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Starlight Imaging Catheter with Hyper Vue Imaging System is intended for imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The Starlight Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.

The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.

The Starlight Imaging Catheter is a sterile, single-use, non-pyrogenic device and consists of two main assemblies: the catheter body and the internal rotating fiber optic imaging core. The catheter has an insertable length of 141 cm and a 2.5 Fr imaging window. It is a rapid exchange design with monorail tip, designed for compatibility with 0.014" (0.355mm) steerable guidewires used during coronary interventional procedures.

The Starlight Imaging Catheter connects to the HyperVue Imaging System through the HyperVue Controller (Controller), a reusable catheter connection allowing direct control of basic data acquisition. All fiber optic rotation and translational pullback is driven by the Controller and occurs inside the catheter.

The provided text is a 510(k) summary for the Starlight Imaging Catheter. It discusses the device's substantial equivalence to a predicate device and details performance testing. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The summary states that no clinical testing was provided in this pre-market notification (Section 7.9), and usability evaluation testing was not required for the modifications (Section 7.8). This indicates that the device's performance against specific clinical acceptance criteria, as evaluated through human-in-the-loop or standalone algorithm studies with detailed ground truth establishment, is not described in this document.

The performance testing described (Sections 7.1-7.7) includes:

• Bench testing: Optical performance, catheter deliverability, pullback performance, trackability, kink resistance, tensile strength. These tests were performed using "well-established methods used for the predicate devices."
• Biocompatibility testing: In accordance with ISO 10993-1.
• Animal testing: Performed in 3 porcine models (18 imaging passes) to evaluate vascular injury, thrombogenicity, device safety, and device performance.

Therefore, I cannot provide the requested table and details because the information is not present in the provided document.

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The STARlight is intended for medical purposes for use on infants from 3 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 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalicand scaphocephalic-shaped heads.

The STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or a scan of the infant'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 further modified 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 STARlight product family as it was released in K090587 are essentially still the same devices. The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4'' to 3/8" clear Surlyn. The STARband Bi-Valve design 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 and in addition optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

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 PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design 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 proposed device modification is the addition of a new shape capture method. specifically the scanGogh-11" by Vorum Research, Inc. This scanner uses one laser, either Class 1 or Class 2 depending on the option, and one camera to capture shape data. The Class I laser option of the scanGogh-II is as safe as other scanner devices previously cleared for the STARlight and will not require any extra safety precautions. The Class 2 laser option is safe to use on infant patients when used in conjunction with eye protection. The Class I laser option of the scanGogh-II shall be the recommended option for scanning infants. If the Class 2 option of the scanGogh-II is used, the infant should wear eye protection as instructed in the proposed labeling.

Here's a breakdown of the acceptance criteria and study information for the STARlight® Cranial Orthosis, based on the provided text:

Acceptance Criteria and Device Performance

The core of this submission is the addition of a new shape capture method, the scanGogh-II, for the STARlight Cranial Orthosis. The acceptance criteria and performance are tied to the accuracy of this new scanner compared to existing methods.

Table of Acceptance Criteria and Reported Device Performance

Study Information

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

• Sample Size:
  • For the Cranial Shape Capture Accuracy Study: "a representative cranial shape that possesses a predefined shape with known dimensions" was utilized. This implies a single, standardized phantom or model rather than a dataset of patient scans.
  • For the Repeatability and Reproducibility (R&R) Analysis: "uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age" were utilized. No specific number is given, but it implies a set of phantoms or models.
  • For the Eye Shield Fit Assessment: "infants" were assessed. No specific number is provided.
• Data Provenance: The studies appear to be prospective in nature, conducted specifically for this submission. The "country of origin" for this data is not explicitly stated, but given the company's location (Orlando, FL) and FDA submission, it's presumed to be within the US or compliant with US standards.

