(66 days)
The ProLift® Lateral Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ProLift® Lateral Fixated is to be filled with autograft and/ or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation.
The ProLift® Lateral Fixated is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6AI-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. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
This document (K200338) is a 510(k) premarket notification for a medical device called ProLift® Lateral Fixated, which is an intervertebral body fusion device. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is at least as safe and effective.
The provided document does not contain information about software, artificial intelligence (AI),
or a study involving human readers and AI assistance. This submission focuses on the mechanical and material performance of an implantable intervertebral fusion device, not on diagnostic or AI-powered image analysis.
Therefore, I cannot fulfill the request for information regarding AI acceptance criteria, human reader studies, or ground truth establishment in the context of an AI device, as the content is irrelevant to those topics.
The document describes the following acceptance criteria and the study that proves the device meets them for this specific type of medical device (intervertebral fusion device):
Here's the relevant information from the document regarding the device's performance validation:
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A table of acceptance criteria and the reported device performance:
- The document primarily refers to standard ASTM testing for intervertebral body fusion devices. It implies that the acceptance criteria are adherence to these standards.
- Acceptance Criteria (Implied by standard testing): Meets the performance requirements for static compression, dynamic compression, static shear, and dynamic shear as specified by ASTM F2077.
- Reported Device Performance: "Static compression, dynamic compression, static shear and dynamic shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the Pro-Lift Expandable System (K191005)." (This suggests the ProLift® Lateral Fixated met these criteria as it's being compared to a predicate that already demonstrated this).
- The document states: "The ProLift® Lateral Fixated was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance."
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Sample sizes used for the test set and the data provenance:
- The document does not specify sample sizes for mechanical testing. This information would typically be in a detailed test report, which is not included in this summary.
- Data provenance is not applicable here as it's lab-based mechanical testing of the physical device, not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is mechanical engineering testing, not expert interpretation of diagnostic data. The "ground truth" is established by the physical properties and performance measured against ASTM standards.
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Adjudication method for the test set:
- Not applicable. This is not a study involving human adjudication of data; it's mechanical testing.
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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, an MRMC comparative effectiveness study was not done. This device is an implantable medical device, not an AI or diagnostic software.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not relevant to an implantable device.
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The type of ground truth used:
- The "ground truth" for the mechanical performance of this device is established by compliance with recognized consensus standards (ASTM F2077) for intervertebral body fusion devices and direct measurement of mechanical properties (e.g., strength, durability) under load.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical testing for an implantable device, as there is no machine learning or AI involved.
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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.