The Half Dome Posterior Lumbar Interbody System are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to LS-S1. DDD is defined as discogenic with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Device Description

The Half Dome Posterior Lumbar Interbody TLIF and OTLIF are implants developed for the substitution of the classical autogenous bone graft blocks. They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). X-ray markers allow the position to be determined post-op.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Half Dome Posterior Lumbar Interbody System. It describes the device, its intended use, and its equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for a diagnostic algorithm.

The information provided is for a physical medical device (an intervertebral body fusion device), not a diagnostic algorithm or AI system. Therefore, the questions related to algorithmic performance metrics, sample sizes, ground truth, experts, and MRMC studies are not applicable to the content of this document.

Here's what can be extracted from the document regarding the "study" for this type of device and its equivalence:

The "study" in this context refers to non-clinical testing to demonstrate mechanical safety and performance, and the "acceptance criteria" are implied by showing the device performs similarly to or better than predicate devices according to established engineering standards.

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

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent or superior mechanical performance to predicate devices	Results indicate equivalence to predicate devices for all tests
Specific Tests Conducted:
Static and Dynamic Compression per ASTM F2077	Passed, equivalent to predicate devices
Subsidence per ASTM F2267	Passed, equivalent to predicate devices

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 specified in the document. For mechanical testing, this would typically refer to the number of physical device samples tested.
Data Provenance: Not applicable in the traditional sense for non-clinical mechanical testing. The tests are performed in a lab setting by the manufacturer (Astura Medical, located in Carlsbad, CA, USA).

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

Not applicable. Ground truth for mechanical testing is based on engineering standards (ASTM F2077, ASTM F2267) and direct measurement of physical properties, not expert consensus on medical images or clinical outcomes.

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

Not applicable. Mechanical test results are objective measurements against established ASTM standards, not subject to adjudication by medical experts.

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 a physical medical device, not a diagnostic algorithm. No MRMC study was performed.

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

Not applicable. This is a physical medical device.

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

For non-clinical mechanical testing, the "ground truth" is defined by adherence to specific engineering standards (e.g., ASTM F2077 for static and dynamic compression, ASTM F2267 for subsidence) and objective measurements of device performance under controlled conditions.

8. The sample size for the training set:

Not applicable. There is no training set as this is not an AI/ML algorithm.

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

Not applicable. There is no training set.

In summary: The provided document is a 510(k) submission for a physical intervertebral body fusion device. The "study" referenced refers to a series of non-clinical mechanical tests to demonstrate the device's safety and performance characteristics and its substantial equivalence to previously cleared predicate devices. It does not involve patient data, clinical outcomes, or AI algorithm performance metrics.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human profiles.

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

January 28, 2016

Astura Medical % Mr. J. D. Webb Authorized Correspondent The Orthomedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K152512

Trade/Device Name: Half Dome Posterior Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 23, 2015 Received: December 28, 2015

Dear Mr. Webb:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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)

K152512

Device Name

Half Dome Posterior Lumbar Interbody 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

K152512 Page 1 of 1

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510(k) Summary: Half Dome Posterior Lumbar Interbody System

Date Prepared	December 10, 2015
Submitted By	Astura Medical5670 El Camino Real, Suite BCarlsbad, CA 92008760-814-8047 Tele
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net
Trade Name	Half Dome Posterior Lumbar Interbody System
Common Name	intervertebral body fusion device
Classification Name	Intervertebral body fusion device - lumbar
Class	II
Product Code	MAX
CFR Section	21 CFR section 888.3080
Device Panel	Orthopedic
Primary PredicateDevice	SEASPINE Pacifica Cage (K082310)
Additional PredicateDevices	Synthes T-PAL Spacer (K100089)DePuy Brantigan I/F Cage (P960025)Surgical Dynamics Ray Threaded Lumbar Fusion Cage (P950019)Spinal Elements Lucent Cage (K071724/K081968)
Device Description	The Half Dome Posterior Lumbar Interbody TLIF and OTLIF are implantsdeveloped for the substitution of the classical autogenous bone graft blocks. Theyare available in a range of footprints and heights to suit the individual pathologyand anatomical conditions of the patient. The implants have a hollow center toallow placement of autogenous bone graft. The superior and inferior surfaces areopen to promote contact of the bone graft with the vertebral end plates, allowingbone growth (arthrodesis). X-ray markers allow the position to be determined post-op.
Materials	Vestakeep® PEEK per ASTM F2026Tantalum per ASTM F560
SubstantialEquivalence Claimedto Predicate Devices	The Half Dome Posterior Lumbar Interbody System is substantially equivalent tothe predicate devices in terms of intended use, design, materials used, mechanicalsafety and performances.
Indications for Use	The Half Dome Posterior Lumbar Interbody System is indicated for intervertebralbody fusion procedures in skeletally mature patients with degenerative discdisease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 toL5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmedby history and radiographic studies. These DDD patients may also have up toGrade I spondylolisthesis or retrolisthesis at the involved level(s). Half Domeimplants are to be used with autogenous bone graft and supplemental fixation.Patients should have at least six (6) months of non-operative treatment prior totreatment with an intervertebral cage.
Non-clinical TestSummary	The following analyses were conducted:• Static and dynamic compression per ASTM F2077• Subsidence per ASTM F2267The results of these evaluations indicate that the Half Dome Posterior LumbarInterbody System is equivalent to predicate devices.
Clinical Test Summary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Astura Medical considers the Half Dome Posterior Lumbar Interbody System to beequivalent to the predicate devices listed above. This conclusion is based uponthe devices' similarities in principles of operation, technology, materials andindications for use

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

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Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.