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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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The HIGH V+ is used for the fixation of pathological fractures of the vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lessons (hemangiona), or malignant lesions (metastatic cancers, myeloma).

HIGH V+ is a self-hardening and ready to use Poly Methylmethacrylatebone cement with 36.4% of radiopaque agentsfor the treatment of painfulvertebral fractures based on the predicate devices Spineplex. Vertecem. It can be injected directly into the fractured vertebral body by either Vertebroplasty or Kylphoplasty procedures to relieve pain. HIGH V+ allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The HIGH V+ cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.

This document is a 510(k) summary for the HIGH V+ bone cement, which is a medical device for fixing vertebral fractures. The summary focuses on demonstrating the substantial equivalence of HIGH V+ to predicate devices (Vertecem and Spineplex) rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) submission primarily relies on non-clinical (bench) testing to show equivalence in material properties and functional characteristics.

Here's the breakdown of the information that can be extracted from the document, and where the requested details are not present:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in the traditional sense of a clinical trial's primary endpoints. Instead, it presents various physical and chemical characteristics of the HIGH V+ and compares them to predicate devices and the ISO 5833 standard. The "acceptance" is implied by meeting or being comparable to these established benchmarks for bone cement.

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

• Sample Size: Not specified for each individual non-clinical test. The document states "Test data indicate that the final properties of HIGH V+ are in compliance..." but does not detail the number of samples tested for each property (e.g., number of specimens for compressive strength).
• Data Provenance: The tests were conducted by Teknimed, SAS, located in L'Union, France. The data appears to be prospective as it's part of the premarket submission for a new device.

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. This is a non-clinical (bench) study involving material properties, not diagnostic interpretation or clinical outcomes requiring expert ground truth.

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

• Not applicable. This is a non-clinical (bench) study.

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 a non-clinical (bench) study about a bone cement, not an AI-assisted diagnostic device.

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

• Not applicable. This is a non-clinical (bench) study of a physical material.

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

• For the non-clinical tests, the "ground truth" or reference for comparison is the established performance of legally marketed predicate devices (Vertecem, Spineplex) and the chemical/physical requirements outlined in the international standard ISO 5833 "Implants for surgery - acrylic resin cements."

8. The sample size for the training set

• Not applicable. This is a non-clinical study for a physical device, not a machine learning model requiring a training set.

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

• Not applicable, as there is no training set for this type of device submission.

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The F20 is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

F20 is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates F20 allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liguid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder components are polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerization is included in the polymer powder.

The medical device described in the 510(k) summary is a bone cement called F20, intended for use in vertebroplasty and kyphoplasty procedures to fix pathological fractures of the vertebral body.

Here's an analysis of the acceptance criteria and study information provided in the document:

This document describes a non-clinical study for device F20 as depicted in the 510(k) summary provided.

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

The F20 bone cement’s performance was evaluated against the standards outlined in ISO 5833 "Implants for surgery - acrylic resin cements". The acceptance criteria are implicitly defined by compliance with this standard and similarity to predicate devices.

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each non-clinical test (e.g., number of samples for compressive strength testing). It only states that tests were "conducted."

The data provenance is from non-clinical laboratory testing conducted by Teknimed SAS, the manufacturer, in France. The specific nature of the data is experimental results from material science and mechanical engineering tests.

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

This information is not applicable as there was no clinical study. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards (ISO 5833) and the performance characteristics of the predicate devices. The experts involved would be the engineers and scientists conducting these tests, but their number and qualifications are not specified.

4. Adjudication method for the test set

This information is not applicable as there was no clinical study involving subjective interpretation. The assessment was based on objective measurements against ISO standards.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone cement, not an AI-assisted diagnostic tool.

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

No, this is not an AI algorithm. The performance evaluation was of the physical and chemical properties of the bone cement in a standalone non-clinical setting.

7. The type of ground truth used

The "ground truth" for the non-clinical tests was based on:

• Established scientific and engineering standards: Specifically ISO 5833 "Implants for surgery - acrylic resin cements."
• Performance characteristics of legally marketed predicate devices: Vertecem (K090435), Opacity+ (K080873), and Spine-Fix® (K045593). The F20 was shown to have similar properties to these predicates.

8. The sample size for the training set

This information is not applicable as this is not a machine learning or AI device. There is no concept of a "training set" for the evaluation of a bone cement's physical and chemical properties.

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

This information is not applicable as this is not a machine learning or AI device.

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