(58 days)
When used as an interbody fusion device, the PROLIFT® Expandable Spacer 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 Spacer 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® Expandable Spacer System components with components from any other system or manufacturer. The PROLIFT® Expandable Spacer System components should never be reused under any circumstances.
The provided FDA 510(k) clearance letter for the ProLift Expandable Spacer System does not describe the specific acceptance criteria and study proving the device meets those criteria in the level of detail requested. This document primarily focuses on the regulatory aspects of substantial equivalence for a medical device (an intervertebral body fusion device), not a software or AI-based diagnostic tool, which typically entails the type of performance evaluation outlined in your request.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies are not applicable or not present in this type of regulatory submission for a physical implant.
However, I can extract the information that is present and explain why other information is not available in this document.
Analysis of the Provided Document for Acceptance Criteria and Study Details
The provided document is an FDA 510(k) clearance letter for a medical device, specifically an intervertebral body fusion device (ProLift Expandable Spacer System). This type of clearance is based on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than a de novo approval that often requires extensive clinical performance data with specific acceptance criteria as you've requested for an AI/software device.
For a physical device like this, performance data typically refers to mechanical testing, biocompatibility, and sterilization validation, not diagnostic accuracy metrics.
Here's what can be gathered from the document, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria and reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC). For this physical device, "performance" refers to mechanical properties and material characteristics.
What is present regarding "performance":
- Performance Data Section (Page 6): "Through the Comparison Analysis it is determined that the mechanical performance has not change as the worst case is still the same and therefore is substantially equivalent to the Life Spine ProLift Expandable Spacer System (K190488) and ProLift Micro Expandable Spacer System (K223430 & K212520)."
This indicates that the key "acceptance criterion" related to performance for this 510(k) submission was demonstrating that the mechanical performance of the new device is substantially equivalent to its predicate devices, meaning it performs similarly in relevant mechanical tests (e.g., strength, durability under load). No specific numerical acceptance values for mechanical performance are provided in this regulatory letter itself, as they would typically be detailed in the full 510(k) submission document.
2. Sample sizes used for the test set and the data provenance
- Not applicable/Not provided in this document. For a physical mechanical device, "test set" in the context of AI/software performance is not relevant. Mechanical testing would involve a certain number of device samples, but this is not typically referred to as a "test set" in the same way. The document does not specify the number of devices or test conditions used for mechanical performance comparison. Data provenance (country of origin, retrospective/prospective) is also not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided in this document. "Ground truth" established by experts (like radiologists for imaging devices) is for diagnostic devices where human interpretation is being evaluated or augmented. For an intervertebral body fusion device, the "ground truth" of its mechanical properties would be established through engineering tests following industry standards, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided in this document. Adjudication methods are relevant for resolving discrepancies in human expert interpretations, which is not the type of evaluation described for this 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
- Not applicable/Not provided in this document. MRMC studies are specific to evaluating diagnostic accuracy, especially for AI-assisted image interpretation. This device is a physical implant, not a diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided in this document. This applies to algorithms. The device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this device, the "ground truth" for its performance would implicitly be based on engineering standards, material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI), and biomechanical testing standards to ensure it meets safety and functional requirements equivalent to established devices. The document explicitly mentions "mechanical performance" and "material."
8. The sample size for the training set
- Not applicable/Not provided in this document. "Training set" is a concept for machine learning models.
9. How the ground truth for the training set was established
- Not applicable/Not provided in this document.
In summary, the provided FDA 510(k) clearance letter for the ProLift Expandable Spacer System is for a physical medical implant, not an AI or software-based diagnostic device. Therefore, the detailed performance study information typically associated with AI/software (acceptance criteria tables, expert adjudication, MRMC studies, ground truth establishment for training/test sets) is not present and generally not part of a 510(k) submission for this class of device.
The "study" that proves the device meets the (unspecified but implied mechanical) acceptance criteria is the "Comparison Analysis" mentioned on Page 6, which determined that the mechanical performance of the new device is substantially equivalent to the predicate devices. The specifics of this comparison (e.g., number of tests, exact parameters) would be in the full 510(k) submission, not typically in the public clearance letter itself.
§ 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.