(88 days)
Valeo II Interbody Fusion Devices - Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level.
DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. Valeo II Interbody Fusion Devices-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Valeo II Interbody Fusion Devices-Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Valeo II Interbody Fusion Devices-Lumbar are indicated for use with autograft bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo II Interbody Fusion Devices-Lumbar are intended to be used with supplemental spinal fixation systems, such as the Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
The Valeo II Interbody Fusion Device consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is offered in various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from to 22mm in height and 14mm to 34mm in length.
This document describes the premarket notification (510(k)) for the Valeo II Interbody Fusion Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for a new clinical indication. Therefore, many of the requested categories for AI/ML device studies are not directly applicable.
Here's an analysis based on the provided text, addressing the closest relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present clinical acceptance criteria in terms of accuracy, sensitivity, or specificity for diagnostic or prognostic tasks. Instead, the acceptance criteria are met by demonstrating the device's mechanical and biological equivalence to a legally marketed predicate device.
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ASTM F2077-11 (Standard Test Methods for Intervertebral Body Fusion Devices) | |
| Static Compression | Meet performance requirements comparable to the predicate device (Phantom Plus Ceramic Cage System K121892). The specific numerical criteria are not detailed in this summary but would be defined by the standard and equivalence to the predicate. | Pass |
| Dynamic Compression | Meet performance requirements comparable to the predicate device. | Pass |
| Static Torsion | Meet performance requirements comparable to the predicate device. | Pass |
| Dynamic Torsion | Meet performance requirements comparable to the predicate device. | Pass |
| Biocompatibility | ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | |
| Cytotoxicity | ISO 10993-5:2009 (Tests for in vitro cytotoxicity): Demonstrate no unacceptable cytotoxic effects. | Pass (MEM/ISO Elution Test, Neural Cytotoxicity) |
| Sensitization | ISO 10993-10:2010 (Tests for irritation and skin sensitization): Demonstrate no unacceptable sensitization. | Pass (Maximization Sensitization) |
| Irritation | ISO 10993-10:2010: Demonstrate no unacceptable irritation. | Pass (ISO Intracutaneous Irritation Study in Rabbits) |
| Systemic Toxicity | ISO 10993-11:2006 (Tests for systemic toxicity): Demonstrate no unacceptable adverse systemic effects. | Pass (Mutagenicity ISO Systemic Toxicity Study in Mice) |
| Genotoxicity | ISO 10993-3:2003 (Tests for genotoxicity, carcinogenicity and reproductive toxicity): Demonstrate no unacceptable genotoxic effects. | Pass (Bacterial Reverse Mutation, Genotoxicity (Mouse Lymphoma), Mouse Peripheral Blood Micronucleus Study) |
| Material/Design | The device is manufactured using similar processes and has the same intended use as the predicate device, with comparable materials and design features (e.g., hollow vertebral body spacers, convex, bullet nose design, axial void, angular teeth for expulsion resistance) and dimensions (22mm in height, 14mm to 34mm in length) that ensure equivalence to the predicate. The "material change" is supported by testing that demonstrates the device meets the same performance requirements as the predicate and raises no new biocompatibility concerns. | The Valeo II device exhibited "Pass" results for all listed mechanical and biocompatibility tests, indicating it meets the relevant standards and is comparable to the predicate device. The conclusion states "The Valeo II Interbody Fusion device has the same intended use, comparable performance, and is manufactured using similar processes." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes non-clinical performance and biocompatibility testing for a medical implant device, not a data-driven AI/ML diagnostic or prognostic device.
- Test Set Sample Size: Not applicable in the context of clinical data for AI/ML. The "sample size" for mechanical testing refers to the number of devices or iterations tested per condition (e.g., for static compression, dynamic compression, etc.), and for biocompatibility, it refers to the number of animals or cell cultures used for in vitro/in vivo tests. These specific numbers are not provided in the summary but would be detailed in the full test reports.
- Data Provenance: Not applicable in the context of clinical data. The tests are conducted according to international standards (ASTM, ISO).
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 the mechanical and biological safety testing of an interbody fusion device. The "ground truth" here is the established performance requirements of the relevant ASTM and ISO standards for mechanical properties and biocompatibility.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies involving interpretation (e.g., image reading). The testing performed here (mechanical and biocompatibility) involves objective measurements against established standards.
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 a 510(k) submission for an interbody fusion device, not an AI/ML diagnostic aid. No MRMC study was conducted or is relevant to this device's regulatory pathway.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for an AI/ML context. The "ground truth" for the device's performance is adherence to:
- Mechanical Standards: ASTM F2077-11 for static and dynamic compression/torsion.
- Biocompatibility Standards: ISO 10993 series (ISO 10993-5, 10993-10, 10993-11, 10993-3).
- Predicate Device Performance: Demonstrating "comparable performance" to the Phantom Plus Ceramic Cage System (K121892).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set" or corresponding ground truth establishment in that context.
§ 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.