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The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) 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 Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) is the remote control unit of legally marketed ancillary equipment. The new clinical functions are not added to the ancillary equipment by the subject device. The subject device enables the remote control of the ancillary equipment, the display of their active states and the memory of the previous set-up values. The remote control is achieved by a touch-panel monitor, remote controller, and voice control. The voice control function enables the subject device to control the ancillary equipment by voice. The subject device does not come in contact with patients and is not subject to sterilization.

The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) Software Version 3 did not conduct a study with specific performance metrics such as sensitivity, specificity, or AUC against a ground truth. Instead, the device's modifications were verified against established in-house acceptance criteria based on ISO 14971:2000 through design verification tests.

Here is the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Surgeon's controller operation test: Confirmed whether the Surgeon's controller operation is performed correctly.
3. Voice operation test: Confirmed whether the voice operation is performed correctly. | 1. All the operations that are in specification operate.
4. All the operations that are in specification operate.
5. All the operations that are in specification operate. | The document implies that these tests were performed and passed, meeting the acceptance criteria, as the device was deemed substantially equivalent. |

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the traditional sense of a dataset for evaluating AI performance. The tests described are functional verification tests of the device's operational capabilities. Therefore, there is no information on sample size or data provenance as it pertains to clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. The tests performed are functional verification tests related to the device's operation, not clinical performance requiring expert ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The device is a control unit for endosurgery, and the modifications involved adding operating functions for new ancillary equipment and different input methods (wireless microphone, larger touch panel). The studies were functional verification tests.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device itself is a control unit that facilitates human interaction with other ancillary equipment. Its "performance" is inherently linked to its ability to control these devices. The tests performed are functional verification tests of these control capabilities, not an algorithm performing a task independently. Therefore, the concept of a "standalone" algorithm-only performance study as typically understood for AI/ML devices is not applicable here.

7. The Type of Ground Truth Used:

The "ground truth" for the functional verification tests was the device specification itself. The tests confirmed whether the operations performed by the device (nurse's control panel, surgeon's controller, voice operation) operated as specified.

8. The Sample Size for the Training Set:

Not applicable. The device is not described as an AI/ML device in the context of learning from a training set of data. The modifications are related to integrating new hardware and input methods.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set or an AI/ML component that requires establishing ground truth for training.

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The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)"has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interfocking operation of the ancillary equipment.

The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) Software Version 2" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment.

Addition of the operating function for ancillary equipment (UES-40, OTV-SP1C, LUS-2, DSR-45, UPA-P100MD and SonoSuro-IU) enables the following:

• The operating function for ancillary equipment operates the additional ancillary equipment (UES-40, OTV-SP1C, LUS-2, DSR-45, UPA-P100MD and SonoSurg-IU) by Nurse's control panel and voice control.
  The voice control function enables the subject device to control the ancillary equipment by voice. You will find the details for voice commands and voice controllable equipment in "Standard set and ancillary equipment" and "Operation by voice control" in G. Device Description and Comparison.

The intended use of the EndoALPHA is to enable a central system to control various pieces of ancillary equipment. However, the approved indications for use for each separate ancillary device dictate the type of procedures that may be performed. This information is included in the instruction manual for each anciliary piece of equipment.

Here's an analysis of the provided text regarding the acceptance criteria and study for the OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) Software Version 2:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size:
  • For the voice recognition test: "some sample voice data." The exact number or duration of samples is not specified.
  • For the wrong recognition test: "some noise in operation room." The exact number or types of noise samples are not specified.
  • For the operating function tests (Nurse's control panel and Surgeon's controller): Not specified, though the phrasing "whether the... operation is performed correctly" implies testing of the various operations.
• Data Provenance: Not specified. It's likely an in-house test ("established in-house acceptance criteria") performed by the manufacturer, but the country of origin of the data is not mentioned. The study appears to be retrospective due to the focus on verification of developed features rather than prospective observation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not specified. The document does not mention the use of external experts or their qualifications for establishing ground truth for these performance tests. The ground truth for these functional tests would inherently be the correct operation and recognition as defined by the device's specifications.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. The tests described are functional verification tests ("Voice recognition test", "Wrong recognition test", "Nurse's control panel operation test", "Surgeon's controller operation test") rather than diagnostic or interpretative tests requiring adjudication of results between experts. The "ground truth" for these tests is the expected functional behavior based on specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a MRMC comparative effectiveness study was not done. The document describes functional verification tests for software and system operation, not a study involving human readers or cases to assess diagnostic performance or comparative effectiveness.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, in essence, standalone performance was evaluated. The "Voice recognition test" and "Wrong recognition test", as well as the "Operating function" tests, are evaluations of the system's performance (the algorithm/software) independent of continuous human intervention beyond initial commands or control inputs. The performance of the voice recognition and system functions is described as being directly from the device's actions.

7. Type of Ground Truth Used:

• Functional Specification/Expected Behavior. For the voice recognition and operation tests, the ground truth is implicitly defined by the device's design specifications and expected correct behavior as implemented by the manufacturer. For example, for the voice recognition test, the ground truth is simply whether the device correctly recognizes the specified words. For the wrong recognition test, the ground truth is that the device should not recognize noise as a command.

