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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:

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.

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The Boston Band Cranial Molding Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes.

The Static Cranioplasty Orthosis is a cranial orthosis used to treat abnormally shaped craniums in infants three to 18 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. The Static Cranioplasty Orthosis is only available if prescribed by a physician.

The orthosis is custom designed for each patient from a cast of the infant's head , a scan using the STARscanner from Orthomerica, or a scan from the Hand held FastScan Handheld Laser Scanner. The mold, either plaster from the cast, or foam from the scan, is modified and prepared for fabrication by the treating practitioner using mathernatical analyses and plaster modification techniques. The orthosis is then fabricated under the direction of the same practitioner. Each orthosis is composed of an outer shell of thermoformable plastic, 5-6 layers of hypoallergenic polyethylene foam and a strap for securing the orthosis. Optimum fit and alignment is insured and monitored by the same clinical practitioner.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured as requested:

1. Table of Acceptance Criteria & Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The text refers to "clinical trials" and "infants" in a general sense, but no specific number of patients or cases is mentioned for the effectiveness study.
• Data Provenance: Retrospective or Prospective is not specified. The study cited, "Orthotic Treatment Protocols for Plagiocephaly, Jeff Larson, CO:JPO 2004, Vol 16, Num 4s," is a published clinical trial, suggesting prospective data collection, but this is an inference, not explicitly stated in the summary. The origin (country) is not specified, but the applicant is based in Avon, MA, USA, suggesting a US-based study.

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

Not explicitly stated. The document refers to "clinical trials" which implies that clinicians (likely orthopedic specialists, pediatricians, or orthotists) would be involved in patient assessment and outcome evaluation, but their specific roles in establishing ground truth (e.g., severity of plagiocephaly, correction) and their qualifications are not detailed.

4. Adjudication Method for the Test Set

Not explicitly stated. The nature of the study (clinical trial for a physical orthosis) is less likely to involve a formal adjudication method like 2+1 or 3+1 typically seen in diagnostic AI studies, as the "ground truth" would be the patient's physical head shape and its improvement over time, likely measured by practitioners or specialized equipment.

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

No, an MRMC comparative effectiveness study was not done. The document describes a clinical trial evaluating the effectiveness of the device itself, not comparing human readers' performance with and without AI assistance.

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

This question is not applicable to the device described. The Boston Band Cranial Remolding Orthosis is a physical medical device, not an AI algorithm. Therefore, there is no "standalone" algorithm performance to evaluate. Its "performance" is its physical effect on the infant's skull when worn.

7. The Type of Ground Truth Used

The ground truth appears to be based on clinical outcomes data related to the correction of abnormal head shape. The text states, "The effects of treatment with cranial orthoses on infants have concluded that the devices are significantly effective in correcting abnormal head shape..." This suggests that clinical assessments and measurements (though not detailed) of head shape before and after treatment served as the ground truth for effectiveness.

8. The Sample Size for the Training Set

This question is not applicable. The Boston Band Cranial Remolding Orthosis is a physical medical device, not an AI algorithm that requires a "training set."

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

This question is not applicable, as there is no "training set" for this type of device.

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