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The ORI is intended for augmentation or restoration and to separate tissues. The Orbital Reconstructive Implant is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos. The ORI is also indicated as a temporary device to maintain the shape of the eye and prevent closure or adhesion during the postoperative period.

The ORI is a non-absorbable, inert, sterile, porous, surgical implant composed of silicone elastomer and expanded polytetrafluoroethylene (ePTFE). If desired, the thickness of the ORI can be augmented by adding a small volume of saline prior to implantation. This polymeric implant is available in a range of lengths, widths and thicknesses to accommodate the surgical application and the needs of the individual surgeon practicing medicine.

The provided text describes a 510(k) submission for the Orbital Reconstructive Implant (ORI), which is a medical device. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study.

Therefore, the input document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document states:

• "The safety and effectiveness evaluations based on biocompatibility and biomechanical performance data provided in this 510(k) demonstrate that the ORI is substantially equivalent to the cited predicate devices."
• "The results of these evaluations of the ORI support the conclusion that it is safe and effective for its intended use and that it is sub- stantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness."

This indicates that the submission relies on demonstrating similarity to already approved devices (predicates) in terms of materials, intended use, and general characteristics, along with biocompatibility and biomechanical performance data, rather than a clinical study establishing specific quantitative or qualitative performance metrics against predefined acceptance criteria for a new clinical application or diagnostic capability.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The submission focuses on demonstrating substantial equivalence, not on meeting specific quantitative or qualitative performance acceptance criteria from a clinical trial.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical "test set" study is described in this document. The evaluations mentioned are likely pre-clinical (biocompatibility, biomechanical).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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 is a medical implant, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an implant, not an algorithm.
7. The type of ground truth used: Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is the regulatory acceptance of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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Intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

The BeckerBand™ is a thermoplastic helmet prepared with USP Class VI materials, consisting of a polypropylene or polypropylene-polyethylene copolymer outer shell. To this shell is thermobonded a medium density polyethylene foam inner lining. The device is fabricated by taking a plaster-of-paris impression of the infants head. This impression is filled with a plaster to create a positive mold of the skull. The deformity is corrected to the desired configuration by building the mold up in selected areas with molding material. This corrected model serves as a template for preparation of the Becker Band orthosis. The completed device applies gentle pressure to the elevated areas of the skull while leaving space for cranial growth in the depressed regions.

The provided text is a 510(k) summary for the BeckerBand™ Cranial Remolding Orthosis. It states that "The BeckerBand" complies with the Class II special controls established for this device in the classification process to provide assurance of safety and effectiveness." However, it does not include any information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects requested in your prompt (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies, or standalone performance data).

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on similar materials, technology, and compliance with general controls and special controls. The "Clinical Discussion and Literature" section only states "A comprehensive review of the literature was provided," without presenting specific study findings or data.

Therefore, I cannot complete the table or answer the subsequent questions based on the information provided in the input document. The document explicitly states "Performance standards: None, Special Controls required," further suggesting that the submission relied on demonstrating equivalence and adherence to general and special controls rather than a specific performance study against predefined acceptance criteria.

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Ask a specific question about this device