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The TRAUMACEM™ V+ Injectable Bone Cement is indicated for augmentation of the TFN-ADVANCED® Proximal Femoral Nailing System through cannulated implants and instruments for patients with poor bone quality (e.g., osteoporosis).

TRAUMACEM™ V+ Injectable Bone Cement consists of sterile packed powder and liquid components to create radiopaque TRAUMACEM™ V+ Injectable Bone Cement. The powder component is pre-packed in the mixer. The liquid component is stored in a glass ampoule. A transfer lid for the mixing and transfer of the bone cement in the application system is also contained in the kit. Mixing the two sterile components produces the injectable bone cement.

The provided text describes the regulatory filing for a medical device, TRAUMACEM™ V+ Injectable Bone Cement, and discusses its substantial equivalence to predicate devices, supported by various performance tests and clinical evidence. However, this document does not describe a study that proves a device meets acceptance criteria related to an AI/ML algorithm or a comparative effectiveness study involving human readers with and without AI assistance.

The information provided pertains to the premarket notification (510(k)) process for a physical medical device (bone cement). The "acceptance criteria" discussed are in the context of demonstrating substantial equivalence to a legally marketed predicate device, primarily through physical, chemical, and biomechanical testing, as well as review of existing clinical data.

Therefore, many of the requested points related to AI/ML device validation (e.g., sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone AI performance) are not applicable to the content of this document.

Here's a breakdown based on the provided text, highlighting what is present and what is not:

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

The document doesn't present a formal table of acceptance criteria and corresponding performance for the bone cement in the way one would for an AI/ML diagnostic device with specific metrics like sensitivity, specificity, or AUC. Instead, it states that the device was compared to predicate and reference devices and "meets the requirements of ASTM F451-08/ISO 5833:2002 (apart from setting and dough time)." It also lists various performance tests conducted:

Reported Outcomes: No cases of cut-out were observed. Potential risks (e.g., cement leakage) had a low rate of occurrence. Data correlated well with real-world market experience outside the US. Indications, method of use, and patient populations confirmed to align with intended use. |

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

• Test Set (for clinical evidence):
  • One prospective, multicenter, randomized, postmarket study conducted. The sample size for this specific study is not provided in the document.
  • Two summaries of peer-reviewed publications. The sample sizes for these publications are not provided.
  • Data Provenance: Studies were conducted outside the US. The randomized study described was prospective and postmarket. The publications summarized outcomes from patients treated with PMMA bone cements (presumably retrospective or prospective depending on the original study designs, but not specified here). Real-world market experience outside the United States also mentioned.

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)

This is not applicable as the studies described are clinical outcome studies for a bone cement, not diagnostic studies where experts establish ground truth from images. The "ground truth" here would be clinical outcomes (e.g., presence/absence of cut-out, leakage rates) observed by clinicians.

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

Not applicable. This is relevant for diagnostic studies with image interpretations, not for a bone cement clinical outcome study. Clinical outcomes would be determined by treating physicians and follow-up assessments.

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, an MRMC comparative effectiveness study was not done. This document describes a physical bone cement, not an AI/ML diagnostic device that assists human readers.

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

• No, this is not applicable. The device is a physical bone cement, not an algorithm.

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

• For the clinical evidence presented, the "ground truth" was outcomes data (e.g., presence/absence of cut-out, cement leakage rates) gathered from clinical studies and real-world market experience.

8. The sample size for the training set

• Not applicable. This isn't an AI/ML device that uses a training set.

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

• Not applicable. This isn't an AI/ML device that uses a training set.

In summary: The provided document is a regulatory clearance letter and summary for a physical medical device (bone cement). It demonstrates the device's equivalence to existing products through a combination of physical, chemical, biomechanical, and biocompatibility testing, along with references to existing clinical studies and real-world data. It does not provide information relevant to the validation of an AI/ML-driven diagnostic or treatment planning system.

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