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The device is intended for use as a specialized manual surgical instrument. It is reusable and is intended to provide access to the anterior thoracic and lumbar spinal column during minimally invasive and endoscopic surgical procedures. Provides a self-locking type surgical retraction system with inflatable tissue protectors.

The miaspas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation is a specialized manual surgical instrument. It is reusable and provides a self-locking type surgical retraction system with inflatable tissue protectors. Components include Tray, retractor, counter retractor, lung retractor, rib retractor Sm. & Lg., diaphragm retractor Sm., Med., Lg., Lung retractor w/ inflatable cuff Sm., Med., Lg., handle for retractor blades, forceps for retractor blade & drape.

The provided text is a 510(k) premarket notification for a medical device called the "miaspass® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation." This document focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data in the way you've outlined.

Therefore, I cannot provide the information in the requested format because the document does not contain a study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Instead, the document asserts substantial equivalence based on:

• Same intended use and/or indications for use.
• Comparable instrument grade materials.
• Similar function, surgical approach, instruments, and features.
• Use of ISO & QSR based process controls.

The only "comparison" is a table comparing features with predicate devices, but this is not a study measuring performance against pre-defined acceptance criteria.

Here's a breakdown of why this information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document argues for substantial equivalence based on design and functional similarities to predicate devices, not on meeting specific, quantifiable performance thresholds in a test.
2. Sample size used for the test set and the data provenance: Not applicable, as no performance testing study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 a surgical instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission establishes substantial equivalence through a comparison of device features and intended use with predicate devices, not through a performance study against specific acceptance criteria.

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