(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.
§ 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.