(157 days)
The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.
The Vertebral Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The 11 gauge, 152mm needle set is identical in gauge and length to the predicate devices: OnControl™ Bone Marrow Biopsy System (cleared via K072045) and the Parallax EZFlow Cement Delivery System (cleared via K051820). The powered driver is identical to the predicate driver cleared via K072045.
This document describes a 510(k) submission for the "Vertebral Access System by Vidacare®". This submission is for substantial equivalence to existing devices, not for demonstrating new clinical effectiveness. Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" as might be seen for a novel device demonstrating performance metrics are not directly applicable in the terms you've presented for medical imaging AI.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to legally marketed devices.
Based on the provided text, here's a breakdown in relation to your questions:
1. A table of acceptance criteria and the reported device performance
For a 510(k) focusing on substantial equivalence, the "acceptance criteria" are not performance metrics like sensitivity/specificity for a diagnostic device. Instead, the acceptance criteria are met by demonstrating that the new device is as safe and effective as predicate devices. The "reported device performance" is essentially that the new device shares similar technological characteristics and indications for use with the predicate devices.
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison to predicates) |
|---|---|
| Same Indications for Use | Intended for use with a standard cement delivery system for fixation of vertebral body fractures using vertebroplasty. This matches the intended use of predicate devices (implicitly, as part of the substantially equivalent finding). |
| Similar Target Population | Used for patients requiring vertebroplasty. |
| Similar Driver Design Features | The powered driver is identical to the predicate driver cleared via K072045. |
| Similar Needle Design | The 11-gauge, 152mm needle set is identical in gauge and length to the predicate devices (OnControl™ Bone Marrow Biopsy System (K072045) and Parallax EZFlow Cement Delivery System (K051820)). |
| Similar Technique | Implied to be similar given the identical/similar components and intended use. |
| Sterility | Disposable sterile needle set. Implied to meet sterility standards similar to predicates. |
| Biocompatibility | Implied to meet biocompatibility standards similar to predicates. |
| Similar Anatomical Sites Where Used | Vertebral body. |
2. Sample size used for the test set and the data provenance
There is no "test set" in the context of an AI/diagnostic device study. This 510(k) is for a medical instrument (Vertebral Access System). Device performance is demonstrated through comparison of specifications and design features, not clinical data from a "test set" analyzing patient outcomes in the way a diagnostic AI would.
- Sample size: Not applicable in this context.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of AI refers to expert-labeled data. For a hardware medical device submission like this, there isn't a "ground truth" to establish for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process for clinical outcomes described in this 510(k) summary.
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 not an AI device. No MRMC study was performed or required for this type of medical instrument submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices based on their prior FDA clearances. The new device demonstrates substantial equivalence to these predicates. This is a technical comparison of specifications and intended use, not an evaluation against a clinical ground truth for diagnostic accuracy or outcomes.
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
In summary: The provided document is a 510(k) premarket notification for a medical instrument, not a diagnostic AI system. Therefore, the questions related to acceptance criteria, test sets, ground truth, experts, and AI performance metrics are not relevant to this specific regulatory submission type. The "study" proving the device meets its "acceptance criteria" is the detailed comparison of its technological characteristics and indications for use against legally marketed predicate devices, which led to the FDA's finding of "substantial equivalence."
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.