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

• The ground truth for the Cranial Shape Capture Accuracy Study and R&R Analysis was established using "uniform shapes with known dimensions" and "a representative cranial shape that possesses a predefined shape with known dimensions". This suggests that the ground truth was based on pre-defined, precisely measured physical models or phantoms, rather than relying on human expert consensus or clinical data. Therefore, no human experts were explicitly mentioned as establishing the ground truth for the performance testing of the scanner itself.

4. Adjudication method for the test set

• Not applicable as the ground truth was established by known physical dimensions of models/phantoms, not by human review requiring adjudication.

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 comparative effectiveness study was performed or needed. This device is a cranial orthosis and a new scanning method. There is no "human reader" component in the sense of image interpretation for diagnosis that would benefit from AI assistance. The scanning method replaces manual measurement or other digital scanning methods.

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

• Yes, the performance of the scanGogh-II (the algorithm/hardware for shape capture) was evaluated in a standalone manner against known physical dimensions without a human-in-the-loop performance scenario in the context of the Cranial Shape Capture Accuracy Study and R&R Analysis.

7. The type of ground truth used

• Known physical dimensions of uniform and representative cranial shapes/phantoms. This is a form of engineered or precisely measured ground truth.

8. The sample size for the training set

• The document does not describe any "training set" in the context of machine learning or AI. This submission is for a physical medical device (cranial orthosis) and a new shape capture tool. The scanGogh-II is a scanner, not an AI algorithm that would typically require a training set to learn.

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

• Not applicable, as no training set for an AI/ML algorithm is mentioned.

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The Starlight Pro and Silverlight devices are dental curing light units intended for use in the oral cavity for the polymerization of photo-hardening dental materials that are activated in the 440 - 480 nm wavelength range.

The Starlight Pro and Silverlight are dental curing light units intended for the polymerization of photo-hardening dental materials in the oral cavity. A light emitting diode (LED) with a wavelength between 440 nm is used in both devices as the light source. The spectrum of the light emitted by the LED corresponds to the absorption spectrum of camphorquinone photo-initiator, which is the most common and widely used visible light photo-initiator in among available photohardening dental materials. Camphorquinone photo-initiator has an light absorption curve ranging approx. from 400 - 500 nm, with a peak absorption at approx. 468 nm. This range falls within the emission spectrum of the LED used in the subject devices, making the units effective for the polymerization of camphorquinone-based dental materials. The subject devices consist of a cordless handpiece, powered by a rechargeable battery, and incorporating a LED as light source, a battery charger unit and a fiber optic that directs the light onto the material being polymerized. The devices allow the user to activate two curing modes ('Fast' and 'Slow Rise') by pressing the relevant push-button on the handpiece. These two curing modes differ in the light exposure and in the mode with which the light is emitted. In particular: The fast curing mode has an exposure time of 10 sec. at the maximum light intensity. The slow rise exposure mode has an exposure time of 20 sec. with a gradual increase of light during the first 3 seconds up to the maximum intensity. Acoustic signal timings are emitted by the handpiece during program execution. The charger unit allows recharging of the battery and it has an integrated light meter to check the light output. On the charger unit are three signaling LED lamps, indicating the on/off unit state, the battery charge state, and the functionality of the battery.

Here's a summary of the acceptance criteria and study information for the Mectron Starlight Pro and Silverlight dental curing light units, based on the provided 510(k) summary:

Overview of Device and Study Type:

The Mectron Starlight Pro and Silverlight are dental curing light units used for polymerizing photo-hardening dental materials. This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Translux Power Blue (K042199) - Heraeus Kulzer GmbH) rather than establishing novel clinical performance. Therefore, the "acceptance criteria" and "study" are geared towards proving this equivalence through non-clinical functional and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in a typical pass/fail format with specific thresholds. Instead, it describes general compliance and functional equivalence. The reported performance is an affirmation of compliance and functional similarity to the predicate.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of how many devices were tested or how many resin samples were used for the depth of cure measurement. It generically states "resin samples."
• Data Provenance: The data is from non-clinical testing conducted by the manufacturer, Mectron S.p.A. The country of origin for the data (testing location) would be Italy, where Mectron S.p.A. is based. The data is prospective in the sense that it was generated specifically for this submission to demonstrate device performance and safety.

