The PolyLock System is indicated for use in the treatment of bone fractures, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand and foot. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.

Device Description

The PolyLock Plating System consists of various shapes and sizes of plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact plate capable of dynamic/manual compression, with threaded screw holes accepting both poly-axial and locking screws. The system also consists of poly-axial and locking screws with diameters consisting of 2.0mm, 2.4mm, 2.7mm, 3.5mm and 4.0mm with lengths from 8mm to 60mm. System instrumentation includes: drill bits, countersinks, K-wires, olive wires, depth gauges, reamers, driver shafts, guides, plate benders, clamps, and driver handles to facilitate the placement of the screws. The implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: drill bits, countersinks, reamers, K-wires, and olive wires.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving device meets acceptance criteria:

Based on the provided FDA 510(k) summary for the PolyLock Plating System, it's crucial to understand that this submission does not involve an AI/ML powered device. The device is a traditional orthopedic implant (plating system). Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI, standalone performance, ground truth establishment for training set, etc.) are not applicable here.

The "acceptance criteria" in this context refer to demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than performance metrics for an AI algorithm.

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

Acceptance Criteria Category	Reported Device Performance (Summary)
Material Equivalence	The PolyLock Plating System is manufactured from Stainless steel (ASTM F899) and Ti-6AI-4V (ASTM F136), which are standard materials for orthopedic implants and are equivalent to those used in the predicate devices.
Design/Dimensional Equivalence	The PolyLock Plating System has similar size screws, widths, thickness, lengths, and designs/shapes compared to the predicate plating systems.
Functional Equivalence	The plates are capable of dynamic/manual compression, with threaded screw holes accepting both poly-axial and locking screws, mirroring predicate devices.
Cleaning Validation	Validations performed show proper cleaning of implants and associated surgical instruments.
Packaging Validation	Validations performed confirm suitable packaging of implants and associated surgical instruments.
Sterilization Validation	Validations performed confirm effective sterilization of implants and associated surgical instruments.
Performance (Engineering Rational)	Engineering rational was performed to show performance equivalence to predicate devices, based on material and design similarities, and mechanical properties typically tested for such devices (though specific tests like bending or torsional strength are not detailed in this summary).
Indications for Use Equivalence	The indications for use are considered equivalent to the predicate devices (treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and interfragmentary indications in small bones of the hand and foot).

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

Not applicable in the context of an AI/ML device. For this traditional medical device (orthopedic plating system), the "test set" refers to the specific implant designs and materials subjected to non-clinical testing (e.g., sterilization tests, mechanical property tests).
The document does not specify exact "sample sizes" for each non-clinical test (e.g., how many plates were sterilized, how many screws were tested for torque). However, engineering rationales and validation protocols typically involve statistically relevant sample sizes for specific tests.
Data provenance: Not explicitly stated beyond "non-clinical tests were performed." These would generally be performed in a laboratory setting by the manufacturer or a third-party testing facility.

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

Not applicable. "Ground truth" in the context of expert consensus is specific to AI/ML performance evaluation. For a traditional medical device, the "ground truth" for material properties or mechanical performance is established through standardized engineering tests and specifications (e.g., ASTM standards for materials).
The "experts" would be the engineers and quality assurance professionals conducting and verifying the non-clinical tests, following recognized standards and protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts when establishing ground truth for AI/ML performance studies.
For non-clinical device testing, results are typically objective (e.g., passing a specific mechanical load, achieving a certain sterility assurance level) and validated against established standards. Data analysis and interpretation would be reviewed by internal quality and regulatory personnel.

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

No. A Multi-Reader Multi-Case (MRMC) study is specifically for evaluating the performance of AI-assisted diagnostic devices with human readers. This device is an orthopedic implant, not an AI diagnostic tool.

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

No. This device does not have an algorithm or AI component.

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

Not applicable in the AI/ML sense. For this device, the "ground truth" is defined by:
- Material Standards: Adherence to ASTM F899 (Stainless steel) and ASTM F136 (Ti-6Al-4V) specifications.
- Engineering Standards: Meeting predefined mechanical performance criteria (e.g., strength, stiffness, fatigue resistance) typically derived from industry standards or comparison with predicate devices.
- Validation Standards: Compliance with validated cleaning, packaging, and sterilization protocols (e.g., ISO or AAMI standards).

8. The sample size for the training set

Not applicable. This device is not an AI/ML model, so there is no "training set."

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

Not applicable. This device is not an AI/ML model, so there is no "training set" or ground truth established for one.

Summary

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November 24, 2020

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 in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

Fusion Orthopedics, LLC Eli Jacobson Official Correspondent 4135 S. Power Rd., Suite 110 Mesa, Arizona 85212

Re: K202959

Trade/Device Name: PolyLock 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: September 30, 2020 Received: September 30, 2020

Dear Eli Jacobson:

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,

For: 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K202959

Device Name PolyLock Plating System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary: PolyLock Plating System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

Date Prepared	September 30th, 2020
Submitted By	Fusion Orthopedics, LLC4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876
Primary Contact	Eli Jacobson4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876 Telee-mail: eli@fusionorthopedics.com
Trade Name	PolyLock Plating System
Common Name	Plate, Fixation, Bone
Class	ll
Product Code	HRS, HWC
Regulation	21 CFR Section 888.3030 - Single/multiple component metallic bone fixationappliances and accessories.
Device Panel	Orthopedic
Predicate Devices	Fusion Orthopedics: PolyLock Small Bone Plating System (K192323) [Primary Predicate]Medline UNITE: Foot Recon Plating System (K151235)Wright Medical ORTHOLOC 3Di Reconstruction System: CROSSCHECK Module (K152974)Stryker: Anchorage Plating System (K172148)
DeviceDescription	The PolyLock Plating System consists of various shapes and sizes of plates for themanagement of small bone orthopedic osteotomies, reconstruction, and trauma. Featuresinclude a low profile, limited contact plate capable of dynamic/manual compression, withthreaded screw holes accepting both poly-axial and locking screws. The system alsoconsists of poly-axial and locking screws with diameters consisting of 2.0mm, 2.4mm,2.7mm, 3.5mm and 4.0mm with lengths from 8mm to 60mm. System instrumentationincludes: drill bits, countersinks, K-wires, olive wires, depth gauges, reamers, driver shafts,guides, plate benders, clamps, and driver handles to facilitate the placement of the screws.The implants are intended for single use only. Instruments designed for bone removal areintended for single use only, such as: drill bits, countersinks, reamers, K-wires, and olivewires.
Indications forUse	The PolyLock System is indicated for use in the treatment of bone fractures, osteotomies,arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the handand foot. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 3rd, 4th, and5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valqus/rigiduscorrection, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiformjoint, and arthrodesis/fusion of the first metatarsophalangeal joint.
Materials	Stainless steel (ASTM F899)Ti-6AI-4V (ASTM F136)

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Comparison ofTechnologicalCharacteristics	The PolyLock Plating System and the predicate plating systems are manufactured fromtitanium, are compatible with similar sized screws, have similar widths, thickness, lengthsand designs/shapes.
Non-clinical TestSummary	Validations were performed on the cleaning, packaging and sterilization of the implants andassociated surgical instruments. Engineering rational was performed to show performanceequivalence. The results of the testing demonstrate that the device is substantiallyequivalent to the predicate device identified above.
Clinical TestSummary	No clinical studies were performed
Conclusions:Non- clinical andClinical	Fusion Orthopedics LLC considers the PolyLock Plating System to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, materials and indications for use.

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.