(82 days)
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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