(280 days)
OLYMPUS NEEDLESCOPE MSS-28CS-301/701 has been designed to be combined with the OPERATION MICROSCOPE OME-8000 for use in observation of the brain ventricles , and the brain parenchyma, in confirmation of clips on cerebral aneurysms, and for performing diagnostic procedures, such as observation of cerebral aneurysms, observation of cerebral tissues including brain tumors, observation of cerebral vascular systems and cranial nerves, and observation of hypophysis tumors.
This instrument has been designed to be used with the OPERATION MICROSCOPE OME-8000 for use in observation of the brain ventricles and the brain parenchyma, in confirmation of clips on cerebral aneurysms, and for diagnostic procedures, such as observation of cerebral aneurysms, observation of cerebral tissues including brain turnors, observation of cerebral vascular systems and cranial nerves, and observation of hypophysis tumors.
This Instruments are two types (MSS-28CS-301/701) of NEEDLESCOPE used with OPERATION MICROSCOPE OME-8000 which is 510(k) exemption device, and SCOPE CONNECTING ADAPTER FOR MICROSCOPE (MAJ-943) which Intervenes between the NEEDLESCPE and the OME-8000.
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NEEDLESCOPE (MSS-28CS-301/701)
This device is used with the OPERATION MICROSCOPE OME-8000 for observing the brain ventricles and the brain parenchyma and for performing diagnostic procedures. -
SCOPE CONNECTING ADAPTER FOR MICROSCOPE (MAJ-943) This device is for connecting the NEEDLESCOPE and OPERATION MICROSCOPE OME-8000.
Because this is an older 510(k) summary, it does not contain the detailed study information typically found in more recent submissions. The submission explicitly states that clinical data is not required due to the device having no significant changes in intended use, method of operation, materials, or design that could affect safety or effectiveness compared to predicate devices. Therefore, the information requested regarding acceptance criteria and performance study details is not present in the provided text.
Specifically:
- No acceptance criteria or reported device performance are listed. The submission relies on substantial equivalence to predicate devices rather than demonstrating performance against specific criteria.
- No specific study is described that proves the device meets acceptance criteria, as none was deemed necessary.
Given the information available, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
- Not applicable. The submission does not define specific acceptance criteria or report performance data. It relies on demonstrating substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance
- Not applicable. No test set is described, as clinical data was not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No test set and no ground truth establishment for a test set are described.
4. Adjudication method for the test set
- Not applicable. No test set and no adjudication method are described.
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
- Not applicable. This device is an endoscope, not an AI-powered diagnostic device, so an MRMC study with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an endoscope, not an algorithm, so a standalone performance study as described is not relevant.
7. The type of ground truth used
- Not applicable. No specific ground truth establishment method for device performance is mentioned as clinical data was not required. The submission implicitly relies on the proven safety and effectiveness of predicate devices and general medical literature for the application of this type of device.
8. The sample size for the training set
- Not applicable. This is a hardware device (endoscope), not a machine learning algorithm, so a training set as typically understood for AI/ML is not applicable.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of Device Substantiation (based on the provided text):
The manufacturer (Olympus Optical Co., Ltd.) determined that clinical data was not required for the NEEDLESCOPE (MSS-28CS-301/701) and SCOPE CONNECTING ADAPTER FOR MICROSCOPE (MAJ-943). This determination was based on the following reasons:
- The application to the brain ventricles is the same as the predicate device (Olympus Neuro Endoscope A7595).
- Literature supports that the application of this type of device to brain parenchyma is "usual."
- An evaluation of thermal influence (using a Cow's brain) to the brain ventricles and parenchyma by illumination light showed "no visible change on the surface and inside of the brain."
- No "significant changes in the intended use, method of operation, materials or design" were identified that could affect the safety or effectiveness of this device compared to predicate devices.
Therefore, the submission relies on the concept of substantial equivalence to already legally marketed predicate devices rather than presenting de novo clinical study data against defined acceptance criteria.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).