(143 days)
PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, TransContinental® and TransContinental® M Spacers) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, and TransContinental® and TransContinental® M Spacers) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. The Constitution® PLIF Spacer is inserted using a posterior approach. The Signature® TLIF Spacer is inserted using a transforaminal approach. The Continental® ALIF Spacer is inserted using an anterior approach. The Transcontinental® and Transcontinental® M Spacers are inserted using an anterior or lateral approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
PATRIOT® Spacers are made from PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). The Signature® R Spacer also includes an internal titanium alloy or commercially pure titanium (ASTM F67) component, and the TransContinental® M Spacer also includes an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium. The titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295).
The provided text describes a 510(k) submission for PATRIOT® Spacers, which are intervertebral body fusion devices. The submission aims to gain clearance for additional spacers and sterile lumbar PATRIOT® spacers. The study presented is a confirmatory static compression testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| In accordance with ASTM F2077-03 | Subject device met all acceptable criteria |
The document states, "Confirmatory static compression testing was conducted in accordance with ASTM F2077-03 with the subject device meeting all acceptable criteria." This indicates that the acceptance criteria were defined by the ASTM F2077-03 standard, and the device successfully met those criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text only mentions "confirmatory static compression testing" without specifying the number of samples or whether the data was retrospective or prospective, or its country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of study. The study involves mechanical testing (static compression testing), not clinical or diagnostic evaluation requiring expert review of medical data. The "ground truth" here is the performance metrics defined by the ASTM standard.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human interpretation or adjudication involved in static compression testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This study is a mechanical test for substantial equivalence, not a clinical study involving human readers and AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not an algorithm-based device. PATRIOT® Spacers are physical medical devices (intervertebral body fusion devices), and the testing described is mechanical performance testing, not software or AI algorithm testing.
7. The Type of Ground Truth Used
The ground truth used for this study is the performance specifications and criteria outlined in the ASTM F2077-03 standard for static compression testing of intervertebral body fusion devices.
8. The Sample Size for the Training Set
This information is not applicable as this is a mechanical performance study, not a machine learning study that would have a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of mechanical testing.
§ 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.