The intended use is to facilitate the placement of the pedicle screws using the power technique (cordless). When the attachment is attached, the Stryker Power Tools provide power to rotate the screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implemented in the non-cervical spine using powered instrumentation.

Device Description

The Stryker POWEReam Xia/Serrato is an attachment used with a Stryker battery powered handpiece that drives accessories to achieve their intended function. The design reduces the speed and increases the torque output from the handpiece by a ratio of 5:1.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called POWEReam Xia/Serrato, which is an attachment used with a Stryker battery-powered handpiece to facilitate the placement of pedicle screws. The submission seeks to demonstrate substantial equivalence to a predicate device, the Stryker POWEReam ¼” Drive (K233300).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that "All pre-defined acceptance criteria for the above tests have been met." However, it does not explicitly list the specific acceptance criteria or provide detailed performance data in a table format. It only broadly states that the device performs as intended.

Acceptance Criteria Category	Reported Device Performance	Comments
Performance Design Verification Testing	"All pre-defined acceptance criteria for the above tests have been met."	Specific criteria and data are not provided. This suggests fundamental functional performance tests were passed.
Human Factors and Usability Engineering	"All pre-defined acceptance criteria for the above tests have been met."	Specific criteria and data are not provided. This indicates the device's design is user-friendly and safe for its intended use.
Simulated Use Design Validation Testing	"All pre-defined acceptance criteria for the above tests have been met."	Specific criteria and data are not provided. This suggests the device was tested under conditions mimicking real-world surgical use and performed adequately.

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

The document does not specify the sample size used for the test set for any of the non-clinical tests (Performance Design Verification, Human Factors, Simulated Use Design Validation). It also does not provide information about the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

Since this is a non-clinical submission for a mechanical instrument, the concept of "experts" establishing ground truth in the same way it would be for diagnostic AI is not directly applicable. The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and potentially a team of engineers or quality assurance personnel. The document does not specify the number of individuals involved in establishing these engineering "truths" or their specific qualifications (e.g., "mechanical engineer with 15 years of experience in medical device design").

4. Adjudication Method for the Test Set

As this is a non-clinical device focused on mechanical performance and usability, traditional adjudication methods like 2+1 or 3+1 (common in AI diagnostic studies) are not mentioned or typically used. The "adjudication" of test results would likely involve review and approval by qualified engineers and quality personnel based on established test protocols and acceptance criteria. No specific adjudication method is detailed in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not required for this Traditional 510(k)." MRMC studies are typically clinical studies designed to compare diagnostic performance, especially with AI assistance. This device is a surgical instrument attachment, not a diagnostic tool.

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

This question is not applicable to the device described. The POWEReam Xia/Serrato is a mechanical attachment for a surgical power tool, not an algorithm, and it inherently requires human-in-the-loop operation. "Standalone performance" in the context of an algorithm does not apply here. The non-clinical tests (Performance Design Verification, Human Factors, Simulated Use Design Validation) assessed the device's functional performance and usability.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established by:

Engineering Specifications: The design parameters, torque outputs, speed reductions, and material properties defined during the device's development.
Validated Test Methods: Standardized procedures and instruments used to measure the device's performance against its specifications.
Regulatory Standards: Adherence to relevant industry and regulatory standards for medical devices.

It does not involve expert consensus, pathology, or outcomes data in the manner of diagnostic devices.

8. The Sample Size for the Training Set

This question is not applicable. The POWEReam Xia/Serrato is a mechanical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

This question is not applicable as there is no training set for a mechanical device.

Summary

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April 29, 2024

Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, which includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Stryker Instruments Kelebogile Moumakwa Staff Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002

Re: K240526

Trade/Device Name: POWEReam Xia/Serrato Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, HWE Dated: February 23, 2024 Received: February 23, 2024

Dear Kelebogile Moumakwa:

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 QS 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,

Eileen
Digitally signed
by Eileen Cadel

Cadel -S Date: 2024.04.29
09:44:20-04'00' for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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) K240526

Device Name POWEReam Xia/Serrato

Indications for Use (Describe)

Pedicle screws from select Stryker Spine implant systems may be implemented in the non-cervical spine using powered instrumentation.

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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Submitter Information

This Premarket Notification is submitted by:

Stryker Instruments 1941 Stryker Way Portage MI 49002 USA

Contact Information

Kelebogile Moumakwa Staff Regulatory Affairs Specialist Ph: 011-353-86-8617273 Email: kelebogile.moumakwa(@stryker.com Date Prepared: February 2024

Device Name

Subject Device Information
Trade/ Proprietary Name	POWEReam Xia/Serrato
Regulation Names	Thoracolumbosacral pedicle screw systemInstrument, Surgical, Orthopedic, Ac-Powered MotorAnd Accessory/Attachment
Regulation Numbers	21 CFR 888.307021 CFR 878.4820
Review Panel	Orthopedic
Product Codes	NKB, HWE
Regulatory Class	Class II

Table 1: Subject Device Information

Predicate Device

The legally marketed predicate for the subject device is detailed in Table 2.

