The Valkyrie Thoracic Fixation System is indicated for use in the stabilization of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.

Device Description

The Valkyrie Thoracic Fixation System consists of a variety of screws and plates intended for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.

To accommodate varying patient anatomy and surgeon preference, the Valkyrie Thoracic Fixation System includes screws in diameters from 2.5mm to 3.5mm diameters and lengths from 7-20mm. The system also includes various styles of plates. The Valkyrie Thoracic Fixation System plates are made from PEEK per ASTM F2026, and the screws are made from Ti-6Al-4V per ASTM F136.

AI/ML Overview

The provided text is a 510(k) summary for the Valkyrie Thoracic Fixation System, which is a medical device for stabilizing chest wall fractures. It is not a software-as-a-medical-device (SaMD) or AI product. Therefore, the questions regarding acceptance criteria and studies typical for AI/SaMD are not applicable to this document.

The document discusses the mechanical and material aspects of the device and its substantial equivalence to a predicate device, not the performance of an algorithm.

However, I can extract the acceptance criteria and related information for the device's physical attributes as described in the summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
MR Conditional Labeling	Magnetically induced displacement force	Not explicitly stated, but implies compliance with ASTM F2052.	"All testing has met the documented acceptance criteria."
	Magnetically induced torque	Not explicitly stated, but implies compliance with ASTM F2213.	"All testing has met the documented acceptance criteria."
	MR Image artifact	Not explicitly stated, but implies compliance with ASTM F2119.	"All testing has met the documented acceptance criteria."
	Radio frequency induced heating	Not explicitly stated, but implies compliance with ASTM F2182.	"All testing has met the documented acceptance criteria."
Additional Screw Sizes	Screw torsional strength testing	Not explicitly stated, but implies compliance with ASTM F543.	"All testing has met the documented acceptance criteria."
	Screw axial pullout strength testing	Not explicitly stated, but implies compliance with ASTM F543.	"All testing has met the documented acceptance criteria."
	Screw driving torque testing	Not explicitly stated, but implies compliance with ASTM F543.	"All testing has met the documented acceptance criteria."
General	Material composition, manufacturing process, sterilization, and packaging	Substantially equivalent to predicate device (K202889).	Substantially Equivalent to the predicate device (K202889) in these aspects.

Regarding the other points, as this is a physical medical device and not an AI/SaMD, the following information is not present or applicable in the provided text:

Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components of the device, and the testing is laboratory-based mechanical and MR compatibility testing, not data-driven performance evaluation.
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" in this context would refer to established engineering standards (ASTM standards in this case), not expert interpretation of data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is not a concept used for mechanical and material testing of a physical device.
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 is for an AI-assisted diagnostic tool, which this device is not.
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): For the physical tests, the "ground truth" is defined by the requirements of the ASTM standards (F2052, F2213, F2119, F2182, F543). The ultimate "ground truth" for regulatory approval is demonstrating substantial equivalence to a legally marketed predicate device.
The sample size for the training set: Not applicable. There is no training set for a physical device.
How the ground truth for the training set was established: Not applicable.

Summary

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December 8, 2023

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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

JM Longyear Manufacturing, LLC d/b/a Able Medical Devices Katie Barron Project Manager 512 4th Street Gwinn, Michigan 49841

Re: K232515

Trade/Device Name: Valkyrie Thoracic Fixation 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 18, 2023 Received: August 18, 2023

Dear Katie Barron:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S

Shumaya Ali, MPH 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

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Indications for Use

510(k) Number (if known) K232515

Device Name Valkyrie Thoracic Fixation System

Indications for Use (Describe)

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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K232515 510(k) Summary

