The subject device includes plates to be applied using a dorsal approach: two (2) plates with an anatomical pre-bent design specifically for the left and right wrist; and an additional plate design appropriate for either the left or right wrist. The plates have an overall length of 196 mm, a maximum width of 10 mm, and a maximum thickness of 3.4 mm tapering to 1.6 mm. The plates are made from titanium allov conforming to ASTM F136. The plates are designed to accommodate appropriately sized bone screws presently marketed as part of the APTUS® System and previously cleared in K103332 (cortical screws) and K051567 (TriLock locking screws). The subject device plates also are compatible with Medartis APTUS® K-Wires previously cleared in K092038.

AI/ML Overview

The provided text describes a medical device, the APTUS® Wrist Spanning Plates 2.5, seeking 510(k) clearance. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the details requested in your prompt regarding acceptance criteria, study design, and performance metrics are largely absent in the provided document, as they are not typically required for a 510(k) clearance for this type of device.

However, I can extract information related to the equivalent of "acceptance criteria" through the lens of establishing "substantial equivalence" and the "study" that supports it, based on the non-clinical performance data provided.

Here's a breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) summary):

For a 510(k) submission, "acceptance criteria" are generally interpreted as demonstrating that the new device performs at least as well as, or equivalently to, the predicate device in relevant non-clinical (and sometimes clinical, though not in this case) tests. The performance is measured against established standards.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance	Comments & Standards Applied
Sterilization Efficacy	Device is sterile.	Sterilization validation was performed according to ISO 11137-1 and ISO 11137-3.
Bacterial Endotoxin Levels	Device meets acceptable endotoxin limits.	Bacterial endotoxin testing was performed according to ANSI AAMI ST72.
Shelf Life & Sterile Barrier Integrity	Device maintains sterility and integrity over its shelf life.	Sterile barrier shelf life testing was performed according to ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F2096, DIN EN 868-5, and ASTM F88/F88M.
Biocompatibility	Device material is biocompatible.	Biocompatibility testing was performed according to ISO 10993-12, ISO 10993-15, and ISO 10993-18.
Mechanical Performance (Comparison to Predicate)	Mechanical strength and stability are comparable to the predicate device.	Comparative mechanical testing was performed according to ASTM F382, demonstrating substantial equivalence to the reference device K131764 (Acumed Wrist Spanning Plate).
Material Composition	Identical material to primary predicate.	Made from titanium alloy conforming to ASTM F136, identical to the primary predicate K142906.
Manufacturing Process	Identical manufacturing process to primary predicate.	Manufactured in the same facilities using the same processes as components cleared in K142906.
Design Compatibility	Compatible with existing screws and wires.	Compatible with Medartis APTUS® K-Wires (K092038) and APTUS® System bone screws (K103332, K051567).
Anatomical Fit (for minor dimension changes)	Slight length increase does not impact safety or effectiveness.	The plates are "slightly longer than the reference device K131764; this difference does not impact safety or effectiveness because the plates are to be used in an anatomic location that can safely accommodate a slightly longer plate design."
Fixation Screw Compatibility (for minor dimension changes)	Smaller number and size of screws are mitigated by mechanical testing.	"The subject device plates are to be used with a smaller number of fixation screws, and smaller size (diameter) screws than the reference device K131764. These differences are mitigated by the mechanical testing according to ASTM F382..."

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

The document describes non-clinical performance data, which typically does not involve human patient test sets.
For mechanical testing, the "sample size" would refer to the number of physical devices tested. This information is not specified in the provided text.
Data provenance is also not explicitly stated beyond stating that "Non-clinical testing data submitted" was performed. This implies internal company testing or testing by contract research organizations (CROs).

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

This information is not applicable as the clearance is based on non-clinical performance and not a clinical study requiring expert assessment of patient outcomes or images. The "ground truth" for non-clinical tests is based on adherence to established engineering standards and specifications.

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

This is not applicable as there was no clinical test set requiring expert adjudication.

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 MRMC study was done. This device is a bone fixation plate, not an AI-powered diagnostic or assistive tool for human readers.

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

No standalone algorithm performance was done. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by established engineering and material science standards and specifications (e.g., ISO, ASTM, ANSI AAMI standards for sterilization, biocompatibility, shelf life, and mechanical properties).
For demonstrating substantial equivalence in overall design and indications for use, the "ground truth" is the legally marketed predicate devices (K142906 and K131764).

8. The sample size for the training set:

This is not applicable. This device is a physical product, not an AI model that requires a training set.

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

This is not applicable for the same reason mentioned above.

