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The intended use of the Hanson Pectoralis Implant is augment or reconstruct the male chest by inserting the implant under the pectoralis muscle usually through a transaxillary incision. The proposed device can also be used for the correction of surface defects resulting from congenital anomalies such as depressions secondary to Poland's Syndrome. This product will be delivered non sterile.

Silicone Carving Blocks are to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle)

The Hanson Pectoralis Implant is made from the same Silicone liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that the same materials or equivalent materials will be used. These raw materials are the LSR 30 of Applied Silicone and the MED 4211 unrestricted silicone fluid of Nusil Technologies. The durometers or hardness (Shore A) will range from 5 to 30. The appearance is described as clear to slightly opaque. The raw materials for these blocks will be Applied Silicone's LSR series and Nusil Unrestricted MED 4211. Tensile strength from lot to lot average 600 PSI or greater. The percent elongation is over 400 percent. Each lot is certified and tested for compliance to the parameters set for in the raw material certifications for each lot tested by the manufacturer. The Chemical components of this device are polysiloxanes catalyzed by a two part system.

The provided text is a 510(k) summary for the Hanson Medical Pectoralis implant. It states that the device is substantially equivalent to a predicate device, meaning it's similar enough to an existing legally marketed device that it does not require significant new testing or data.

Therefore, this document does not describe acceptance criteria for device performance or a study proving the device meets said criteria. Instead, it focuses on demonstrating equivalence to an already approved device based on material composition, manufacturing processes, and intended use.

Here's an explanation of why the requested information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on equivalence rather than establishing new performance criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or performance data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review is mentioned for performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 silicone implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a silicone implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for substantial equivalence based on material and intended use similarity, not a performance study with acceptance criteria.

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