(47 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone "M Ascent POCT System is indicated for:
a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
b) spondylolisthesis
c) spinal stenosis
d) fracture/dislocation
e) atlanto/axial fracture with instability
occipitocervical dislocation f)
g) revision of previous cervical spine surgery
h) tumors
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) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System to be used with the Blackstone™ POCT System allows for wire/cable attachment to the posterior cervical spine.
The Blackstone Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial Connector.
The Blackstone™ Ascent POCT System is a 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 Blackstone™ Ascent POCT System consists of an assortment of rods, set-screws, cross connectors, multi-axial screws, plates, bone screws and Songer Cables.
The 5.5mm/3.0mm Single Axial Connector addition will function as a rod connector. There are clinical applications in which a surgeon will need to have the inter-operative ability to connect rods of different diameter when extending a construct.
This 510(k) summary for the Blackstone™ Ascent POCT System 5.5mm/3.0mm Single Axial Connector is a premarket notification for a system modification of an existing device. It establishes substantial equivalence by referencing a previously cleared device (K030197). Medical devices cleared through the 510(k) pathway, especially those that are modifications or additions to existing systems, often rely on established engineering principles, material properties, and mechanical testing to demonstrate performance rather than clinical studies in the same way a novel pharmaceutical drug would.
The document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of clinical performance metrics like sensitivity, specificity, or reader studies. Instead, the "study" demonstrating the device meets "acceptance criteria" here refers to the comparison to a predicate device and the implied mechanical and material performance inherent in a spinal implant system.
Here's an analysis based on the provided text, highlighting the absence of the requested information for AI/diagnostic devices:
Summary of Information from the Provided Text:
| Acceptance Criteria Category | Information Provided in Document |
|---|---|
| Acceptance Criteria & Device Performance | Not explicitly stated as statistical measures of performance (e.g., sensitivity, specificity, accuracy). The "acceptance criteria" are implied to be substantial equivalence to a predicate device (Blackstone™ Ascent POCT System, K030197) in terms of intended use, indications for use, and technological characteristics, particularly as a rod connector. The performance is that it successfully functions as a rod connector for connecting rods of different diameters.** |
| Sample Size (Test Set) & Data Provenance | Not applicable/not provided. This is a mechanical device, not an AI/diagnostic device that would have a "test set" in the traditional sense of patient data. |
| Number & Qualifications of Experts for Ground Truth | Not applicable/not provided. Ground truth is not established by expert review of patient data for this type of device. |
| Adjudication Method | Not applicable/not provided. |
| MRMC Comparative Effectiveness Study | No. This type of study (human readers with/without AI assistance) is not relevant for this device. |
| Standalone Performance Study (Algorithm Only) | No. This device does not involve an algorithm. |
| Type of Ground Truth Used | Not applicable in the usual sense. For a mechanical spinal implant, "ground truth" would relate to its material properties, mechanical strength, biocompatibility, and functional performance in a simulated or cadaveric environment. The document implies these are met by demonstrating substantial equivalence to the predicate. |
| Sample Size for Training Set | Not applicable/not provided. This device does not involve a "training set." |
| How Ground Truth for Training Set was Established | Not applicable/not provided. |
Expanded Explanation:
-
Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The primary acceptance criterion for a 510(k) cleared device like this system modification is "substantial equivalence" to a legally marketed predicate device. This means the device is as safe and effective as the predicate device. For mechanical attributes, acceptance criteria would typically involve engineering specifications (e.g., strength, fatigue life, torsional stability), material compatibility, and dimensional conformity. These are not explicitly detailed in the provided summary, as is common in 510(k) summaries which focus on clinical indications and comparison to predicates.
- Reported Device Performance: The performance reported is its function as a "rod connector" that allows surgeons to "connect rods of different diameter" when extending a construct. This claim, vital to its intended use, implies that mechanical testing (e.g., tensile strength, bending strength, fatigue testing to simulate physiological loads) would have been performed and passed to ensure its structural integrity when connecting rods. The summary does not provide specific numerical results from such tests.
-
"Study" Proving Device Meets Acceptance Criteria:
- The "study" that proves this device meets the acceptance criteria (i.e., is substantially equivalent to a predicate) is the 510(k) submission itself. This submission would have included:
- Comparison to Predicate: Detailed analysis comparing the new 5.5mm/3.0mm Single Axial Connector to the predicate Blackstone™ Ascent POCT System (K030197) in terms of intended use, indications for use, technological characteristics (materials, design, performance principles), and safety/effectiveness profiles.
- Mechanical Testing (Implied): While not explicitly stated in this summary, the FDA's clearance of such a device implies that mechanical validation testing (e.g., static and fatigue testing according to ASTM or ISO standards for spinal implants) was conducted to demonstrate the device's structural integrity and ability to perform its function (connecting rods, maintaining fixation) under expected physiological loads. These tests would verify that the connector meets specified strength and durability criteria.
- Material Characterization (Implied): Confirmation that the titanium alloy materials meet established standards for biocompatibility and mechanical properties.
- The "study" that proves this device meets the acceptance criteria (i.e., is substantially equivalent to a predicate) is the 510(k) submission itself. This submission would have included:
-
Specific Requirements from the Prompt (Not Applicable in This Context):
- Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" of patient data for an implantable spinal device like there would be for an AI diagnostic. Performance is demonstrated through engineering verification and validation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant like this is established through engineering and biomechanical principles, not expert review of patient cases in the diagnostic sense.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance study (algorithm only): Not applicable.
- Type of ground truth used: For mechanical devices, "ground truth" equates to established engineering standards, material properties, and experimental mechanical testing results, rather than clinical outcomes or pathology from patients.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In conclusion, this 510(k) summary represents a regulatory filing for a modification to a medical device,
not a clinical trial for an AI-powered diagnostic tool. The "acceptance criteria" and "study" are interpreted within the context of mechanical engineering and regulatory substantial equivalence, not clinical performance metrics typical of AI.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.