Search Results
Found 4 results
510(k) Data Aggregation
(96 days)
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
This medical control unit for endosurgery has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 (hereinafter referred to as "UCES-4") has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets specific acceptance criteria. The document is an FDA 510(k) premarket notification letter and a 510(k) summary for the SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (UCES-3 Software Version 4) and lists general non-clinical testing performed, such as software validation, electromagnetic compatibility, electrical safety, risk management, and human factors activities, in accordance with various FDA guidances and international standards. However, it does not provide specific acceptance criteria or performance results from these tests in a format that allows for the completion of the requested table and study details.
Therefore, I cannot extract the information required to answer your request.
Ask a specific question about this device
(21 days)
SYSTEMS INTEGRATION
Ask a specific question about this device
(144 days)
SYSTEMS INTEGRATION
SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2
The Systems Integration ENDOALPHA has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943
This equipment has been designed to install software on the ENDOALPHA UCES-3, MAJ-1831, MAJ-1832, MAJ-1834, and MAJ-1862.
The Systems Integration ENDOALPHA has been designed to be used with an Olymous endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The ENDOALPHA integrated electrosurgical system has the following system functions.
- Centralized control from a non-sterilized area
- Centralized control from a sterilized area
- Centralized display
- Message display
- Voice reply
- Automatic settings
- Scene settings
- Display customization
- Still image viewing
- Automatic smoke evacuation
The Olympus Medical Systems Corp. 510(k) summary for the SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 describes design verification and software validation activities rather than a clinical study with human subjects. The device is a system for central operation, display, and control of ancillary endosurgery equipment, performing functions like centralized control, display customization, and automatic settings, with software modifications including additional compatible devices, improved interfacing, increased surgical light capacity, reduced startup time, and an additional language setting.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests / Criteria | Reported Device Performance |
|---|---|---|
| Risk Analysis | Based on ISO 14971:2007 (established in-house acceptance criteria). | Design verification tests performed as a result of risk analysis assessment. |
| Design Verification (Hardware & Integration) | Operation/verification testing for improved interfacing between UCES-3 and the Advanced System. | Implied successful, as the summary states the modifications are "minor and substantially equivalent" and have "similar technological characteristics" and "performance." No specific performance metrics or pass/fail rates are provided beyond the statement that tests were performed. |
| Operation/verification testing for new compatible ancillary equipment. | Implied successful. | |
| Operation/verification testing for the increase in the maximum number of connectable surgical lights. | Implied successful. | |
| Performance testing for the startup time of the UCES-3. | Implied successful, as reduced startup time is listed as a modification. | |
| Operation testing for additional language setting for text indications. | Implied successful. | |
| Software Validation (FDA Guidance) | Unit level testing (Module verification). | Implied successful. The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Integration level testing (Task verification). | Implied successful. | |
| System level testing (System verification). | Implied successful. | |
| Simulated use testing (Validation). | Implied successful. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes software validation and design verification tests, not a clinical study involving human patients or a traditional "test set" of patient data. Therefore, information regarding human sample size or data provenance (country of origin, retrospective/prospective) is not applicable or provided. The "test set" in this context refers to the system itself, its components, and its software functions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for this type of device (an integration system for endosurgery equipment) is based on engineering specifications, functional requirements, and safety standards rather than expert clinical consensus on patient data.
4. Adjudication Method for the Test Set
Not applicable, as this was not a study involving human readers or interpretation of medical images. The acceptance of testing results for design verification and software validation would have been based on engineering and quality assurance protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The device is a control system for endosurgery equipment, not a diagnostic or AI-assisted interpretation tool that would involve human readers or image analysis.
6. Standalone Performance Study
Yes, the testing described appears to be for the standalone system in a simulated environment. The "Operation/verification testing" and "Performance testing" for various aspects like interfacing, new equipment compatibility, surgical light capacity, startup time, and language settings, along with "Unit level testing," "Integration level testing," "System level testing," and "Simulated use testing" for software, all represent standalone performance evaluation of the device's functionality. This is "algorithm only without human-in-the-loop performance" in the sense that the system's functions are verified independently of live clinical use.
7. Type of Ground Truth Used
The ground truth used for this type of device is primarily based on:
- Engineering Specifications: Adherence to defined parameters for electrical, mechanical, and communication characteristics, as well as operational principles.
- Functional Requirements: Verification that the system performs its designed functions (e.g., centralized control, display, automatic settings, smoke evacuation) as intended.
- Safety Standards: Compliance with relevant medical device safety standards like ISO 14971:2007 for risk management.
- Software Design Documents: Verification against software requirements specifications and design documents.
8. Sample Size for the Training Set
Not applicable. This device is a control system, not an AI/ML algorithm that requires a "training set" of data in the typical sense (e.g., for image recognition or clinical prediction). The software developed for this system follows conventional software engineering principles rather than machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/ML algorithm.
