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The Diamond Digital Sleep Orthotic (DDSO) is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Diamond Digital Sleep Orthotic (DDSO) is a removable intraoral device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward, (protrusive) position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space and decrease air turbulence, therefore improving their ability to exchange air during sleep.

The DDSO is a patient-matched prescription medical device, indicated for use during sleep to treat patients who snore and/or have mild to moderate obstructive sleep apnea. The design consists of two splints that fit independently over the upper and lower teeth and engage by means of an adjustable mechanism. This mechanism enables the practitioner to set the amount of mandibularadvancement at the time of fitting the device.

The amount of titration (mandibular protrusion) ranges from in 1.0 mm increments.

The provided text is a 510(k) summary for the Diamond Digital Sleep Orthotic (DDSO). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them (such as acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details, and ground truth establishment) are not explicitly present in this document.

The document states that:

• "Internal verification and validation testing demonstrate that product specifications are met and equivalent in design, performance, and technological characteristics." (Page 7)
• "Bench testing was conducted to determine the critical process parameters for Selective Laser Sintering... Results demonstrate that design outputs meet the design inputs and specifications for Diamond's additive manufacturing processes and control." (Page 7)
• "human clinical studies are not needed" (Page 7-8) because the device's design, technology, and indications for use are similar to previously cleared devices.
• "no new risks are introduced with the new device that are not present in the predicate device" (Page 9).

The document primarily relies on non-clinical performance testing (bench testing) and comparison to predicates to show substantial equivalence. It does not describe a clinical study designed to demonstrate quantitative performance metrics against pre-defined acceptance criteria for efficacy in reducing snoring or OSA. Instead, the "performance" discussed is related to mechanical properties, biocompatibility, and manufacturing process validation.

Given this, I will address the questions based on the information available in the document, and explicitly state when the requested information is not present.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary: The Diamond Digital Sleep Orthotic (DDSO) received 510(k) clearance based on demonstrating substantial equivalence to a predicate device (The Panthera Anti-Snoring Device, K143244) and a reference device (The Panthera Anti-Snoring X3 Device, K171576). The "study" proving the device meets acceptance criteria was primarily a series of non-clinical performance verification and validation tests (bench testing), along with biocompatibility testing and a risk analysis, rather than a clinical trial with pre-defined efficacy endpoints for snoring or OSA reduction. The acceptance criteria were therefore focused on demonstrating mechanical integrity, material safety, and comparable design/technology to the predicates, ensuring no new questions of safety or effectiveness.

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

The document does not provide a quantitative table of acceptance criteria or performance metrics for clinical efficacy (e.g., AHI reduction, snoring severity reduction). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence through:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable in the context of a clinical test set for efficacy. The "test set" for performance was actual devices for bench testing (e.g., "fatigue testing was conducted on the new device," "a final custom load test was performed on the new device and the predicate"). The exact number of devices tested is not specified.
• Data Provenance: The testing was "Internal verification and validation testing" (Page 7) conducted by Diamond Orthotic Laboratory. No specific country of origin for data is stated beyond the company's US base. It was non-clinical bench testing, not human subject data, and thus neither retrospective nor prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This was bench testing and comparison to a predicate, not a study requiring expert readers or ground truth derived from clinical data labeled by experts.

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

• Not applicable. No expert adjudication process was described or required for this type of submission.

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. This device is an intraoral medical device, not an AI system or an imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI was not performed or 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.

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

• For the non-clinical performance and biocompatibility testing, the "ground truth" was established by engineering specifications, material science standards (e.g., ISO, ASTM), and comparative analysis against the predicate device's known characteristics. For example, biocompatibility was assessed against ISO standards, and mechanical performance was compared to the predicate.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable, as no training set was used.

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The Cranial Remolding Orthosis is prescribed for use on infants between 3-18 months with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, scaphocephalic, and brachycephalic-shaped heads, by applying pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. The Cranial Remolding Orthosis is also prescribed for use following minimally invasive surgery for infants between 3-18 months with craniosynostosis who still need moderate to severe correction of plagiocephali-shaped, brachycephalic-shaped, and/or scaphocephalic-shaped heads.

