(171 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 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.
The provided text describes a medical device, the ProLift® Micro Expandable Spacer System, and its clearance through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data to establish specific acceptance criteria for device performance in a clinical setting.
Therefore, the document does not contain information typically found in a study that proves a device meets acceptance criteria related to AI/algorithm performance, human reader improvement, or detailed clinical efficacy. It focuses on the mechanical and material equivalence of the new device to existing ones.
Based on the provided text, I can extract information relevant to the device's technical specifications and the basis for its substantial equivalence, but not the specific clinical performance criteria, study design, or AI-related metrics requested in the prompt.
Here's an analysis of the information not present in the provided text, related to your specific questions:
- Acceptance Criteria and Reported Device Performance (Table): The document does not describe clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) or report specific clinical performance metrics. It focuses on mechanical testing for substantial equivalence.
- Sample Size for Test Set and Data Provenance: No clinical test set or patient data is mentioned as part of a performance study.
- Number of Experts and Qualifications: No experts were used to establish ground truth for a clinical test set because no such study is described.
- Adjudication Method: Not applicable as no clinical test set with ground truth is discussed.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned. The document is about a physical medical implant, not an AI or diagnostic tool that would directly assist human readers.
- Standalone Performance (Algorithm Only): Not applicable, as this is a physical implant, not an algorithm.
- Type of Ground Truth Used: Not applicable for a performance study in the context of your questions. The "ground truth" for this device relates to its mechanical integrity and biocompatibility, which are verified through material specifications and mechanical testing rather than clinical outcomes established by experts or pathology.
- Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable as this is not an AI/machine learning device.
Information that is extractable from the document, though not directly answering your specific questions about AI/clinical performance studies:
The document describes the mechanical performance data used to demonstrate substantial equivalence, which is a different kind of "acceptance criterion" based on engineering standards:
- Acceptance Criteria/Performance (Mechanical):
- Type of Testing: Static Axial Compression, Dynamic Axial Compression, Static Shear, and Dynamic Shear testing.
- Standard: According to ASTM F2077.
- Purpose: To demonstrate substantial equivalency to the predicate device (Life Spine ProLift Micro Expandable System K212520).
- Reported Performance: The document states that this testing "was presented to demonstrate the substantial equivalency," implying the device met the requirements of the standard consistent with the predicate. Specific numerical results are not provided in this summary.
In summary, the provided FDA 510(k) document is for a physical medical device (an expandable spinal spacer) and therefore does not contain the type of information requested about AI/algorithm performance studies, human-in-the-loop studies, or clinical ground truth establishment.
§ 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.