(189 days)
The MOUNTAINEER:ER® Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograff material from expulsion or impinging the spinal cord.
The proposed MOUNTAINEER Laminoplasty System is an implant system that consists of various sizes of plates and screws. The proposed plates are available in various configurations to address surgeon and patient needs as necessary similar to the predicate devices, the Medtronic CENTERPIECE Plate Fixation System (K050082) and Synthes ARCH Fixation System (K032534). The proposed plates are available in the Inline, Inline Side-By-Side, and Offset Side-By-Side configurations. The proposed plate devices come in a preformed shape with holes for bone screws. The plates also contain a slot in the middle portion of the plate for allograft or autograft material attachment. The allograft or autograft material is secured to the plate using bone screws that are inserted through the middle slot on the top portion of the plate. The Inline, Inline Side-By-Side, and Offset Side-By-Side plates are available in 6mm to 18mm lengths in increments of 2mm. The three configurations are manufactured from commercially pure titanium as specified on the attached engineering drawing. The proposed plate device comes in a preformed shape with holes for bone screws. The Hinge Plate is attached to both the lamina and lateral mass using bone screws that are inserted through the holes on the top portion of the plate. The Hinge Plate is available in one length. The Hinge Plate is manufactured from commercially pure titanium as specified on the attached engineering drawing. The screws intended for use with the plates are available in 2.30mm and 2.60mm diameters and in 4mm to 12mm lengths in increments of 2mm. The screws attach the plates to the lamina and lateral mass through the holes incorporated within the plates. The screws are manufactured from titanium alloy as specified on the attached engineering drawing. The proposed MOUNTAINEER Laminoplasty System includes manual surgical instruments such as drivers, drill bits, graft loading block, plate holders, plate benders, rongeur, trials, and cases that are considered exempt from premarket notification.
The provided text describes the DePuy Spine MOUNTAINEER® Laminoplasty System. However, it does not contain specific acceptance criteria, performance data, details of a study with sample sizes, expert qualifications, adjudication methods, or ground truth establishment. The document is a 510(k) summary for a medical device submitted to the FDA for substantial equivalence determination, not a detailed study report.
The relevant section states:
"Performance data was submitted to characterize the MOUNTAINEER Laminoplasty System. Test data is available in Exhibit D (of the original submission)."
This indicates that performance data exists and was submitted to the FDA, but the provided text does not include the content of "Exhibit D" or any explicit description of the acceptance criteria or how the device performance met them.
Therefore, most of the requested information cannot be extracted from the given text.
Here's what can be stated based on the provided input:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided document.
- Reported Device Performance: Not explicitly stated in the provided document. The document only mentions that "Performance data was submitted to characterize the MOUNTAINEER Laminoplasty System."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not explicitly stated in the provided document.
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 as no specific clinical or image-based test set and ground truth establishment are described for this device. The performance data mentioned would likely refer to mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no specific clinical or image-based test set and adjudication are described.
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. This is a medical device (spinal implant system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (spinal implant system), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The performance data would likely involve mechanical properties and biomechanical testing, rather than clinical ground truth for diagnostic accuracy.
8. The sample size for the training set
- Not applicable as this is a physical medical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established
- Not applicable as this is a physical medical device, not an AI system.
§ 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.