The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral body replacement in the cervical spine (C3-C7) in skeletally mature patients. The Alta Anterior Cervical Corpectomy Spacer is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The 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 expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

Device Description

The ALTA Anterior Cervical Corpectomy Spacer is a vertebral body replacement system manufactured from PEEK-OPTIMA LT120HA (HA PEEK) or titanium alloy (Ti6Al4VELI). The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy and graft windows to help facilitate bony integration. The HA PEEK spacers have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion and X-ray markers in the form of tantalum pins. The titanium alloy spacers have roughened superior and inferior surfaces to prevent migration/expulsion.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the ALTA Anterior Cervical Corpectomy System. It is a submission for substantial equivalence to legally marketed predicate devices, not for a new AI/ML-based diagnostic or assistive technology requiring extensive clinical performance studies with human readers.

Therefore, many of the requested details, such as "acceptance criteria for device performance" in the context of an AI study, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details, are not applicable to this specific submission as it pertains to a physical orthopedic implant device.

The relevant information from the document pertains to the device's physical and mechanical performance, not its diagnostic or interpretative accuracy.

Here's a breakdown of the applicable information based on the provided document, addressing the relevant parts of your request and noting what is not applicable:

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

Since this is a physical implant, the "acceptance criteria" are related to mechanical and material properties, and the "reported device performance" refers to the results of non-clinical (bench) testing.

Acceptance Criteria (Relevant to physical device)	Reported Device Performance
Meet Static and Dynamic Compression per ASTM F2077	Results indicate equivalence to predicate devices.
Meet Static and Dynamic Torsion per ASTM F2077	Results indicate equivalence to predicate devices.
Meet Subsidence per ASTM F2267	Results indicate equivalence to predicate devices.
Biocompatibility of materials (PEEK-OPTIMA LT120HA, Tantalum, Ti-6Al-4V ELI)	Materials are standard for implants and comply with relevant ASTM and MAF standards.
Designed to accommodate patient anatomy and facilitate bony integration.	Devices have trapezoidal footprints and multiple sizes; HA PEEK spacers have unidirectional teeth and X-ray markers; titanium alloy spacers have roughened surfaces to prevent migration/expulsion.
Intended to restore spinal column integrity and facilitate fusion.	Design features (graft windows, surface treatments) are incorporated for these functions.

2. Sample sizes 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: This is not applicable in the context of an AI/ML test set. For physical device testing, "samples" refer to the number of devices or test coupons subjected to mechanical testing. The document states "The following analyses were conducted," implying standard mechanical testing as per the ASTM standards. The exact number of test samples (e.g., number of implants tested per condition for compression, torsion, subsidence) is not explicitly provided in this summary but would be detailed in the full test reports referenced by the ASTM standards.
Data Provenance: Not applicable in the context of clinical patient data as no clinical studies were performed. The "data" comes from bench testing of the physical devices.

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)

This question is not applicable. The "ground truth" for a physical orthopedic implant is established by engineering specifications, material standards, and biomechanical testing standards (e.g., ASTM F2077, ASTM F2267). It does not involve human expert consensus on medical images or diagnoses.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth by reconciling discrepancies among human readers/experts. For a physical device's mechanical testing, there is no such adjudication process.

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 question is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human interpretation. This submission is for a physical implant, not a diagnostic or AI-assisted system.

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

This question is not applicable. This refers to the performance of an AI algorithm in isolation. The product is a physical implant.

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

For the non-clinical testing of this physical device, the "ground truth" is defined by engineering specifications, material properties, and relevant ASTM (American Society for Testing and Materials) standards (e.g., ASTM F2077 for compression/torsion and ASTM F2267 for subsidence) which dictate acceptable performance characteristics for spinal implants.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

This question is not applicable. There is no "training set."

Summary of Device Performance Study:

The study proving the device meets its acceptance criteria is a non-clinical bench testing program.

Tests Conducted: Static and dynamic compression per ASTM F2077, Static and dynamic torsion per ASTM F2077, and Subsidence per ASTM F2267.
Results: The results of these evaluations indicated that the ALTA Corpectomy implants are equivalent to predicate devices.
Clinical Studies: No clinical studies were performed as substantial equivalence was demonstrated through non-clinical testing and comparison to legally marketed predicate devices.

Summary

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October 24, 2019

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

Re: K190426

Trade/Device Name: ALTA Anterior Cervical Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR Dated: October 10, 2019 Received: October 10, 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/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 Ronald P. Jean, PhD Director (Acting) DHT6B: Division of Spinal Devices 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)

K190426

Device Name ALTA Anterior Cervical Corpectomy 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 10, 2019
Submitted By	Astura Medical3186 Lionshead Ave, Suite 100Carlsbad, CA 92010Phone: 760-814-8047
Contact	Parker KelchEmail: quality@asturamedical.com
Trade Name	ALTA Anterior Cervical Corpectomy Spacer
Common Name	vertebral body replacement device
Classification Name	vertebral body replacement device – cervical
Class	II
Product Code	PLR
CFR Section	21 CFR section 888.3060
Device Panel	Orthopedic
Primary PredicateDevice	NuVasive Monolith Cervical Corpectomy System (K180550)
Secondary PredicateDevice	ALTA Anterior Cervical Interbody Spacer (K160154, K173324)
Device Description	The ALTA Anterior Cervical Corpectomy Spacer is a vertebral body replacementsystem manufactured from PEEK-OPTIMA LT120HA (HA PEEK) or titanium alloy(Ti6Al4VELI). The devices have trapezoidal footprints and multiple sizes toaccommodate patient anatomy and graft windows to help facilitate bonyintegration. The HA PEEK spacers have unidirectional teeth on both of theirinferior and superior surfaces to prevent migration/expulsion and X-ray markersin the form of tantalum pins. The titanium alloy spacers have roughenedsuperior and inferior surfaces to prevent migration/expulsion.
Materials	PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227 (addedMaterial)Tantalum per ASTM F560Titanium alloy (Ti-6Al-4V ELI) per ASTM F136
SubstantialEquivalence Claimedto Predicate Devices	The ALTA Anterior Cervical Corpectomy System is substantially equivalent tothe predicate devices in terms of intended use, design, materialsused, mechanical safety and performances.
Indications for Use	The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral bodyreplacement in the cervical spine (C3-C7) in skeletally mature patients. TheAlta Anterior Cervical Corpectomy Spacer is intended to replace a diseased ordamaged vertebral body caused by fracture, osteomyelitis, or tumor, or forreconstruction following corpectomy performed to achieve decompression ofthe spinal cord and neural tissues in cervical degenerative disorders. TheSystem is intended to be used with supplemental fixation that has beencleared by the FDA for use in the cervical spine. The System is designed for usewith autogenous and/or allogeneic bone graft comprised of cancellous and/or
	corticocancellous bone graft as an adjunct to fusion. The System is alsointended to restore the integrity of the spinal column even in the absence offusion for a limited time period in patients with advanced stage tumorsinvolving the cervical spine in whom life expectance is of insufficient durationto permit achievement of fusion, with bone graft used at the surgeon'sdiscretion.
Non-clinical TestSummary	The following analyses were conducted:● Static and dynamic compression per ASTM F2077● Static and dynamic torsion per ASTM F2077● Subsidence per ASTM F2267The results of these evaluations indicate that the Alta Corpectomy implantsare equivalent to predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-Clinical and Clinical	Astura Medical considers the ALTA Anterior Cervical Corpectomy Spacer to beequivalent to the predicate devices listed above. This conclusion is based uponthe devices' similarities in principles of operation, technology, materialsand indications for use.

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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.