Search Results

The NATRELLE® Tissue Expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expanders are intended for temporary subcutaneous implantation and are not intended for use beyond six months.

Allergan's Tissue Expanders are constructed from silicone elastomer and consist of an expansion envelope with a BIOCELL® textured surface, three suture tabs, a MAGNA-SITE® integrated injection site (incorporating a titanium needle guard), and a stable, reinforced base to enable outward expansion. The three suture tabs are attached to the posterior surface of the shell at approximately the 12 o'clock, 4 o'clock, and 8 o'clock positions of the tissue expander. The Tissue Expanders are available in seven styles and each style consists of six sizes for a total of 42 products, to meet diverse surgical needs. The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. All injection sites contain a self-sealing port and a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

The provided text describes a 510(k) summary for a medical device called NATRELLE® 133 Tissue Expander with Suture Tabs. The submission is for a device modification of an existing predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

• A silicone expansion envelope with a BIOCELL® textured surface.
• A silicone injection site with self-sealing port, magnetic locating system, and titanium needle guard. | The modified device uses the same fundamental technological characteristics as the predicate device. |
  | Biocompatibility | Materials used in the suture tabs (Mohawk P118 polyester mesh) must be approved and considered qualified for use in NATRELLE® Tissue Expanders, based on ISO 10993-1:2009 and Allergan's internal standards. | Based on test results, Mohawk P118 polyester mesh is approved and considered qualified for use in the suture tabs. All other materials are identical to the predicate device. |
  | Performance Testing (Suture Tab Bond Integrity) | Suture tab bond integrity must meet pre-determined acceptance criteria as per ISO 14607:2007(E), ASTM F1441, and Allergan's internal standards and procedure. | The device passed all preclinical testing, and pre-determined acceptance criteria were met for suture tab bond integrity. |
  | Safety and Effectiveness | The modification should not introduce new questions of safety and effectiveness. | Preclinical testing indicates no new questions of safety and effectiveness are introduced. |

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state a "test set" in the context of human data or clinical trials. The studies mentioned are preclinical testing (biocompatibility and performance testing of the device itself).

• Sample Size for Test Set: Not applicable in the context of human subjects. For the preclinical tests, specific sample sizes for the materials or devices tested are not provided, only that "test results" and "preclinical testing" were conducted.
• Data Provenance: Not applicable in the context of human subjects. The tests were likely conducted on manufactured device components or materials in a laboratory setting by Allergan's internal standards or external laboratories for ISO/ASTM compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. The studies described are preclinical testing, not human-read clinical evaluations. Ground truth for biocompatibility and mechanical performance is established by standardized testing protocols and material specifications, not expert consensus in the clinical sense.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for preclinical device testing. Adjudication methods are typically used in clinical studies where multiple human readers interpret data, and their findings need to be reconciled to establish a consensus ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study would involve human readers evaluating clinical cases, which is not described in this submission focused on device modification and preclinical testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study (for an algorithm without human-in-the-loop performance) was not done. This submission is for a physical medical device (tissue expander), not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for the studies mentioned is based on:

• Standardized Material Specifications: For biocompatibility (ISO 10993-1:2009 and internal standards).
• Standardized Mechanical Testing Protocols: For suture tab bond integrity (ISO 14607:2007(E), ASTM F1441, and internal standards).

8. Sample Size for the Training Set

This information is not provided and is not applicable. There is no mention of a "training set" as this is not a submission for an AI/machine learning device. The "training" here refers to the development and validation of the physical product and its manufacturing processes, not an algorithm.

9. How the Ground Truth for the Training Set was Established

This information is not provided and is not applicable. As stated above, this is not an AI/ML device, so the concept of a training set ground truth, in that context, does not apply.

Ask a specific question about this device