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The OnControl Bone 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 and for bone biopsy. This system does not contain cement.

The OnControl Bone 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 (Access and) Biopsy Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices: the Vertebral Access System (cleared via K081713) and 11g, the same as Clearview Plus Bone and Vertebral Body Biopsy Needles (cleared via K022169). The powered driver is identical to the predicate driver cleared via K081713.

Under fluoroscopic imaging guidance, activation of the driver assists the clinician to insert the vertebral needle set through the cortex of the bone, into the vertebral body. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism ring on the OnControl Connector. The needle set consists of two parts, an 11g outer cannula (3.05mm x 197mm) with an inner stylet (diameter of 2.54mm). The inner stylet is used only to penetrate the cortex and is then removed. A standard Luer lock (part of the 11 gauge cannula) permits attachment of the syringe for aspiration. The driver is activated and advanced to obtain the biopsy specimen and then withdrawn.

The driver is then separated from the needle assembly for specimen removal.

The provided text is a 510(k) summary for the Vidacare OnControl Bone Access System. This type of document is for premarket notification of a medical device to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. It typically doesn't contain a full study protocol with acceptance criteria and detailed device performance data in the way a clinical trial report would. Instead, it focuses on comparing the new device's technological characteristics, indications for use, and safety/effectiveness to existing, cleared devices.

Therefore, many of the requested items (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance details, and ground truth establishment) are not present in this type of document.

The document states that the new device has "similar technological characteristics and to be equivalent" to its predicate devices in areas such as indications for use, target population, driver design, needle design, technique, sterility, biocompatibility, and anatomical sites. This "equivalence" is the primary "acceptance criterion" for a 510(k) submission, and the basis of the "study" (which is more accurately a comparison) presented.

Here's a breakdown of what can be extracted from the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implied for 510(k) Equivalence):

  • Indications for Use: Equivalent to predicate devices.
  • Target Population: Equivalent to predicate devices.
  • Driver Design Features: Equivalent to predicate devices.
  • Needle Design: Equivalent to predicate devices (specifically, 11g, 152mm cannula of 304 stainless steel, beveled cutting tip and stylet, identical in gauge, length and materials).
  • Technique: Equivalent to predicate devices.
  • Sterility: Equivalent to predicate devices.
  • Biocompatibility: Equivalent to predicate devices.
  • Anatomical Sites: Equivalent to predicate devices.

• Reported Device Performance:

  • The document states that the new device was "found to have similar technological characteristics and to be equivalent" to the predicate devices across the criteria listed above.
  • Specifically, for the needle: "The Vertebral (Access and) Biopsy Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices..."
  • For the driver: "The powered driver is identical to the predicate driver cleared via K081713."
  • The system "assists the clinician to insert the vertebral needle set through the cortex of the bone, into the vertebral body."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. This document does not detail a specific "test set" with a sample size as it's a comparative equivalence submission, not a new clinical study with performance endpoints. The "test" is the comparison to predicates.

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/Not provided. No explicit "ground truth" establishment process for a test set is described in this 510(k) summary. The ground for "equivalence" is based on comparing device specifications and intended use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. No adjudication method is described.

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

• No. This device is a mechanical bone access system, not an AI software. Therefore, an MRMC study related to AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided. This is a hardware device; the concept of "standalone algorithm performance" does not apply. The device description explicitly states it "assists the clinician."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided in the traditional sense. For a 510(k) submission, the "ground truth" for demonstrating substantial equivalence lies in the established performance and safety of the predicate devices. The new device is simply shown to be functionally and materially similar, therefore inheriting the "truth" of the predicate's clearance.

8. The sample size for the training set

• Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable/Not provided. As there is no training set, this information is not relevant.

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