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

This type of information is not applicable to this submission. The "ground truth" here is objective physical measurements and compliance with standards, not expert interpretation of clinical images or outcomes.

4. Adjudication Method for the Test Set

This is not applicable. The non-clinical tests involved objective measurements (e.g., spectrum, irradiance, depth of cure, EMC compliance) rather than subjective assessments requiring adjudication.

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

No, a MRMC comparative effectiveness study was not done. This submission relies on non-clinical testing and comparison to a predicate device for substantial equivalence, not a clinical trial evaluating human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable in the context of an "algorithm" as this is a physical dental curing light, not an AI or software algorithm in the conventional medical device sense. The device's "standalone performance" was evaluated through the non-clinical tests (spectrum, irradiance, depth of cure, software validation, EMC).

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• Physical measurements: Objective measurements of light spectrum, irradiance, and depth of cure in resin samples.
• Established standards: Compliance with electromagnetic compatibility standards (EN IEC 60601 -1 and EN IEC 60601-1-2).
• Performance specifications: Validation of the device's software functionality.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The STARlight is intended for medical purposes for use on 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 proposed modification is the addition of the STARlight PRO design, which is an amalgamation of the STARlight Side Opening design and the STARlight Cap design. The STARlight Side Opening design, STARlight Bi-Valve design and the STARlight Cap design are all made of a plastic shell of 5/32" -- 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design uses a 1/4" to 3/8" clear Surlyn shell for patients with a head circumference over 18" (over approximately 1 year of age) and a 5/32" to 1/4" clear Surlyn shell for all patients with a head circumference less than 18". The STARband Bi-Valve design 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 and in addition optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design. 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 PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bivalve design and the STARband Bi-Valve design 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 provided text is a 510(k) Summary for a device modification, specifically the STARlight® Cranial Orthosis. It describes the device, its intended use, and compares the modified device to its predicate. However, it does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The FDA letter (Sections 5-7) confirms that the device is substantially equivalent to legally marketed predicate devices, but this is a regulatory determination based on comparison of technological characteristics and indications for use, not on a new study demonstrating performance against specific acceptance criteria.

The submission is for a "Special 510(k)" for a device modification, which means that the sponsor is asserting that the changes do not raise new questions of safety or effectiveness and can be considered substantially equivalent to the previously cleared device without extensive new performance data. The core principle of operation remains the same ("applies pressure to the prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape"). The main change is an increase in material thickness for the STARlight PRO design, intended for older, larger-headed infants, to provide increased rigidity. The submission argues that this change is minor and does not alter the fundamental mechanism or clinical effect.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment because this data is not present in the provided document. The document describes a medical device, its intended use, and modifications, but does not include clinical efficacy studies or performance metrics with predefined acceptance criteria.

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The STARlight is intended for medical purposes for use on 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 STARlight Side Opening design, STARlight Bi-Valve design and the STARlight Cap design are all made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARband Bi-Valve design 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 the STARband Bi-Valve design 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 proposed device modification is the addition of a new shape capture method, specifically the Ohio Willow Wood (OWW) Omega Scanner. Like the STARscanner Laser Data Acquisition system cleared with the STARlight (K021207 and K081994), the OWW Omega Scanner is a class 1 laser device. The OWW Omega Scanner is a handheld scanner consisting of two cameras, one laser, and eight LED lights.

The provided text describes a 510(k) submission for a modification to the STARlight Cranial Orthosis, specifically the addition of the Ohio Willow Wood (OWW) Omega Scanner as a new shape capture method. The study focuses on demonstrating the safety and efficacy of this new scanner.

Here's an analysis of the acceptance criteria and study as per your request:

Acceptance Criteria and Reported Device Performance

The core of this submission is the evaluation of the OWW Omega Scanner. The acceptance criteria and reported performance relate to its accuracy, reproducibility, and repeatability.

