The NOVA Minimally Invasive System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),
Spondylolisthesis,
Trauma (i.e., fracture or dislocation)
Spinal stenosis,
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
Tumor,
Pseudoarthrosis, and
Failed previouis fusion

Device Description

The NOVA Minimally Invasive System consists of cannulated polyaxial screws, straight and pre-bent rods, and set screws. The components are manufactured from titanium alloy per ASTM F136. The screws range in diameter from 5.5 mm to 7.0 mm and in length from 20 mm to 70 mm. The implants are not compatible with components or metal from any other manufacturer's system. The NOVA Minimally Invasive System can be used for both percutaneous and mini-open surgerv.

AI/ML Overview

The provided document (K182416) is a 510(k) summary for the NOVA Minimally Invasive System, a thoracolumbosacral pedicle screw system. It focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical performance testing.

This document does NOT contain information about any study involving human readers, AI assistance, or the establishment of ground truth for a test set or training set for an AI/algorithm. The performance testing described is purely mechanical, comparing the device's physical properties to established standards and a predicate device.

Therefore, for most of your requested information (related to AI performance, human readers, ground truth, sample sizes for test/training sets, and expert qualifications/adjudication), the provided document does not contain the answer.

Here's the information that is available:

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

The document states: "The following tests were performed on the subject components per ASTM F1717: static compression bending, static torsion, and dynamic compression bending. Results of these mechanical tests demonstrate substantially equivalent mechanical performance to predicate devices."

As specific acceptance criteria (e.g., "must withstand X N of force") and exact reported performance values are not detailed in this summary, the table below provides a generalized summary based on the provided text.

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Static Compression Bending (per ASTM F1717)	Substantially equivalent mechanical performance to predicate devices.	Demonstrates substantially equivalent mechanical performance to predicate devices.
Static Torsion (per ASTM F1717)	Substantially equivalent mechanical performance to predicate devices.	Demonstrates substantially equivalent mechanical performance to predicate devices.
Dynamic Compression Bending (per ASTM F1717)	Substantially equivalent mechanical performance to predicate devices.	Demonstrates substantially equivalent mechanical performance to predicate devices.

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

This information is not provided. The testing was mechanical, not on human subjects or clinical data.

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 device is a pedicle screw system, and the testing was mechanical. There was no "ground truth" to be established by experts in a clinical context within this submission summary.

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

Not applicable. This was mechanical testing, not a clinical study requiring human 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

No. This is a pedicle screw system, and the submission does not mention any AI component or MRMC study.

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

No. This is a physical medical device (pedicle screw system), not an algorithm.

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

Not applicable. The "ground truth" for mechanical testing is typically defined by engineering specifications and material properties, against which the device's performance is measured. It's not a clinical "ground truth."

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/algorithm device submission.

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

Not applicable. There is no mention of a training set as this is not an AI/algorithm device submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 11, 2019

BAUI Biotech CO., LTD. Mr. Herman Jhan Regulatory Affairs Specialist 6F, No. 8, Sec. 1, Zhongxing Road, Wugu District New Taipei City, 24872 Taiwan (R.O.C.)

Re: K182416

Trade/Device Name: NOVA Minimally Invasive System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: May 13, 2019 Received: May 16, 2019

Dear Mr. Jhan:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/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 Raquel Peat, PhD, MPH, USPHS Director 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) K182416

Device Name NOVA Minimally Invasive System

Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),
Spondylolisthesis,

1. Trauma (i.e., fracture or dislocation)

Spinal stenosis,

1. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

Tumor,

1. Pseudoarthrosis, and

Failed previouis fusion

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

This 510(k) summary information is being submitted in accordance with the requirements of 21 C.F.R. §807.92.

Preparation Date:	June 6, 2019
Applicant/Sponsor:	BAUI BIOTECH CO., LTD.6F., No.8, Sec.1, Zhongxing Rd., Wugu Dist., 24872New Taipei City, Taiwan(R.O.C.)
Contact Person:	Herman JhanPhone: +886-2-8976-9538 #154Fax: +886-2-8976-9608Email: ra.bu@baui.com.tw
Proprietary Name:	NOVA Minimally Invasive System
Common Name:	Pedicle Screw Fixation System
Classification Name:	Thoracolumbosacral pedicle screw system (21 CFR888.3070)
Classification Identification:	Class II
Product code:	NKB

Primary Predicate Device: Firebird Spinal Fixation System (K171082)

Device Description:

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Minimally Invasive System can be used for both percutaneous and mini-open surgerv.

Indications for Use:

The NOVA Minimally Invasive System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

1. Spondylolisthesis,
1. Trauma (i.e., fracture or dislocation),
1. Spinal stenosis.
1. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
1. Tumor,
1. Pseudoarthrosis, and
1. Failed previous fusion

Substantial Equivalence:

The NOVA Minimally Invasive System is substantially equivalent to the predicate device listed above based on intended use, materials, designs, and operational principles.

Performance Testing:

The following tests were performed on the subject components per ASTM F1717: static compression bending, static torsion, and dynamic compression bending. Results of these mechanical tests demonstrate substantially equivalent mechanical performance to predicate devices.

Conclusion:

The NOVA Minimally Invasive System is substantially equivalent to predicate devices with respect to intended use, materials, technological characteristics, and mechanical performance.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.