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For temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts and to aid treatment of soft tissue deformities.

The Motiva Flora® SmoothSilk® Tissue Expander (MFSTE) is intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and is not intended for use beyond six (6) months. All MFSTEs require periodic, incremental inflation with sterile saline for injection until the desired tissue expansion is developed. Once the desired tissue expansion is achieved, the tissue expander is surgically removed and a breast implant is inserted within the breast pocket.

The MFSTE is constructed of successive cross- linked layers of silicone elastomer with an Integrated Injection Port system for incremental expander filling. The Tissue Expanders are available in a range of sizes to meet diverse patient needs and achieve individualized aesthetic results. The MFSTE has a controlled surface architecture produced by the mandrel imprinting technique with an average roughness of 4 microns. Each MFSTE is supplied sterile.

The injection port is dome-shaped with a radiofrequency identification (RFID) coil embedded in the needle stop. This needle stop prevents inadvertent puncture through the base of the injection port during the filling process.

The injection port is found with the Motiva Flora® Port Locator accessory through the air wound coil's RFID signal placed inside the needle stop. The RFID wireless system comprises two components: the tag and the reader. The Motiva Flora® Port Locator (the reader) has antennas that emit radio waves and receive the signal coming from the RFID coil tag in the needle stop to locate the center of the injection port. The user interface of the Motiva Flora® Port Locator includes LED lights to guide the user during the process. This is an innovative technology not available in other tissue expanders on the market.

In addition, the RFID transponder functions as a traceability feature, which provides a unique electronic serial number (ESN) for each expander. The ESN allows access to a database with the device information (serial and lot number, size, projection, model, manufacturing date, etc.).

Additional design features of the MFSTE include a non-ferromagnetic component design that allows the device to be used with Magnetic Resonance (MR) and Computerized Tomography (CT) under certain conditions.

The MFSTE includes six (6) fixation tabs (TrueFixation®) to provide the surgeon options to suture the tissue expander in the breast pocket. Another design feature is its reinforced base.

The provided text describes a medical device, the Motiva Flora® SmoothSilk® Tissue Expander, and the studies conducted to demonstrate its substantial equivalence to a predicate device for FDA 510(k) clearance.

However, the information provided does not pertain to an AI/ML-enabled medical device. The document describes tests related to:

• Biocompatibility: Testing to ensure the materials are safe for use in the human body.
• Animal Testing: To compare tissue reaction to the device and a predicate.
• Mechanical Testing: To evaluate physical properties like elongation, tensile strength, and injection port integrity.
• Sterilization Testing: To confirm the device can be properly sterilized.
• Port Locator Electrical Safety & EMC Testing: For the accessory device that helps locate the injection port (this is not an AI/ML component; it relies on RFID and basic electrical/electromagnetic principles).
• Port Locator Software Testing: Standard software validation, not specifically AI/ML performance.
• MR Conditional Testing: To ensure compatibility with MRI environments.

Therefore, many of the specific questions about AI/ML device acceptance criteria and study design (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, effect size) are not applicable to this document. The document focuses on demonstrating physical, chemical, and biological equivalence, along with the safety and basic functionality of the device and its non-AI accessory.

To answer your request based on the provided text, I can only address aspects relevant to a non-AI medical device.

Since the provided document does not describe an AI/ML-enabled medical device, many of the requested categories related to AI/ML specific studies (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance) are not applicable.

However, I can extract the general acceptance criteria and the performance studies conducted for this non-AI medical device.

1. A table of acceptance criteria and the reported device performance:

The document describes "pre-determined acceptance criteria" for various tests, and states that "All testing met the requirements" or "All testing results met their pre-determined acceptance criteria," or "demonstrate[d] that the MFSTE is substantially equivalent." Specific numerical acceptance thresholds are not explicitly listed in the summary, but the types of criteria are implied by the tests performed.

2. Sample sizes used for the test set and the data provenance:

• Sample Size: Not specified in the provided summary for any of the tests (e.g., number of devices tested for mechanical properties, number of animals in the GLP study).
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Unclear from the summary. Animal studies are typically prospective. Mechanical, sterilization, and electrical/EMC tests are conducted under controlled, often laboratory, conditions.

