(140 days)
The BLACKBIRD™ Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion for stabilization of the cervical spine (C1-T3) for the following conditions:
- degenerative disc disease (DDD; defined as neck pain of discogenic origin with . degeneration of the disk as confirmed by history & radiographic studies)
- spondylolisthesis ●
- trauma ●
- fracture / dislocation .
- spinal stenosis
- atlanto/axial fracture with instability .
- . tumor
- revision of previous cervical spine surgery .
The use of polyaxial screws is limited to placement in the thoracic spine (T1-T3) "for anchoring the construct only" and is not intended to be placed in the cervical spine. The use of the rods and hook components are intended for use in (C1-T3). This system can be linked to a Ø6.0mm rod system such as the Choice Spine Starfire™ Pedicle Screw System.
The Choice Spine BLACKBIRD™ Spinal System is a comprehensive system for posterior fixation of the cervical and upper thoracic spine. It is to be implanted posteriorly. The system is composed of polyaxial screws and smooth shaft polyaxial screws in various sizes, set screws, straight rods, pre bent rods, transition rods, rod to rod cross connectors, lateral offset connectors, rod transition connectors. and hooks. All implant components will be made from Ti 6Al 4V-ELI alloy or Cobalt 28- Chromium 6- Molybdenum per ASTM F1537.
The provided text is a 510(k) summary for the Choice Spine BLACKBIRD™ Spinal System, a medical device for spinal fixation. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about clinical studies, acceptance criteria, or performance metrics in a way that would allow for the detailed answers requested.
The document primarily focuses on:
- Device Description: What the device is made of and its components.
- Indications for Use: The medical conditions for which the device is intended.
- Predicate Devices: Other similar devices already on the market that the BLACKBIRD™ Spinal System is compared against.
- Performance Standards: It mentions that "Performance testing was completed by an independent laboratory following ASTM F1717" and "Torsional gripping capacity, axial gripping capacity, flexion extension / cantilever bending results were tested per ASTM 1798-97(20008)." It also states that the "performance testing required is the equivalent same for the predicate devices."
Crucially, the document does NOT provide:
- Specific acceptance criteria values. It only refers to ASTM standards.
- Reported device performance values against those criteria.
- Details of any study that "proves the device meets the acceptance criteria" in terms of clinical or algorithm performance. The performance testing mentioned is mechanical testing of the implants, not clinical efficacy or AI/algorithm performance.
- Sample sizes for test or training sets.
- Data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used (clinical, pathology, etc.) (since no clinical study data is presented).
- How ground truth for a training set was established.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, expert involvement, or AI performance, as this type of information is not present in the provided 510(k) summary. The document confirms that mechanical performance testing was done according to ASTM standards, implying that the device met these standards to achieve 510(k) clearance, but it does not specify the numerical criteria or results.
Summary of what cannot be provided from the text:
| Information Requested | Status (Based on Provided Text) |
|---|---|
| Table of Acceptance Criteria & Reported Performance | Cannot be provided. The document states "Performance testing was completed... following ASTM F1717" and "Additionally Torsional gripping capacity, axial gripping capacity, flexion extension / cantilever bending results were tested per ASTM 1798-97(20008)." It also notes "The performance testing required is the equivalent same for the predicate devices." However, it does not detail the specific acceptance criteria values (e.g., "Must withstand X N of force") nor the reported performance outcomes (e.g., "The device withstood Y N of force"). |
| Sample size (test set) and data provenance | Not applicable/Cannot be provided. This document refers to mechanical device testing, not clinical studies involving patient data or AI algorithm performance. Therefore, there's no "test set" in the context of clinical data or AI. |
| Number of experts and qualifications (ground truth for test set) | Not applicable/Cannot be provided. Ground truth establishment by experts is not relevant to the mechanical device testing described. |
| Adjudication method (test set) | Not applicable/Cannot be provided. Adjudication methods are not relevant to the mechanical device testing described. |
| MRMC comparative effectiveness study? Effect size? | No. The document does not mention any clinical or MRMC study. It is about a spinal fixation system, not typically an AI-driven diagnostic or assistive device that would undergo such a study. |
| Standalone (algorithm only) performance study? | No. This device is a physical spinal implant; it does not involve an algorithm for standalone performance. |
| Type of ground truth used | Not applicable/Cannot be provided. For mechanical testing, the "ground truth" is typically defined by the test standard's pass/fail criteria and measurable physical properties. Not clinical outcomes, pathology, or expert consensus in the diagnostic sense. |
| Sample size (training set) | Not applicable/Cannot be provided. This concept is not relevant to the mechanical device testing described. |
| How ground truth for training set was established | Not applicable/Cannot be provided. This concept is not relevant to the mechanical device testing described. |
§ 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.