(135 days)
The Spinal Simplicity Posterior Fusion Plate/HA Posterior Flate is a posterior, non-pedicle fusion device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving fusion in the following conditions:
· Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
• spondylolisthesis.
The Posterior Fusion Plate/HA Posterior Fusion Plate is intended for use with bone graft material. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).
The Spinal Simplicity Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving fusion in the following conditions:
• Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
• spondylolisthesis.
The Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).
The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving fusion in the following conditions:
• Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
• spondylolisthesis.
The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).
The Spinal Simplicity HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving fusion in the following conditions:
· Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
• spondylolisthesis.
The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a minimally invasive lateral approach (L1-S1).
The Spinal Simplicity Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving fusion in the following conditions:
- Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
• spondylolisthesis.
The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).
The Minuteman devices consist of bilateral Plates and a Body/Post that connects the Plates. The Plate components include several gripping features for attachment of the device to the spinous processes. The Minuteman devices are available in multiple sizes to accommodate varying patient anatomy. The Minuteman devices are made from Ti6A14V and Ti6A14V ELI. The HA versions of the Minuteman devices have an additional hydroxyapatite coating on the distal regions of the device.
The provided text is a 510(k) summary for the Spinal Simplicity Minuteman family of implants. It focuses on updating the Indications for Use for these devices. The document explicitly states that no technological, engineering, performance, or material changes have been made to the devices, and no performance bench testing data has been submitted in this particular 510(k) submission because the changes are primarily to the Indications for Use.
Therefore, the information required to populate the acceptance criteria and study details for device performance as typically associated with a new device or significant modification is largely absent or explicitly stated as not applicable in this summary.
However, the document does mention "Clinical data were provided to demonstrate satisfactory clinical and radiological outcomes to support the modified Indications for Use." This implies that a study was conducted to support the clinical effectiveness for the updated indications, but the detailed methodology and results of that study are not included in this 510(k) summary.
Based on the provided text, here is the information:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Device Performance: Not explicitly stated in this document as the submission focuses on updated Indications for Use rather than new device performance evaluation. The document indicates "no performance bench testing data has been submitted."
- Reported Device Performance: Not explicitly reported in terms of specific metrics like sensitivity, specificity, accuracy, etc., as this 510(k) is not for a new device or performance claim change. The core claim is that since no changes were made to the device itself, its performance remains substantially equivalent to the previously cleared predicate devices.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified in the provided text. The document only mentions "Clinical data were provided."
- Data Provenance: Not specified in the provided text.
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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 specified in the provided text.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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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:
- This is not applicable. The device is a spinal fusion plate, not an AI or imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a spinal fusion plate, a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document mentions "satisfactory clinical and radiological outcomes." This suggests that the ground truth would be based on clinical outcomes relevant to spinal fusion (e.g., fusion rates, pain reduction, functional improvement) and radiological assessment of fusion, but the specific methodologies are not detailed.
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The sample size for the training set:
- Not applicable/not specified. The device is a physical implant, not a machine learning model requiring a training set in the typical sense. The "clinical data" mentioned would likely be for validation/support.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.