Ask a specific question about this device
(45 days)
SYSTEMS INTEGRATION MODEL: ENDOALPHA
The Systems Integration ENDOALPHA has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The Systems Integration ENDOALPHA has been designed to be used with an Olymous endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The ENDOALPHA integrated electrosurgical system has the following system functions.
- Centralized control from a non-sterilized area
2} Centralized control from a sterilized area - Centralized display
- Message display
- Voice reply .
- Automatic settings
- Scene settings
- Display customization
- Still image viewing
- Automatic smoke evacuation
The modifications made to the subject device are as follows:
A) Addition or deletion of recommended ancillary equipment
B) A change involving the communication interface
C) A change in the design of the Graphical User interface (GUI)
D) Addition of a voice reply function
E) Deletion of Surgeon's controller for EndoALPHA (MAJ-1140)
F) Transfer of Input/Output function for video signals to the Advanced system
G) Addition of additional connectable touch panel
H) Addition of Scene settings function
l) Addition of system components
Changes to the specifications of system components S
This document is a 510(k) summary for the Olympus Systems Integration ENDOALPHA, a system designed to integrate and control various ancillary equipment used with Olympus endoscopes. The summary focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (like sample size, ground truth, expert qualifications, MRMC study, standalone performance, and training set details) are not available in the provided text because the 510(k) premarket notification process for this type of device (an integration system, not a diagnostic or AI-driven tool) does not typically require such detailed performance studies in the same way as, for example, an AI diagnostic algorithm. The primary goal here is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
However, I can extract the available information and explain why other details are absent.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Not explicitly stated in this document as performance metrics) | Reported Device Performance (Summary of functional capabilities) |
|---|---|---|
| Primary Goal | Substantial Equivalence to Predicate Device (Olympus Integrated Endosurgery System EndoALPHA - K051613) | Concluded to be substantially equivalent based on intended use and operating principle. |
| Intended Use | To be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation. | Device has been designed for this intended use, which is identical to the predicate. |
| Operating Principle | Same operating principle as the predicate device. | Device uses the same operating principle as the predicate. |
| Functional Capabilities | Demonstrate integrated control and display of ancillary equipment, automatic settings, etc. | Offers centralized control (from non-sterilized and sterilized areas), centralized display, message display, voice reply, automatic settings, scene settings, display customization, still image viewing, and automatic smoke evacuation. |
| Safety and Effectiveness | General controls provisions of the Act (e.g., registration, listing, GMP, labeling, MDR). | Implied compliance with general controls to be marketed. No specific safety/effectiveness performance metrics are reported in this summary. |
| Modifications | Modifications should not raise new questions of safety or effectiveness. | Modifications A-I are listed (e.g., added/deleted ancillary equipment, GUI changes, added functions like voice reply and scene settings). The overall conclusion is substantial equivalence. |
Explanation for Missing "Acceptance Criteria" Details:
For a device like the ENDOALPHA, which is an integration and control system, "acceptance criteria" for demonstrating substantial equivalence are typically evaluated against the predicate device's functionality and safety profile, rather than quantitative performance metrics like accuracy or sensitivity. The FDA's review for a 510(k) largely focuses on whether the new device is as safe and effective as the predicate. The "performance" in this context refers to its functional capabilities and how they compare to the predicate, and whether any changes introduce new risks or questions of effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided in the document.
This document does not describe a clinical performance study using a test set of data (e.g., images, patient records). The evaluation for this device appears to be based on engineering verification and validation, functional testing, and comparison to the predicate device's specifications and intended use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not provided in the document.
Since there's no clinical performance study involving a "test set" with "ground truth" (e.g., diagnosing conditions), expert review for establishing ground truth is not part of this 510(k) summary for the ENDOALPHA system.
4. Adjudication Method for the Test Set
Not applicable/Not provided in the document.
No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No.
This document does not mention or report the results of an MRMC study. The device is a system integration tool, not a diagnostic aid that would typically involve human readers interpreting output to improve diagnostic performance.
6. Standalone Performance Study
Not applicable/Not provided in the document in the context of diagnostic performance.
While the system itself has standalone functional performance (e.g., its ability to control equipment, display messages), the concept of "standalone performance" as it relates to AI algorithms or diagnostic tools (i.e., algorithm only without human-in-the-loop performance) is not relevant or evaluated for this type of system in this document. The document describes its functional capabilities in isolation and in integration.
7. Type of Ground Truth Used
Not applicable/Not provided in the document.
There is no mention of "ground truth" (e.g., pathology, outcomes data) as this pertains to diagnostic accuracy studies. For this system, the "truth" would refer to whether the system correctly performs its programmed functions (e.g., does it centralize control as intended, do automatic settings work). This is validated through engineering and functional testing rather than clinical "ground truth" data.
8. Sample Size for the Training Set
Not applicable/Not provided in the document.
This device is an integration and control system, not an AI/machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided in the document.
As there is no training set mentioned, this information is not relevant.
Ask a specific question about this device
Page 1 of 1