The BRIDALVEIL Occipital Cervical Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine from TI-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions ( e.g., pseudarthrosis ); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The BRIDALVEIL Occipital Cervical Thoracic System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the BRIDALVEIL Occipital Thoracic System may be connected to the OLYMPIC Posterior Spinal Fixation System rods and connectors. Transition rods with differing diameters may also be used to connect the BRIDALVEIL Occipital Cervical Thoracic System to the OLYMPIC Posterior Spinal Fixation System. Refer to the OLYMPIC Posterior Spinal Fixation System package insert for instructions for use and indications for use.

Device Description

The BRIDALVEIL Occipital Cervical Thoracic System is a spinal fixation system intended to stabilize the uppermost portion of the spine during the fusion process. The system contains a wide variety of implants and instruments which allows for the transition across multiple spinal segments: Occipital Plate with Screws, Cervical Polyaxial Screws, Laminar Hooks, Cross Connectors, Rod Connectors, and Rods manufactured from Ti6Al4V ELI (ASTM F136) and cobalt chrome alloy (ASTM F1537).

AI/ML Overview

The provided text describes the regulatory clearance for the BRIDALVEIL Occipital Cervical Thoracic System, a spinal fixation system. It does not detail acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML device.

This document is a 510(k) premarket notification for a traditional medical device (spinal fixation system), not an AI/ML device. Therefore, the details requested in the prompt, such as reported device performance, sample size for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set, are not applicable in the context of this submission.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

Intended Use: Providing immobilization and stabilization of spinal segments as an adjunct to fusion for various conditions (traumatic fractures/dislocations, instability, tumors, degenerative disease, etc.) in the craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3). It also mentions restoring spinal column integrity for a limited time in advanced stage tumor patients.
Design: The system includes occipital plates with screws, cervical polyaxial screws, laminar hooks, cross connectors, rod connectors, and rods.
Materials: Ti6Al4V ELI (ASTM F136), cobalt chrome alloy (ASTM F1537), Elgiloy CoCrNi alloy (ASTM F1058), and Nitinol #1 (ASTM E2063).
Mechanical Safety and Performance: Evaluated through non-clinical bench testing.

Here's the information extracted from the document, framed in the context of a traditional medical device submission, rather than an AI/ML one:

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

For this traditional medical device (BRIDALVEIL Occipital Cervical Thoracic System), "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices through conformity to recognized standards for mechanical performance and material properties. "Reported device performance" is derived from the results of these non-clinical tests meeting the requirements of those standards.

Acceptance Criterion (Demonstrating Substantial Equivalence)	Reported Device Performance (Summary from Non-Clinical Tests)
Mechanical Performance:	The BRIDALVEIL Occipital Cervical Thoracic System demonstrated mechanical performance equivalent to the predicate devices across various tests.
Static Compression Bending (ASTM F1717)	Results indicated equivalence to predicate devices.
Dynamic Compression Bending (ASTM F1717)	Results indicated equivalence to predicate devices.
Static Torsion (ASTM F1717)	Results indicated equivalence to predicate devices.
Static Compression Bending (ASTM F2706)	Results indicated equivalence to predicate devices.
Dynamic Compression Bending (ASTM F2706)	Results indicated equivalence to predicate devices.
Static Torsion (ASTM F2706)	Results indicated equivalence to predicate devices.
Dynamic Torsion (ASTM F2706)	Results indicated equivalence to predicate devices.
Static Axial Grip (ASTM F1798)	Results indicated equivalence to predicate devices.
Static Torsional Grip (ASTM F1798)	Results indicated equivalence to predicate devices.
Static Transverse Moment (ASTM F1798)	Results indicated equivalence to predicate devices.
Material Biocompatibility:	Materials used (Ti6Al4V ELI, CoCrMo alloy, Elgiloy CoCrNi alloy, Nitinol #1) are commonly accepted in spinal implants and are equivalent to those used in predicate devices, implying established biocompatibility. (No specific biocompatibility tests are listed, but material equivalence is claimed.)
Sterility:	(Not explicitly detailed in the summary, but implicit for an implantable device that it would meet relevant sterility standards.)

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

Sample Size for Test Set: Not applicable in the context of human data. The "test set" here refers to physical specimens of the device components tested in a laboratory setting. No human patients or retrospective/prospective data were used for performance evaluation.
Data Provenance: The data provenance is from non-clinical bench testing conducted in a laboratory. The specific country of origin of the lab is not stated in the provided text.

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. "Ground truth" in this context refers to the defined parameters and performance standards derived from the ASTM standards for mechanical testing. These standards are established by expert committees in engineering and materials science, but individual experts are not "adjudicating" a test set as they would for clinical images or diagnoses.

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

Not applicable. There's no human adjudication process described for the mechanical test results; rather, the results are compared against predefined criteria within the ASTM standards.

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/ML device, and no MRMC studies or human reader performance evaluations were conducted.

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

Not applicable. This is not an AI/ML device. The "standalone performance" is the mechanical testing of the device itself against engineering standards.

