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The SnugKap is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional Plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

The SnugKap devices are cranial orthoses intended to be utilized on infant patients that suffer from head shape abnormalities. The SnugKap devices are additively manufactured from a 3D scan file of the patient's head. The scan file is digitally modified to address the anatomical/shape abnormalities in the skull. The SnugKap is then 3D printed and fabricated according to the case plan approved by the orthotist. The SnugKap is manufactured from a copolymer made of polylactic acid; additional parts are made of a variety of materials including thermoplastic polyurothane, polypropylene, and Plastazote® (white or pink) polymer foam.

This FDA 510(k) summary for the SnugKap cranial orthosis does not contain specific acceptance criteria or a detailed study report with performance metrics in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance study with defined acceptance criteria and calculated performance.

However, based on the information provided under "Performance Testing Summary" and the "Substantial Equivalence Summary" table, we can infer the types of testing performed and the general intent, but not specific numerical acceptance criteria or quantitative performance results.

Here's an attempt to structure the answer based on the available information, noting where specific details are missing:

The provided FDA 510(k) summary for the SnugKap cranial orthosis primarily demonstrates substantial equivalence to predicate devices, rather than a standalone performance study with explicit acceptance criteria and quantitative performance results for clinical metrics. The performance testing described is focused on ensuring the device functions as intended and is safe.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria and direct performance metrics (e.g., success rates for cranial symmetry improvement) are not reported in this 510(k) summary, the table below reflects what types of testing were performed and the implied "acceptance" as demonstrated by the conclusion of substantial equivalence.

Missing Information:

• Specific numerical acceptance criteria for strength, durability, and pressure tests (e.g., minimum force, number of cycles, pressure range).
• Quantitative results for any of the performance tests.
• Clinical efficacy outcomes (e.g., percentage of infants achieving a certain degree of cranial symmetry improvement).

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

The document does not detail specific sample sizes for test sets in the context of clinical efficacy, as it's not a clinical trial report. The performance tests mentioned (strength, durability, pressure, biocompatibility) would have involved samples of the device materials or finished products for engineering and lab testing. The sample size for these lab tests is not specified.

Data provenance (country of origin, retrospective/prospective) is not applicable or detailed for efficacy/test sets, as there is no human clinical data presented for this purpose in the summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as a test set requiring expert ground truth (e.g., for image interpretation or diagnosis) is not described in this 510(k) summary. The ground truth for biocompatibility and mechanical tests would be established by standardized testing protocols and analytical results.

4. Adjudication Method for the Test Set

Not applicable, as there is no expert-adjudicated test set described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. The device is a physical cranial orthosis, not an AI-assisted diagnostic tool typically assessed with MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable in the conventional sense of an AI algorithm. The device itself is the physical orthosis. While there is "Software Validation" and "3D Printing Validation" mentioned, these refer to the manufacturing process for creating the custom orthosis and not an independent, standalone diagnostic or assistive algorithm.

7. The Type of Ground Truth Used

For the engineering and biocompatibility tests:

• Mechanical Performance: Ground truth would be established by engineering specifications, material properties, and relevant industry standards.
• Biocompatibility: Ground truth would be established by recognized standards for biological evaluation of medical devices (e.g., ISO 10993 series) using established laboratory tests.

For overall effectiveness for the Indications for Use:

• The primary ground truth for demonstrating the device's acceptable performance is its substantial equivalence to legally marketed predicate devices that have established safety and effectiveness. The assumption is that if the new device is substantially equivalent in design, materials, and intended use, it will have similar effectiveness.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device requiring a training set for an algorithm.

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

Not applicable, as there is no training set mentioned.

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