The MAXFRAME AUTOSTRUT System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused or will not be crossed with hardware:

· fracture fixation (open and closed)
· pseudoarthrosis of long bones
· limb lengthening (epiphyseal or metaphyseal distraction)
· joint arthrodesis
· infected fractures or nonunions
correction of bony or soft tissue deformities
· correction of segmental defects.

Device Description

The MAXFRAME AUTOSTRUT System is comprised of a control system, software, and six length-adjustable struts powered by a motor. The devices are used in conjunction with the DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software, except that the MAXFRAME struts are substituted with the MAXFRAME AUTOSTRUT Hexapod Struts.
This submission is solely for the clearance of a sterile version of the MAXFRAME AUTOSTRUT Hexapod Struts. The MAXFRAME AUTOSTRUT Hexapod Struts are provided sterile and are comprised of telescopic rods made of stainless steel and aluminum and a motor adapter made from polymeric material. The MAXFRAME AUTOSTRUT Hexapod Struts are available in three lengths - short, medium, and long.
The MAXFRAME AUTOSTRUT Control System and Software have been cleared under K202810.

AI/ML Overview

The provided text describes the 510(k) clearance for the DEPUY SYNTHES MAXFRAME AUTOSTRUT System. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of effectiveness for a diagnostic or therapeutic purpose.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (AutoStrut G2 K202810), primarily based on changes to the sterilization method of the Hexapod Struts (from non-sterile to sterile).

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them, as this information is not present in the provided text. The document explicitly states: "Clinical Performance Data was not necessary for the determination of substantial equivalence."

Here's a breakdown of what is mentioned, which largely pertains to non-clinical performance and a comparison to the predicate device:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as performance metrics an AI or device output would be measured against. The "acceptance" here relates to demonstrating comparable safety and effectiveness to a predicate device.
Reported Device Performance: The primary "performance" discussed is that "Bench testing demonstrates that the sterile MaxFrame AutoStrut Hexapod Strut is as safe and effective as its predicate device." This implies the new sterile version performs mechanically equivalent to the predicate, as validated by non-clinical tests.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance equivalent to predicate (K202810)	Bench testing demonstrates equivalence.
Packaging maintains sterility and device integrity.	Packaging Validation performed.
Sterilization process is effective and safe.	Sterilization Validation performed.
Biocompatibility of materials.	Biocompatibility Evaluation performed.
Shelf life meets expectations.	Shelf-Life Validation performed.

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

Not applicable as no clinical or diagnostic efficacy study is mentioned for this 510(k) submission. The testing performed was "Non-Clinical Performance Testing," including Mechanical Testing, Shelf-Life Validation, Packaging Validation, Sterilization Validation, and Biocompatibility Evaluation. No specific sample sizes for these tests are provided in the summary, nor is data provenance in terms of origin or retrospective/prospective nature.

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

Not applicable as no diagnostic or clinical performance study with "ground truth" established by experts is described.

4. Adjudication method for the test set:

Not applicable for the same reasons as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states, "Clinical Performance Data was not necessary for the determination of substantial equivalence."

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

Not applicable. This device is an external fixation system (hardware), not a diagnostic algorithm. While it has a control system and software (cleared under K202810), this specific submission is only for sterile struts and does not detail a standalone algorithm performance study.

7. The type of ground truth used:

Not applicable as no clinical or diagnostic performance study requiring ground truth (e.g., pathology, outcomes data) is mentioned. "Ground truth" for the non-clinical tests would be defined by engineering standards and test protocols.

8. The sample size for the training set:

Not applicable as this is not a machine learning or AI algorithm development study.

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

Not applicable for the same reasons as point 8.

In summary, the provided document focuses on regulatory clearance based on substantial equivalence for a medical device (external fixation system) where the primary change is the sterilization method of a component. It does not contain information about clinical performance trials, diagnostic accuracy studies, or AI algorithm validation against performance acceptance criteria.

Summary

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July 26, 2023

Depuy Synthes Mitchel Bartko Regulatory Affairs Specialist III 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K231922

Trade/Device Name: DEPUY SYNTHES MAXFRAME AUTOSTRUT System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: June 29, 2023 Received: June 29, 2023

Dear Mitchel Bartko:

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.

