HALF DOME Posterior Lumbar Interbody System by Astura Medical, LLC

The HALF DOME POSTERIOR LUMBAR INTERBODY SYSTEM is 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 L5-S1. DDD is defined as discogenc pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). HALF DOME SYSTEM implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). 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). The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called the "HALF DOME Posterior Lumbar Interbody System". This type of submission is for demonstrating substantial equivalence to a predicate device, rather than for proving safety and effectiveness through clinical trials with specific acceptance criteria related to device performance in generating data. Therefore, the information requested in your prompt regarding acceptance criteria for a study proving the device meets acceptance criteria is not applicable in the context of this 510(k) submission.

Here's why and what information is available:

510(k) Submissions are for Substantial Equivalence: A 510(k) seeks to demonstrate that the new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and indications for use, and by performing non-clinical (bench) testing. They generally do not involve clinical studies with acceptance criteria for algorithm performance, expert ground truth, or MRMC studies.
"Acceptance Criteria" in a 510(k) context: When the term "acceptance criteria" is used in a 510(k) non-clinical test summary, it refers to pre-defined thresholds for mechanical performance during bench testing (e.g., minimum load required to fail, maximum displacement under load). These tests are designed to show the device performs mechanically similar to or better than the predicate device.

Information provided in the document related to your prompt, adapted for a non-clinical device submission:

Here's a breakdown of the relevant sections from your request, with an explanation of why some are not applicable to this type of regulatory submission:

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

Since this is a mechanical interbody fusion device, the "acceptance criteria" and "reported device performance" are related to non-clinical (bench) testing methods to ensure the physical integrity and function of the implant. The document states:

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Static and Dynamic Compression (ASTM F2077)	Comparable to or exceeding predicate device performance.	"equivalent to predicate devices" with positive results.
Static and Dynamic Shear (ASTM F2077)	Comparable to or exceeding predicate device performance.	"equivalent to predicate devices" with positive results.
Subsidence (ASTM F2267)	Comparable to or exceeding predicate device performance.	"equivalent to predicate devices" with positive results.

Note: The document explicitly states "The results of these evaluations indicate that the Titanium Half Dome implants are equivalent to predicate devices." This implies that the device met the pre-defined criteria for equivalence to the predicate devices in these mechanical tests. Specific numerical acceptance criteria and performance values are typically detailed in the full test reports, which are not included in this summary.

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: Not explicitly stated for each test in this summary. For mechanical bench testing, sample sizes are typically small (e.g., n=5 or n=10 per test condition) and determined by statistical considerations for materials testing.
Data Provenance: The tests are non-clinical, controlled laboratory experiments. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply. The tests were performed by the manufacturer (Astura Medical) or a contracted lab.

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 is a mechanical device, not an AI or diagnostic device that requires expert interpretation to establish ground truth for a test set. The "ground truth" for mechanical testing is derived from physical measurements and material properties.

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

Not Applicable. As there's no expert interpretation for ground truth, there's no adjudication method.

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 device is a surgical implant, not a diagnostic or AI-powered imaging tool that would involve human readers or AI assistance.

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

Not Applicable. This device does not involve an algorithm.

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

Ground Truth: For non-clinical bench testing, the "ground truth" is established through physical measurement standards and engineering specifications. For example, the load at which a device deforms or fractures is a directly measurable physical property, not subject to expert consensus in the same way clinical diagnoses are. The "truth" is defined by the physical laws and material science.

8. The sample size for the training set

Not Applicable. There is no "training set" for this type of mechanical device submission, as it does not involve machine learning algorithms.

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

Not Applicable. As there is no training set, this question is irrelevant.

In summary, the provided document relates to a 510(k) submission for a physical medical device (interbody fusion system), not a diagnostic or AI-powered software device. Therefore, many of the questions asked in your prompt are not applicable to this context, as they pertain to the evaluation of algorithms or diagnostic performance with human interpretation. The "proof" for this device meeting acceptance criteria comes from its performance in standardized mechanical bench tests, demonstrating its equivalence to existing predicate devices.

Summary

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May 3, 2019

Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Astura Medical, LLC Parker Kelch Quality Manager 3186 Lionshead Ave, Suite 100 Carlsbad, California 92010

Re: K182877

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: April 8, 2019 Received: April 9, 2019

Dear Mr. Kelch:

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/cfpmp/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 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

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

For comprehensive regulatory information about medical devices and radiation-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,

For CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 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) K182877

Device Name HALF DOME POSTERIOR LUMBAR INTERBODY SYSTEM

Indications for Use (Describe)

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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510(k) Summary

Date Prepared	October 12, 2018
Submitted By	Astura Medical3186 Lionshead Ave, Suite 100Carlsbad, CA 92010Phone: 760-814-8047
Contact	Parker KelchEmail: quality@asturamedical.com
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	Globus Medical Rise® Intervertebral Body Fusion Device (K113447)
Secondary PredicateDevice	Spinal Elements Lucent Spacer (K071724, K081968)Globus Medical Caliber® Spacers (K102293, K123231)Half Dome Posterior Lumbar Interbody System (K152512, K163481, K172947)
Device Description	The Half Dome Posterior Lumbar Interbody devices are implants developed forthe substitution of the classical autogenous bone graft blocks. The cages assistto avoid complications related to the bone graft donation site (chronic pain,hematoma, infection, bone removal from the donor site making it impossibleto remove bone again, quality of the iliac bone, accessing a healthy donor sitethat may become an unhealthy site, hernias by the incision). They are availablein a range of footprints and heights to suit the individual pathology andanatomical conditions of the patient. The implants have a hollow center toallow placement of autogenous bone graft. The superior and inferior surfacesare open to promote contact of the bone graft with the vertebral end plates,allowing bone growth (arthrodesis). The Half Dome cages are designed to beused in conjunction with supplemental spinal fixation instrumentation.
Materials	Titanium alloy (Ti-6Al-4V ELI) per ASTM F136Nitinol #1 per ASTM F2063
SubstantialEquivalence Claimedto Predicate Devices	The Half Dome Posterior Lumbar Interbody System is substantially equivalentto the predicate devices in terms of intended use, design, materialsused, mechanical safety and performances.
Indications for Use	The Half Dome Posterior Lumbar Interbody System is indicated forintervertebral body fusion procedures in skeletally mature patients withdegenerative disc disease (DDD) of the lumbar spine at one or two contiguouslevels from L1-L2 to L5-S1. DDD is defined as discogenic pain withdegeneration of the disc confirmed by history and radiographic studies. TheseDDD patients may also have up to Grade I spondylolisthesis or retrolisthesis atthe 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 prior to treatment with an intervertebral cage.
Non-clinical TestSummary	The following analyses were conducted:• Static and dynamic compression per ASTM F2077• Static and dynamic shear testing per ASTM F2077• Subsidence per ASTM F2267The results of these evaluations indicate that the Titanium Half Dome implantsare equivalent to predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusion	Astura Medical considers the Half Dome expandable to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices'similarities in principles of operation, technology, materials and indications foruse.

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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.