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510(k) Data Aggregation
(88 days)
The POSKOM Portable X-ray unit is a device that can conveniently generate X-rays for diagnosis when the patient condition is difficult to move. Mainly used by trained specialists, doctors or radiologists.
Indication:
The POSKOM Battery Type Portable X-ray Unit is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the body parts.
The device must be used for stand mounted diagnostic imaging of head, abdomen, or extremities.
The device must be used for stand mounted imaging of the chest.
Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Contraindication:
The use of X-radiation for diagnostic purposes in the following subjects is contraindicated.
- Pregnancy, especially first trimester
The device is intended to assist the diagnosis of bones and tissues through X-ray exposure using an imaging receptor. The image receptor (an integral part of a complete diagnostic system) is not part of this submission.
The provided text describes a 510(k) premarket notification for a mobile X-ray system named "AirRay" (K222896). The submission focuses on demonstrating substantial equivalence to a predicate device (TR90BH, K182207) primarily through comparisons of technical characteristics and compliance with recognized standards.
Based on the provided document, here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance with corresponding "reported device performance." Instead, it focuses on demonstrating substantial equivalence through a comparison of technical characteristics and compliance with electrical safety, EMC, and software validation standards.
The most relevant "performance" aspects discussed are technical specifications compared to a predicate device. If we were to infer "acceptance criteria" from the comparative table (Table 1. Comparison of Proposed Device to Predicate Devices on page 11) and the summary of non-clinical tests, it would revolve around meeting safety and essential performance standards.
| Acceptance Criteria (Inferred from non-clinical tests & predicate comparison) | Reported Device Performance (as stated) |
|---|---|
| Electrical Safety Compliance | "The AirRay complies with the electrical safety and electromagnetic compatibility requirements established by the standards." |
| (Specifically: IEC 60601-1:2005/AM1:2012, IEC 60601-1-3:2008+AMD:2013, IEC 60601-2-54:2009/AM2:2018, IEC 60601-1:2005+AMD1:2012, IEC 60601-1-2:2014, IEC 60601-1-3:2008+AMD:2013, IEC 60601-1-6:2010+AMD1:2013) | |
| Electromagnetic Compatibility (EMC) Compliance | "The AirRay complies with voluntary standards for electromagnetic compatibility." |
| (Specifically: IEC 60601-1-2:2014) | |
| Software Validation | "The software was designed and developed according to a software development process and was verified and validated." |
| (Specifically: IEC 62304:2006, FDA guidance "The content of premarket submissions for software contained in medical devices, on May 11, 2005") | |
| Battery Performance | "Rechargeable Li-ion polymer battery pack has been tested and is in conformity with the standard IEC 62133." |
| "And we performed the battery performance test about battery charging time. discharge time and usage count, Battery rated load, overcurrent protection and recovery." | |
| Radiation Safety | Conforms to "Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use," 21 CFR 1020 Subchapter J, 21 CFR 1020.30, 21 CFR 1020.31. |
| Intended Use | Similar to predicate device, not introducing a new intended use. (Pages 10-11) |
| Technical Characteristics | "Similar" or "Same" as predicate device for key parameters like Tube Voltage Range, HF Generator, Memory settings. "Similar" for Output Power, Size, Weight, Energy Source, Exposure Times. "Different" for X-ray Tube and Collimator, but not deemed to adversely affect safety or effectiveness. (Pages 10-11) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical study with a "test set" of patient data for evaluating the diagnostic performance of the X-ray unit. The submission appears to rely on non-clinical (engineering and safety) testing and comparison to a predicate device to establish substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set with ground truth established by experts is described in this document.
4. Adjudication method for the test set
Not applicable. No clinical test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in this document. The submission focuses on the safety and technical characteristics of the X-ray generation device itself, not on the interpretation of images produced by it, or the comparative diagnostic accuracy of human readers with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device, "AirRay," is a portable X-ray unit, which generates X-rays for diagnostic imaging. It is a hardware device, not an AI algorithm for image analysis. Therefore, a standalone performance assessment of an algorithm is not relevant to this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As this submission focuses on the X-ray generating device and not on a diagnostic algorithm, there's no mention of ground truth related to image interpretation. The "ground truth" here would be that the device meets its technical specifications and safety standards as verified through engineering tests.
8. The sample size for the training set
Not applicable. The AirRay device is hardware (an X-ray unit), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As clarified in point 8, this is a hardware device and does not involve AI algorithms requiring a training set.
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(90 days)
The °AirRay® Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (
The ° AirRay® Subdural Cortical Electrodes Subdural electrodes are single patient use, disposable, sterile devices. The electrodes are invasive as they are placed in contact with the brain. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of subdural electrodes.
The provided text is a 510(k) summary for the CorTec AirRay Subdural Cortical Electrodes. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, much of the requested information regarding acceptance criteria, a test set, ground truth establishment for a test set, expert involvement, and comparative effectiveness studies is not present in this document, as these are typically part of a different type of submission (e.g., a PMA or De Novo) or a more detailed clinical study report, which is not included here.