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

• Not applicable for a non-AI physical device validation. "Ground truth" in this context refers to established standards (e.g., ASTM standards for mechanical properties, ISO standards for biocompatibility) or direct measurements. For the animal study, histopathologic evaluation would be performed by qualified pathologists, but the number of experts is not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for a non-AI physical device validation. Adjudication methods are typically for subjective assessments, like image interpretation in AI studies. The tests described are objective (e.g., measurement of tensile strength, electrical output, presence/absence of foreign body reaction by pathologists).

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:

• Not applicable. This device is a physical tissue expander; it does not involve human readers interpreting images, nor does it have an AI component to assist them.

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

• Not applicable. This is a physical device, not an algorithm. The "Port Locator" is an accessory device that functions using RFID, not an AI algorithm.

7. The type of ground truth used:

• For Mechanical, Sterilization, Electrical/EMC, and MR Conditional Testing: Ground truth is defined by established engineering and medical device standards (e.g., ASTM, ISO, IEC, FCC) which specify acceptable performance ranges and test methodologies.
• For Biocompatibility: Ground truth is established by ISO 10993 standards and FDA guidance, relying on recognized biological reactions and toxicology principles.
• For Animal Testing: Ground truth is based on histopathological evaluation by qualified experts (pathologists) determining typical vs. adverse tissue responses.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

• Not applicable. As above, no training set for an AI algorithm is involved.

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Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are temporary intraoperative placement devices used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term breast implant to use.

Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are sizing devices designed for temporary intraoperative placement, to assist in determining the desired breast implant volume and shape for each patient prior to implantation of a Motiva Implant Matrix® silicone breast implant. They are used during breast augmentation or reconstruction procedures.

The Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are constructed with a low diffusion shell featuring a barrier layer between various layers of silicone elastomer to minimize gel diffusion; a patch, and cohesive restricted medical grade silicone gel, which is aimed for intraoperative temporary implantation only. The filling gel is tinted with pigments, in order for the Round Sizers to be clearly differentiated from the long term implantable devices.

The Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® have been designed to match every Motiva Implant Matrix® silicone breast implant reference, and are therefore available in the same range of bases or diameters, projections and volumes as the long term implants.

The provided document is a 510(k) premarket notification for a medical device: "Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the document describes performance testing to establish equivalence, not to meet independent acceptance criteria in the same way a novel device might.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense for a new clinical claim. Instead, it describes non-clinical testing performed to demonstrate that the new device meets established specifications necessary for consistent performance and does not raise new safety or effectiveness concerns compared to the predicate device.

The non-clinical tests conducted are listed as:

• Gel Cohesion and Penetration
• Patch to Shell Joint Testing
• Elongation
• Break Force
• Tension Set
• Tear Force

The reported device performance is summarized as: "The collective results of the non-clinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® meet the established specifications necessary for consistent performance during its intended use."

The acceptance criteria are implicitly that the device's performance in these tests is comparable to or better than the predicate device and meets established specifications for such devices, ensuring it is "as safe and as effective as the predicate device." However, specific numerical thresholds or comparative data points are not provided in this summary.

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

The document does not specify the sample sizes for the non-clinical tests. It only states that "All necessary bench testing was conducted." Since the data is from bench testing of the device itself (materials, manufacturing, design), the "data provenance" would be the manufacturing site or testing facility. There is no mention of country of origin of data or whether it was retrospective/prospective in the context of human subjects, as no clinical testing was performed.

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

This question is not applicable. The evaluations were non-clinical bench tests of physical and mechanical properties. There was no "ground truth" to be established by experts in the context of clinical interpretation or diagnosis.

4. Adjudication method for the test set

This question is not applicable. There was no clinical ground truth or human interpretation requiring adjudication.

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

This question is not applicable. The device is a physical intraoperative sizer, not an AI or imaging diagnostic tool. No MRMC study was performed.

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

This question is not applicable. The device is a physical intraoperative sizer, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This question is not applicable in the clinical sense. The "ground truth" for the non-clinical tests would have been industry standards, internal specifications, and performance characteristics of legally marketed predicate devices, against which the new device's material and design properties were compared.

8. The sample size for the training set

This question is not applicable, as no machine learning or AI component is involved, and no clinical training set was used.

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

This question is not applicable, as no machine learning or AI component is involved, and no clinical training set was used.

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