(119 days)
Intended for medical purposes to apply static or gentle 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 Hanger Cranial Band™ is a thermoplastic helmet prepared with USP Class VI materials; a polypropylene or polypropylene-polyethylene copolymer outer shell. The Hanger Cranial Band™ was initially cleared on December 8, 2000, under 510(k) K001669. This submission provides for the use of a hand held 3-dimensional laser scanner to acquire accurate measurements and a CAD/CAM system to fabricate the orthosis. A medium density polyethylene foam inner lining is thermo-bonded to this shell. The device is custom fabricated for individual patients by obtaining accurate measurements via a hand held 3-dimensional laser scanner. Clinical measurements of the infant's cranium are taken from the digital file. The addition of digital imaging allows for increased clinical accuracy and objective clinical documentation. The scan is then modified utilizing a CAD/CAM technology package. The 3-dimensional cranial scan is modified utilizing computer aided design tools to add or remove material, increase or decrease the circumference of model to aid in fit and functionality of the cranial band/orthosis. Modifications include but are not limited to: relief areas opposite of cranial bossing, circumference modifications for growth and remolding, suspension, and rotational modifications. The modified file is then emailed to the central manufacturing facility for fabrication and delivery. The modified file measurements are validated and a positive model carved for fabrication. The carved model is evaluated for clinical accuracy and used to fabricate the definitive orthosis. The definitive Hanger Cranial Orthosis is processed through a quality control check list to ensure clinical accuracy, appropriate fabrication techniques, and quality assurance. The Hanger Cranial Band is sent to the practitioner for patient fit and delivery. A digital record of each patient scan and modifications will be maintained on file at Hanger for each patient.
This 510(k) summary (K072566) describes a cranial orthosis, the Hanger Cranial Band™, and its manufacturing process, which now includes a 3D laser scanner and CAD/CAM system. The submission primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed device performance metrics.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or quantitative reported device performance in the way a typical clinical study would for efficacy. The core of this 510(k) is to demonstrate substantial equivalence, which means showing that the device is as safe and effective as a legally marketed predicate device.
The "Performance Characteristic Summary" (K072566 pg 5 of 5) explicitly states: "There has been no change to the performance characteristics of the device system." This implies that the performance characteristics are considered to be the same as the originally cleared Hanger Cranial Band (K001669) and the predicate device (K014012).
The key "performance" aspect discussed is the accuracy of measurements obtained via the hand-held 3-dimensional laser scanner and the CAD/CAM system for fabricating the orthosis. However, no specific metrics (e.g., degree of accuracy, mean error) or acceptance criteria (e.g., "accuracy must be within X mm") are quantified or presented.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a specific test set, its sample size, or its data provenance (country of origin, retrospective/prospective). This 510(k) is about incorporating a new manufacturing technology (laser scanning and CAD/CAM) into an already cleared device, asserting that the change does not alter the fundamental performance. Therefore, a separate "test set" for a new clinical performance study is not described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. As no specific test set and ground truth establishment study are described, there are no details on experts or their qualifications for this purpose.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document, as no specific test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The device in question is a cranial orthosis, not an imaging interpretation or diagnostic AI device that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study of the algorithm (e.g., for the laser scanner's accuracy or the CAD/CAM's precise fabrication) was not explicitly described or reported in terms of specific performance metrics or studies in this 510(k). The document highlights that the "addition of digital imaging allows for increased clinical accuracy and objective clinical documentation," but it doesn't quantify or prove this with a standalone study. The focus is on the process change and its substantial equivalence to an existing device.
7. Type of Ground Truth Used
The document does not describe a specific "ground truth" (expert consensus, pathology, outcomes data) for a new performance study. The ground truth for the device's efficacy is implicitly linked to the existing understanding and clinical outcomes of cranial orthoses, particularly the predicate devices that have established their effectiveness for treating cranial deformities. The new technology (laser scanning and CAD/CAM) is presented as an improvement to the manufacturing process leading to increased accuracy in fabrication based on clinical measurements, rather than a new diagnostic or prognostic tool requiring distinct ground truth establishment.
8. Sample Size for the Training Set
There is no mention of a training set or its sample size. The CAD/CAM system uses design tools to modify a 3D cranial scan. It's a design and manufacturing process, not a machine learning algorithm that typically requires a "training set" in the conventional sense. The "training" would be more akin to engineering and design validation of the CAD/CAM system itself, which is not detailed in this 510(k) for public consumption.
9. How the Ground Truth for the Training Set Was Established
Since there is no described "training set" in the context of an AI/ML algorithm, the method for establishing its ground truth is not applicable and not provided.
§ 882.5970 Cranial orthosis.
(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).