DePuy Synthes 3.5mm Intrapelvic Acetabular System by DePuy Synthes

The DePuy Synthes 3.5 mm Intrapelvic Acetabular Plates are indicated for fractures of the acetabulum in adults and adolescents (greater than 12 through 21 years of age) where all growth plates within the acetabulum are fused.

Device Description

The DePuy Synthes 3.5 mm Intrapelvic Acetabular System can be used to treat fractures of the acetabulum involving the anterior column, with or without involvement of the posterior column, including the quadrilateral surface (QS). The subject system is comprised of four plate types per anatomic side, left and right, (Large Extended, Small Extended, Large Standard and Small Standard) which are designed to accept the following existing cortex screws: 3.5 mm Cortex Screws, 3.5 mm Pelvic Cortex Screws, 3.5 mm Cortex Screws with low-profile head, 3.5 mm Stardrive Cortex Screws, and 4.5 mm Cortex Screws. The implants are available in a sterile configuration and are offered in Stainless Steel (SSt). In total the system is comprised of eight different plate designs. Each plate configuration consists of a long, slender suprapectineal portion that is intended to be placed along the anterior column, superior to the pelvic brim and a trapezoidal quadrilateral surface portion that is intended to be placed against the medial aspect of the posterior column, overlapping at least a portion of the quadrilateral surface. The suprapectineal portion is divided into anterior and posterior segments that are configured to mimic existing 3.5 mm reconstruction plates and a central segment, to which the quadrilateral surface portion is connected by two connecting bars.

AI/ML Overview

This document is a 510(k) summary for the DePuy Synthes 3.5 mm Intrapelvic Acetabular System, a medical device for bone fixation. It describes the device, its intended use, comparison to predicate devices, and performance data.

Based on the provided document, here's an analysis of the acceptance criteria and study that proves the device meets the criteria:

The provided text describes a medical device (bone fixation appliance) and its regulatory clearance process, not an AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically have acceptance criteria related to algorithmic performance (e.g., sensitivity, specificity, AUC).

Therefore, I cannot extract the information required for questions 1, 2, 3, 4, 5, 6, 7, 8, and 9 in the context of an AI/SaMD study. The document focuses on the physical and mechanical properties of a metallic implant and its substantial equivalence to previously cleared implants.

Let's break down why the requested information isn't present in this specific document:

Acceptance Criteria for AI/SaMD: The document does not specify acceptance criteria like sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), or Area Under the Curve (AUC), which are common for AI/SaMD devices. Instead, the acceptance criteria for this structural implant are related to mechanical performance (e.g., strength, durability), biocompatibility, and sterilization.
Study Proving Device Meets Acceptance Criteria: The "studies" mentioned are non-clinical performance data for a physical implant, not studies involving algorithms, human readers, or ground truth derived from expert consensus on images.

However, I can extract the information that is present in the document related to its non-clinical performance and its comparison to predicate devices, which serve as its "proof" of meeting safety and effectiveness for a traditional device clearance.

Information Extractable from the Provided Document:

1. A table of acceptance criteria and the reported device performance:

Since this is a physical medical device (implant) and not a diagnostic AI/SaMD, the "acceptance criteria" are related to mechanical and biocompatibility standards rather than typical AI performance metrics.

Acceptance Criteria Category	Specific Test/Performance Measured	Reported Device Performance / Conclusion
Mechanical Performance	Static and Dynamic Physiologic Loading Conditions (worst-case construct)	Mechanical performance of the subject device is non-inferior to that of the predicate device.
Biocompatibility	Endotoxin testing (using LAL test method)	Meets the specified endotoxin requirement of 20 EU/device.
Imaging Compatibility	Magnetic Resonance (MR) compatibility testing	Established MR Conditional parameters.
Substantial Equivalence	Comparison of Intended Use and Design Features to Predicate Devices	The device has the same intended use as the predicate device. Differences in technological characteristics do not raise any new issues related to mechanical performance, safety or efficacy.

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

Sample Size for Test Set: Not applicable in the context of a "test set" for an AI algorithm. The mechanical and endotoxin tests would have involved a specific number of device samples, but this quantity is not disclosed in the summary.
Data Provenance: Not applicable in the context of human data or geographical origin for a physical device's mechanical testing. The testing was conducted internally or by a contracted lab to industry standards.

3. 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. This is not an AI/diagnostic device where expert 'ground truth' is established for a test set of medical images. The "ground truth" for this device's performance is derived from standardized mechanical and biological testing.

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

Not applicable. This concept applies to human reader consensus in image interpretation, not to the testing of a physical implant.

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:

Not applicable. This device is a surgical implant, not an AI-powered diagnostic or assistance tool. No MRMC study was conducted.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical performance data, the "ground truth" is established by adherence to pre-defined engineering standards, mechanical testing protocols (e.g., ASTM standards), and biological safety limits (e.g., endotoxin limits). It's essentially "physical ground truth" based on material science and biomechanics.

8. The sample size for the training set:

Not applicable. There is no AI model or "training set" for this physical device.

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

Not applicable. There is no AI model or "training set" for this physical device.

Summary

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September 20, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.

