(231 days)
The PATHWAY AVID intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have Grade I Spondylolisthesis at involved levels. The patients may have had a previous non-fusion spinal surgery at the involved level(s).
The device is intended to be used with supplemental fixation systems that have been cleared for the lumbosacral spine (i.e. posterior pedicle screws and rod systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted from a transforaminal approach (TLIF).
The proposed modification subject device is to be provided to the users in one of two configurations: the predicate device containing PEEK Optima LT1with titanium hinges and linkages (Ti-6Al-4V, ASTM F136) or the proposed PEEK Optima LT1 with MP35N (Co-Cr-Ni-Mo Alloy, ASTM F562).
Here's an analysis of the provided text regarding the acceptance criteria and study for the PATHWAY AVID device, conforming to your requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Proving Performance |
|---|---|---|---|
| Mechanical Strength | Equivalence in tensile strength of linkages and hinge pins. | "mechanical data indicates that the linkage and hinge pins with the proposed modification show equivalence to the titanium linkages and hinge pins of the predicate." | Tensile testing comparing the predicate device (K090566) and the modified device. |
| Failure Mode | Failure should occur in the PEEK spacer, not the linkages or hinge pins. | "Previous mechanical testing conducted on the predicate (K090566) demonstrated that the failure modes were in the PEEK spacer, and not the linkage or hinge pins." | Previous mechanical testing on predicate device (K090566). |
| Corrosion Resistance | Acceptable corrosion resistance. | "The data demonstrates that these devices display acceptable corrosion resistance in the ASTM F 2129 test." | Corrosion testing performed in accordance with ASTM F 2129-08. (Full report in Section 2 of deficiency letter response). |
Note: This document is a 510(k) summary for a modification to an existing device. The acceptance criteria and performance data are primarily focused on demonstrating substantial equivalence to the predicate device, rather than proving de novo clinical efficacy or specific accuracy metrics.
Here's a breakdown of the other requested information based on the provided text. Many of these points are not applicable or explicitly stated in a 510(k) summary for a device modification, which focuses on engineering and material equivalence:
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 for Test Set: Not explicitly stated in terms of number of devices tested, but implied to be sufficient for mechanical and corrosion testing. Specific numbers of units are not provided.
- Data Provenance: Not specified. Standard practice for such tests is in a laboratory setting.
- Retrospective or Prospective: Not applicable for engineering bench testing.
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. The "ground truth" for these tests are objective measurements based on engineering standards (tensile strength, corrosion). No human experts are used to interpret the results in the same way as they would for medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to human interpretation/review, not objective engineering tests.
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. This is a medical device (intervertebral body fusion device), not an AI/software device. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For mechanical testing, the ground truth is defined by the objective physical properties and performance under specific force/environmental conditions. For corrosion testing, the ground truth is determined by electrochemical measurements according to ASTM F 2129-08 standards.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device. The "training set" concept is not relevant.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 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.