(135 days)
Foundation™ Cervical Interbody Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical some with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by pairent history and radies. Foundation™ Cervical implants are used to facilitate interverebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation Cervical implants 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
The Foundation™ Lumbar Interbody Devices are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Foundation™ Interbody Devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the graft donation site. They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).
The changes to the Foundation™ Interbody Devices cleared in K0733440 and included in this Special 510(k) are:
• Removal of specific surgical approaches for the lumbar devices
• Addition of additional sizes and configurations
The provided text is a 510(k) premarket notification for the "Foundation™ Interbody Devices." It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information (like specific performance acceptance criteria, test set details, expert ground truth adjudication, MRMC studies, and standalone algorithm performance) is not applicable or available in this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify performance acceptance criteria in terms of clinical outcomes or diagnostic accuracy, as it is a 510(k) submission for a physical medical device (an intervertebral body fusion device). The "performance" being evaluated here is primarily related to mechanical safety, materials, and functional equivalence to existing devices.
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance |
|---|---|
| Material Equivalence | Uses Invibio® PEEK Optima LT1 (ASTM F2026) and Tantalum (ASTM F560), which are standard materials for such implants and claimed to be substantially equivalent to predicate devices. |
| Design Equivalence | Available in a range of footprints and heights; hollow center for bone graft; superior and inferior surfaces open for bone growth. Changes from predicate (K0733440) include removal of specific surgical approaches for lumbar devices and addition of sizes/configurations. Claimed to be substantially equivalent to predicate devices. |
| Mechanical Safety/Performance | Finite Element Analysis for bone graft area, contact with endplates, graft volume, and cross-sectional area. Results indicate equivalence to predicate devices. |
| Intended Use Equivalence | Indications for Use (Cervical and Lumbar DDD with supplemental fixation) are comparable to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No clinical test set involving patients or data for measuring diagnostic/clinical performance was used in this 510(k) summary. The "test set" for this device's evaluation primarily consisted of engineering analyses (Finite Element Analysis) and material characterization.
- Data Provenance: Not applicable. The evaluations were non-clinical, involving engineering simulations and material specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. As no clinical data or diagnostic performance was being evaluated, there was no need for expert ground truth establishment in this context. The "ground truth" for material properties and mechanical performance would be based on established engineering standards and material science data.
4. Adjudication Method for the Test Set
- Not applicable. No expert adjudication method was employed as there was no clinical test set requiring interpretation or consensus on outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This evaluation is for a physical orthopedic implant, not an AI or diagnostic imaging device that would typically undergo MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical implant and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is implicitly based on engineering standards, material specifications (ASTM F2026, ASTM F560), and the established performance and safety profiles of the predicate devices. The device's substantial equivalence is a regulatory judgment based on these data points, not on clinical outcomes or pathology.
8. The Sample Size for the Training Set
- Not applicable. No machine learning algorithm or AI was involved, so there was no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there was no training set, no ground truth needed to be established for it.
§ 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.