.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic or AI performance. The "ground truth" for the device's safety and effectiveness relies on established material science, mechanical testing standards, and a comparison to a legally marketed predicate device (Inion FreedomPlate™).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is involved.

Summary

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K0815-88 page 42

ACUTE Innovations® LLC

Section 5: 510(k) Summary

21421 NW Jacobson Road, Suite 700, Hillsboro, OR 97124 Phone: (503) 686-7200 Fax: (503) 549-8959

510(k) Summary

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

June 2, 2008

Submitter Information:

Acute Innovations LLC 21421 N.W. Jacobson Road, Suite 700 Hillsboro, OR 97124-9432 Phone: (503) 686-7200 FAX: (503) 549-8959 Contact: Alyssa Thomas, Regulatory Specialist

SEP - 3 2008

Classification Name:

Single/multiple component metallic bone fixation appliances and accessories

Common Name: Plate, Fixation, Bone

Proprietary Name: Re-Zorb™ Plating System

Proposed Regulatory Class: Class II, 21 CFR 888.3030

Device Product Code: HRS

Legally Marketed Equivalent Device(s): Inion FreedomPlate™ (K 063410)

Intended Use:

In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grofts, and, maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft subsitives, or bone fragments from comminuted fractures), in trauma and reconstructive procedures.

The intended use is identical to the predicate device.

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ACUTE Innovations® LLC 21421 NW Jacobson Road, Suite 700, Hillsboro, OR 97124

Section 5: 510(k) Summary

Phone: (503) 686-7200 Fax: (503) 549-8959

Device Description:

Technological Characteristics:

Based on the performance data and specifications presented, it can be concluded that the Acute Innovations Re-Zorb™ Plating System has substantially equivalent intended use, scientific technology, degradation profile and mechanical properties to the predicate. The only difference to the predicate is the type of degradable material used, which has been shown through performance data and specifications not to raise any new questions of safety and effectiveness.

No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application. Clinical and non-clinical tests are not applicable.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Acute Innovations, LLC % Ms. Alyssa Thomas Regulatory Specialist 21421 Northwest Jacobson Road Hillsboro, Oregon 97124

SEP - 3 2008

Re: K081588 Trade/Device Name: Re-Zorb" Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: June 3, 2008 Received: June 5, 2008

Dear Ms. Thomas:

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 indicions for use stated in the enclosure) to legally marketed predicate devices marketed in intenstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or to 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, isting 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.

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 100-1050.

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Page 2 - Ms. Alyssa Thomas.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millican

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Re-Zorb™ Plating System

Indication For Use:

General indications:

In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures.

Specific indications:

Craniofacial skeleton, cranium, mid-face, maxilla, and mandible

1. Metacarpus, proximal and middle phalangeal bones

Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use No.
(21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic De

Here is the markdown representation of the image:

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

Loubare Breen
(Division Sign-Off)

510(k)

Page 1 of 1

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.