(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 or Parallel 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 510(k) notification for the Blackstone™ Ascent POCT System (K080394) describes a spinal implant system, not a medical device that would have performance metrics like sensitivity, specificity, or image quality. Therefore, most of the requested information regarding acceptance criteria and studies that prove the device meets these criteria in the context of an AI/imaging device is not applicable.
This submission is for a modification to an existing device (plate and rod modifications) and primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "performance" of such a device is typically assessed through mechanical testing to ensure it meets established standards for strength, durability, and biocompatibility, rather than diagnostic accuracy.
Here's an attempt to answer the questions based on the provided document, noting when information is not applicable or available:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
Given that this is a spinal implant system and a modification, the "acceptance criteria" are generally related to mechanical properties, biocompatibility, and meeting design specifications. The document does not provide a table of quantitative acceptance criteria or detailed test results. Instead, it asserts substantial equivalence based on the device description and intended use aligning with predicate devices.
Not Applicable in the traditional sense for a diagnostic device. For a spinal implant, acceptance criteria would typically involve:
- Mechanical Integrity: Withstanding specified forces (e.g., bending, torsion) without fracture or permanent deformation.
- Dimensional Accuracy: Conforming to design specifications.
- Biocompatibility: No adverse tissue reaction, assessed through materials testing and history of use of similar materials.
- Sterilization: Ability to be sterilized without degradation (if applicable, though this device is described as non-sterile).
The document implicitly "reports performance" by claiming substantial equivalence, which means its performance is expected to be comparable to the predicate devices based on design and materials.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. This type of information is generally for diagnostic devices or those involving clinical studies. Mechanical testing of implants does not involve "test sets" of patient data.
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 the context of this device would relate to engineering specifications and mechanical testing standards, not clinical diagnostic accuracy assessed by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. This concept applies to expert review processes for diagnostic studies, not mechanical testing or design comparisons for implants.
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 specific to AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is specific to AI/diagnostic algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a spinal implant modification, the "ground truth" for demonstrating substantial equivalence is typically:
- Engineering Standards: Conformance to established ASTM/ISO standards for spinal implants (strength, fatigue, etc.).
- Material Specifications: Compliance with material properties for titanium alloy.
- Predicate Device Performance: The known, clinically accepted performance and safety profile of the predicate devices.
- Design Intent: Whether the modified components still fulfill the same functional requirements as the original device.
The document states the basis of substantial equivalence is that the modified components "are 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 implies the "ground truth" is adherence to the established safety and effectiveness of the predicates and relevant engineering principles.
8. The sample size for the training set
Not Applicable. This is relevant for machine learning models, not mechanical devices.
9. How the ground truth for the training set was established
Not Applicable. This is relevant for machine learning models, not mechanical devices.
In summary, the K080394 document is a 510(k) for a device modification to a spinal implant system. The regulatory pathway relies on demonstrating substantial equivalence to predicate devices. This involves showing that the modified device has the same intended use, technological characteristics, and performance (e.g., mechanical properties, biocompatibility) as a legally marketed device. The document does not describe a study involving diagnostic accuracy, expert review, or AI performance, as it is for a physical implant. The "proof" relies on engineering principles, materials science, and a comparison to previously cleared 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.