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Serralapg™ Synthetic Surgical Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in Ophthalmic, as a preliavascular and Neurological procedures.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Serralapg™ Synthetic Surgical Absorbable Sutures). It does not contain any information about acceptance criteria or a study proving the device meets those criteria. My purpose is to extract information from the provided context, and in this case, the context does not contain the requested details.

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SERRALGUT™ sutures are indicated for use in general soft tissue approximation and/or ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

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The provided text is an FDA 510(k) clearance letter for a medical device (SERRALGut™ Suture). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The letter is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It does not include the technical details of performance testing or clinical studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The requested information is not present in the document.

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SERRALESTER™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

SERRALESTER™ Surgical Suture

The provided text is a 510(k) clearance letter from the FDA for a surgical suture. It declares the device, SERRALESTER™ Surgical Suture, substantially equivalent to legally marketed predicate devices.

This type of document does not typically contain detailed information about acceptance criteria or specific studies proving a device meets these criteria in the way that a clinical trial report or a performance study summary would.

Therefore, based only on the provided text, I cannot extract the requested information. The document is an administrative clearance, not a scientific study report.

Here's why each of your requested points cannot be addressed by the provided text:

1. A table of acceptance criteria and the reported device performance: This document states the device is "substantially equivalent" to predicate devices, but it does not define specific performance acceptance criteria for the new device nor report its performance against such criteria.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. Such studies are more common for diagnostic imaging AI than for surgical sutures.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable to a surgical suture.
7. The type of ground truth used: Not applicable/mentioned. For sutures, "ground truth" might refer to material properties or in vivo performance, but specific metrics are not in this document.
8. The sample size for the training set: Not applicable/mentioned. This refers to AI algorithms, not a physical medical device like a suture.
9. How the ground truth for the training set was established: Not applicable/mentioned.

In summary, the provided FDA 510(k) letter confirms regulatory clearance but does not detail the technical studies, acceptance criteria, or performance data that would have been submitted to the FDA as part of the clearance process.

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SERRALSILK™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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This document is a 510(k) clearance letter from the FDA for surgical sutures, not a study report for an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving device performance for an AI/ML product.

Specifically, the document discusses:

• Trade/Device Name: Serralsilk™, Non-absorbable Surgical Sutures
• Regulation Number: 21 CFR 878.5030 (Natural nonabsorbable silk surgical suture)
• Regulatory Class: II
• Product Code: GAP
• Indications for Use: General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

There is no mention of AI/ML, algorithms, performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert readers, ground truth establishment, or any other elements related to the evaluation of an AI-powered diagnostic or assistive device.

Therefore, I cannot provide the requested table or information because this document is entirely unrelated to the study of an AI/ML device.

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SERRALNYL™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic and neurological procedures.

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This document is a 510(k) clearance letter from the FDA for Serral S.A. de C.V.'s Serralny1™ Non-absorbable Surgical Sutures. It confirms that the device is substantially equivalent to legally marketed devices.

However, this document does not contain any information regarding acceptance criteria, device performance, or any studies. The letter is a regulatory clearance and precedes the need for such data in a premarket notification, particularly for a Class II device like this, which is typically cleared based on substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information based on the provided text.

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SERRALENE™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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This appears to be a 510(k) clearance letter from the FDA for a medical device: Serralene™ Non-absorbable Surgical Sutures. This document does not contain the information requested about acceptance criteria and a study proving the device meets them.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on meeting specific, pre-defined acceptance criteria through a performance study. While the manufacturer would have performed tests to ensure the device's safety and effectiveness for substantial equivalence, the clearance letter itself doesn't typically detail those studies in the way you've outlined for AI/diagnostic devices.

Therefore, I cannot extract the requested information from the provided text. The document is primarily an administrative letter granting clearance for marketing the device based on its substantial equivalence to an existing product.

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