(29 days)
The BUTTERFLYT™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
- Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Pseudoarthrosis.
- Spondylolysis.
- Spondylolisthesis.
- Fracture.
- Neoplastic disease.
- Unsuccessful previous fusion surgery.
- Lordotic deformities of the spine.
- Idiopathic thoracolumbar or lumbar scoliosis.
- Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
- Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.
Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.
The BUTTERFLY PLATE Fixation System construct consists of a plate fitted to match the antero-lateral vertebral bodies of the thoracic and lumbar spine. The plate is fastened to the bodies by either rigid bolts or variable-angle screws. The BUTTERFLY PLATE consists of a variety of shapes and sizes of plates, screws, bolts, and nuts, as well as ancillary products and instrument sets. The BUTTERFLY PLATE anterior implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The purpose of this submission is to add a cover plate to the system and to add a 6.5mm screw. The implant components are made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832- 3. Stainless steel and titanium implant components must not be used together in a construct.
The provided text describes a medical device, the Medtronic Sofamor Danek BUTTERFLY PLATE Fixation System, and its regulatory clearance (510(k) K014267). It does not contain information about acceptance criteria or a study that proves the device meets those criteria, particularly in the context of AI, machine learning, or diagnostic performance metrics.
The document is a 510(k) summary for a physical medical device (spinal fixation system) and focuses on describing the device, its intended use, and establishing substantial equivalence to previously cleared predicate devices.
Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria, device performance, study methodology, or AI-related metrics because the provided text does not contain this type of information.
However, I can provide the following based on the document's content, explaining why specific parts of your request cannot be met:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document is a 510(k) summary for a physical implant (spinal fixation system). It establishes substantial equivalence based on device design, materials, and intended use to predicate devices, rather than clinical performance metrics or acceptance criteria typically seen for diagnostic devices or AI algorithms. The "Functionality & Safety Testing" section mentions "A Risk Analysis was performed," but does not detail acceptance criteria or performance results as you would expect for AI or diagnostic studies.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (N/A) | Not applicable (N/A) |
| (The document does not specify quantitative acceptance criteria or clinical performance metrics for this physical implant in a manner that would fit this table. Instead, it relies on substantial equivalence to predicate devices for safety and effectiveness.) | (The document states the device is "substantially equivalent" to predicate devices, implying comparable safety and effectiveness. However, no specific performance data or studies are presented to meet predefined acceptance criteria.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe any test set or clinical study involving data collection on human subjects or samples in the context of device performance evaluation. It is a regulatory submission for a physical implant based on substantial equivalence.
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)
- Cannot be provided. This information is relevant to diagnostic or AI studies. The provided text is for a physical medical implant and does not involve establishing ground truth through expert review for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This information is relevant to diagnostic or AI studies. The provided text is for a physical medical implant and does not involve adjudication of a test set.
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. An MRMC study was not done, as this regulatory submission is for a physical spinal implant, not an AI or diagnostic tool. Therefore, there are no effect sizes related to human readers improving with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. A standalone algorithm performance study was not done, as this device is a physical spinal implant and does not incorporate an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. This information is relevant to diagnostic or AI studies. The provided text is for a physical medical implant and does not describe establishing ground truth for performance evaluation in this context. The "ground truth" for a physical implant pertains to its mechanical integrity, biocompatibility, and clinical outcomes, which are implicitly addressed through material standards and substantial equivalence, not data labeling or expert consensus.
8. The sample size for the training set
- Cannot be provided. This information is relevant to AI/ML development. The provided text describes a physical medical implant and does not refer to any training set.
9. How the ground truth for the training set was established
- Cannot be provided. This information is relevant to AI/ML development. The provided text describes a physical medical implant and does not refer to any training set or its ground truth establishment.
In summary: The provided 510(k) summary (K014267) is for a physical medical device (spinal fixation system) and focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain the type of AI/ML or diagnostic study information (acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert reviews, MRMC studies) requested in your prompt.
§ 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.