(59 days)
When used as an interbody fusion device, the ProLift® Micro Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
The ProLift® Micro Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.
All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Micro Expandable System components with components from any other system or manufacturer. The ProLift® Micro Expandable System components should never be reused under any circumstances.
This looks like a medical device submission to the FDA, specifically concerning an intervertebral body fusion device. The document primarily focuses on establishing substantial equivalence to previously cleared devices rather than describing a study with acceptance criteria and device performance in the way one might for an AI/software device.
Therefore, many of the requested categories for AI/software-centric studies (like MRMC studies, ground truth establishment for training sets, etc.) are not applicable to this type of submission. The "performance data" here refers to mechanical testing of the physical device, not the performance of an algorithm.
Here's an analysis based on the provided text, indicating where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the context of clinical or AI performance. Instead, it refers to mechanical performance tests against ASTM standards to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Adherence to ASTM F2077 for Static Axial Compression, Dynamic Axial Compression, Static Shear, Dynamic Shear. | "Substantial equivalency" to predicate device's performance in these tests. The document states these tests were "presented to demonstrate the substantial equivalency." Actual numerical results are not provided in this summary. |
| Adherence to ASTM F2267 for Subsidence Testing. | "Substantial equivalency" to predicate device's performance in these tests. | |
| Material Composition | Use of Titanium Alloy (Ti-6Al-4V ELI) as described by ASTM F136. | The device is "fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136." This matches the material of predicate devices. |
| Design & Function | Similar design features (sizes, footprints, expansion mechanism, superior/inferior teeth for vertebral interface, single-use). | "The ProLift Micro® Expandable Spacer System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing." |
| Indications for Use | Alignment with predicate devices' indications for use. | Matches the indications for use of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable for a software/AI test set. The document refers to mechanical testing of physical device samples. No information on the number of physical samples tested is provided in this summary.
- Data Provenance: Not applicable in the context of data for an AI/software device. The tests are for mechanical properties of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical medical device. Ground truth as typically understood for AI (e.g., expert labels on images) is not relevant to this submission.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. This is a physical hardware device, not an AI/software device. An MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- Not Applicable for AI/Software. For the physical device, the "ground truth" or reference standards are the ASTM material and mechanical performance standards (ASTM F136, F2077, F2267) and the characteristics of the predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/software device; there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 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.