The document states, "The OWW Omega Scanner met the predetermined acceptance criteria and was found safe and effective for use with Cranial Orthoses." However, specific numerical thresholds for these criteria (e.g., a specific accuracy percentage, standard deviation for reproducibility) are not detailed in the provided text.

Study Details

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

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

   • Not specified. The study appears to be a technical validation of the scanner's performance (accuracy, reproducibility, repeatability) rather than a clinical study requiring expert ground truth for diagnosis or outcome measurement. The "ground truth" for scanner performance would likely involve physical measurements from a reference object or repeated scans, not expert consensus on patient data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable as the study appears to be a technical validation of a measurement device, not a diagnostic or treatment outcome study requiring adjudication of expert interpretations.

4. 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 comparative effectiveness study was done. This submission is for a physical measurement device (scanner) used to create an orthosis, not an AI-assisted diagnostic or interpretative tool.

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

   • The OWW Omega Scanner's performance (accuracy, reproducibility, repeatability) was evaluated in a standalone manner, meaning the scanner itself was tested for its ability to capture shape accurately and consistently. The results relate to the scanner's intrinsic technical performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this type of technical validation would typically involve a precisely known reference object or repeated measurements against a highly accurate standard. The document does not specify the exact nature of the ground truth, but it would not be expert consensus, pathology, or outcomes data in this context. It would be a physical reference standard or highly precise measurement method to compare the OWW Omega Scanner's output against.

7. The sample size for the training set:

   • Not applicable. The OWW Omega Scanner is a commercial device being integrated into a workflow, not a machine learning algorithm that requires a training set in the conventional sense.

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

   • Not applicable, as there is no training set for this device in the context of this submission.

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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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STARLIGHT® is a light-based system intended for the removal of unwanted hair (permanent hair reduction*) and the treatment of benign cutaneous, vascular and pigmentary lesions in skin phototypes I to V of the Fitzpatrick Table.
*Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

STARLIGHT® is a light-based system that delivers Intense Pulsed Light in the region of 530 to 1200 nanometers of the Electromagnetic Spectrum. The system has been designed to be compact and self-contained, comprising:
-A central module
-An LCD and soft-touch keyboard interface
-Two application handpieces housing a flash lamp, a light conducting glass w/filter and two shooting buttons
-An integrated Hydraulic Cooling System
The system's electronics and user interface are controlled by a microcontroller.

This document is a 510(k) summary for the STARLIGHT® Pulsed Light Device. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study performing acceptance criteria. Therefore, the requested information cannot be fully provided from the text and describes the device's technical characteristics, and intended use as well as declares substantial equivalence to a predicate device, but does not present a study with acceptance criteria and device performance results as would be found in a clinical trial.

However, based on the provided text, here's what can be extracted and inferred regarding 'acceptance criteria' in the context of a 510(k) submission:

1. A table of acceptance criteria and the reported device performance

The document does not contain a table of explicit acceptance criteria with numerical performance metrics. In a 510(k) submission for substantial equivalence, the "acceptance criteria" are typically met by demonstrating that the new device has "technological characteristics, performance, intended use, indications, operation and application" that are similar to a legally marketed predicate device, and thus no new questions on safety and effectiveness are raised.

The key "performance" reported is related to its similarity to the predicate:

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

The document does not describe a "test set" in the context of a performance study with a specific sample size. As a 510(k) submission, it likely relies on existing data or literature for the predicate device, or internal bench testing, but these details are not provided in this summary.

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

This information is not applicable to a 510(k) summary focused on substantial equivalence. There is no mention of "ground truth" or experts for a specific test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to an equivalence submission and is not provided.

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

This is not an AI device, and no MRMC study or AI-related effectiveness study is mentioned or implied.

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

This is not an AI device, and no standalone algorithm performance study is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable as no clinical study with "ground truth" is described in this summary.

