(169 days)
PATRIOT® COLONIAL® ACDF Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radioulopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated versions.
PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.
When used as cervical intervertebral body fusion devices, SUSTAIN® SUSTAIN® R are intended for one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (0) weeks of non-operative treatment. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated versions.
SUSTAIN® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems.
PATRIOT® COLONIAL® ACDF Spacers are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. PATRIOT® Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
SUSTAIN® Spacers, including SUSTAIN® R, are devices that may be used as cervical intervertebral fusion devices. These spacers are available in different shapes and heights to accommodate various surgical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
The provided text is a 510(k) premarket notification for an intervertebral body fusion device. While it describes the device, its indications for use, and a basis for substantial equivalence, it does not include the detailed information required to answer your specific questions about acceptance criteria and a study proving device performance against those criteria.
Specifically, the document mentions:
- Mechanical testing (static compression-shear and torsion) in accordance with ASTM F2077 to demonstrate substantial equivalence to predicate spacers.
- Bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST72:2011.
- Clinical literature being provided in the submission to support additional indications.
However, it does not provide:
- A table of acceptance criteria and reported device performance. It only states that testing was conducted "to demonstrate substantial equivalence."
- Sample size used for the test set or data provenance for any clinical study.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes.
- Details of a standalone (algorithm-only) performance study. The device is a physical implant, not an AI algorithm.
- The type of ground truth used (e.g., pathology, outcomes data), as no specific clinical study is described in detail.
- Sample size for the training set. There's no mention of a "training set" as this is not an AI/machine learning device.
- How ground truth for the training set was established. (Not applicable for this type of device).
The document is a regulatory submission for a physical medical device (intervertebral body fusion spacers), not an AI/software device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or reader studies with ground truth established by experts.
Therefore, I cannot provide the requested information based on the given input.
§ 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.