(90 days)
The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative 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. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine.
The Plateau Spacer System 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 either analonical considered one (PEEK-OPTIMA LT1) with titanium markers. The implant is hollow to I oryeneredier with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to as in the interface with the vertebral endplates to prevent rotation and/or migration.
The provided text describes a 510(k) summary for the "PLATEAU® Spacer System," an intervertebral body fusion device. While it mentions "Performance Data" and biomechanical testing, it does not provide specific acceptance criteria or a study demonstrating the device meets those criteria in the way typically expected for a diagnostic AI device.
Here's a breakdown of why it's not possible to extract the requested information based on the provided text:
- Device Type: The PLATEAU® Spacer System is a physical medical implant (intervertebral body fusion device), not a diagnostic AI device. The questions in the prompt (e.g., about sensitivity, specificity, MRMC studies, training/test sets, ground truth establishment) are relevant to AI/diagnostic software.
- Performance Data: The text states, "Biomechanical testing in accordance with ASTM standards was conducted to demonstrate substantial equivalence to the predicate intervertebral body fusion devices." This refers to physical and mechanical properties, not diagnostic accuracy.
- Substantial Equivalence: The primary goal of a 510(k) for this type of device is to demonstrate "substantial equivalence" to a legally marketed predicate device, meaning it's as safe and effective as the existing device. This is different from meeting specific numerical performance targets for an AI algorithm.
Therefore, the requested information cannot be found in the provided document.
To directly answer your questions based on the absence of this information for an AI device:
1. A table of acceptance criteria and the reported device performance
- Not Applicable: The device is a physical implant, not an AI diagnostic tool. Acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC) and reported device performance metrics are not included. The document only mentions "Biomechanical testing in accordance with ASTM standards."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: No test set in the context of AI performance is discussed. The "testing" referred to is biomechanical.
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)
- Not Applicable: No ground truth establishment for a diagnostic test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No diagnostic test set or adjudication method is mentioned.
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: No MRMC study or AI assistance is mentioned as the device is a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable: No ground truth in the context of diagnostic accuracy is mentioned.
8. The sample size for the training set
- Not Applicable: No training set for an AI algorithm is mentioned.
9. How the ground truth for the training set was established
- Not Applicable: No ground truth for a training set is mentioned.
§ 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.