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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 Posterior Occipital Cervical Thoracic 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 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) summary for the Blackstone™ Ascent® Posterior Occipital Cervico-Thoracic (POCT) System is a pre-market notification seeking clearance based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial or performance study would for a diagnostic or AI-driven device.

Instead, the submission focuses on:

• Device Description: What the device is made of and its components.
• Intended Use/Indications: The medical conditions and anatomical regions for which the device is designed.
• Substantial Equivalence: How this new device is similar to previously cleared devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets, training set sample size, ground truth establishment for training set) are not applicable to this type of submission.

Here is a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance
This document, K073420, is a 510(k) summary for a spinal implant system. Performance for such devices is typically assessed through mechanical testing (e.g., strength, fatigue) and biocompatibility, as well as by demonstrating substantial equivalence to predicate devices. The document does not provide a table of specific quantitative acceptance criteria or a report of measured device performance against such criteria. The "performance" claimed is its substantial equivalence to other legally marketed spinal fixation systems for the stated indications.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document does not describe a clinical performance study with a "test set" of patients or data in the context of diagnostic or AI device evaluation. The assessment is based on a comparison to predicate devices, material specifications, and design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth establishment by experts is not a component of this 510(k) submission for a spinal implant.

4. Adjudication Method for the Test Set
Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or an AI-assisted device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used
Not applicable in the context of clinical "ground truth" for diagnostic evaluation. The "ground truth" for this device's safety and effectiveness is established by its similarity (substantial equivalence) to devices that have been deemed safe and effective in prior regulatory clearances, along with meeting recognized material and mechanical engineering standards.

8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an algorithmic or AI device.

9. How the Ground Truth for the Training Set Was Established
Not applicable.

Summary of Device Rationale from the Document:

The basis of substantial equivalence is stated as: "The modified Blackstone™ Ascent Multiaxial Screws 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 that the device's design, materials, and intended use are sufficiently similar to approved devices that it is expected to perform in a similar safe and effective manner, without requiring new clinical efficacy trials. The predicate devices listed are other spinal fixation systems.

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