The Exsomed Wrist Plating System is a set of implantable metallic (Titanium Alloy) bone plates, locking and non-locking screws of various lengths. The system consists of a series of straight tubular plates of varying lengths as well as a 4-hole carpal fusion plate. Screws are provided for plate fixation in locking and non-locking versions and in Ø2.5 and Ø3.2mm diameters. All of the Implants are made from Titanium Alloy (Ti-6AL-4VELI) per ASTM F136 and are provided non-sterile.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device, which typically does not involve the kind of AI/machine learning performance study you're asking about. The document describes a biocompatibility and mechanical performance assessment for a traditional medical device (metallic bone fixation plates and screws), not an AI/ML powered device.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document because it pertains to a different type of device and regulatory submission.

However, I can extract the relevant "performance analysis" information related to the device's mechanical properties, which is the "acceptance criteria" and "study" described in this context.

Here's a breakdown of what can be extracted based on the provided text, and what is not applicable in this context:

Acceptance Criteria and Study for Exsomed Wrist Plating System (Mechanical Performance)

This document describes the premarket notification (510(k)) for the Exsomed Wrist Plating System, a traditional medical device consisting of metallic bone plates and screws for hand and wrist fracture repair and fusion. The "acceptance criteria" and "study" described herein relate to the mechanical and material performance of these physical implants, not to the performance of an AI/ML algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Metric	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength	Bending strength (ASTM F382-17 Annex 1) - Straight Plate	Substantially equivalent or superior to predicate	Higher bending strength than the Synthes predicate device.
Mechanical Stiffness	Bending stiffness (ASTM F382-17 Annex 1) - Straight Plate	Substantially equivalent or superior to predicate	Higher bending stiffness than the Synthes predicate device.
Screw Performance	Ultimate torsional strength of screws	Not introducing new safety/effectiveness issues	Compared to predicate, screws "did not introduce new issues of safety or effectiveness with respect to insertion and removal torque."
Screw Performance	Insertion and removal torque of screws	Not introducing new safety/effectiveness issues	Compared to predicate, screws "did not introduce new issues of safety or effectiveness with respect to insertion and removal torque."
Screw Performance	Bending stress of screws	No new worst-case compared to predicate	"Exsomed screws do not introduce a new worst case with respect to bending stress... when compared to the predicate devices."
Screw Performance	Torsional stress of screws	No new worst-case compared to predicate	"Exsomed screws do not introduce a new worst case with respect to... torsional stress... when compared to the predicate devices."
Screw Performance	Resistance to axial pullout of screws	No new worst-case compared to predicate	"Exsomed screws do not introduce a new worst case with respect to... resistance to axial pullout when compared to the predicate devices."
Biocompatibility	Material Composition	Consistent with established safe materials (Titanium)	Implants made from Titanium Alloy (Ti-6AL-4VELI) per ASTM F136, same as predicates. This implies accepted biocompatibility.
Functional Equivalence	Indications for Use	Equivalent to predicate devices	"has been compared to the previously cleared predicate devices in regards to indications for use, materials, and sizes." The system offers plates and screws in similar dimensions. Indicating substantial equivalence clinically.

Information Not Applicable/Available for an AI/ML Device (Based on this document):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "tests" were mechanical assays on physical samples of the device and predicate devices, not data analysis for an AI/ML algorithm.
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. Ground truth for mechanical testing is based on industry standards (ASTM) and physical measurements, not expert consensus on medical images/data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No expert adjudication is involved in mechanical testing.
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 not an AI/ML diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is derived from standardized mechanical testing methods (e.g., ASTM F382-17) and material specifications, which provide objective, measurable results.
The sample size for the training set: Not applicable. There is no training set for a mechanical device.
How the ground truth for the training set was established: Not applicable. There is no training set for a mechanical device.

Summary

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December 3, 2019

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Exsomed Corporation Michael Zwolinski Senior Engineering Designer 135 Columbia, Suite 201 Aliso Viejo, California 92656

Re: K192473

Trade/Device Name: Exsomed Wrist 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, HWC Dated: August 9, 2019 Received: September 10, 2019

Dear Michael Zwolinski:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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) K192473

Device Name Exsomed Wrist Plating System

Indications for Use (Describe)

The Exsomed Wrist Plating System is intended for the repair of fractures and fusions of the hand and wrist.

