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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 CPX4 (TM) Breast Tissue Expanders can be utilized for breast reconstruction after mastection 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 Mentor® CPX™4 Breast Tissue Expander consists of a silicone elastomer shell, with superior and anterior reinforcement to allow 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 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 Mentor® CPX™4 Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The Mentor® CPX™4 Breast Tissue Expander are provided sterile and deflated. The proposed Mentor® CPX™4 Breast Tissue Expander is provided in Tall Height Style with fill volume range from 850 cc to 1445 cc.

This document is a 510(k) premarket notification for the Mentor® CPX™4 Breast Tissue Expanders. It describes the device, its intended use, and substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the mechanical testing or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "testing was conducted on the modified device," implying internal testing.

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

Not applicable. This is a medical device submission, primarily focused on mechanical and biocompatibility performance, not diagnostic accuracy requiring expert panel review for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The testing described is objective mechanical and material testing, not subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is a breast tissue expander, not an AI diagnostic tool.

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

Not applicable, as this is a medical device, not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993-1, which are international standards for biological evaluation of medical devices.

For mechanical testing, the ground truth is established by meeting the requirements of ASTM F1441-03, which is a standard specification for soft-tissue expanders. This involves objective measurements of physical properties like resistance to overexpansion and leak integrity.

8. The Sample Size for the Training Set

Not applicable. This document refers to the evaluation of a physical medical device. There is no "training set" in the context of an AI algorithm here.

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

Not applicable. There is no training set for this type of medical device evaluation.

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The Contour Profile 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 CPX™4 Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

In order to provide these tissue expanders with elasticity and integrity, the shells are made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the devices have integral, silicone elastomer, magnetically detected, injection ports and incorporate a BUFFERZONE® area with self-sealing technology that is attached to the inside of the anterior surface of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The textured shell provides a disruptive surface for collagen interface.

Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. 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.

Suture fixation tabs are incorporated into some models of the MENTOR® CPX™4 Tissue Expanders to give surgeons the option to attach the device to surrounding tissue for enhanced device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience.

This document is a 510(k) summary for the Mentor CPX™4 Tissue Expander, a physical medical device, not an AI/ML powered software product. Therefore, many of the requested categories in your prompt, which are typically relevant for AI/ML device studies, are not applicable.

Here's an attempt to extract and frame the information based on the provided document, addressing the prompt's specific points where possible, and indicating "N/A" where the information is not relevant or available for a physical device submission:

Acceptance Criteria and Device Performance for Mentor CPX™4 Tissue Expander

This 510(k) summary describes modifications to an existing physical medical device, the Mentor Contour Profile Tissue Expander. The "studies" conducted are non-clinical performance tests to demonstrate substantial equivalence to the predicate device, not clinical trials or AI/ML model performance evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Acceptance Criteria:
The document states, "All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device performs as well as or better than the predicate device." The specific numerical or qualitative thresholds for these criteria are not detailed in this 510(k) summary. The overarching acceptance criterion for the submission is demonstrating "substantial equivalence" to the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated as "test set" in the context of an AI/ML model. For non-clinical performance testing of a physical device, this would typically refer to the number of units tested per parameter. This information is not detailed in the 510(k) summary.
• Data Provenance: N/A for AI/ML data provenance. The testing was non-clinical performance testing conducted by the manufacturer, MENTOR Worldwide LLC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This concept is not applicable to the non-clinical performance testing of a physical product where "ground truth" typically refers to physical measurements and adherence to engineering specifications, rather than expert interpretation of data.

4. Adjudication method for the test set

N/A. Adjudication methods (e.g., 2+1) are common in clinical studies or AI/ML ground truth establishment. For non-clinical performance testing, results are typically determined by adherence to pre-defined specification limits.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is a physical medical device, not an AI/ML system, so MRMC studies involving human readers and AI assistance are not relevant.

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

N/A. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used

For physical device testing, "ground truth" refers to established engineering specifications, performance standards, and the physical properties of the device. The non-clinical testing was based on meeting pre-determined acceptance criteria for parameters like joint strength and leak performance, likely against internal specifications and potentially relevant industry standards.

8. The sample size for the training set

N/A. There is no AI/ML model or "training set" for this physical device.

9. How the ground truth for the training set was established

N/A. There is no AI/ML model or "training set" for this physical device. The "ground truth" for physical device manufacturing and testing would be based on validated design specifications and quality control procedures.

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