(115 days)
When used as an Intervertebral Body Fusion System:
The T-Space Spinal Implant System are indicated 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 of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The AIS T-Space Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The AIS T-Space Spinal Implant System implants can be used individually or in pairs. The AIS T-Space Spinal Implant System is also intended for use 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 Aesculap device.
The T-Space Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The implants are offered in a coated and uncoated version and a variety of shapes and sizes to meet the requirements of the individual patient anatomy. The uncoated PEEK version is manufactured from PEEK - Optima (per ASTM F2026). The coated version will be the same in design as the uncoated PEEK implant with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have tantalum radiographic markers per ASTM F-560.
I'm sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, including details like sample sizes, data provenance, expert qualifications, and MRMC study information.
Here's why:
- The document is a 510(k) Premarket Notification from the FDA. This type of document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific, novel acceptance criteria through a full clinical trial or detailed performance study.
- The "Performance Data" section (page 5) describes non-clinical (mechanical) testing, not a clinical study. It lists various ASTM standards for static and dynamic mechanical properties, as well as coating-related tests. These tests are designed to show that the new device performs at least as well as, or exceeds the performance of, the predicate devices in these physical characteristics.
- Missing Information: The document does not contain the following information you requested, as it is generally not part of a 510(k) summary for devices demonstrating substantial equivalence through non-clinical testing:
- Specific acceptance criteria beyond "meets or exceeds the performance of the predicate devices" in mechanical tests.
- Sample sizes for test sets in a clinical context.
- Data provenance (country of origin, retrospective/prospective for clinical data).
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study details.
- Standalone algorithm performance (as this is a physical implant, not an algorithm).
- Type of ground truth used (pathology, outcomes data, etc.).
- Training set sample size (for an AI/algorithm).
- How ground truth for a training set was established (for an AI/algorithm).
In summary, the provided text describes mechanical performance testing to demonstrate substantial equivalence of a spinal implant to predicate devices, not a clinical study with acceptance criteria related to patient outcomes or a study involving AI/algorithms or human readers.
§ 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.