Primary Predicate Device Name	510(k)	Product Code	Manufacturer
POWEReam ¼” Drive	K233300	NKB/HWE	StrykerInstruments

Table 2: Predicate Device Information

Traditional 510(k) POWEReam Xia/Serrato

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Indications for Use

Pedicle screws from select Stryker Spine implant systems may be implemented in the noncervical spine using powered instrumentation.

Device Description

The purpose of this premarket notification is to seek clearance for the Stryker POWEReam Xia/Serrato (part number 4405-240-000).

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Description	Subject	Predicate	Comparison Assessment
	Stryker POWEReam Xia/Serrato	StrykerPOWEReam ¼"Drive (K233300)
Type of Use	Prescription Use Only	Prescription Use Only	Identical
Classification of Device	Class II	Class II	Identical
Primary Product Code	NKB, HWE	NKB, HWE	Identical
Primary Regulation	21 CFR 888.3070	21 CFR 888.3070	Identical
Regulation Name	Thoracolumbosacral Pedicle Screw System	ThoracolumbosacralPedicle Screw System	Identical
Review Panel	Orthopedic	Orthopedic	Identical
Indications for Use	The intended use is to facilitate theplacement of the pedicle screws using thepower technique (cordless). When theattachment is attached, the Stryker PowerTools provide power to rotate thescrewdrivers for the insertion of pediclescrews.Pedicle screws from select Stryker Spineimplant systems may be implemented in thenon-cervical spine using poweredinstrumentation.	The intended use is fordrilling, reaming, anddecorticating of bone andother bone-related tissueduring general surgicalorthopedic procedures in avariety of surgicalprocedures. It is also usablein the placement of screws,wires, pins, and otherfixation devices.This attachment is designedfor general surgical usewhere hard tissue and/orbone must be cut, reamed,	IdenticalThe first two paragraphs ofthe predicate devicecontain the orthopedicindications. Theseindications are not in scopeof this submission.The intended use related toplacement of pediclescrews is equivalent.

Comparison of Regulatory Information

Traditional 510(k) POWEReam Xia/Serrato

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K240526
Page 4 of 5

Page 4 of 5

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Description	Subject
	Stryker POWEReam X

Description	Subject	Predicate	Comparison Assessment
	Stryker POWEReam Xia/Serrato	StrykerPOWEReam ¼”Drive (K233300)
		drilled, and/or fixated withscrews, including but notlimited to, the hand, wrist,elbow, sternum, shoulder,foot, ankle, knee, and hip.The intended use is also tofacilitate the placement ofthe pedicle screws usingthe power technique(cordless). When theattachment is attached, theStryker Power Toolsprovide power to rotate thescrewdrivers for theinsertion of pedicle screws,in non-cervical spinesurgical procedures.
Patient Population	General	General	Identical
Contraindications	None Known	None Known	Identical
Conditions for Use	Professional use only in a professionalhealthcare environment.	Professional use only in aprofessional healthcareenvironment.	Identical

Traditional 510(k) POWEReam Xia/Serrato

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Comparison of Technological Characteristics

The subject device has the same intended use as the predicate device as they are both used to facilitate placement of pedicle screws in non-cervical spine procedures. The subject device is indicated to facilitate the placement of pedicle screws using the Stryker Spine Xia and Serrato screwdrivers, while the predicate device is indicated to facilitate the placement of pedicle screws using tools with a 1/4" square fitting.

The design of both the subject and predicate device are similar. Both transmit torque and speed provided from the powered handpiece to associated accessories and both reduce the speed and increase the torque output from the handpiece at a 5:1 gear ratio reduction. The accessory connection end is similar with quick connection design technology; however, the geometries are different as they are designed to connect to different accessories.

Risk evaluation and performance testing have shown that the differences do not introduce new questions of safety and effectiveness and that the subject is at least as safe and effective as the predicate, supporting a determination of substantial equivalence. The evaluation and testing have demonstrated that the subject device is substantially equivalent to the predicate device.

Summary of Non-Clinical Testing

A suite of non-clinical testing was executed to demonstrate substantial equivalence to the predicate device. Testing included:

Performance Design Verification Testing ●
Human Factors and Usability Engineering ●
Simulated Use Design Validation Testing ●

All pre-defined acceptance criteria for the above tests have been met. Results from this testing confirm that the subject device performs as intended and supports a determination of substantial equivalence to the predicate device.

Summary of Clinical Testing

Clinical testing was not required for this Traditional 510(k).

Conclusion

The Stryker POWEReam Xia/Serrato is substantially equivalent to the predicate device currently cleared under K233300 as it has the same intended use, same design, principle of operation and technological characteristics. No new questions of safety or effectiveness have been raised as compared to the predicate. Performance testing has demonstrated that the Stryker POWEReam Xia/Serrato is substantially equivalent to the predicate device.

Traditional 510(k) POWEReam Xia/Serrato

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.