(179 days)
The LIBERTY" Posterior Spinal System is intended to provide temporary stabilization and to help augment the development of a solid spinal fusion. Except for situations using pedicle screws in patients, (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass, the specific indications for the LIBERTY" Posterior Spinal System are the following:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
- Pseudoarthrosis
- Stenosis
- Spondylolisthesis
- Spinal deformities: scoliosis, kyphosis, and lordosis
- Fracture
- Unsuccessful previous attempts at spinal fusion
- Tumor resection
The LIBERTY" Posterior Spinal System is intended for use only in the thoracic, lumbar, and/or sacral levels of the posterior spine. The LIBERTY™ Posterior Spinal System is limited to noncervical use. The LIBERTY" Screws and TSRH® Variable Angle Screws, when used as pedicle screws with the LIBERTY" Posterior Spinal System, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and not lower than the sacrum. Otherwise the LIBERTY" screws and TSRH® Variable Angle Screws, when used with the LIBERTY™ Posterior Spinal System, are intended for sacral/iliac attachment only. The CCD" Screws for Sacral Block are intended for sacral/iliac attachment only. All of the CD HORIZON" and LIBERTY" hooks are intended for thoracic and/or lumbar attachment only. TSRH® CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates, and CCD Transverse links, domino, and cylinder are intended for posterior thoracic, lumbar, and/or sacral use only.
The LIBERTY" Posterior Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors and connecting components. The LIBERTY™ Posterior Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or its ISO equivalent. Alternatively, the LIBERTY" Posterior Spinal System may be made from titanium alloy as described by such standards as ASTM F136 or its ISO equivalent. Do not use stainless steel and titanium implant components in the same construct. Sofamor Danek expressly warrants that these devices are fabricated from the foregoing material specifications. No other warranties, expressed, or implied, are made.
The LIBERTY" Posterior Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Implant components comprising the LIBERTY™ Posterior Spinal System and those from other Sofamor Danek spinal systems which can be used with the LIBERTY™ Posterior Spinal System are listed in the following table.
This document is a 510(k) summary for a medical device called the "LIBERTY™ Posterior Spinal System," which is a spinal implant system. It describes the device, its intended use, and states that mechanical test data was supplied to support its substantial equivalence to other devices.
However, the provided text does not contain information regarding detailed acceptance criteria for device performance in terms of clinical outcomes or accuracy, nor does it detail a clinical study proving the device meets specific acceptance criteria in that sense.
The "acceptance criteria" and "study" described in the input request usually refer to performance metrics in fields like artificial intelligence or diagnostic devices, where accuracy, sensitivity, specificity, etc., are measured against a ground truth. This document is for a spinal implant system, where "acceptance criteria" are typically related to biocompatibility, mechanical strength, and previous regulatory clearances, and the "study" would involve mechanical testing and demonstration of substantial equivalence to predicate devices, rather than a performance study measuring outcomes like those requested.
Therefore, I cannot fill out the requested table and answer the questions completely as the provided text does not contain that type of information.
Here's what I can extract based on the context of a 510(k) summary for an implantable device:
1. A table of acceptance criteria and the reported device performance:
This type of table, with metrics like sensitivity or accuracy, is not applicable to this document. For an implantable device like a spinal system, acceptance criteria would typically revolve around:
| Acceptance Criteria (Implied for Spinal Implants) | Reported Device Performance (Implied from 510(k) context) |
|---|---|
| Material Biocompatibility | Fabricated from medical grade stainless steel (ASTM F138/ISO equivalent) or titanium alloy (ASTM F136/ISO equivalent). |
| Mechanical Strength & Durability | Mechanical test data were supplied in support of this 510(k) notification. (Specific values or tests not detailed in this summary). |
| Substantial Equivalence | The LIBERTY™ Posterior Spinal System was declared to be substantially equivalent to several commercially available devices. |
| Compatibility with Cleared Components | Use of several stainless steel components from other cleared Sofamor Danek systems with stainless steel LIBERTY™ components. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not applicable in the context of clinical performance as this is a device clearance based on substantial equivalence and mechanical testing, not a clinical trial with a "test set" of patients. The "sample size" would refer to the number of implants or test specimens used in mechanical testing, which is not provided.
- Data Provenance: Not applicable. The "data" refers to mechanical test data, likely generated in a lab setting, not clinical data from specific countries or patient populations.
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. "Ground truth" in this context would likely be established through engineering standards for materials and mechanical performance, not expert clinical consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study requiring adjudication of expert opinions on clinical cases.
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 not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For an implantable device 510(k), the "ground truth" for demonstrating safety and effectiveness relies on:
- Engineering standards for material properties and mechanical strength.
- Pre-clinical mechanical testing results.
- Comparison to a legally marketed predicate device (substantial equivalence).
8. The sample size for the training set:
Not applicable. This is not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning model.
In summary, the provided text is a 510(k) summary for a spinal implant system. The type of information requested (related to performance metrics, clinical study design, and ground truth establishment often associated with AI or diagnostic devices) is not present in this document, as the regulatory pathway and evaluation criteria for spinal implants differ significantly. The "study" mentioned is mechanical testing and the demonstration of substantial equivalence to predicate devices, which are the typical pathways for 510(k) clearance of such devices.
§ 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.