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The CPX 14 Breast Tissue Expanders with Smooth Surface can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The CPX™4 Tissue Expanders with Smooth Surface consist of a silicone elastomer shell, with superior and anterior reinforcement that allows for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE® is intended to minimize and/or prevent leakage in the event of an accidental needle puncture. Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The CPX™4 Tissue Expanders with Smooth Surface incorporate suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The CPX™4 Tissue Expanders with Smooth Surface are provided sterile. The devices are provided in three styles (Low, Medium and Tall) and in various sizes. The following accessories are packaged with the CPX™4 Tissue Expanders with Smooth Surface: Centerscope Magnetic Injection Port Finder, Winged Infusion Set.

This document is a 510(k) Premarket Notification for a medical device (breast tissue expander). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI device meets specific acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment will not be found in this document.

However, I can extract information related to the device's
mechanical testing performance and the acceptance criteria for those tests.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria values (e.g., specific force in N, volume thresholds) are not provided in this summary, only that they were "pre-determined" and met.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "mechanical testing was conducted on the modified device." It does not specify the number of devices or test repetitions.
• Data Provenance: Not applicable in the context of clinical data for AI. This is a report on mechanical bench testing for a physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• Not applicable. This relates to mechanical bench testing, not image analysis or clinical diagnosis where expert ground truth would be established. The "ground truth" here is the physical measurement of mechanical properties.

4. Adjudication Method for the Test Set

• Not applicable. This relates to mechanical bench testing. Adjudication methods are typically used for subjective human assessments, e.g., in clinical trials or image labeling.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. This document is not about an AI device. It's about a physical medical implant (a breast tissue expander).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done

• No. This is not an AI device.

7. The Type of Ground Truth Used

• Engineering/Physical Measurements: The "ground truth" for this device's performance is derived from standardized mechanical testing (specifically, ASTM F1441-03 for soft-tissue expanders) and risk analysis procedures. The results are objective measurements of physical properties (joint strength, overexpansion).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. There is no training set as it's not an AI device.

Summary of what the document addresses regarding the device:

The document focuses on demonstrating that the modifications to the CPX™4 Breast Tissue Expander (specifically, a smooth surface instead of textured and increased suture tabs) do not negatively impact its safety and effectiveness compared to the predicate device. This is primarily done through:

• Comparison of Technological Characteristics: Stating that the fundamental technology, principles of operation, intended use, and indications for use remain the same.
• Mechanical Testing: Bench testing was performed to evaluate parameters related to "joint strength and overexpansion" according to ASTM F1441-03. The key finding is that "All mechanical performance testing results met their pre-determined acceptance criteria."
• Biocompatibility Assessment: Confirming that all patient-contact materials are identical to the predicate device, thus new biocompatibility testing was not warranted.

The "acceptance criteria" are implied to be the thresholds or standards outlined in the ASTM F1441-03 standard and Mentor's internal design control procedures for mechanical performance, which the modified device successfully met.

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The Natrelle® 133 Plus Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The Natrelle® 133 Plus Tissue Expanders are designed to develop tissue flaps as part of 2stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of an expansion envelope with a BIOCELL® textured surface, an orientation line, three suture tabs (optional), a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes 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. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

The provided text is a 510(k) summary for the Natrelle® 133 Plus Tissue Expander, a medical device. This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove a device meets specific acceptance criteria based on a clinical study for AI or diagnostic performance. Instead, it focuses on non-clinical performance data and technological characteristics.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) is not applicable to this document. This document does not describe a study proving a device meets acceptance criteria related to AI or diagnostic performance.

Explanation based on the provided text:

• Type of device: The Natrelle® 133 Plus Tissue Expander is a physical medical device (tissue expander made of silicone elastomer) used for breast reconstruction, scar revision, and tissue defect procedures. It is not an AI or diagnostic software/device.
• Purpose of the 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. This means it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.
• Performance Data mentioned: The document states: "Non-clinical performance data were submitted to support the substantial equivalence of the Natrelle® 133 Plus Tissue Expander to the predicate device. These data included biocompatibility data and mechanical testing data. Where appropriate, testing was conducted according to methods prescribed by relevant ASTM and/or ISO standards. All pre-established acceptance criteria were met."

This refers to engineering and material testing (e.g., strength, durability, biocompatibility), not clinical diagnostic accuracy or AI performance. The "acceptance criteria" here would be specific thresholds for these physical properties and material safety, not metrics like sensitivity, specificity, or AUC for an AI model.

In summary, as this document pertains to a physical medical device and a 510(k) submission focused on substantial equivalence through non-clinical testing, the requested information about AI/diagnostic study setup is not present.

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