8. Sample Size for the Training Set:

• Training set information is not provided. The document describes verification tests for an existing software version and its new features. It does not mention the machine learning component (if any) or training data used in the development of the voice recognition capability.

9. How the Ground Truth for the Training Set Was Established:

• Not specified. As the training set size and details are not provided, how its ground truth was established is also not mentioned.

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The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking of the ancillary equipment.

The "OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)" has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment.

The additional voice control function enables the subject device to control the ancillary equipment by voice, while the conventional products control them manually. You could find the details for voice commands and voice controllable equipment in "Standard set and ancillary equipment" and "Operation by voice control" of this section.

Addition of Image switching, recording and playback functions enables the followings;

• Images input into the UCES-2 and MAJ-1139 are displayed on two monitors by switching from one to another.
• · Images input into the UCES-2 and MAJ-1139 are displayed on the MAJ-1176 as reference images.
• · Still images input into UCES-2 and MAJ-1139 are recorded in a PC card (SmartMedia) The images recorded in the PC card (SmartMedia) are displayed on the MAJ-1176.

The intended use of the EndoALPHA is to enable a central system to control various pieces of ancillary equipment. However, the approved indications for use for each separate ancillary device dictate the type of procedures that may be performed. This information is included in the instruction manual for each ancillary piece of equipment.

The provided text describes the Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) and the non-clinical tests performed for its voice operation function. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for voice recognition test: "some sample voice data" - The exact number of samples is not specified.
• Data provenance: Recorded by "members of Olympus America Inc." This suggests retrospective data from internal company personnel, likely collected in the USA for the purpose of testing.

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

This section of the document describes non-clinical tests for software functionality (voice control). While "members of Olympus America Inc." provided the voice samples for testing, these are not described as "experts" establishing a medical ground truth for a diagnostic or clinical outcome. The ground truth for voice recognition would be the intended interpretation of the spoken commands, which is inherent in the device's design specifications. No medical experts are mentioned as being involved in establishing this ground truth.

4. Adjudication method for the test set

The document does not describe an adjudication method for these non-clinical tests. The tests appear to be direct verification against predefined functional specifications.

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 MRMC study is mentioned. The device described, the Olympus Integrated Endosurgery System EndoALPHA, is a control unit for ancillary surgical equipment with added voice control and image management functions. It is not an AI diagnostic or interpretive tool that would typically be evaluated in an MRMC study for human reader improvement.

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

This is essentially what the voice recognition and wrong recognition tests describe. They assess the algorithm's performance (voice recognition system) independently of a human "in-the-loop" making clinical decisions. The tests evaluate the system's ability to correctly interpret voice commands and avoid misinterpretations from noise.

7. The type of ground truth used

For the voice recognition test, the ground truth is the correct interpretation of the spoken command as defined in the device's specifications. For the wrong recognition test, the ground truth is the absence of an action when noise is present, implying the noise should not be recognized as a command. This is a functional truth, not a clinical or pathological one.

8. The sample size for the training set

The document does not mention a training set for the voice recognition function. It only describes the test phase.

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

Since no training set is mentioned, information on how its ground truth was established is not available in the provided text.

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The Olympus Integrated Endosurgery System EndoALPHA has been designed to be used with an Olympus endoscope ancillary equipment for central operation, central display, automatic initial setting and interlocking operation of the ancillary equipment.

Olympus EndoAlpha Integrated Endoscopy System is the remote control unit of Olympus legally marketed ancillary equipment. No new clinical functions are added to the above ancillary equipment by the proposed device. This subject device enables the remote control of the ancillary equipment, the display of their action status and the memory of the previous set-up values.

The provided text describes the Olympus Integrated Endoscopy System EndoALPHA, but it does not contain any information about acceptance criteria, device performance metrics, or a study conducted to prove that the device meets specific criteria.

The document is a 510(k) summary from 1998, which primarily focuses on:

• Identification of the device and manufacturer.
• Comparison to predicate devices: It states the device is a remote control unit for legally marketed ancillary equipment and adds no new clinical functions. This is the core of its argument for substantial equivalence.
• Intended Use.
• Technological Characteristics: Emphasizes that "no new clinical functions are added" and therefore "does not affect safety or effectiveness when compared to the predicate devices."
• Non-clinical Tests: Mentions compliance with voluntary safety standards (IEC 60601-1, IEC 60601-2, CISPR 11) and software validation.
• FDA's finding of substantial equivalence.

Because the device is a remote control unit that does not add new clinical functions, the validation appears to be centered around demonstrating electrical safety, material compatibility (no new patient-contacting materials), software validation for the remote control functionality, and adherence to relevant safety standards. There is no mention of clinical performance studies, diagnostic accuracy, or human factor studies in the context of specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document positions the device as substantially equivalent to existing predicate devices due to its lack of new clinical functionality, rather than presenting new performance data against specific clinical criteria.

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