(63 days)
The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.
The Vault ALIF System consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and autogenous bone graft size. All components are manufactured from medical grade polyetheretherketone (PEEK LT1).
The request asks for acceptance criteria and study details for the provided text, however, the text describes a medical device (Vault ALIF System) and its 510(k) summary, not a study evaluating an AI/ML device against acceptance criteria. Therefore, most of the requested information is not applicable.
Here's an analysis of what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated as specific performance metrics and thresholds in the context of an AI/ML device. For this physical medical device, the acceptance criteria are inherent in demonstrating "substantial equivalence" to a predicate device, primarily through non-clinical mechanical testing.
- Reported Device Performance: The document states that the "results of this testing indicate that the Redesigned Vault ALIF System is equivalent to predicate device." Specific numerical performance metrics (e.g., stiffness values, fatigue cycles) are not provided in this summary.
| Acceptance Criteria (Implicit for Substantial Equivalence via Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Mechanical equivalence to predicate device based on: |
- Dynamic axial compression per ASTM F2077
- Dynamic shear compression per ASTM F2077 | The Redesigned Vault ALIF System is equivalent to the predicate device in terms of dynamic axial compression and dynamic shear compression. Specific numerical results are not provided in this summary. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document describes a physical medical device (intervertebral body fusion device), not an algorithm or AI/ML device that would use a "test set" of data. The "testing" referred to is mechanical testing of the physical implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This pertains to an AI/ML medical device and ground truth establishment, which is not described in this document.
4. Adjudication method for the test set:
- Not Applicable. Pertains to an AI/ML medical device, not a physical implant.
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 relevant for AI/ML diagnostic or assistive devices, not for a physical surgical implant. The document explicitly states: "No clinical studies were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This refers to AI/ML algorithm performance, which is not the subject of this 510(k) summary.
7. The type of ground truth used:
- Not Applicable. Pertains to an AI/ML medical device. For this physical device, the "ground truth" related to its performance is established through standardized mechanical testing (ASTM F2077) and comparison to a legally marketed predicate device.
8. The sample size for the training set:
- Not Applicable. This applies to AI/ML algorithms, not a physical medical device.
9. How the ground truth for the training set was established:
- Not Applicable. This applies to AI/ML algorithms, not a physical medical device.
Summary of Device and Study Information from the Text:
- Device Name: Vault ALIF System (Redesigned)
- Device Type: Intervertebral Body Fusion Device with Integrated Fixation, Lumbar (Physical implant)
- Purpose of Submission: Special 510(k) for a redesigned system.
- Substantial Equivalence to Predicate: Spinal USA Vault ALIF System - K103369
- Basis for Equivalence: Intended use, design, mechanical safety and performances, materials, packaging, and sterilization methods.
- Non-Clinical Tests Performed:
- Dynamic axial compression per ASTM F2077
- Dynamic shear compression per ASTM F2077
- Test Results: Indicate the Redesigned Vault ALIF System is equivalent to the predicate device.
- Clinical Tests: None performed.
- Ground Truth (for substantial equivalence): Established through non-clinical mechanical testing and comparison of results to a legally marketed predicate device, demonstrating mechanical equivalency as per FDA guidelines for intervertebral body fusion devices.
§ 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.