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The STARlight is intended for medical purposes for use in infants from three to 18 months of age, with moderate to severe non-synostotic 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 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 STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or scan of the baby's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARlight provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is modified further by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The original three devices from 510(k) K021207 are made of a plastic shell of 5/32" -1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. Since the original clearance a variation of the STARlight Bivalve has been released. It is identical in design to the STARlight Bivalve, but is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic and an inner liner of 1/2" pelite polyethylene foam. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands.

The STARlight Cap design is made of the above plastic and contains no straps. The STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap across the side opening. The STARlight Bivalve design and its variation consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The SEP 1 2 2008 510(k) summary provides details about the STARlight Cranial Orthosis, but it does not present a typical clinical study with acceptance criteria and device performance metrics in the way a diagnostic or AI-based device submission might. Instead, it focuses on demonstrating substantial equivalence to a predicate device and discussing changes to a related data acquisition system.

Therefore, it is not possible to fully complete the requested table and answer all questions as a traditional clinical study with acceptance criteria and measured device performance (e.g., sensitivity, specificity, accuracy) is not described for the STARlight device itself in this submission.

However, I can extract the information that is present regarding performance testing, particularly for the STARscanner™ Data Acquisition System.

Here's an attempt to answer the questions based on the provided document, highlighting what is not available:

Acceptance Criteria and Study Details for STARlight Cranial Orthosis

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing for the STARscanner™ Data Acquisition System, not the STARlight cranial orthosis itself. The "acceptance criteria" for the STARlight orthosis are implicitly related to its substantial equivalence to a predicate device and its continued successful use in clinical practice since 2002. For the STARscanner, the acceptance criterion was about achieving better accuracy than its predecessor.

2. Sample size used for the test set and the data provenance:

• STARscanner: Three different cylindrical shapes (100mm, 125mm, 150mm diameters) were scanned. Each shape was scanned five times at five different positions.
• Data Provenance: Not explicitly stated, but implies laboratory testing of the scanner hardware. No information on human subject data provenance is provided for the orthosis's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• STARscanner: "Standard measurement systems statistical process control procedures were utilized" – this implies metrology experts, but no specific number or qualifications are given.
• STARlight Orthosis: Not applicable as no such study is described for the orthosis's clinical performance.

4. Adjudication method for the test set:

• STARscanner: Not explicitly stated beyond "Standard measurement systems statistical process control procedures were utilized."
• STARlight Orthosis: 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:

• No MRMC or AI-assisted study is described. The STARlight is a physical orthosis, and the STARscanner is a 3D scanner for head shape.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No standalone algorithm performance study is described for the STARlight orthosis. The STARscanner is a measurement device, and its accuracy was tested in a standalone manner (without a "human-in-the-loop" influencing its measurement accuracy directly).

7. The type of ground truth used:

• STARscanner: The ground truth would be the known, precisely measured diameters of the three cylindrical shapes used in the testing.
• STARlight Orthosis: Not applicable for a clinical performance study. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

• Not applicable as the document describes a 510(k) submission for a physical device and a scanner, not a machine learning model.

9. How the ground truth for the training set was established:

• Not applicable.

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