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The Mitaka Point Setter is intended for use by qualified surgeons for holding rigid and flexible endoscopes during diagnostic and therapeutic neurologic procedures.

The Mitaka Point Setter is a manual/pneumatic surgical device composed of materials commonly used in medical devices for a wide range of applications.

The provided document is a 510(k) summary for a medical device called the "Mitaka Point Setter," an endoscope holder. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling strict performance acceptance criteria based on a clinical study or algorithm performance.

Therefore, the document does not contain information on acceptance criteria, a study proving device performance in the way described in the request (e.g., sample size for test set, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details common for AI/diagnostic devices).

The "study" in this context is the submission for substantial equivalence. The "performance" is implicitly deemed acceptable because it is substantially equivalent to a device already on the market.

Here's a breakdown of why this information is missing based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. For a device like an endoscope holder, performance is typically assessed through engineering specifications, material biocompatibility, and functional testing to ensure it holds the endoscope securely and safely. These specific criteria are not detailed in this public 510(k) summary. The document states its performance is "substantially equivalent" to a predicate device.

2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI/diagnostic algorithm that would have a "test set" in the sense of patient data. Testing would involve engineering verification and validation (e.g., mechanical stress tests, sterility tests) on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" to establish for an endoscope holder in the context of diagnostic accuracy.

4. Adjudication method for the test set: Not applicable for the same reasons as above.

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 is a mechanical device, not an AI diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.

8. The sample size for the training set: Not applicable. There is no "training set" for a mechanical endoscope holder.

9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The document describes a medical device seeking 510(k) clearance based on substantial equivalence. It does not provide the kind of performance data (acceptance criteria, test/training sets, expert consensus) that would be expected for an AI or diagnostic device. The "study" is the 510(k) submission itself, demonstrating that the "Mitaka Point Setter" is substantially equivalent to a previously cleared predicate device, meaning its safety and effectiveness are considered comparable.

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The point setter is indicated for use as a holder for an endoscope.

Not Found

This document is an FDA 510(k) clearance letter for a device called "Point Setter Endoscope Holder." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone (algorithm only) performance study.
• Types of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

This is a regulatory clearance document, not a scientific study or technical report detailing performance testing.

Ask a specific question about this device