(29 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone Ascent POCT System is indicated for:
a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
b) spondylolisthesis;
c) fracture/dislocation;
d) spinal stenosis;
e) atlanto-axial fracture with instability;
f) occipito-cervical dislocation;
g) tumors;
h) revision of previous cervical spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Blackstone Ascent POCT System allows for wire/cable attachment to the posterior cervical spine.
The Blackstone Ascent POCT System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial Connector or the Blackstone Ascent Parallel Rod Connector.
The Blackstone Ascent POCT System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and Songer Cables.
The provided document from K073654 is a 510(k) Premarket Notification for a system modification to the Blackstone™ Ascent® POCT System. This is a spinal implant system and the submission is for the addition of a "Parallel Rod Connector."
Medical devices like the Ascent POCT System, particularly spinal instrumentation, are evaluated for substantial equivalence to existing legally marketed predicate devices, not typically against acceptance criteria in the same way an AI/software device would be. The "study" here refers to the engineering and design controls required to demonstrate that the modified device functions as intended and is as safe and effective as its predicate.
Therefore, the requested information elements (1-9) which are typically applied to AI/software performance studies, or clinical trials for novel devices, do not directly apply in the context of this 510(k) for a system modification to a spinal implant. The "acceptance criteria" for this type of submission are primarily around demonstrating mechanical integrity, biocompatibility (if new materials are introduced), and overall functional equivalence to predicate devices.
Here's how to interpret the request in the context of this 510(k):
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied for a system modification): The new Parallel Rod Connector must meet the same mechanical performance, material specifications, and design requirements as the predicate devices and other components of the Ascent POCT System. This would include tests for strength, fatigue, torsional stability, and compatibility within the construct. These are typically defined by recognized standards (e.g., ISO, ASTM for spinal implants).
- Reported Device Performance: The document does not provide specific test data or performance metrics for the Parallel Rod Connector. Instead, it states: "The additional Blackstone™ Ascent Parallel Rod Connector is substantially equivalent to the identified predicate systems, which have been cleared by FDA for the purpose of building a spinal implant construct in the occipito-cervico-thoracic spine." This statement implies that the necessary testing was performed and demonstrated equivalence.
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Sample size used for the test set and the data provenance:
- This is not a "test set" in the context of AI or clinical studies. For mechanical testing of medical devices, the "sample size" refers to the number of devices or components tested to ensure statistical significance for mechanical properties. This information is not provided in the public 510(k) summary. The data provenance would be in vitro laboratory testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. "Ground truth" in this context would be engineering specifications and standards for spinal implants, and the expertise would come from biomechanical engineers and material scientists performing the testing and design verification.
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Adjudication method:
- Not applicable for mechanical testing of a device modification.
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If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. This is not an imaging or diagnostic device requiring MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical spinal implant, not a software algorithm.
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The type of ground truth used:
- Not applicable as "ground truth" for a spinal implant modification consists of adherence to validated engineering specifications, material standards, and biomechanical performance criteria.
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The sample size for the training set:
- Not applicable. There is no concept of a "training set" for physical device modifications in this context.
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How the ground truth for the training set was established:
- Not applicable.
Summary based on the provided document for K073654:
The 510(k) submission for the Blackstone™ Ascent® POCT System Parallel Rod Connector is a system modification to an existing spinal instrumentation system. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices.
- Acceptance Criteria (Implied): The Parallel Rod Connector must meet biomechanical and material specifications consistent with its intended use in spinal fusion and be equivalent in safety and effectiveness to the predicate devices. These criteria are typically derived from recognized standards for spinal implants.
- Study Proving Acceptance: The document states that the device "is substantially equivalent to the identified predicate systems." This implies that internal design verification and validation testing (e.g., mechanical strength, fatigue, material compatibility) were performed to demonstrate that the new connector performs equivalently to previously cleared devices. Specific test data, sample sizes for mechanical testing, and detailed methodologies are not disclosed in the public 510(k) summary provided.
- Data Provenance: The "data" would primarily be in vitro laboratory test results from the manufacturer.
- Experts/Ground Truth: Not applicable in the context of expert consensus or pathology for clinical cases. The "ground truth" for a medical device modification relates to engineering specifications and performance standards established by regulatory bodies and industry best practices.
- No clinical or AI studies: This submission does not involve clinical trials, AI algorithms, or human-reader performance studies.
§ 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.