Date Prepared:	August 18, 2023
510(k) Owner /Manufacturer:	JM Longyear Manufacturing, LLC d/b/a Able Medical Devices512 4th StreetGwinn, MI 49841
Contact Person:	Katie BarronAble Medical DevicesPhone: (906) 372-3213Email: KatieB@abledev.us
Trade or ProprietaryName:	Valkyrie Thoracic Fixation System
Common or UsualName:	Bone Plate
Classification:	Class II per 21 CFR §888.3030 (primary) and 21 CFR §888.3040
Regulation Name:	Single/multiple component metallic bone fixation appliances and accessories(primary); Screw, Fixation, Bone
Product Code:	HRS (primary), HWC
Classification Panel:	Panel Code 87: Orthopedics
Primary Predicate	K202889 Valkyrie Thoracic Fixation System
Additional Predicate	K221412 JEIL Medical ARIX Rib System
Description	The Valkyrie Thoracic Fixation System consists of a variety of screws and platesintended for use in the stabilization and fixation of fractures in the chest wallincluding sternal reconstructive surgical procedures, trauma, or plannedosteotomies. The system is intended for use in patients with normal and/or poorbone quality.To accommodate varying patient anatomy and surgeon preference, the ValkyrieThoracic Fixation System includes screws in diameters from 2.5mm to 3.5mmdiameters and lengths from 7-20mm. The system also includes various styles ofplates. The Valkyrie Thoracic Fixation System plates are made from PEEK perASTM F2026, and the screws are made from Ti-6Al-4V per ASTM F136.
Indications for Use	The Valkyrie Thoracic Fixation System is indicated for use in the stabilization andfixation of fractures in the chest wall including sternal reconstructive surgicalprocedures, trauma, or planned osteotomies. The system is intended for use inpatients with normal and/or poor bone quality

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Summary of	The subject Valkyrie Thoracic Fixation System has nearly identical technological
Technological	characteristics as the primary predicate device cleared for use in stabilization and

Characteristics	fixation of fractures in the chest wall. Similarities to the predicate device include:
	Identical indications for use while clarifying the term "indicated for"
	Identical principles of operation and fundamental technology: intended
			to stabilize and fixate fractures of the anterior chest wall through the
		use of plates and screws

	Identical implant materials and manufacturing processes●
	●	Identical sterilization processes

			Able Medical DevicesValkyrie Thoracic Fixation	PRIMARY PREDICATE:Able Medical Devices
			System	Valkyrie Thoracic Fixation
			(Subject Device)	System
				(K202889, K211695)
			The Valkyrie Thoracic	The Valkyrie Thoracic
			Fixation System is indicated	Fixation System is intended
			for use in the stabilization and	for use in the stabilization and
			fixation of fractures in the	fixation of fractures in the
			chest wall including sternal	chest wall including sternal
	Indications for Use:		reconstructive surgical	reconstructive surgical
			procedures, trauma, or	procedures, trauma, or
			planned osteotomies. The	planned osteotomies. The
			system is intended for use in	system is intended for use in
			patients with normal and/or	patients with normal and/or
			poor bone quality.	poor bone quality.
	Sterility:		Provided Sterile	Provided Sterile
			Rib Plate	Rib Plate, V-Plate, Box Plate,
		Configurations:		X-Plate, M-Plate, T-Plate,
	Plate			Ladder Plate
	Features:	# Screw Holes:	8 to 16	4 to 16
		Material:	PEEK per ASTM F2026	PEEK per ASTM F2026
	Screw	Diameter:	Ø2.5mm, Ø2.8mm	Ø3.0mm, Ø3.5mm
	Features:	Length:	7mm – 15mm	7mm - 20mm
		Material:	Ti-6Al-4V per ASTM F136	Ti-6Al-4V per ASTM F136

			The differences of the subject devices as compared to the primary predicate
	device are as follows:

	Updated labeling to include MR conditional●
	Inclusion of additional plate and screw sizes
		O	Additional predicate K212412 is included to leverage the
			technological characteristics of the smaller screw sizes

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Discussion ofSupporting Non-Clinical Testing	To support the inclusion of MR Conditional labeling, the following tests werecompleted:Magnetically induced displacement force per ASTM F2052 Magnetically induced torque per ASTM F2213 MR Image artifact per ASTM F2119 Radio frequency induced heating per ASTM F2182
	To support the inclusion of additional screw sizes, the following tests werecompleted:Screw torsional strength testing per ASTM F543 Screw axial pullout strength testing per ASTM F543 Screw driving torque testing per ASTM F543
	All testing has met the documented acceptance criteria.
Clinical PerformanceData	Clinical testing was not necessary for the determination of substantial equivalence.
SubstantialEquivalence	The subject device is substantially equivalent to the Valkyrie Thoracic FixationSystem (K202889) in terms of material composition, manufacturing process,sterilization, and packaging and both are manufactured in the same facility.
	The subject device and the predicate device have the same intended uses, thesame product classification and produce code and have identical Indications forUse statements. The subject device and the predicate incorporate the same basicdesign, same materials, have identical manufacturing processes, and are bothprovided sterile for single-patient and single-use.
Conclusion	The overall technological similarities to the predicate and non-clinical performancedata lead to the conclusion that the Valkyrie Thoracic Fixation System issubstantially equivalent to the predicate system. The devices are determined to beMR Conditional based on the results of testing completed.

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.