The SkyOPSTM Orthopedic Plate System is indicated to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bone fragments of the foot. The system can be used in both adult and pediatric patients aged >12 years (adolescent, transitional adolescent B).

Device Description

The subject SkyOPS™ Orthopedic Plate System consists of various plates and screws that are used to stabilize and aid in the fusion or repair of fractures or osteotomies of small bones. The plates are offered in different lengths and sizes. The screws are offered in one diameter with different lengths. All implantable metal components are made from Ti-6Al-4V ELI per ASTM F136 or ASTM F3001. The devices are provided non-sterile to be cleaned and steam sterilized by the end user.

AI/ML Overview

The provided text is a 510(k) summary for the SkyOPS™ Orthopedic Plate System, which is a metallic bone fixation appliance. This type of device does not typically involve AI or software for diagnosis or image analysis, but rather is a physical implant. Therefore, questions related to AI performance, such as acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and standalone performance, are not applicable in this context.

Instead, the performance evaluation for this device focuses on mechanical and biocompatibility testing to demonstrate substantial equivalence to predicate devices.

Here's the relevant information about the performance and acceptance criteria for the SkyOPS™ Orthopedic Plate System based on the provided document:

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

Acceptance Criteria Category	Standard/Test Method	Reported Device Performance
Biocompatibility	ISO 10993-1	Testing conducted, and results demonstrated substantial equivalence. (Implies meeting biocompatibility requirements outlined in ISO 10993-1)
Mechanical Performance	ASTM F534-17 (Annexes 1-3)	Testing conducted, and results demonstrated substantial equivalence to predicate devices. (Implies meeting or exceeding the mechanical performance of the predicates as defined by these ASTM standards)
Mechanical Performance	ASTM F384-17 (Annexes 1-2)	Testing conducted, and results demonstrated substantial equivalence to predicate devices. (Implies meeting or exceeding the mechanical performance of the predicates as defined by these ASTM standards)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample size for the mechanical or biocompatibility testing. These tests typically involve a defined number of samples for each specific test (e.g., a certain number of plates for fatigue testing).
The data provenance (country of origin, retrospective/prospective) is not applicable or specified for this type of in-vitro and material testing.

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

Not applicable. This device is a physical implant, and its performance is evaluated through standardized mechanical and biological tests, not by human expert assessment of clinical data.

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

Not applicable. Performance is based on objective measurements from standardized tests, not expert adjudication.

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 is not an AI-assisted diagnostic device.

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 biocompatibility: Ground truth is implicitly defined by the pass/fail criteria of the ISO 10993-1 standard, often through laboratory assays and biological response evaluations.
For mechanical performance: Ground truth is implicitly defined by the specified load, displacement, or fatigue life criteria within ASTM F534-17 and ASTM F384-17, aiming to demonstrate performance comparable to, or better than, predicate devices. The "ground truth" here is objective physical properties.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

In summary, the SkyOPS™ Orthopedic Plate System is an orthopedic implant, and its performance is demonstrated through well-established biocompatibility and mechanical testing standards. The acceptance criteria are meeting the requirements of these standards and demonstrating substantial equivalence to the predicate devices in terms of performance. The study proving this involves laboratory testing in accordance with ISO 10993-1, ASTM F534-17, and ASTM F384-17.

Summary

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December 21, 2023

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Sky Surgical LLC % Danielle Besal Principal Consultant MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial, Colorado 80112

Re: K233154

Trade/Device Name: SkyOPSTM Orthopedic Plate 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 27, 2023 Received: September 27, 2023

Dear Danielle Besal:

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"

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(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).

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, 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

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Indications for Use

510(k) Number (if known) K233154

Device Name SkyOPSTM Orthopedic Plate System

Indications for Use (Describe)

The SkyOPS™ Orthopedic Plate System is indicated to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bone fragments of the foot. The system can be used in both adult and pediatric patients aged >12 years (adolescent, transitional adolescent B).

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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K233154

510(k) Summary

SkyOPS™ Orthopedic Plate System December 21, 2023

Company:	Sky Surgical39 Nettleingham RdSandpoint, ID 83864
Primary Contact:	Danielle BesalPrincipal Consultant MRC Global901.827.8670Danielle.Besal@askmrcglobal.com
Company Contact:	Jeff SanderChief Operating Officer Sky Surgical480.266.8605jsander@sky-surgical.com
Trade Name:	SkyOPS™ Orthopedic Plate System
Common Name:	Plate, Fixation, Bone; Screw, Fixation, Bone
Classification:	Class II
Regulation Number:	21 CFR 888.3030 (Primary) Single/multiple component metallic bonefixation appliances and accessories; 21 CFR 888.3040 Smooth orthreaded metallic bone fixation fastener
Panel:	Orthopedic
Product Code:	HRS (Primary), HWC
Predicate Devices:	K121437 Mini MaxLock Extreme Plating System (Primary)K170214 Additive Orthopaedics Locking Lattice PlateK010321 Modular Foot System – 2.7mm ModuleK221181 TMC Plating System

Device Description:

Indications for Use:

Substantial Equivalence:

The SkyOPS™ Orthopedic Plate System is substantially equivalent to the predicate devices (K121437, K170214, K010321, K221181). The subject and predicate devices are identical in intended use and materials and equivalent in technological characteristics. Testing has demonstrated that performance of

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K233154

the subject devices is equivalent to that of the predicates and, thus, the differences in geometry and manufacturing versus the predicates do not raise different questions of safety and effectiveness.

Performance Testing:

Biocompatibility testing per ISO 10993-1 and performance testing per ASTM F534-17 (Annexes 1-3) and ASTM F384-17 (Annexes 1-2) was conducted on the subject devices and results demonstrated substantial equivalence to the predicates.

Conclusion:

The SkyOPS™ Orthopedic Plate System is considered substantially equivalent to the predicate devices (K121437, K170214, K010321, K221181).

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.