(71 days)
The Paramount™ IBF device, when used with autogenous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). 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 six months of non-operative treatment.
Paramount™ IBF devices are to be implanted via a direct posterior or transforaminal approach. The Paramount™ IBF device may be used singly or in pairs in the lumbosacral spine with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.
The Paramount™ Intervertebral Body Fusion Device is made of PEEK-OPTIMA®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The devices are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.
The provided 510(k) summary for the Paramount™ Intervertebral Body Fusion Device describes performance data primarily related to mechanical testing and biocompatibility, not an AI/algorithm-based device. Therefore, many of the requested criteria (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document, as they relate to AI/algorithm performance rather than a traditional medical device's physical and biological properties.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Mechanical Testing | The device passed mechanical tests based on ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02, demonstrating substantial equivalence to predicate devices. |
| Biocompatibility Testing | Biocompatibility was demonstrated via testing per ISO10993. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a physical implant, not an AI/algorithm. The "test set" in this context would refer to material samples or device prototypes subjected to mechanical and biological tests, not a dataset of patient information. The document does not specify the number of samples used for these tests.
- Country of origin of the data: Not specified.
- Retrospective or prospective: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for mechanical testing is defined by the standards themselves (e.g., passing a certain load or fatigue cycle). For biocompatibility, it's defined by biological assays. No human experts in the sense of adjudicating medical images or clinical outcomes were involved in establishing "ground truth" for these performance tests.
4. Adjudication Method for the Test Set
Not applicable. This concept pertains to resolving discrepancies in expert labeling of data, which is not relevant for the described performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or interpretative devices to assess the impact of AI on human reader performance. The Paramount™ Intervertebral Body Fusion Device is a therapeutic implant.
- Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The device is not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Testing: Ground truth is established by the pass/fail criteria defined in industry standards (ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02) which relate to structural integrity, strength, and fatigue resistance.
- Biocompatibility Testing: Ground truth is established by the pass/fail criteria defined in international standard ISO10993, which assesses the biological response to the device material (PEEK-OPTIMA®).
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Summary regarding AI/Algorithm Context:
The provided 510(k) document is for a physical medical device (an intervertebral body fusion device) and does not describe an AI or algorithm. Therefore, requests relating to AI/algorithm validation methodologies (like training/test sets, ground truth establishment by experts, MRMC studies, standalone performance) are not applicable to the information contained within this specific regulatory submission. The performance data focuses on mechanical and biocompatibility testing to demonstrate substantial equivalence to predicate devices, which is standard for orthopedic implants.
§ 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.