Summary

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September 30, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Medartis AG % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K191848

Trade/Device Name: APTUS Wrist Spanning Plates 2.5 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 1, 2019 Received: August 2, 2019

Dear Kevin 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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191848

Device Name

APTUS® Wrist 2.5 System

Indications for Use (Describe)

APTUS® Wrist Spanning Plates 2.5 are intended for use in forearm fractures.

Type of Use (Select one or both, as applicable)


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510(k) Summary

Medartis AG

APTUS® Wrist 2.5 System

July 9, 2019

ADMINISTRATIVE INFORMATION

Manufacturer Name	Medartis AGHochbergerstrasse 60ECH-4057 Basel, Switzerland
Telephone:	+41 61 633 34 34
Fax:	+41 61 633 34 00
Official Contact	Andrea SchweizerHead of Quality Management

Representative/Consultant	Kevin A. Thomas, PhD
	Floyd G. Larson, MS, MBA
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
Telephone:	+1 858-792-1235
Fax:	+1 858-792-1236
Email:	kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Device Name	APTUS® Wrist 2.5 System
Common Name	Plate, Fixation, Bone
Regulation Number	21 CFR 888.3030
Regulation Name	Single/multiple component metallic bone fixation appliancesand accessories
Regulatory Class	Class II
Product Code	HRS
Classification Panel	Orthopedic Products Panel
Reviewing Division	Division of Health Technology 6 C(Restorative, Repair and Trauma Devices)

PREDICATE DEVICE INFORMATION

Primary Predicate Device K142906, APTUS® Wrist 2.5 System, Medartis AG Reference Device K131764, Acumed Wrist Spanning Plate, Acumed, LLC

INDICATIONS FOR USE STATEMENT APTUS® Wrist Spanning Plates 2.5 are intended for use in forearm fractures.

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SUBJECT DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1, and ISO 11137-3; bacterial endotoxin testing according to ANSI AAMI ST72; sterile barrier shelf life testing according to ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F2096, DIN EN 868-5, and ASTM F88/F88M; biocompatibility testing according to ISO 10993-12, ISO 10993-15, and ISO 10993-18; and comparative mechanical testing according to ASTM F382. Clinical data were not provided in this submission.

EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference device listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference device.

The primary predicate device K142906 is for support of substantial equivalence based upon a similar Indications for Use Statement (IFUS), similar device designs, and identical materials. The reference device K131764 is for support of substantial equivalence based upon a similar IFUS, similar device designs, similar materials, and performance in side-by-side mechanical testing.

The subject device, the primary predicate device, and reference device have the same intended use for internal fixation of the wrist. The IFUS is similar for the subject device, the primary predicate device K142906, and the reference device K131764. The IFUS for K142906 includes language for use in the hand and for osteotomies and arthrodeses. The IFUS for K131764 includes language concerning osteotomies, non-unions, and the radius. These slight differences in language do not impact substantial equivalence because the subject devices cleared in K142906 and K131764 are intended for similar fixation (fusions) of the upper extremity.

The subject device and the primary predicate device K142906 have the same technological characteristics and are fabricated from identical titanium alloy conforming to ASTM F136. The subject device and the primary predicate device K142906 also are compatible with the same previously-cleared screws and K-Wires. The reference device K131764 also is fabricated from titanium alloy conforming to ASTM F136, and has similar design features. The subject device, the primary predicate device K142906, and the reference device K131764 all include plates that are to be placed by a dorsal surgical approach, and are to be fixed with locking and non-locking bone screws.

The titanium alloy material of the subject device in its final finished form is identical to the titanium alloy used in the primary predicate K142906 in formulation and processing. The subject device is manufactured

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in the same facilities using the same manufacturing processes as used for the components previously cleared in K142906.

The subject device and the reference device K131764 are provided sterile to the end user; the sterilization method is not stated in the 510(k) Summary for K131764.

The subject device plates are slightly longer than the reference device K131764; this difference does not impact safety or effectiveness because the plates are to be used in an anatomic location that can safely accommodate a slightly longer plate design.

The subject device plates are to be used with a smaller number of fixation screws, and smaller size (diameter) screws than the reference device K131764. These differences are mitigated by the mechanical testing according to ASTM F382 that demonstrated the subject device plates to be substantially equivalent to the reference device plates cleared in K131764.

CONCLUSION

The subject device, the primary predicate device, and the reference device have the same intended use, have similar technological characteristics, and encompass a similar range of physical dimensions appropriate to the anatomy. The subject device and the primary predicate device are made of the identical material. The data included in this submission demonstrate substantial equivalence to the primary predicate device K142906 and the reference device K131764.

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.