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The Hydroset XT Mixing and Delivery System is intended to be used for the delivery of Hydroset XT to an orthopedic surgical site.

HydroSet XT is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, posterolateral spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. HydroSet XT is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

HydroSet XT cured in-situ provides an open void/gap filler that can augment provisional hardware (e.g. k-wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support medium and is not intended to provide structural support during the healing process.

HydroSet XT is a self-setting calcium phosphate cement. The device includes a pre-filled liquid syringe and a pre-filled powder syringe utilized for mixing and delivery of the cement. The device also includes the necessary components to prepare and deliver the cement (syringe cap, luer adapter, luer cap, threaded plunger, and cannula). After preparation, the cement may be delivered by traditional plunger advancement or by rotating the threaded plunger to deliver the cement.

The provided text describes a 510(k) premarket notification for a medical device called "HydroSet XT". This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria and performance data for an AI/ML device. Therefore, the requested information elements related to AI model evaluation (like sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, MRMC studies, standalone performance) are not applicable or available in this document.

However, I can extract the relevant information regarding the non-clinical performance testing conducted for the HydroSet XT device, which serves as the "study" proving the device meets certain acceptance criteria.

Acceptance Criteria and Device Performance (Non-Clinical Testing)

The document does not explicitly state numerical acceptance criteria for "Working Time" or "Compression Setting Time." Instead, it indicates that "Performance testing was completed for HydroSet XT to determine its suitability for use," and "The following tests were performed to evaluate the performance of HydroSetXT." The conclusion states that the device "demonstrated substantial equivalence" based on this performance testing, implying that the results met the criteria for suitability and equivalence.

Therefore, the table will reflect the tests performed and the implied "acceptance" through the substantial equivalence claim, rather than specific numerical criteria and results.

Detailed Information about the "Study" (Non-Clinical Performance Testing):

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided document for each test.
   • Data Provenance: Not specified, but generally, such testing is conducted in a laboratory setting by the manufacturer. It is non-clinical, not patient-derived data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This device is a bone void filler, and the described tests are physical/chemical performance evaluations, not diagnostic assessments requiring clinician ground truth.

3. Adjudication method for the test set:

   • Not applicable. The tests performed are objective measurements of physical properties (e.g., working time, setting time, endotoxin levels), not subjective assessments requiring adjudication.

4. 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 document is for a medical device (bone void filler) and does not involve AI or human reader interpretation.

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

   • Not applicable. This is not an AI/ML device.

6. The type of ground truth used:

   • For the non-clinical performance tests (Working Time, Compression Setting Time): The "ground truth" is established by standard laboratory testing methodologies and specifications for these physical/chemical properties.
   • For Bacterial Endotoxin Testing (BET): The "ground truth" is a Pass/Fail criterion based on the specified endotoxin limit (, Ph. Eur. 8.0 2.6.14).

7. The sample size for the training set:

   • Not applicable. The described testing is not for an AI/ML algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. There is no AI/ML training set.

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