(130 days)
The ALTA Anterior Cervical Interbody Spacer is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ALTA Anterior Cervical Interbody Spacer is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The ALTA Anterior Cervical Interbody Spacer was developed as implants for the stabilization of the cervical column. The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy. This device is offered in PEEK OPTIMA LT120HA. The PEEK OPTIMA LT120HA implants have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery. The titanium implants have roughened superior and inferior surfaces to prevent migration of the spacer post implantation.
Here's an analysis of the provided text regarding the ALTA Anterior Cervical Interbody Spacer, focusing on acceptance criteria and supporting studies:
This submission is a 510(k) premarket notification for a medical device (ALTA Anterior Cervical Interbody Spacer), not an artificial intelligence (AI) or machine learning (ML) enabled device. Therefore, the questions related to AI/ML specific criteria (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size) are not applicable.
The acceptance criteria described for this device are based on its mechanical performance and material characteristics, and the study proving it meets these criteria is a non-clinical bench testing study, comparing its performance to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static compression | Must meet or exceed the performance of the predicate devices under static compression testing as defined by ASTM F2077. | "The results of these evaluations indicate that the PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) ALTA Anterior Cervical Interbody Spacer is equivalent to predicate devices." This implies the device met or exceeded the performance of the predicate device/s, satisfying the acceptance criteria. |
| Mechanical Performance | Dynamic compression | Must meet or exceed the performance of the predicate devices under dynamic compression testing as defined by ASTM F2077. | "The results of these evaluations indicate that the PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) ALTA Anterior Cervical Interbody Spacer is equivalent to predicate devices." This implies the device met or exceeded the performance of the predicate device/s, satisfying the acceptance criteria. |
| Mechanical Performance | Static torsion | Must meet or exceed the performance of the predicate devices under static torsion testing as defined by ASTM F2077. | "The results of these evaluations indicate that the PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) ALTA Anterior Cervical Interbody Spacer is equivalent to predicate devices." This implies the device met or exceeded the performance of the predicate device/s, satisfying the acceptance criteria. |
| Mechanical Performance | Dynamic torsion | Must meet or exceed the performance of the predicate devices under dynamic torsion testing as defined by ASTM F2077. | "The results of these evaluations indicate that the PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) ALTA Anterior Cervical Interbody Spacer is equivalent to predicate devices." This implies the device met or exceeded the performance of the predicate device/s, satisfying the acceptance criteria. |
| Mechanical Performance | Subsidence | Must meet or exceed the performance of the predicate devices under subsidence testing as defined by ASTM F2267. | "The results of these evaluations indicate that the PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) ALTA Anterior Cervical Interbody Spacer is equivalent to predicate devices." This implies the device met or exceeded the performance of the predicate device/s, satisfying the acceptance criteria. |
| Material Equivalence | Material Composition | Must use materials equivalent to or deemed acceptable for use in interbody fusion devices (PEEK-OPTIMA LT120HA and Tantalum). The new PEEK-OPTIMA LT120HA material is specifically stated as "added material" and its performance must be equivalent to the predicate's materials. | The device is explicitly made from PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) and Tantalum per ASTM F560, and the conclusion states "similarities in principles of operation, technology, materials and indications for use" with predicate devices. This indicates material equivalence was found. |
| Design Equivalence | Device Design | Must demonstrate equivalence in design features (e.g., trapezoidal footprints, multiple sizes, unidirectional teeth, graft windows, X-ray markers) to predicate devices. | The device description outlines these features, and the conclusion claims "similarities in principles of operation, technology, materials and indications for use" with predicate devices, implying design equivalence. |
| Intended Use | Indications for Use | Must share the same indications for use as the predicate devices: intervertebral body fusion for cervical disc degeneration/instability at C2-T1, with supplemental fixation and bone graft. | The stated "Indications for Use" for the ALTA Anterior Cervical Interbody Spacer are identical to those of the 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: Not explicitly stated regarding the number of devices or tests performed. For non-clinical bench testing, typically a statistically significant number of samples are tested to ensure robustness and reproducibility of results for each test (e.g., static compression, dynamic cyclic loading, etc.). The document indicates "analyses were conducted" without specifying the number of units per analysis.
- Data Provenance: Not applicable in the context of human data. This refers to non-clinical bench testing conducted in a laboratory setting.
