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1. As a stent to aid in the rehabilitation of tracheal stenosis
2. As a stent to temporarily aid in laryngotracheal injuries
3. To support a Reconstituted Trachea
4. As a stent to provide an airway for a cervical trachea that cannot be repaired

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "Silicone Tracheal T-Tube." This document focuses on the regulatory approval process based on substantial equivalence to a predicate device, rather than a study detailing acceptance criteria and device performance as a standalone product.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text. The document is a regulatory approval letter, not a scientific study report.

Specifically, it doesn't contain:

1. A table of acceptance criteria and reported device performance.
2. Details about a test set, its sample size, or data provenance.
3. Information on experts, their qualifications, or ground truth establishment.
4. Adjudication methods.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone performance study results.
7. Type of ground truth used.
8. Information about a training set or how its ground truth was established.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device's market approval is based on its similarity to an already approved device, not necessarily on a new, comprehensive performance study meeting specific acceptance criteria in the way you've outlined.

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The purchaser shall sufficiently inform themselves regarding the use of silicone materials in any surgical procedure to insure its proper use. Sil-Tec Medical Grade Oval Shape is a soft, radiopaque silicon elastomer shape intended for reconstruction and surgical repair procedures. Some uses have been: As temporary stents for the formation of new tendon sheaths. Other surgical repair procedures demanding a highly inert and flexible oval shaped material.

Sil-Tec Medical Grade Oval Shape is a soft, radiopaque silicon elastomer shape intended for reconstruction and surgical repair procedures.

I am sorry, but based on the limited information provided in the given text, I cannot answer the questions about acceptance criteria and study details. The document is an FDA 510(k) clearance letter for a medical device called "SilTec™ Oval Shapes," issued in 1997.

This type of letter indicates that the FDA has found the device to be substantially equivalent to a legally marketed predicate device, meaning it doesn't require a new premarket approval. However, it does not contain the detailed acceptance criteria or the specific study results. It mentions the device's intended use and regulatory classification but doesn't elaborate on performance metrics or the studies used to establish substantial equivalence.

To answer your questions, I would need access to the actual 510(k) submission (which often includes performance data and acceptance criteria) or a separate study report for the SilTec™ Oval Shapes.

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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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Sil Tec Medical Grade Silicone Sheeting is suitable for external use or short-term mplantanon (30 days or less). Sil-Tec sheeting is intended for modification with a scalpel or scissors, by the surgeon or medical practical practions patientspecific applicanons. Patient selection and suitability is up to the surgeon/medical practioner user The surgeon/medical practitioner user must rely on his or her own best medical judgment and training as to the use of this device.

The following are some indications where silicone sheeting bas been successfully employed Surgical repairs, anchoring device for hemodialysis shunts; temporary covering for a presentally ruptured omphalocele during staged repair of wethral strictures; protective to help facilitate neural regeneration and tendon healing, surgical repair of fractured orbital floors; to prevent soft tissue fibrosis or bony michlosis following surgical correction of trismus (Waming Note: Not for permanent use in the presence of degenerative bone changes, chronic bruxism, or temporomandibular 1011 applications); other surgical procedures; and as insulating material for recoveramulation.

It is the surgeon/medical practitioner users responsibility to thoroughly test any products made in part or otherwise incorporating Sil-Tec medical grade sheeting to determine the acceptability of the products performance in a specific application.

Sil-Tec Sheeting

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA for a medical device called "Sil-Tec Sheeting" and does not contain the specific information requested about acceptance criteria, device performance, study details, ground truth, or sample sizes.

The document primarily focuses on:

• The FDA's decision of substantial equivalence for the "Sil-Tec Sheeting" device.
• Regulatory classifications and general controls applicable to the device.
• Indications for Use for the device.

Therefore, I cannot extract the requested information from this document.

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The purchaser should thoroughly test products made in part or otherwise incorporating Sil-Tec medical grade tubing to determine the acceptability of the products performance in a specific application

Applications for Tubing include :

• Stillcone tubing has been used in artificial external or l .. internal blood circulatory systems where temporary substitution is needed for the heart, lungs, and arieriovenous system
• 2 Blood transfusions
• Suction drainage of surgical wounds 3
• Temporary tube gastrostomy following abdominal surgery 4
• Connecting glass tubing of different bores 5

Sil-Tec Medical Grade Tubing

This document is a marketing clearance letter from the FDA for a medical device called "Sil-Tec Medical Grade Tubing." It does not contain information about acceptance criteria or a study proving device performance in the way a typical medical device study report would.

Therefore, I cannot provide the requested information. This letter is a regulatory clearance, not a study report.

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