8. The sample size for the training set

The document does not mention any "training set" as it is not a machine learning or AI device that would typically have one.

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

Not applicable, as there is no training set mentioned.

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The STARlight is available by prescription only and intended for use in infants from three to 18 months of age with moderate to severe non-synostotic positional plagiocephaly, including infants with plagicephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild manta wer prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape.

The STARlight is a cranial remolding orthosis used to treat abnormal head shape (clinically referred to as positional or deformational plagiocephaly) in infants aged three to 18 months. The orthosis provides total contact over the protruding areas of deformity and leaves room for growth over those areas of the infant's head that were flattened during deformation. The STARlight cranial remolding orthosis is available only when prescribed by a physician.

The orthosis is custom made for each patient from a mold or three-dimensional scan of the infant's head initially prepared by the treating clinician. The mold or electronic file is then sent to Orthomerica where it is used to create the orthosis. Each orthosis is comprised of a plastic shell, either in full form with no openings, side-opening, or with bi-valved design and sliding/overlap closure system. The treating clinician modifies and adjusts for a precise fit, and monitors its use throughout the treatment program to ensure that no severe adverse reactions occur.

This document describes the STARlight Cranial Remolding Orthosis and summarizes its safety and effectiveness.

Here's an analysis based on the provided text, focusing on the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The most comprehensive assessment mentioned "monitored the treatment of more than 750 infants over a span of nearly ten years." This appears to refer to the primary effectiveness study.
• Data Provenance: The document does not explicitly state the country of origin. Given the submission to the FDA, it's likely primarily US-based or at least applicable to the US context. The study is described retrospectively ("monitored the treatment of... over a span of nearly ten years") but the exact design (prospective vs. retrospective data collection within that ten-year period) is not fully clarified for the "750 infants" study. The general description "Researchers studying the effects of treatment with cranial orthoses on infants have concluded..." suggests a synthesis of existing research rather than a single prospective trial for the STARlight device specifically.

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

• The document does not provide details on the number or qualifications of experts used to establish ground truth for the effectiveness studies. The assessment relies on the "conclusion of researchers" and the "documentation" from the study rather than a formal expert panel for ground truth assessment of individual cases.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method for the test set or for how "complete or near complete correction of asymmetry" was definitively determined. It implies clinical assessment by treating clinicians/researchers.

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

• Not applicable. This document describes a medical device (cranial orthosis), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance effect size are not relevant.

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

• Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent in its physical properties and clinical application by healthcare professionals.

7. The Type of Ground Truth Used

• The ground truth for effectiveness appears to be clinical assessment and outcomes data (improvement in cranial symmetry, correction of abnormal head shape, avoidance of additional surgery, lack of relapse). This is based on the "results were recorded" and "concluded that the devices are effective" statements.
• For safety, the ground truth is established through biocompatibility assessments (laboratory tests) and the absence of reported adverse events like skin irritation or toxic harms, and proper design to prevent pressure/abrasion issues.

8. The Sample Size for the Training Set

• Not applicable. This device is custom-made for each patient based on an individual mold or 3D scan. There isn't a "training set" in the sense of machine learning. Its design and manufacturing processes are likely informed by clinical experience and general biomechanical principles, but not a formal training dataset for an algorithm.

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

• Not applicable. As there is no "training set" in the machine learning context, there's no ground truth established for one. The efficacy of the design principle (total contact over protruding areas, voids over flattened areas) is based on established medical understanding of cranial reshaping and clinical experience, supported by the studies mentioned.

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The StarLight™ Pulsed Diode Array Laser System is intended for the treatment of leg veins in Dermatology and Plastic Surgery procedures.

The StarLight system delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable fluence of 10 – 40 J/cm². The corresponding pulse energy delivered through the 9 x 9 mm handpiece tip is 8 – 32 J. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece. The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.