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

For this device, the "ground truth" (or reference for evaluation) is established through recognized industry standards for mechanical testing of spinal implants (e.g., ASTM F1717, ASTM F2706, ASTM F1798). The device's performance is compared against the requirements and typical performance of predicate devices as measured under these standardized conditions.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 2, 2017

Astura Medical Mr. Thomas Purcell Vice President 3186 Lionshead Avenue, Suite 100 Carlsbad, California 92010

Re: K171250

Trade/Device Name: BRIDALVEIL Occipital Cervical Thoracic System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: September 1, 2017 Received: September 6, 2017

Dear Mr. Purcell:

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. 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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) K171250

Device Name

BRIDALVEIL Occipital Cervical Thoracic System

Indications for Use (Describe)

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: BRIDALVEIL Occipital Cervical Thoracic System

Date Prepared	September 1, 2017
Submitted By	Astura Medical3186 Lionshead Ave, Suite 100Carlsbad, CA 92010Phone: 760-814-8047
Contact	Thomas Purcell3186 Lionshead Ave, Suite 100Carlsbad, CA 92010Phone: 760-814-8047Email: thomas@asturamedical.com
Trade Name	BRIDALVEIL Occipital Cervical Thoracic System
Common Name	Occipital Cervical Thoracic System
Classification Name	Othosis, Cervical Pedicle Screw Spinal FixationSpinal interlaminal fixation orthosis
Class	Unclassified
Product Code	NKGKWP
CFR Section	N/A
Device Panel	Orthopedic
Primary Predicate Device	Medtronic VERTEX® Reconstruction System - K143471, K152338
Secondary PredicateDevices	NuVasive® VuePoint® OCT System - K150474, K153336Zimmer Spine Virage® OCT Spinal Fixation System - K153631Ulrich GmbH neon3™ universal OCT spinal stabilization - K150650Blackstone Ascent POCT System - K073654
Reference Devices	Alphatec Spine Solanas™ Posterior Stabilization System - (K052201)Alphatec Spine Solanas Avalon Posterior Fixation System (K111076)Medtronic VERTEX® Reconstruction System - K123906NuVasive® VuePoint® OCT System - K093319Synthes Spine Synapse System - K070573, K091689, K141897DePuy Spine MOUNTAINEER® OCT Spinal System - K110353, K132332Stryker Spine OASYS® System - K142741, K111719, K032394Orthofix Inc. Centerion POCT System - K131833LnK Cervical Screw System - K143278
Device Description	The BRIDALVEIL Occipital Cervical Thoracic System is a spinal fixationsystem intended to stabilize the uppermost portion of the spine duringthe fusion process. The system contains a wide variety of implants andinstruments which allows for the transition across multiple spinalsegments: Occipital Plate with Screws, Cervical Polyaxial Screws, LaminarHooks, Cross Connectors, Rod Connectors, and Rods manufactured fromTi6Al4V ELI (ASTM F136) and cobalt chrome alloy (ASTM F1537).
Materials	Ti-6Al-4V ELI (ASTM F136)CoCrMo alloy (ASTM F1537)Elgiloy CoCrNi alloy (ASTM F1058)Nitinol #1 (ASTM E2063)
Substantial EquivalenceClaimed to PredicateDevices	The BRIDALVEIL Occipital Cervical Thoracic System is substantiallyequivalent to the predicate devices in terms of intended use, design,materials used, mechanical safety and performances.
Indications for Use	The BRIDALVEIL Occipital Cervical Thoracic System is intended to provideimmobilization and stabilization of spinal segments as an adjunct tofusion for the following acute and chronic instabilities of thecraniocervical junction, the cervical spine (C1 to C7) and the thoracicspine from T1-T3: traumatic spinal fractures and/or traumaticdislocations; instability or deformity; failed previous fusions (e.g.,pseudarthrosis); tumors involving the cervical spine; and degenerativedisease, including intractable radiculopathy and/or myelopathy, neckand/or arm pain of discogenic origin as confirmed by radiographicstudies, and degenerative disease of the facets with instability.The BRIDALVEIL Occipital Cervical Thoracic System is also intended torestore the integrity of the spinal column even in the absence of fusionfor a limited time period in patients with advanced stage tumors involvingthe cervical spine in whom life expectancy is of insufficient duration topermit achievement of fusion.In order to achieve additional levels of fixation, the BRIDALVEIL OccipitalCervical Thoracic System may be connected to the OLYMPIC PosteriorSpinal Fixation System rods and connectors. Transition rods with differingdiameters may also be used to connect the BRIDALVEIL Occipital CervicalThoracic System to the OLYMPIC Posterior Spinal Fixation System. Referto the OLYMPIC Posterior Spinal Fixation System package insert forinstructions for use and indications for use.
Non-clinical TestSummary	The following analyses were conducted:● Static Compression Bending – ASTM F1717● Dynamic Compression Bending – ASTM F1717● Static Torsion - ASTM F1717● Static Compression Bending – ASTM F2706● Dynamic Compression Bending - ASTM F2706● Static Torsion - ASTM F2706● Dynamic Torsion – ASTM F2706● Static Axial Grip – ASTM F1798● Static Torsional Grip - ASTM F1798● Static Transverse Moment – ASTM F1798The results of these evaluations indicate that the BRIDALVEIL OccipitalCervical Thoracic System is equivalent to the predicate devices.
Clinical Test Summary	No clinical studies were performed
Conclusions: Non-Clinicaland Clinical	Astura Medical considers the BRIDALVEIL Occipital Cervical ThoracicSystem to be equivalent to the predicate devices listed above. Thisconclusion is based upon the devices' similarities in principles ofoperation, technology, materials, and indications for use.

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

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Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.