(149 days)
The Binder Intervertebral Body Fusion Device ("Binder Fusion System") is intended to be used for intervertebral body fusion.
The Binder Intervertebral Body Fusion Device is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) 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 had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Binder Fusion devices are to be used with autogenous bone graft material and supplemental fixation.
The Binder Fusion System is comprised of a series of PEEK-OPTIMA® spacers shaped to accommodate autogenous bone graft and anatomical variation at different spinal levels. The Binder Fusion System also has a series of ridges on its superior and inferior surfaces to improve fixation and prevent migration. The Binder Fusion System is provided non-sterile.
The provided text describes a 510(k) summary for a medical device, the Binder Intervertebral Body Fusion Device. It outlines the device's intended use, technological characteristics, and a statement about performance data. However, it does not contain the detailed acceptance criteria or a specific study proving the device met those criteria in the way a clinical or AI-based performance study would.
Instead, the document focuses on the regulatory submission process for substantial equivalence to predicate devices, primarily through mechanical testing.
Here's the breakdown of the information requested, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| Function as intended per ASTM F2077-03 | Met |
| Function as intended per ASTM F2267-04 | Met |
| Specified requirements (not detailed) | Met |
Note: The document states "In all instances, the Binder Fusion System functioned as intended and specified requirements were met." but does not provide the specific numerical acceptance criteria or the quantitative results from the tests.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or AI model evaluation. The "performance data" refers to mechanical testing.
- Sample Size for Mechanical Testing: Not specified.
- Data Provenance: Not applicable in the context of clinical patient data or AI data. The "data" refers to engineering test results.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable to the information provided. The performance testing described is mechanical, not involving expert interpretation of patient data.
4. Adjudication Method for the Test Set
This is not applicable to the information provided, as there is no "test set" in the context of human or AI interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document describes mechanical performance testing, not a clinical study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" would be the engineering specifications and performance standards defined by ASTM F2077-03 and ASTM F2267-04.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of Missing Information in Relation to AI/Clinical Study Criteria:
The provided document is a 510(k) summary focusing on a physical medical device (intervertebral body fusion device) and its mechanical performance testing for regulatory clearance. It does not provide information relevant to the performance evaluation of an AI algorithm, clinical trials with human readers, or detailed patient data analysis that would typically involve many of the criteria you asked for (e.g., test set size, expert ground truth, adjudication, MRMC studies, training sets). The "acceptance criteria" discussed are for the physical properties of the implant based on recognized ASTM standards.
§ 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.