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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 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.

Lixin Liu -S

Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231922

Device Name

DEPUY SYNTHES MAXFRAME AUTOSTRUT System

Indications for Use (Describe)

· fracture fixation (open and closed)
· pseudoarthrosis of long bones
· limb lengthening (epiphyseal or metaphyseal distraction)
· joint arthrodesis
· infected fractures or nonunions
correction of bony or soft tissue deformities
· correction of segmental defects.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Sponsor	DePuy Synthes	Address
Primary Contact	Mitchel BartkoRegulatory Affairs Specialist IIIDePuy Synthes	1301 Goshen ParkwayWest Chester, PA USAT: 908-808-6541Email: mbartko1@its.jnj.com
Secondary Contact	Silvia De La BarraManager, Regulatory AffairsDePuy Synthes	1301 Goshen ParkwayWest Chester, PA USAT: 385-258-9397Email: sdelabar@its.jnj.com
Date Prepared	June 29, 2023
Device Trade Name	DEPUY SYNTHES MAXFRAME AUTOSTRUT System
Common Name	External Fixation System
Classification	Class II
Product Code	KTT (Appliance, fixation, nail/blade/plate combination, multiple components)
Regulation Number	888.3030 : Single/multiple component metallic bone fixation appliances andaccessories
Predicate Device(s)	K202810 - Autostrut G2
Device DescriptionSummary	The MAXFRAME AUTOSTRUT System is comprised of a control system,software, and six length-adjustable struts powered by a motor. The devices areused in conjunction with the DePuy Synthes MAXFRAME multi axialcorrection system (K161417), including all its parts and software, except that theMAXFRAME struts are substituted with the MAXFRAME AUTOSTRUTHexapod Struts.This submission is solely for the clearance of a sterile version of theMAXFRAME AUTOSTRUT Hexapod Struts. The MAXFRAMEAUTOSTRUT Hexapod Struts are provided sterile and are comprised oftelescopic rods made of stainless steel and aluminum and a motor adapter madefrom polymeric material. The MAXFRAME AUTOSTRUT Hexapod Struts areavailable in three lengths - short, medium, and long.The MAXFRAME AUTOSTRUT Control System and Software have beencleared under K202810.
Intended Use
Indications for Use	The MAXFRAME AUTOSTRUT System is indicated for the followingtreatments in adults, and in both children (3-12) and adolescents (12-21) inwhich growth plates have fused or will not be crossed with hardware:• fracture fixation (open and closed)• pseudoarthrosis of long bones• limb lengthening (epiphyseal or metaphyseal distraction)• joint arthrodesis• infected fractures or nonunions• correction of bony or soft tissue deformities• correction of segmental defects.
Indications for UseComparison	The MAXFRAME AUTOSTRUT System has the same indications for use as thepredicate device (AutoStrut G2 [K202810]).
TechnologicalComparison	The DePuy Synthes MAXFRAME AUTOSTRUT System has similartechnological characteristics (design, material and chemical composition) as thepredicate device AutoStrut G2 (K202810). The only differences between thepredicate and subject device is that the subject device struts are providedethylene oxide sterilized and packaged within sterile barrier packaging. Thepredicate device struts are provided non-sterile and are end user steam sterilized.
Non-clinicalPerformanceTesting	Non-Clinical Performance Testing was performed and included MechanicalTesting, Shelf-Life Validation, Packaging Validation, Sterilization Validationand Biocompatibility Evaluation. The data was used for the determination ofsubstantial equivalence.
ClinicalPerformance Data	Clinical Performance Data was not necessary for the determination of substantialequivalence.
Conclusion	These minor differences in the technological characteristics compared to thepredicate do not raise different questions of safety or effectiveness. Benchtesting demonstrates that the sterile MaxFrame AutoStrut Hexapod Strut is assafe and effective as its predicate device. Therefore, MaxFrame AutoStrutSystem is substantially equivalent to its predicate.The purpose of this 510(k) submission is to clear the sterile version of theMAXFRAME AUTOSTRUT Hexapod Strut only. The MAXFRAMEAUTOSTRUT Control System and Software have been cleared under K202810.

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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.