Search Results

OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.

The provided text is a 510(k) summary for a medical device called OSSDSIGN Cranial PSI. It outlines the device's characteristics and its substantial equivalence to a predicate device. However, it does not include the detailed information about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies that would be necessary to fully answer your request.

The document states that "Nonclinical tests demonstrate that Cranial PSI is as safe and effective as its legally marketed predicate device," and mentions "in vivo studies show biocompatibility, adequate resorption rate and osteoconduction." but doesn't provide the acceptance criteria for these.

Based on the provided text, I can only provide the following information:

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

Note: The document implies these as critical performance aspects, but does not explicitly state quantitative acceptance criteria or detailed performance metrics.

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

• Sample Size for Test Set: 52-week sheep implantation study. The exact number of sheep is not specified.
• Data Provenance: In vivo (animal study - sheep). The country of origin is not specified.

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

This information is not provided in the document. The study mentioned is an in vivo implantation study, which typically relies on pathological analysis rather than expert human interpretation of imaging.

4. Adjudication method for the test set:

This information is not provided in the document.

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 information is not provided in the document. The device, OSSDSIGN Cranial PSI, is a patient-specific implant for cranial reconstruction, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable.

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

This information is not provided in the document. As mentioned, the device is an implant, not an algorithm.

7. The type of ground truth used:

For the in vivo implantation study, the ground truth would typically be established through histopathological analysis of tissue samples from the implanted area to assess biocompatibility, resorption, and osteoconduction.

8. The sample size for the training set:

This information is not provided in the document. The device is a physical implant, not a machine learning algorithm that requires a training set.

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

This information is not provided in the document, as it's not relevant to this type of device.

Ask a specific question about this device

Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.

OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient's unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set.
Anatomical Model Original supports OSSDSIGN Cranial PSI by facilitating visual and tactile orientation for the physician of the patient's anatomy. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
Anatomical Model Modified supports OSSDSIGN Cranial PSI by facilitating visual ● and tactile orientation for the physician after removal of physician-specified regions. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
Plastic Drawing Guide supports accurate placement and fitting of OSSDSIGN Cranial PSI by assisting physicians in marking of bone intended for removal. Provided sterile.
Cranial Implant Trial supports placement and fitting of OSSDSIGN Cranial PSI by . assisting physicians in confirming OSSDSIGN Cranial PSI fit, fixation point positions and soft tissue coverage. Provided sterile.

The provided text describes a 510(k) premarket notification for "OSSDSIGN Cranial PSI Accessories." This document focuses on demonstrating substantial equivalence to a predicate device and includes details on biocompatibility and performance testing of the accessories. However, it does NOT describe an AI/ML medical device, nor does it contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

The document primarily focuses on physical, non-AI medical device accessories. Therefore, I cannot extract the requested information in the format of an AI/ML device study.

Here's why the prompt cannot be fulfilled from the provided text:

• No mention of AI/ML: The document does not refer to any artificial intelligence, machine learning, algorithms, or software intended for automated analysis or diagnosis.
• Device type: The described devices are physical accessories (Anatomical Model, Plastic Drawing Guide, Cranial Implant Trial) made from PA2200 polyamide, designed to aid in the implantation of a cranioplasty plate.
• Testing methods: The performance tests detailed are related to physical properties like deformation, particle generation, and dimensional integrity, not algorithmic accuracy or clinical outcome prediction by an AI model.
• Ground Truth/Experts: The concepts of "ground truth," "expert consensus," "human readers," "training set," or "test set" in the context of data used for AI model development or validation are absent.

Therefore, I must state that the provided text does not contain the information required to answer the prompt regarding acceptance criteria and a study proving an AI/ML device meets those criteria.

Ask a specific question about this device