(145 days)
When used as an interbody fusion device, the ProLift® 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 radiographic studies. 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 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 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.
The provided text is an FDA 510(k) summary for the ProLift® Expandable System, which is an intervertebral body fusion device. Upon reviewing the text, it is clear that this document describes the submission and clearance of a medical device based on showing substantial equivalence to predicate devices, rather than an AI/ML medical device that requires a study proving its performance against acceptance criteria.
The document discusses:
- Device Name: ProLift® Expandable System
- Regulation Number: 21 CFR 888.3080
- Regulation Name: Intervertebral body fusion device
- Regulatory Class: Class II
- Product Code: MAX
- Indications for Use: Spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1), to be used with autograft/allogeneic bone graft and supplemental internal spinal fixation system.
- Technological Characteristics: Substantially equivalent to predicate systems in terms of design, materials, indications for use, and sizing.
- Material: Titanium alloy (Ti-6Al-4V ELI)
- Performance Data: Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, and subsidence according to ASTM F2267. These are mechanical tests, not AI/ML performance studies.
- Conclusion: Demonstrates substantial equivalency.
Therefore, the information required to specifically answer your questions regarding acceptance criteria and a study proving an AI/ML device's performance (like sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is not present in this document. The provided text describes the regulatory clearance process for a physical medical implant, not a software-as-a-medical-device (SaMD) or an AI/ML-driven diagnostic tool.
However, if we interpret "acceptance criteria" and "study" in the context of this specific device (ProLift® Expandable System) as outlined in the document, it refers to the mechanical and material performance needed to demonstrate substantial equivalence.
Here's an attempt to answer your questions based on the closest relevant information provided, interpreting "study" as the mechanical performance testing conducted for this physical device:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table with numerical acceptance criteria and performance results (e.g., minimum compression strength, actual measured strength) but mentions the types of tests conducted to demonstrate substantial equivalency to predicate devices. The "acceptance criteria" in this context would be that the device performs at least as well as, or comparably to, the predicate devices in these mechanical tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets or exceeds mechanical properties of predicate devices | Static compression, dynamic compression, static and dynamic shear testing demonstrated substantial equivalency. |
| Demonstrates acceptable subsidence characteristics | Subsidence testing according to ASTM F2077 and ASTM F2267 was presented to demonstrate substantial equivalency. |
| Fabricated from specified material with acceptable strength | Fabricated from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136, same material as predicate devices. |
| Conforms to "Indications for Use" and "Intended Use" | The device's design, materials, and mechanical performance support its intended use for spinal fusion in DDD patients with specific conditions and adjunctive therapies. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For mechanical testing of a physical device, "sample size" would refer to the number of devices or components tested. The data provenance (country, retrospective/prospective) is typically relevant for clinical or observational studies, not mechanical bench testing of an implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is geared towards AI/ML diagnostic devices. For a physical implant, "ground truth" would be established by validated test methods (e.g., ASTM standards) and objective measurements using calibrated equipment, not expert consensus or clinical expert review. Therefore, this information is not applicable/provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question refers to the process of resolving discrepancies in expert labeling or diagnoses, common in AI/ML validation. This is not applicable to the mechanical testing described for this physical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was conducted or is applicable for this physical medical implant. MRMC studies are specific to evaluating AI/ML diagnostic tools in a clinical setting with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an AI algorithm on its own. This is not applicable to a physical intervertebral fusion device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" (or basis for evaluation) for performance is established through standardized mechanical testing (e.g., ASTM F2077, ASTM F2267) and material specifications (ASTM F136). It is not based on expert consensus, pathology, or clinical outcomes data presented in this particular 510(k) summary, which focuses on bench testing for substantial equivalence.
8. The sample size for the training set
This question is related to AI/ML model development. It is not applicable to this physical device. The device itself is not "trained."
9. How the ground truth for the training set was established
This question is related to AI/ML model development. It is not applicable to this physical device.
§ 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.