(56 days)
The primaLOK™ SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), tumor, and/or lumbar spinal stenosis. The primaLOK™ SP Interspinous Fusion System is intended for use with bone graft material and not intended for stand-alone use.
The primaLOK™ SP Interspinous Fusion System is a bilateral locking plate system intended for fixation to the spinous process for the purpose of achieving supplemental fusion. It is available in various interspinous heights and can accommodate a variety of spinous process widths. The device, as a system, consists of longitudinal member/anchor components (base and polyaxial locking plates) and an interconnection component (connecting post).
This document (K231807 510(k) Summary) is a premarket notification for a medical device and, as such, does not contain the level of detail typically found in a clinical study report or a publication describing a study proving a device meets acceptance criteria. It primarily focuses on demonstrating "substantial equivalence" to predicate devices rather than proving specific performance metrics derived from a study with defined acceptance criteria.
Therefore, many of the requested details, such as a table of "acceptance criteria" and "reported device performance" in the context of a robust clinical study, sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment methods for training sets, are not present in this 510(k) summary.
The document mentions "A variety of clinical data and biomechanical evaluations have been conducted in order to support the substantial equivalence," but it does not present these data or evaluations with the specificity required to answer your questions.
Here's an attempt to answer your questions based only on the provided text, highlighting what is not available:
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A table of acceptance criteria and the reported device performance
- Not Available: This document does not present acceptance criteria for performance metrics in a table format, nor does it provide detailed reported device performance against such criteria. The "performance testing" mentioned is to support "substantial equivalence," not necessarily to meet specific, quantifiable acceptance criteria for a new clinical claim or feature.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: The document mentions "clinical data" but provides no details on sample size, study design (retrospective/prospective), or data provenance (country of origin).
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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 Available: The document does not describe the establishment of a "ground truth" for a test set, nor does it mention experts or their qualifications in this context.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available: There is no mention of an adjudication method for a test set.
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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
- Not Applicable/Not Available: This device is a physical interspinous fusion system, not an AI-assisted diagnostic device. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Available: As a physical medical device (interspinous fusion system), the concept of "standalone algorithm performance" does not apply.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available: The document informally refers to "clinical data" to support substantial equivalence but does not specify the type of ground truth used from any study data. For an orthopedic implant, "outcomes data" would be the most relevant, but no details are provided.
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The sample size for the training set
- Not Applicable/Not Available: This document is about a physical implant, not a machine learning model, so there is no "training set" in the context of AI/ML.
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How the ground truth for the training set was established
- Not Applicable/Not Available: As above, this concept does not apply to this type of device.
Summary of Device Performance (as stated in the document, which is limited):
The document broadly states that "A variety of clinical data and biomechanical evaluations have been conducted in order to support the substantial equivalence of the primaLOK™ SP System to the predicate devices cited within this Traditional 510(k)." The "performance" in this context is the determination of substantial equivalence itself, based on comparing the new device's indications, intended use, technological characteristics, principles of operation, materials, biocompatibility, sterility, shelf-life, and packaging to the predicate devices.
Key takeaway: This 510(k) summary focuses on regulatory clearance via substantial equivalence, not detailed performance metrics from a rigorous clinical trial against pre-defined acceptance criteria. The "proof" is the FDA's determination of substantial equivalence based on the provided information, which includes unspecified "clinical data and biomechanical evaluations."
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.