DePuy Synthes Alyssa Bryan Regulatory Affairs Specialist I 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K221809

Trade/Device Name: DePuy Synthes 3.5mm Intrapelvic Acetabular 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 Dated: June 21, 2022 Received: June 22, 2022

Dear Alyssa Bryan:

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 (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 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/cdrl-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, 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

Enclosure

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Indications for Use

510(k) Number (if known) K221809

Device Name

DePuy Synthes 3.5 mm Intrapelvic Acetabular System

Indications for Use (Describe)

The DePuy Synthes 3.5 mm Intrapelvic Acetabular Plates are indicated for fractures of the acetabulum in adults and adolescents (greather than 12 through 21 years of age) where within the acetabulum are fused.

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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K221809 - 510(k) Summary

Sponsor	DePuy SynthesAlyssa Bryan1301 Goshen ParkwayWest Chester, PA 19380Phone: +41 61 965 63 14
Date Prepared	August 18, 2022
Proprietary Name	DePuy Synthes 3.5 mm Intrapelvic Acetabular System
ClassificationName	Single/multiple component metallic bone fixation appliances and accessories
Classification	Class IIRegulation Number: 21 CFR 888.3030Product Code: HRS
Predicate devices	Primary Predicate:Synthes (USA) Low Profile Reconstruction PlatesK0423773.5 mm Wide Angle Low Profile Reconstruction Plates 3.5 mm Low Profile Reconstruction J-Plates (non-locking)
	Additional Predicate:Synthes 3.5 mm Low Profile Pelvic Reconstruction PlateK0315733.5 mm Low Profile Reconstruction Plates 3.5 mm Low Profile Curved Reconstruction Plates (radius 108 mm) 3.5 mm Low Profile Curved Reconstruction Plates (radius 88 mm)
Device Description	The DePuy Synthes 3.5 mm Intrapelvic Acetabular System can be used to treat fractures of theacetabulum involving the anterior column, with or without involvement of the posterior column,including the quadrilateral surface (QS). The subject system is comprised of four plate typesper anatomic side, left and right, (Large Extended, Small Extended, Large Standard and SmallStandard) which are designed to accept the following existing cortex screws: 3.5 mm CortexScrews, 3.5 mm Pelvic Cortex Screws, 3.5 mm Cortex Screws with low-profile head, 3.5 mmStardrive Cortex Screws, and 4.5 mm Cortex Screws. The implants are available in a sterileconfiguration and are offered in Stainless Steel (SSt). In total the system is comprised of eightdifferent plate designs. Each plate configuration consists of a long, slender suprapectinealportion that is intended to be placed along the anterior column, superior to the pelvic brim anda trapezoidal quadrilateral surface portion that is intended to be placed against the medial aspectof the posterior column, overlapping at least a portion of the quadrilateral surface. Thesuprapectineal portion is divided into anterior and posterior segments that are configured tomimic existing 3.5 mm reconstruction plates and a central segment, to which the quadrilateralsurface portion is connected by two connecting bars.
Indications for use	The DePuy Synthes 3.5 mm Intrapelvic Acetabular Plates are indicated for fractures of theacetabulum in adults and adolescents (greater than 12 through 21 years of age) where allgrowth plates within the acetabulum are fused.
Contraindications	Not intended for patients with active growth plates.
Comparison topredicate	The subject device has the same intended use as the predicate device. The indications of thesubject system are a subset of the indications of the predicate device.
	The subject devices and the predicate device are metallic plates of similar design intended forbone fracture fixation. Both subject and predicate devices are anatomically contoured plates.Both subject and predicate devices have similar hole specifications and are compatible with thesame screw types.
	Additional features are found in the subject Acetabular Plates that are not found in the predicateLow Profile Reconstruction Plates. However, these features do not alter the fundamentaltechnology of the device and therefore do not raise new issues of safety and effectiveness:
	Trapezoidal quadrilateral surface portion that is intended to be placed against the medial aspect of the posterior column overlapping at least a portion of the quadrilateral surface
	Non-locking screw holes on the quadrilateral surface portion designed to target bone in the sciatic buttress
	A non-locking oblique screw hole in the distal portion of the quadrilateral surface designed to target screw anchorage within the ischium while avoiding the acetabulum Additional holes to facilitate plate placement with instrumentation as well as in-situ and ex-situ contouring

	It can be concluded that the features of the subject device are substantially equivalent to thepredicate device based on the similarities in intended use and design.
Non-clinicalPerformance Data	Mechanical testing of a worst-case construct under static and dynamic physiologic loadingconditions have been performed to compare the proposed DePuy Synthes 3.5 mm AcetabularPlates to the predicate device. The results of this testing support that the mechanicalperformance of the subject device is non-inferior to that of the predicate device.
	Magnetic Resonance compatibility testing has been performed to establish MR Conditionalparameters for the subject DePuy Synthes 3.5 mm Intrapelvic Acetabular System.
	Endotoxin testing has been performed using the LAL test method to establish that the subjectDePuy Synthes 3.5 mm Acetabular System meets the specified endotoxin requirement of20 EU/device.
ClinicalPerformance Data	Clinical testing was not necessary for the determination of substantial equivalence.
SubstantialEquivalence	The subject device has the same intended use compared to the predicate device.
	The non-clinical performance data as well as the comparison of design features included inthis premarket notification demonstrate that any differences in technological characteristics ofthe subject device compared to the predicate device do not raise any new issues related tomechanical performance, safety or efficacy and can be labeled MR Conditional. The proposeddevices are at least as safe and effective as the predicate devices
	It is concluded that the information provided herein supports substantial equivalence of thesubject devices.

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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.