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 as typically defined for AI/ML (e.g., expert consensus on medical images) is not relevant for this type of mechanical device testing. The "ground truth" for these tests are the established ASTM standards and the verified performance of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for resolving disagreements among human experts in AI/ML performance evaluation studies. This is a non-clinical bench testing study.
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, an MRMC comparative effectiveness study was not done. This device is an interbody spacer, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is based on adherence to recognized industry standards (ASTM F2077, ASTM F2267, ASTM F560 for materials) and demonstrated mechanical equivalence to legally marketed predicate devices. The performance of the predicate devices, which have already undergone FDA clearance, serves as the benchmark for "truth."
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 that requires a training set.
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February 27, 2018
Astura Medical Mr. Thomas Purcell Vice President 3186 Lionshead Ave, Suite 100 Carlsbad, California 92010
Re: K173324
Trade/Device Name: ALTA Anterior Cervical Interbody Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 10, 2017 Received: December 15, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Katherine D. Kavlock -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) K173324
Device Name
ALTA Anterior Cervical Interbody Spacer
Indications for Use (Describe)
The ALTA Anterior Cervical Interbody Spacer is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ALTA Anterior Cervical Interbody Spacer is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: ALTA ANTERIOR CERVICAL INTERBODY SPACER
PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced)
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | January 31st 2018 |
|---|---|
| Submitted By | Astura Medical |
| 3186 Lionshead Ave, Suite 100 | |
| Carlsbad, CA 92010 | |
| Phone: 760-814-8047 | |
| Contact | Thomas Purcell |
| 3186 Lionshead Ave, Suite 100 | |
| Carlsbad, CA 92010 | |
| Phone: 760-814-8047 | |
| Email: thomas@asturamedical.com | |
| Trade Name | ALTA Anterior Cervical Interbody Spacer |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral Body Fusion Device With Bone Graft, Cervical |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate Device | Astura Medical ALTA Anterior Cervical Interbody Spacer (K160154) |
| Additional PredicateDevice(s) | SpineFrontier Incorporated, Arena-C HA PEEK Cervical Intervertebral BodyFusion Device (K142026), NuVasive® CoRoent® Small Interbody System(K163491) |
| Device Description | The ALTA Anterior Cervical Interbody Spacer was developed as implantsfor the stabilization of the cervical column. The devices have trapezoidalfootprints and multiple sizes to accommodate patient anatomy. Thisdevice is offered in PEEK OPTIMA LT120HA. The PEEK OPTIMA LT120HAimplants have unidirectional teeth on both of their inferior and superiorsurfaces to prevent migration/expulsion, and graft windows which helpfacilitate bony integration. X-ray markers are integrated for visualizationof the implants during and after surgery. The titanium implants haveroughened superior and inferior surfaces to prevent migration of thespacer post implantation. |
| Materials | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227 (addedmaterial)Tantalum per ASTM F560 |
| Substantial EquivalenceClaimed to PredicateDevices | The PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) ALTA AnteriorCervical Interbody Spacer are substantially equivalent to the predicatedevices in terms of intended use, design, material, and mechanical safetyand performances. |
| Indications for Use | The ALTA Anterior Cervical Interbody Spacer is indicated forintervertebral body fusion of the spine in skeletally mature patients. TheALTA Anterior Cervical Interbody Spacer is intended for use for anteriorcervical interbody fusion in patients with cervical disc degenerationand/or cervical spinal instability, as confirmed by imaging studies(radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/orpain at multiple contiguous levels from C2 - T1. The System is intended tobe used with supplemental fixation. The System is designed for use withautogenous and/or allogeneic bone graft comprised of cancellous and/orcorticocancellous bone graft to facilitate fusion. |
| 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 PEEK-OPTIMA LT120HA(PEEK-OPTIMA HA Enhanced) ALTA Anterior Cervical Interbody Spacer isequivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinicaland Clinical | Astura Medical considers the PEEK-OPTIMA LT120HA (PEEK-OPTIMA HAEnhanced) ALTA Anterior Cervical Interbody Spacer to be equivalent tothe predicate devices listed above. This conclusion is based upon thedevices' similarities in principles of operation, technology, materials andindications for use. |
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§ 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.