Search Results

DirectInject is a self-setting, calcium phosphate cement intended to repair neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects not intrinsic to the stability of the bony structure. It is also intended for augmentation or restoration of bony contour in the craniofacial skeleton to include the cranial and zygomatic bones. DirectInject is intended to repair cranial defects with a surface area of 4 cm2 or less.

DirectInject is indicated for patients in whom skeletal growth is complete. It can be used in patients with surgically created bone defects.

Stryker DirectInject consists of a sterile dual paste system, provided pre-filled in a double barrel delivery syringe system, which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is injectable, moldable and biocompatible. The injected cement paste will harden under normal body conditions to form hydroxyapatite, which is the principle mineral constituent of bone. The contents are supplied sterile for single patient use in sizes of 3 cc, 5 cc, and 10 cc.

The provided text is a 510(k) summary for the Stryker DirectInject device, which is a calcium phosphate cement for cranioplasty. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study with acceptance criteria in the typical sense of a clinical trial for diagnostic devices. Therefore, much of the requested information regarding diagnostic performance, ground truth, experts, and sample sizes for training/test sets is not applicable to this type of submission.

However, I can extract information related to the performance data provided to support the safety and effectiveness of the device, primarily through biocompatibility and bench testing.

Here's a breakdown of the information that can be extracted from the provided text, addressing the points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present acceptance criteria in a table format with corresponding numerical performance metrics for a diagnostic device. Instead, it describes performance testing conducted to demonstrate safety and effectiveness for a medical device (cranioplasty cement).

The acceptance criteria are implied by the standards the device was tested against. The "reported device performance" is generally stated as the device having passed these tests and performing as intended.

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 Sample Size: For the in-vivo animal studies, the document mentions "a sheep and rabbit model." It does not specify the exact number of animals used in these models.
• Data Provenance: The biocompatibility and bench testing are laboratory-based. The in-vivo animal studies are conducted in animal models, likely in a research facility accredited with animal welfare standards. Country of origin for the data is not specified, but the submitter is Stryker Leibinger GmbH & Co. KG (Germany) with regulatory contact in Michigan (USA).

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 information is not applicable. The device is a bone cement, not a diagnostic AI device requiring expert consensus for ground truth. The "ground truth" for biocompatibility and material properties is established by adherence to recognized international standards and scientific testing methodologies. For the animal study, macroscopic and histological evaluations would typically be performed by trained veterinary pathologists, but the number and qualifications are not specified.

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

• This is not applicable as it relates to expert review for diagnostic ground truth, which is not part of this submission type.

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

• This is not applicable. This is a medical device (bone cement), not a diagnostic AI system.

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

• This is not applicable. This is a medical device (bone cement), not a diagnostic algorithm.

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

• For biocompatibility: Ground truth is defined by the passing criteria of the specified ISO and ASTM standards.
• For physical properties: Ground truth is defined by the expected material characteristics (e.g., hydroxyapatite composition, mechanical strength, setting time) as measured against the respective standards and internal specifications.
• For in-vivo testing: Ground truth is established by macroscopic and histological evaluation demonstrating stability, osteoconductivity, and integration with bone tissue, as interpreted by qualified personnel (e.g., veterinary pathologists).

8. The sample size for the training set

• This is not applicable for a non-AI medical device submission.

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

• This is not applicable for a non-AI medical device submission.

Ask a specific question about this device