However, the document does contain information about biocompatibility testing, which does have acceptance criteria for physical and chemical characteristics, and the results of those tests. I will focus on that section for the table, as it is the only part that directly addresses acceptance criteria and performance against them.
Here's a breakdown of what can be extracted and what is not available:
1. Table of acceptance criteria and the reported device performance:
The document provides a "Biocompatibility Summary Table" with test methods, results, and conclusions. The acceptance criteria are implicitly "Pass" for each test, indicating that the device's performance met the required biological safety standards.
| Test (Applicable ISO 10993 Part No.) | Acceptance Criteria (Implicit) | Reported Device Performance | Conclusion (Met Acceptance Criteria) |
|---|---|---|---|
| Cytotoxicity (10993-5) | Non-cytotoxic | Pass | Non-cytotoxic |
| Sensitization (10993-10) | Non-sensitizer | Pass | Non-sensitizer |
| Irritation (ISO 10993-10) | Non-irritant | Pass | Non-irritant |
| Acute Systemic Toxicity (ISO 10993-11) | No acute systemic toxicity | Pass | No acute systemic toxicity |
| Material-mediated Pyrogenicity (ISO 10993-11) | Non-pyrogenic | Pass | Non-pyrogenic |
| Hemocompatibility (ISO 10993-4) | Non-hemolytic | Pass | Non-hemolytic |
| Subchronic Toxicity (ISO 10993-11) | No subchronic systemic toxicity and acceptable local toxicities | No systemic or local toxicities were observed, and all measured parameters (clinical observations, body weights, organ weights, hematology, clinical chemistry, necropsy, microscopic evaluation) were acceptable. | No subchronic systemic toxicity |
| Genotoxicity (ISO 10993-3) - Bacterial Mutagenicity Test (Ames Assay) | Non-mutagenic | Pass | Non-mutagenic |
| Genotoxicity (ISO 10993-3) - In Vitro Mouse Lymphoma Assay | Non-mutagenic / non-clastogenic | Pass | Non-mutagenic / clastogenic |
| Implantation (ISO 10993-6) | No adverse local effects in neural tissues, no neurotoxicity | Overall, no adverse local effects attributed to the implanted articles. All implanted animals survived with no clinical or neurological findings attributable to the test article or negative control. No evidence of CSF leakage or infection. Considered to elicit no or minimal reaction compared to negative control at 1 and 4 weeks. | No adverse local effects in neural tissues, no neurotoxicity |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions that "All biocompatibility studies were conducted in compliance with Good Laboratory Practices (GLP), 21 CFR Part 58." While specific numbers for each test are not listed, the document states, for example, that the "4-week brain implantation study was conducted in rabbits" and "Both male and female animals were used." This implies a typical sample size used in GLP studies for animal testing, which adheres to specific guidelines for statistical significance (though exact numbers are often not in a 510(k) summary).
- Data Provenance: The studies were conducted on the "finished, sterilized device." The location of the studies (e.g., country) is not explicitly stated beyond the submitter's location in Germany. These are prospective tests performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Biocompatibility Ground Truth: For the implantation study, it is stated that "The macroscopic and microscopic evaluations were performed by a board certified veterinary pathologist." This pathologist served as the expert for establishing the "truth" (i.e., the presence or absence of adverse tissue reactions) in that specific test. For other biocompatibility tests (cytotoxicity, sensitization, etc.), these are standardized laboratory assays with defined pass/fail criteria, so the "ground truth" is established by the assay's results per validated protocols, interpreted by qualified lab personnel.
- For human clinical performance (not applicable to this 510(k) summary): No information is provided as this is a device clearance based on substantial equivalence and non-clinical testing.
4. Adjudication method for the test set:
- For the biocompatibility studies, standard GLP practices and validated test protocols are followed. Results are typically reviewed and signed off by the study director and relevant subject matter experts (e.g., the veterinary pathologist). There's no "adjudication" in the sense of multiple human readers disagreeing on clinical image interpretation, as this is laboratory testing.
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. This device is a passive implant (subdural cortical electrodes) and is not an AI-powered diagnostic device. Therefore, a MRMC study of human reader performance with or without AI assistance is not applicable and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device does not have an algorithm or software component that operates in a standalone capacity. It is a physical medical device. The document explicitly states "Contains Software/Firmware: No".
7. The type of ground truth used:
- For the biocompatibility studies, the ground truth was laboratory test results and expert pathological evaluation (specifically for the implantation study). This is empirical data derived from standardized biological and chemical tests.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML device that requires a training set. The clearance is based on substantial equivalence to a predicate device and non-clinical performance testing.
9. How the ground truth for the training set was established:
- Not applicable. As a non-AI/ML device, there is no training set and therefore no ground truth established for one.
In summary, the provided document focuses on the physical and biological safety of the device through non-clinical testing, particularly biocompatibility. It is a substantial equivalence submission, comparing the new device to an existing predicate rather than demonstrating clinical efficacy through a structured clinical study with human patients and expert review of clinical outcomes/interpretations.
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