Acceptance Criteria and Study Details for StarLight™ Pulsed Diode Array Laser System

The provided document describes the StarLight™ Pulsed Diode Array Laser System, intended for the treatment of leg veins. The submission indicates that clinical studies were conducted to demonstrate safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are implicitly defined by demonstrating substantial equivalence to the legally-marketed predicate device, the PhotoGenica LPIR™ by Cynosure, Inc. Therefore, the "acceptance criteria" revolve around the absence of different performance and no new questions of safety or efficacy compared to the predicate device.

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

• Sample Size: The document does not explicitly state the exact sample size (number of subjects) used in the clinical study. It refers to "clinical studies" and "any subject" in the context of safety.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though the description of "clinical studies were conducted" and "observations... were recorded" typically implies a prospective study design.

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

The document does not provide details on the number of experts or their qualifications used to establish ground truth for the test set. It mentions "Observations of vessel clearing and skin responses," which implies clinical assessment by medical professionals, but specific details are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set. Evaluation appears to have been based on direct clinical observation.

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

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The study's purpose was to demonstrate substantial equivalence to a predicate device, focusing on the device's own performance and safety.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a physical laser system for medical treatment, not an algorithm or AI. Therefore, the concept of a "standalone (algorithm only)" performance assessment is not applicable. The performance is inherently "human-in-the-loop" as it is operated by a medical professional.

7. The Type of Ground Truth Used

The ground truth appears to be based on expert clinical observation and assessment of the treatment outcomes. This includes:

• Vessel effects: reduction in vessel diameter, vessel coagulation, and vessel disappearance.
• Skin responses: absence of scarring or permanent depigmentation.

8. The Sample Size for the Training Set

This document describes a clinical study for a physical medical device, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable.

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

As this is not an AI/ML device, there is no "training set" and thus no ground truth established for such a set.

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The StarLight™ Pulsed Diode Array Laser System is intended to remove hair in Dermatology and Plastic Surgery procedures.

The StarLight™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable pulse energy of 8 - 32 J. The corresponding fluence delivered through the 9 x 9 mm handpiece tip is 10 - 40 J/cm. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode. The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.

The provided document is a 510(k) summary for the StarLight™ Pulsed Diode Array Laser System, focusing on substantial equivalence to a predicate device. It contains information about clinical studies but does not explicitly state acceptance criteria or provide a detailed breakdown of device performance against such criteria. It also lacks many of the specific details requested regarding the study methodology.

However, I can extract the available information and highlight what is missing based on your request.

1. A table of acceptance criteria and the reported device performance

Note: The document does not explicitly state acceptance criteria in a quantitative or pass/fail manner. The reported performance implies that these qualitative outcomes were deemed acceptable for substantial equivalence.

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

• Sample Size: Not specified in the provided document.
• Data Provenance: The document states "Clinical studies were conducted," implying prospective data collection for the purpose of the submission. The country of origin is not specified, but the applicant and contact information suggest a US-based study if conducted directly by them.

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

• This information is not provided in the document. The "Observations of hair regrowth and skin responses" would likely have been assessed by clinical professionals, but their number and qualifications are not detailed.

4. Adjudication method for the test set

• This information is not provided in the document.

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, an MRMC study comparing human readers with and without AI assistance was not done. This device is a laser system for hair removal, not an imaging or diagnostic device that would typically involve "human readers" interpreting results assisted by AI.

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

• This question is not applicable. The device is a laser system for hair removal, where the "performance" is the direct physiological effect of the laser on hair and skin, not an algorithm's output.

7. The type of ground truth used

• Clinical observation: The ground truth for efficacy was "Observations of hair regrowth and skin responses" at various time points (1, 3, 6, and 9 months after treatment). For safety, it was the absence of adverse events like scarring or permanent depigmentation. This relies on direct clinical assessment.

8. The sample size for the training set

• This information is not applicable. The device is a physical laser system, not an AI/ML algorithm that requires a "training set." The clinical studies mentioned are for validation of the device's performance, not for training an underlying model.

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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