(74 days)
The Boston Band is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial proportion and symmetry in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes. The device is also indicated for adjunctive use for infants from three to eighteen 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 Boston Band is a cranial orthosis used to treat abnormally shaped craniums in infants three to eighteen months of age. This condition is clinically known as Positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened-areas of the skull into the created spaces to improve proportion and symmetry. The Boston Band is only available if prescribed by a physician. The device is also indicated for adjunctive use for infants from three to eighteen 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 Boston Band is essentially the same device as released by K072862. It is an orthosis designed for each patient from a cast or scan of the infant's head. The mold, either plaster from a cast, or foam, carved from the scan, is modified and prepared for fabrication according to the instructions provided by the treating practitioner using plaster/CAD modification techniques. Each orthosis is composed of an outer shell of thermoformable plastic, a single layer of ½ inch or 5-6 layers of 1/8 inch, or a combination of 1 - 2 1/4 inch layers with 1/8 inch layers of hypoallergenic polyethylene foam (Aliplast/Plastazote) and a strap for securing the orthosis. It has a top and side opening. Optimum fit and alignment is insured and monitored by the same clinical practitioner.
The Boston Band is a cranial orthosis used to treat abnormally shaped craniums in infants between three and eighteen months of age. The document outlines a 510(k) submission for the Boston Band, focusing on proposed changes and comparing it to predicate devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative thresholds for clinical performance metrics (e.g., specific percentages of cranial symmetry improvement). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness with expanded indications and updated manufacturing processes.
However, based on the non-clinical performance data section, we can infer some criteria and how the device met them:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Laser Scanner Safety (Class I) | The Fastscan hands-free class I laser scanner was found to be "inherently safe for use without eye protection under all normal operating conditions." This aligns with Class I laser safety standards. |
| Laser Scanner Effectiveness (Accuracy & Repeatability) | "The effectiveness of this scanning device was evaluated through accuracy and repeatability testing. Positive foam models were scanned using the Fastscan hands free class I laser scanner. The scanned models were then carved and measured to compare to the original model. Each device met the predetermined acceptance criteria and was found acceptable." (Specific metrics for accuracy and repeatability are not provided, but the statement indicates meeting pre-defined thresholds.) |
| CADCAM Software Effectiveness (Accuracy & Repeatability) | "The effectiveness of this modification software was evaluated through accuracy and repeatability testing. A comparison was made between hand modified and Rodin4D modifications of the same models. Four models were selected. Hand modifications were done on carved models and CAD modifications were done on the electronic models. The electronic models were then carved. All models where then measured and compared. The results showed that both modification techniques produced an acceptable model for fabrication." (Specific metrics are not provided.) |
| Manufacturing Process Equivalence (Carver Machine) | The updated 5-axis carver machine maintains equivalence with the predicate device's manufacturing process, with the "only major change is the speed of carving." This implies that the output quality and structural integrity remain consistent. |
| Clinical Equivalence to Predicate Devices | The Boston Band is stated to be "essentially the same device as released by K072862." The comparisons tables (Tables 1, 3, 5) consistently show "Same" for contraindications, warnings, precautions, adverse effects, instructions for use, and expiration date, indicating no new safety or effectiveness concerns with the proposed changes or expanded indications. |
| Expanded Indications Safety and Effectiveness | The core mechanism of the device (passively holding prominent cranial regions) remains the same. The expanded indications to include surgically corrected synostosis cases are considered safe and effective due to the device's fundamental function and similarity to predicate devices already approved for similar uses. |
2. Sample Size for Test Set and Data Provenance:
- Laser Scanner Testing: "Positive foam models were scanned." The exact number of models is not specified, but the plural "models" indicates more than one.
- CADCAM Software Testing: "Four models were selected."
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given the nature of a 510(k) summary, which focuses on device characteristics and substantial equivalence, detailed clinical study data with provenance is often found in separate full study reports, not necessarily in this summary document. The context suggests these were internal engineering validation tests rather than large-scale clinical trials.
3. Number of Experts and Qualifications for Ground Truth:
- The document does not explicitly mention experts establishing ground truth for the test set for the scanner or CADCAM software testing. The "ground truth" for these tests seems to be the original physical models (for scanner accuracy) and the hand-modified carved models (for CADCAM modification equivalence).
- For the overall device, the "predetermined acceptance criteria" mentioned for the scanner testing would likely have been established by Boston Brace International's internal engineering and quality control personnel. The "treating practitioner" and "clinical practitioner" are mentioned in the device description for prescribing, monitoring, and fitting, implying their expertise in clinical application but not in establishing ground truth for these specific non-clinical validation tests.
4. Adjudication Method for the Test Set:
- The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the non-clinical tests mentioned. The comparison was likely direct measurement against a reference or between two methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study is typically used for AI-powered diagnostic tools where human readers interpret medical images with and without AI assistance. The Boston Band is a physical cranial orthosis, not an imaging analysis tool. Therefore, a study of this nature would not be relevant.
6. Standalone Performance Study (Algorithm Only):
- No, a standalone (algorithm only without human-in-the-loop) performance study was not conducted in the context of an AI algorithm. The "Fastscan hands-free class I laser scanner" and "Rodin4D CADCAM software" are components of the manufacturing process, not standalone AI algorithms intended for clinical interpretation. Their performance was evaluated through accuracy and repeatability of scanning and modification, respectively.
7. Type of Ground Truth Used:
- For Laser Scanner Testing: The "original model" (presumably the physical foam model before scanning) served as the ground truth against which the carved models from scanned data were compared for accuracy.
- For CADCAM Software Testing: The "hand modified" carved models served as the ground truth for comparison with the CAD-modified and subsequently carved electronic models.
8. Sample Size for the Training Set:
- The document does not mention any "training set." This device does not appear to involve machine learning or AI models that require training data in the conventional sense. The "modification software" is described as 3D rectification software that records modifications, implying a rule-based or guided modification process rather than an adaptive learning algorithm.
9. How Ground Truth for Training Set Was Established:
- As there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this submission.
§ 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)).