Search Results
Found 2 results
510(k) Data Aggregation
(220 days)
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
(276 days)
OSSDSIGN Cranial PSI is intended for the reconstruction of cranial defects. It is indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with or with or 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 tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.
The provided document is a 510(k) summary for the OSSDSIGN Cranial PSI device. It includes information about acceptance criteria and mechanical/biocompatibility testing comparing it to a predicate device, but it does not describe studies involving human performance or assessment by experts. Therefore, many of the requested fields cannot be answered from this document.
Here's the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Test Method and Relevance Summary | Acceptance Criteria | OSSDSIGN Cranial PSI Performance | KLS Martin - PCI Titanium Mesh (Predicate) Performance |
|---|---|---|---|
| Dynamical Load Test: To verify that the Cranial PSI supports the forces exerted onto the implant from sleeping during the device lifetime. Method: orbital shaker, 125 rpm, 60 hours. Relevance: test simulates changed head position every 20 minutes during 8 hours sleep for 50 years. | No deformation | No deformation | No deformation |
| Max Force [N]: To establish the maximum force that can be applied to the device before failure. Method: Universal testing machine at 1 mm/min. Relevance: protection from falling objects and blunt trauma. | >100 N | 461 N | 383 N |
| Energy absorption [mJ]: To establish the maximum energy the device can absorb before failure. Method: Universal testing machine at 1 mm/min. Relevance: protection from falling objects and blunt trauma. | >1000 mJ | 2260 mJ | 3760 mJ |
| Resistance to Deformation [mm]: To establish device resistance to deformation before device failure. Method: Universal testing machine at 1 mm/min to 100 N applied force. Relevance: Both the subject device and predicate passed the test. | <6 mm | 0.5 mm | 1.1 mm |
Biocompatibility Acceptance Criteria and Results:
| Test | Test Method Summary | Acceptance Criteria (Implied by results) | Results for OSSDSIGN Cranial PSI |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5 Method: L-929 mouse fibroblast cells | Not cytotoxic; No evidence of causing cell lysis or toxicity | Not cytotoxic; No evidence of causing cell lysis or toxicity |
| Sensitization | ISO 10993-10 Method: guinea pig maximization test | Non-sensitizer; No evidence of causing delayed dermal contact sensitization | Non-sensitizer; All test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. |
| Sensitivity, Irritation | ISO 10993-6 Method: polar and non-polar test article extracts intracutaneously injected into five separate sites on the right side of the back of three rabbits. Observations for erythema and edema at 24, 48, and 72 hours. | Non-irritant; Difference between test and control mean scores <1.0 | Non-irritant; Difference between the test and the control mean scores <1.0, confirming the device is a non-irritant |
| Systemic (acute) toxicity | ISO 10993-11 Method: 20 mice observed at 4, 24, 48 and 72 hours. | Non-toxic; No mortality or evidence of systemic toxicity | Non-toxic; No mortality or evidence of systemic toxicity |
| Genotoxicity | ISO 10993-3 Method: mouse lymphoma forward gene mutation assay. | Not mutagenic; <2-fold increase in mean mutant frequency | Not mutagenic; <2-fold increase in mean mutant frequency of the L5178Y/TK cell line. |
| Mutagenicity | ISO-10993-3 Method: bacterial reverse mutation study | Non-mutagenic; <2-fold increase in mutagenic frequency | Non-mutagenic; <2-fold increase in mutagenic frequency. |
| Implantation | ISO 10993-6 Test for local effects after implantation, 2- and 6-week subcutaneous implantations in rabbits. | Non-irritant compared to control | Non-irritant; Non-irritant compared to control. |
| Analytical Extractable Chemical Analysis | ISO 10993-12 Analysis by GC-MS, ICP-MS, LC-MS and HPLC-ELSD | Non-hazardous; No hazardous materials detected in various extractions | Non-hazardous in all results, including extractions in polar, non-polar and mid-polar solvents. No hazardous materials detected. |
| Indirect Hemolysis | ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Hemolytic index within acceptable criteria (implied by "All samples passed the acceptance criteria") | The hemolytic index for the test article extract was 3.8% and the test article extract was slightly hemolytic. All samples passed the acceptance criteria. |
| Material Mediated Pyrogenicity | ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity, Pyrogen Test | Total rise of temperatures during the 3 hour observation period within acceptable limits; Nonpyrogenic (implied by results) | The total rise of temperatures during the 3 hour observation period was within acceptable limits. The test article was judged as nonpyrogenic. All samples passed the acceptance criteria. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a distinct "test set" sample size in the context of human data or image analysis. The tests mentioned are mechanical and biocompatibility tests performed on the device itself or in animal models/in vitro assays.
- For the mechanical tests, the "size" of the device tested was 197 cm² for both the subject device and the predicate. The number of individual samples tested is not stated.
- For biocompatibility:
- Cytotoxicity: L-929 mouse fibroblast cells (number of cells/replicates not specified).
- Sensitization: Guinea pigs (number not specified).
- Irritation: 3 rabbits.
- Systemic toxicity: 20 mice.
- Genotoxicity: Mouse lymphoma cell line (L5178Y/TK).
- Mutagenicity: Bacterial strains (not specified).
- Implantation: Rabbits (number not specified) for 2- and 6-week implantation.
- Data Provenance: The document does not provide information on data provenance (e.g., country of origin, retrospective/prospective) as it relates to clinical or imaging data, which are not part of this 510(k) summary. The company is based in Uppsala, Sweden.
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 as the document describes mechanical and biocompatibility testing of a physical device, not a diagnostic algorithm requiring ground truth established by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes mechanical and biocompatibility testing of a physical device, not a diagnostic algorithm requiring adjudication of human expert interpretations.
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 applicable. No MRMC comparative effectiveness study involving human readers or AI assistance is mentioned in this 510(k) summary. The study is a non-clinical comparison of a device's physical properties with a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document evaluates a physical medical device (a cranial implant), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical tests, the "ground truth" is defined by the objective performance measurements against pre-defined engineering requirements (e.g., no deformation, >100 N max force, <6 mm deformation).
For biocompatibility tests, the "ground truth" is established by the results of standardized biological assays (e.g., looking for cell lysis, sensitization, irritation, toxicity, mutagenicity, pyrogenicity) as per ISO standards. These are objective measures based on biological reactions.
8. The sample size for the training set
This information is not applicable. The device is a physical implant, not an AI algorithm that requires a training set. The term "training set" is not relevant to the described testing.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
Ask a specific question about this device
Page 1 of 1