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510(k) Data Aggregation
(14 days)
MEDIPORT
The MEDIPORT is a medical grade device to be used as a platform for PACS software or DICOM viewer software. It is intended for use in all Hospital environments (OR, ER etc.) as well as Physicians' Offices and Clinical Laboratories.
In light of the fact that MEDIPORT is a high performance computer it may also be used to access patient records or perform other functions that may be required.
This device in not qualified or intended for use for mammographic purposes.
The MEDIPORT is a high performance medical grade computer with DICOM calibrated monitors that may be used as a platform for PACS software. It is designed for use in all Hospital environments (OR, ER etc.) as well as Physicians' Offices and Clinical Laboratories. It may also be used to access patient records or perform other functions that may be required.
The Kobo200 document is a 510(k) summary for a medical device called MEDIPORT, a medical-grade computer system intended as a platform for PACS software. The application was filed in 2006. This document does not contain any information about a study that assesses the device's performance against acceptance criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices by comparing technical specifications and safety certifications. The MEDIPORT is presented as a hardware system acting as a host for PACS software, implying its performance is largely tied to the software it runs and its adherence to relevant standards rather than a specific clinical performance metric.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as this information is not present in the provided text. The document is primarily a regulatory filing to establish equivalence for marketing purposes.
Here's a breakdown of why the requested information cannot be extracted:
- Acceptance Criteria and Reported Device Performance: This document states the device's technical specifications (CPU, RAM, Hard drive, etc.) and its adherence to standards like DICOM and UL60601-1. It does not specify acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity for image interpretation) nor the results of a study demonstrating such performance.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set: All these points relate to a clinical or performance study, which is entirely absent from this 510(k) summary. The document focuses on hardware specifications and regulatory compliance, not on the performance of a clinical algorithm or diagnostic aid.
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(90 days)
MEDIPORT 2000 MOBILE
The Mediport 2000 suction device can be generally used in the ENT sector and is equally suitable for both in-patient and outpatient purposes. It can be used for faryngectomy and in the event of heavy secretion in one of the organisms or other operations in the mouth and throut area. The mobile may only be used for the applications listed above.
Mediport 2000 Mobile is a powered suction pump.
Here's an analysis of the provided text, focusing on the request for acceptance criteria and study details.
Limitations of the Provided Text:
The provided text is an FDA 510(k) clearance letter for a medical device called "Mediport 2000 Mobile." This type of document primarily confirms that a new device is "substantially equivalent" to an already legally marketed device (predicate device). It does not generally contain detailed information about specific acceptance criteria or the full study reports that were submitted for the clearance.
Therefore, the following answers are based only on the information that can be inferred or explicitly stated in the provided FDA letter. Many sections will be marked as "Not provided in the document" because the letter's purpose is not to disseminate this level of detail.
Acceptance Criteria and Study for Mediport 2000 Mobile
Summary:
The provided document is an FDA 510(k) clearance letter indicating that the Mediport 2000 Mobile suction device has been found substantially equivalent to a predicate device. This letter signifies regulatory approval for marketing based on a comparison to an existing device, rather than a presentation of direct performance against specific, pre-defined acceptance criteria. The letter itself does not explicitly list the acceptance criteria or a detailed study report.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The 510(k) clearance process relies on demonstrating "substantial equivalence" to a predicate device, which implies meeting similar performance characteristics. Specific performance metrics (e.g., suction pressure, flow rate, reservoir capacity, noise level, reliability) would have been part of the submission but are not detailed in this clearance letter. | Not explicitly stated in the document. The device is cleared for the indicated uses, implying its performance is sufficient for those uses and comparable to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided. The submission would have included testing data, but its origin (e.g., country, retrospective/prospective nature) is not specified in this clearance letter.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not provided. Given the nature of a powered suction pump, ground truth for performance claims typically comes from engineering and functional testing, not expert clinical interpretation of images or patient outcomes in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set
- Not provided. Not applicable in the context of device performance testing for a powered suction pump, which would involve objective measurements rather than subjective expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No. An MRMC study is relevant for diagnostic devices interpreting medical images or data by human readers. A powered suction pump is a therapeutic device, and this type of study would not be applicable.
- Effect Size (AI vs. without AI assistance): Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done?: Not applicable. The Mediport 2000 Mobile is a physical medical device (powered suction pump), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply. Performance testing would focus on the physical and functional aspects of the pump.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated, but for a powered suction pump, ground truth would typically be established through objective engineering measurements (e.g., suction pressure achieved, flow rate, vacuum maintenance, reservoir integrity, sterile barrier testing if applicable, electrical safety, biocompatibility of materials). It would not be based on expert consensus, pathology, or outcomes data in the same way a diagnostic device would.
8. Sample Size for the Training Set
- Not applicable. The Mediport 2000 Mobile is a hardware device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this type of device.
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