(139 days)
Foundation™ Cervical Interbody Devices 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 radiographic studies. Foundation™ Cervical implants 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. 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 discogenc ne inn 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). Fourdation™ Lumbar implants are to be used with autogenous bone graft and implanted via an open anterior or posterior approach. Foundation™ Lumbar implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The interbody fusion with autogenous bone graft solves and provides a logical solution for discal diseases once the movement of the vertebral segment is eliminated. The theoretical principles of the interbody cages are based on the following foundations:
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Mechanical function, allows restoration of the intervertebral disc height and immediate 1. stability of the mobile segments.
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Biological function, related to the autogenous bone graft introduction into and around 2. the cage, facilitates the interbody fusion.
The posterior Foundation Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Posterior Lumbar Interbody Fusion (PLIF).
The anterior Foundation Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Anterior Lumbar Interbody Fusion (ALIF),
The Foundation Cervical cage is a trapezoidal shape footprint for central placement in the vertebral body from an anterior approach.
Materials:
PEEK Optima® conforming to ASTM F2026
This 510(k) summary for the Foundation Interbody Devices (K073446/K073440) does not describe a study involving software performance or AI evaluation.
Instead, it details a medical device (intervertebral body fusion device), its intended use, materials, and substantial equivalence to previously marketed devices. The "Summary of Nonclinical Tests" section refers to mechanical strength testing of the physical implant, not a clinical study to evaluate diagnostic or therapeutic performance in a human population, nor any AI or software component.
Therefore, I cannot fulfill your request for information about acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, or MRMC studies, as these aspects are not present in the provided document for this type of medical device submission.
The only "acceptance criteria" mentioned in the document relate to the physical device's mechanical properties:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Mechanical Strength) | Reported Device Performance |
|---|---|
| Meet required mechanical strengths | Tests performed according to ASTM F2077 indicate that the Foundation Interbody Devices meet required mechanical strengths. |
The rest of the requested information is not applicable or available in the provided text, as it pertains to AI/software evaluation studies, which are not described for this physical interbody fusion 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.