(106 days)
SPIRA®-P Posterior Lumbar Spacers are lumbar interbody fusion devices indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-P Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.
SPIRA®-T Oblique Posterior Lumbar interbody fusion devices indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-T Oblique Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.
SPIRA Posterior Lumbar Spacers (SPIRA-P Open Matrix PLIF, SPIRA-T Oblique Open Matrix TLIF) are lumbar interbody fusion devices used to provide structural stability following discectomy. SPIRA Posterior Lumbar Spacers have different shapes to accommodate posterior and transforaminal approaches.
The provided text describes a 510(k) premarket notification for SPIRA®-T Oblique Posterior Lumbar Spacers and SPIRA®-P Posterior Lumbar Spacers. This is a submission to demonstrate substantial equivalence to previously cleared devices, not a study evaluating an AI/ML-based device. Therefore, the detailed information typically requested for AI/ML device performance (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.
The document discusses mechanical performance testing of intervertebral body fusion devices, not the diagnostic performance of an imaging AI.
Here's the information that can be extracted regarding the acceptance criteria and proof of mechanical performance for this physical device:
Acceptance Criteria and Device Performance (Mechanical Testing)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Defined by predicate device performance (specifically Globus HEDRON Lumbar Spacers (K191391) and other referenced predicates). | The results demonstrate that the acceptance criteria defined by predicate device performance were met. |
| Specific tests: Static compression-static compression-shear, dynamic compression, dynamic compression-shear, and subsidence per ASTM F2077-18 and F2267-04. | Testing performed indicated that the SPIRA Posterior Lumbar Spacers are as mechanically sound as predicate devices. |
The study described in this document is a series of mechanical performance tests, not a clinical study involving human readers or an AI algorithm.
Therefore, most of the specific questions regarding AI/ML device performance metrics (sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set details) are not relevant or answerable from the provided text, as the device is a physical medical implant, not a software 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.