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The AUTOBAHN Tissue Closure Device and Disposable Cartridge is intended for soft tissue approximation and/ or ligation in general surgical procedures.

The AUTOBAHN Tissue Closure Device is a non-sterile, reusable device for use with the AUTOBAHN Disposable Cartridge. The AUTOBAHN Disposable Cartridge is a sterile; single-use disposable cartridge containing a standard type needle and standard, absorbable and non-absorbable, suture that is attached to the reusable AUTOBAHN Tissue Closure Device. The AUTOAHN Tissue Closure Device and Disposable Cartridge are indicated for soft tissue approximation and/ or ligation in general surgical procedures. The needle is contained within the AUTOBAHN Disposable Cartridge before, during, and after the case, aiding in the prevention of suture needle sticks to the surgeons, nurses, and OR staff. The AUTOBAHN tissue Closure Device needle is driven around inside the cartridge in a complete 360° arc. A completed stitch is placed each time the needle and suture are driven across the aperture and through tissue located within the aperture.

The provided text is a 510(k) Premarket Notification for a medical device (AUTOBAHN Tissue Closure Device and Disposable Cartridge). It focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The provided text primarily describes:

• Device Description and Intended Use: The AUTOBAHN Tissue Closure Device and Disposable Cartridge are for soft tissue approximation and/or ligation in general surgical procedures, designed to prevent needle sticks.
• Predicate Device: FASTCLOSE Fascia Closure Device (K01105).
• Technological Characteristics: Stated as "identical" to the predicate device.
• FDA Communication: A letter from the FDA confirming substantial equivalence to the predicate device based on the submitted information.

To directly answer your specific points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) focuses on substantial equivalence based on technological characteristics and intended use being identical to a predicate device, not on specific performance metrics or acceptance criteria for a new study.
2. Sample size used for the test set and the data provenance: Not applicable, as no dedicated performance study with a test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no dedicated performance study is described.
4. Adjudication method for the test set: Not applicable, as no dedicated performance study is 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 a surgical closure device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no dedicated performance study is described. Substantial equivalence for this device relies on demonstrated technological similarity and safety/effectiveness of the predicate device.
8. The sample size for the training set: Not applicable, as no algorithm or training set is described.
9. How the ground truth for the training set was established: Not applicable, as no algorithm or training set is described.

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