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Sil-Tec Medical Grade rod is a soft, translucent silicon elastomer rod intended for reconstruction and surgical repair procedures.

The rod is made in two grades of material:

1. The short term rods carry a catalog number with a suffix ST for short term procedures requiring implantation for less than 30 days.
2. The long term rods carry a catalog number with a suffix LT for implantation procedures requiring longer than 30 days.

Some uses have been:

1. As temporary stents for the formation of new tendon sheaths
2. Other surgical repair procedures demanding a highly inert and flexible rod shaped material

Sil-Tec Medical Grade rod is a soft, translucent silicon elastomer rod intended for reconstruction and surgical repair procedures.

The rod is made in two grades of material:

1. The short term rods carry a catalog number with a suffix ST for short term procedures requiring implantation for less than 30 days.
2. The long term rods carry a catalog number with a suffix LT for implantation procedures requiring longer than 30 days.

Here's an analysis of the provided FDA document regarding the Sil-Tec Rod, focusing on acceptance criteria and study details.

Based on the provided documents (K973166), there is no information about specific acceptance criteria or a study that proves the device meets those criteria.

The document is an FDA 510(k) clearance letter, which means the device was found to be substantially equivalent to a previously marketed predicate device. This type of clearance often relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate, rather than requiring new, full clinical trials with detailed acceptance criteria.

Therefore, most of your requested information cannot be extracted from these documents. I can only provide what can be inferred or explicitly stated.

Unable to Provide from the Given Documents:

1. A table of acceptance criteria and the reported device performance: Not present. The 510(k) pathway focuses on substantial equivalence, not necessarily on specific performance metrics established through a formal study with acceptance criteria in the same way a PMA (Premarket Approval) might.
2. Sample size used for the test set and the data provenance: Not present. No specific "test set" study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present (and irrelevant for a physical medical device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present, as no detailed study is described.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

What is available or can be inferred from the documents:

The core of this submission is the claim of "substantial equivalence" to predicate devices already on the market. This means the device's safety and effectiveness are established by referring to existing, legally marketed devices.

Product Information:

• Trade Name: Sil-Tec Rod
• Regulatory Class: Unclassified
• Product Code: MIB
• Indications For Use: Soft, translucent silicone elastomer rod intended for reconstruction and surgical repair procedures, including:
  • As temporary stents for the formation of new tendon sheaths
  • Other surgical repair procedures demanding a highly inert and flexible rod-shaped material
• Grades:
  • Short Term Rods (suffix ST): Implantation for less than 30 days.
  • Long Term Rods (suffix LT): Implantation for longer than 30 days.

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