Search Results

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.

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."

Ask a specific question about this device

Replacement Battery for Baxter Flo-Gard Pump 8000, 8100, 8200 Infusion Pumps inidator. Formps This battery is sold only to customers who request a replacement battery for a particular device or to replace a competitor's Dattery for a particular dovice of to a loss equipment technician knows the intended use is as a replacement battery.

Nordix Rechargeable Battery Part Number 2116

This document is a 510(k) clearance letter from the FDA for the Nordix Rechargeable Battery Part Number 2116. This type of document is a regulatory approval, not a scientific study report. It does not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not detail the technical performance studies that might have been conducted for that determination.

Ask a specific question about this device

Replacement battery for IVAC Corp. 124915 Electronic Clinical Thermometer 2000, 510(k) Number K820409.

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Rechargeable Battery Part Number MS822

The provided document is a 510(k) clearance letter from the FDA for a replacement battery (Alexander Manufacturing Co. Rechargeable Battery Part Number MS822). This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would be relevant for a medical device with an algorithm or AI component.

This letter is a regulatory document confirming that the device is "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics but raises no new questions of safety and effectiveness and is as safe and effective as a legally marketed device.

Therefore, I cannot provide the requested information based on the input document. The type of information you're asking for (acceptance criteria, study details, expert involvement, etc.) would typically be found in a detailed submission summary, clinical study report, or a performance testing document, not in the 510(k) clearance letter itself for a simple replacement battery.

Ask a specific question about this device