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Silicone Carving Blocks are to be used for carving implants or bone onlays for various surgical uses by the surgeon. The contour carving blocks with curved surfaces lend themselves to carving chin and malar implants.

The Hanson Medical Carving block is made from the same Silicone carving broom materials and manufacturing processes as the predicate device. The square or rectangular blocks are designed for carving flatter devices for or recearing broom arrection of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carving curved devices such as malar and chin implants. This product will be delivered non sterile. The physical properties of these devices are the same as the predicate device in that the same materials will be used. The durometers or hardness (Shore A) will range from 5 to 60. The appearance is described as clear to slightly opaque. Pigments will be added such as Iron Oxide and Titanium Oxide to create opacity to light and Radiographic exam. 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.

This document describes a 510(k) submission for a medical device called the "Hanson Medical Carving block." The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study in the manner typically seen for novel diagnostic or treatment devices.

Therefore, many of the requested elements (acceptance criteria, specific study details like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets) are not applicable or not provided in this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not describe specific performance acceptance criteria or report device performance in a quantitative manner as would be done for a diagnostic or treatment device. The focus is on demonstrating material and manufacturing equivalence to existing devices.

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

Not applicable. There is no "test set" in the context of performance evaluation as it would be for a diagnostic or treatment device. The submission relies on demonstrating material equivalence to predicate devices.

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

Not applicable. Establishing ground truth by experts is relevant for performance studies of diagnostic/treatment devices. This document focuses on material and manufacturing equivalence.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned as this device is a material for implants, not a diagnostic or treatment system requiring human interpretation comparison.

6. Standalone Performance Study

No. A standalone performance study, usually referring to an algorithm's performance without human intervention, is not applicable to this device, which is a physical implant material.

7. Type of Ground Truth Used

Not applicable. Ground truth, in the context of performance studies, is not relevant here. The "truth" in this submission relates to the chemical and physical properties of the materials being equivalent to predicate devices.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/algorithm-based device.

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

Not applicable. No training set is mentioned.

Information that is provided and relevant to the nature of the submission:

• Substantial Equivalence Claim: The Hanson Medical Carving block is claimed to be substantially equivalent to the "Hanson redrear Carving Block" and the "Allied Biomedical Contour Arred Block."
• Basis for Equivalence: Substantial equivalence is based on using the "same Silicone carving broom materials and manufacturing processes as the predicate device."
• Intended Use: For carving a finished device by the surgeon for custom use, specifically for flatter devices (e.g., surface defect correction from trauma/cancer resection) or curved devices (e.g., malar and chin implants). Delivered non-sterile.
• Physical and Chemical Properties:
  • Materials: Applied Silicone's LSR series and Nusil Unrestricted MED 4211 (same as predicate).
  • Durometer (Shore A): 5 to 60.
  • Appearance: Clear to slightly opaque.
  • Pigments: Iron Oxide and Titanium Oxide added for opacity to light and radiography.
  • Tensile Strength: Lot to lot average 600 PSI or greater.
  • Percent Elongation: Over 400 percent.
  • Certification: Each lot is certified and tested for compliance to raw material certifications.
  • Chemical Components: Polysiloxanes catalyzed by a two-part system.
  • Master Files Referenced: MAF 562 (Applied) and MAF 612 (Nusil) for complete material characterizations.

This 510(k) summary focuses on demonstrating that the new carving blocks are made of essentially the same material, with the same properties, for the same intended use as existing, legally marketed predicate devices, thereby ensuring their safety and effectiveness through analogy rather than novel performance testing.

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