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

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Submitter Information

Submitters Name:Address:	Exsomed Corporation135 Columbia, Suite 201Aliso Viejo, California 92656
Telephone Number:Fax Number:Prepared By:Contact Person:Date Prepared:Device Information	855.397.6633949.240.6633Michael Zwolinski,Michael Zwolinski8/8/19
Trade Name:	Wrist Plating System
Common Name:	Fixation Plate
Classification Name:	Plate,Fixation,Bone
Device Classification:	Single/multiple component metallic bone fixation appliances andAccessories.Class II per 21 CFR 888.3030Panel: Orthopedic,
Product Code:	HRS,HWC
Material Composition:	Titanium Alloy (Ti-6AL-4VELI)
Device Description:	The Exsomed Wrist Plating System is a set of implantable metallic(Titanium Alloy) bone plates, locking and non-locking screws of variouslengths. The system consists of a series of straight tubular plates ofvarying lengths as well as a 4-hole carpal fusion plate. Screws areprovided for plate fixation in locking and non-locking versions and inØ2.5 and Ø3.2mm diameters. All of the Implants are made fromTitanium Alloy (Ti-6AL-4VELI) per ASTM F136 and are provided non-sterile.
Predicate Devices:	The primary predicate device is the existing Synthes Modular Hand Systemcleared under 510(k) K030310. Additional predicates include the BIOMETALPS Hand Fracture System (K081546) and reference device ExsomedInnate (K171558).
Indications for Use:	The Exsomed Wrist Plating System is intended for the repair of fracturesand fusions of the hand and wrist.

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Technological Characteristics:	The Exsomed Wrist Plating System has been compared to the previouslycleared predicate devices in regards to indications for use, materials,and sizes. The Exsomed Wrist Plating system offers plates in similarlengths, widths, and thicknesses as the predicate devices as well aslocking and non-locking screws in similar diameters and lengths as thepredicate devices. All the Implants in the wrist plating system aremanufactured from the same titanium alloy as the Biomet ALPSPredicate (K081546). The Exsomed Wrist Plating System is differentfrom the predicates because the straight plates have a slightly differentoverall shape than those of the predicate and because The Exsomedsystem also includes a contoured carpal fusion plate that has transversescrew holes to secure the plate and perform joint arthrodesis. Thesecomparisons demonstrate substantial equivalence to the predicatedevices.
Performance Analysis:	Mechanical testing per ASTM F382-17 Annex 1 was performed on theExsomed Wrist Plating System straight plate and the Synthes predicatedevice. This showed that the Exsomed Wrist Plating System had ahigher bending strength and bending stiffness than the predicatedevice.Mechanical testing of the Exsomed screws' ultimate torsional strength

Technological Characteristics:

The Exsomed Wrist Plating System has been compared to the previouslycleared predicate devices in regards to indications for use, materials,and sizes. The Exsomed Wrist Plating system offers plates in similarlengths, widths, and thicknesses as the predicate devices as well aslocking and non-locking screws in similar diameters and lengths as thepredicate devices. All the Implants in the wrist plating system aremanufactured from the same titanium alloy as the Biomet ALPSPredicate (K081546). The Exsomed Wrist Plating System is differentfrom the predicates because the straight plates have a slightly differentoverall shape than those of the predicate and because The Exsomedsystem also includes a contoured carpal fusion plate that has transversescrew holes to secure the plate and perform joint arthrodesis. Thesecomparisons demonstrate substantial equivalence to the predicatedevices.

Performance Analysis:

Mechanical testing per ASTM F382-17 Annex 1 was performed on theExsomed Wrist Plating System straight plate and the Synthes predicatedevice. This showed that the Exsomed Wrist Plating System had ahigher bending strength and bending stiffness than the predicatedevice.Mechanical testing of the Exsomed screws' ultimate torsional strength

and insertion and removal torque was performed. The results were compared and demonstrated that the screws did not introduce new issues of safety or effectiveness with respect to insertion and removal torque. Engineering analysis of torsional strength, bending strength and resistance to pullout was conducted on the Exsomed screws and predicate device screws. The results demonstrated that the Exsomed screws do not introduce a new worst case with respect to bending stress, torsional stress and resistance to axial pullout when compared to the predicate devices.

Conclusion: Based upon comparisons against the predicate devices, Exsomed concludes that the Wrist Plating System is substantially equivalent to the previously cleared predicate devices.

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.