The SMG Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:

· degenerative disc disease (as defined by neck pain of discogenic origin with

degeneration of the disc confirmed by patient history and radiographic studies),

· spondylolisthesis,
· trauma (i.e. fractures or dislocations),
tumors.
· deformity (defined as kyphosis, lordosis, or scoliosis),
· failed previous fusion (pseudoarthrosis)
· spinal stenosis.

Device Description

The SMG Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6Al-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, two-level, three-level, four-level fusion configurations (13~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and selfdrilling threaded. This device is provided as non-sterile.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the SMG Anterior Cervical Plate System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive studies with detailed acceptance criteria as one might find for a PMA or de novo submission for a novel AI/ML device.

Therefore, the information you've requested regarding acceptance criteria for device performance in a clinical setting, sample sizes for test and training sets, expert qualifications, and adjudication methods (typical of AI/ML device evaluations) is not present in this document.

Here's an analysis based on the provided text, addressing what information is available:

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

The document does not provide specific quantitative "acceptance criteria" for clinical performance that would typically be seen for an AI/ML device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and performance data.

The "reported device performance" is in the context of bench testing:

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (Bench Testing)
Mechanical performance comparable to predicate devices.	Static compression bending, tension, torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case cervical plate construct. These data demonstrate substantial equivalence in terms of performance bench testing to predicate devices.

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

This information is not applicable/not provided. The assessment for this device is based on mechanical bench testing and comparison to existing predicate devices, not clinical data sets or test sets as would be used for an AI/ML device.

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

This information is not applicable/not provided. Ground truth in the context of expert review for clinical performance is not part of this 510(k) submission.

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

This information is not applicable/not provided. Adjudication methods are relevant for clinical studies with subjective interpretation, which is not the basis of this 510(k).

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

This information is not applicable/not provided. The device is a physical anterior cervical plate system, not an AI-assisted diagnostic tool.

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

This information is not applicable/not provided. The device is a physical implant, not an algorithm.

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

This information is not applicable/not provided. The "ground truth" equivalent for this type of device is its ability to meet engineering specifications and withstand mechanical forces, as demonstrated through bench testing and comparison to established predicate devices.

8. The sample size for the training set

This information is not applicable/not provided. Training sets are relevant for AI/ML models, not for physical medical implants like an anterior cervical plate system.

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

This information is not applicable/not provided.

Summary

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February 11, 2019

Sapphire Medical Group Mr. Anthony Ruggiero President 32565 B Golden Lantern Street, Suite 113 Dana Point, California 92629

Re: K183073

Trade/Device Name: SMG Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 27, 2018 Received: November 27, 2018

Dear Mr. Ruggiero:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183073

Device Name

SMG Anterior Cervical Plate System

· degenerative disc disease (as defined by neck pain of discogenic origin with

degeneration of the disc confirmed by patient history and radiographic studies),

· spondylolisthesis,
· trauma (i.e. fractures or dislocations),
tumors.
· deformity (defined as kyphosis, lordosis, or scoliosis),
· failed previous fusion (pseudoarthrosis)
· spinal stenosis.

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

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

1.	Submitter:	Sapphire Medical Group32565 B Golden Lantern StreetSuite 113, Dana Point, CA 92629, United StatesPhone. +1-949-939-8502
	Contact Person:	Anthony Ruggiero
	Date prepared:	November 01, 2018

Device Identification 2.

Trade Name	SMG Anterior Cervical Plate System
Common Name	Anterior Cervical Plate
Product Code	KWQ
Regulatory Class	Spinal Intervertebral Body Fixation Orthosis(21 CFR888.3060)
Classification Name	Class II

Predicate or legally marketed devices which are substantially equivalent 3.

The design feature and indications for use for the subject SMG Anterior Cervical Plate System is exactly the same as the following predicates:

Primary predicate device: CastleLoc-P Anterior Cervical Plate System (K143271)
Additional predicate device: LnK Anterior Cervical Plate System (K143279)

Description of the Device 4.

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5. Indication for use

The SMG Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:

degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis,
trauma (i.e. fractures or dislocations), •
tumors,
deformity (defined as kyphosis, lordosis, or scoliosis), ●
failed previous fusion (pseudoarthrosis) ●
spinal stenosis.

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No	Item	Subject device	Primary Predicate device	Additional Predicate device
1	Manufacturer	SMG Anterior CervicalPlate SystemSapphire Medical Group(Contract manufacturer: L&KBIOMED CO., LTD.)	CastleLoc-P AnteriorCervical Plate SystemL&K BIOMED Co.,Ltd.	LnK Anterior CervicalPlate SystemL&K BIOMED Co.,Ltd.
2	Material	Ti-6Al-4V ELI(ASTM F136)	Ti-6Al-4V ELI(ASTM F136)	Ti-6Al-4V ELI(ASTM F136)
3	510(K) Number		K143271	K143279
4	Product Code	KWQ	KWQ	KWQ
5	Class	Class II	Class II	Class II
6	Sterility	Non-sterile	Non-sterile	Non-sterile
7	Intended Use	The SMG AnteriorCervical Plate Systemis intended for anteriorscrew fixation to thecervical spine (C2-C7).The System isindicated for use in theimmobilization andstabilization of thespine as an adjunct tofusions in patientswith:-degenerative discdisease (as defined byneck pain of discogenicorigin withdegeneration of thedisc confirmed bypatient history and	The CastleLoc-PAnterior Cervical PlateSystem is intended foranterior screw fixationto the cervical spine(C2-C7). The System isindicated for use in theimmobilization andstabilization of thespine as an adjunct tofusions in patients with:-degenerative discdisease (as defined byneck pain of discogenicorigin withdegeneration of the discconfirmed by patienthistory andradiographic studies),	The LnK AnteriorCervical Plate Systemis intended for anteriorscrew fixation to thecervical spine (C2-C7).The System is indicatedfor use in theimmobilization andstabilization of thespine as an adjunct tofusions in patients with:-degenerative discdisease (as defined byneck pain of discogenicorigin withdegeneration of the discconfirmed by patienthistory andradiographic studies),
	radiographic studies),	-spondylolisthesis,	-spondylolisthesis,
	-spondylolisthesis,	-trauma (i.e. fractures	-trauma (i.e. fractures
	-trauma (i.e. fractures	or dislocations),	or dislocations),
	or dislocations),	-tumors,	-tumors,
	-tumors,	-deformity (defined as	-deformity (defined as
	-deformity (defined as	kyphosis, lordosis, or	kyphosis, lordosis, or
	kyphosis, lordosis, or	scoliosis),	scoliosis),
	scoliosis),	-failed previous fusion	-failed previous fusion
	-failed previous fusion	(pseudoarthrosis)	(pseudoarthrosis)
	(pseudoarthrosis)	-spinal stenosis.	-spinal stenosis.
	-spinal stenosis.

6. Comparison of the technology characteristics of the device to predicate and legally marketed devices

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Comparison of the technology characteristics of the device to predicate and 7. legally marketed devices

The subject device 'SMG Anterior Cervical Plate System' is exactly the same device as the predicate device(s): CastleLoc-P Anterior Cervical Plate System (K143271) and LnK Anterior Cervical Plate System (K143279). Therefore, it is substantially equivalent to these devices which are currently being marketed in terms of design, function and intended use.

Performance Data 8.

Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. These data demonstrate substantial equivalence in terms of performance bench testing.

Conclusion 9.

The SMG Anterior Cervical Plate System is substantially equivalent to the devices referenced above for the intended use.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.