The Cranial Remolding Orthosis is prescribed for use on infants between 3-18 months with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, scaphocephalic, and brachycephalic-shaped heads by applying pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. The Cranial Remolding Orthosis is also prescribed for use following minimally invasive surgery for infants between 3-18 months with craniosynostosis who still need moderate to severe correction of plagiocephali-shaped, brachycephalic-shaped, and/or scaphocephalic-shaped heads.

The device allows for growth of the flattened areas of the infant's skull into the voids within the shell and foam lining. This combination of total contact and relief allows for significant correction of the asymmetrical head shape; thereby giving the infant's skull a more symmetrical and/or proportioned shape.

The Cranial Remolding Orthosis is fabricated from a 3/16" co-polymer base plastic shell with a ½" foam interface liner. The type of material used on the foam interface liner is Pelite polvethylene foam, Plastazote, or Aliplast foam spacer fills a ½" side opening, opposite the deficit, utilizing the same material as the corresponding foam liner. The anterior inferior edge is trimmed just above the eyebrows, and the sides are trimmed above and around the ears. The posterior inferior is trimmed distally to capture the occiput. A hook and loop closure (also referred to as Velcro within the industry) is attached on the side of the deficit, bridging over the side opening, keeping the device securely in place.

The provided text for K111247 primarily focuses on establishing substantial equivalence to a predicate device, the STARband Cranial Remolding Orthosis (K082950/K011350). The FDA 510(k) submission process for this device, a Cranial Remolding Orthosis, relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical studies with acceptance criteria in the same way a novel device might.

Here's an analysis of the "acceptance criteria" and "study" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The "study" or justification for meeting these acceptance criteria is primarily a comparative analysis against the predicate device (STARband) and reference to existing standards and literature.

• For material and biocompatibility: The documentation cites ISO 10993-11, indicating that if a material has a "demonstrated history of use in a specified role," no new testing is needed. The materials used are stated to be "identical" or "substantially equivalent" to those in the predicate, which has such a history.
• For design and manufacturing: A direct comparison (Table 5.1) is presented, highlighting the similarities in intended use, materials, product design, and production processes between the Cranial Remolding Orthosis and the STARband. The document asserts that "The materials used and processes of manufacturing the device are handled in an identical manner to the predicate device."
• For the scanning technology (OMEGA Scanner vs. STARScanner): A specific validation study was performed: "The accuracy, reproducibility, and repeatability of the STARScanner and the OMEGA scanner were evaluated by scanning three cylindrical shapes five times and downloading the files three times to the digital image. Standard measurement system statistical process control procedures were used to evaluate the scan rate of error, standard deviation, repeatability, and reproducibility of multiple scans. Both devices met the predetermined acceptable criteria." This indicates a technical performance study for the measurement component, not the orthosis itself.

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

• Test Set Sample Size:
  • For the orthosis itself: No specific test set sample size for clinical performance is mentioned in the context of this 510(k) submission, as it relies on substantial equivalence to the predicate.
  • For the OMEGA Scanner validation: "scanning three cylindrical shapes five times" means 3 shapes * 5 scans = 15 total scans. The files were downloaded "three times" for each scan, suggesting repeated digital processing.
• Data Provenance: The document does not specify country of origin for the data in the OMEGA scanner validation study. The study appears to be internal validation by the manufacturer or associated entity. It is a prospective study for the OMEGA scanner's technical performance. For the orthosis, the data provenance is primarily from the known performance and history of the predicate device.

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

• For the orthosis: No experts are explicitly mentioned for establishing ground truth for a test set of the Cranial Remolding Orthosis itself, as its effectiveness is inferred from the predicate.
• For the OMEGA Scanner validation: No experts are mentioned for establishing ground truth in the technical validation of the scanner (i.e., measuring cylindrical shapes). The "ground truth" would be the known dimensions of the cylindrical shapes measured instrumentally.

4. Adjudication Method for the Test Set

• No adjudication method is described for the performance of the orthosis, as no clinical test set directly evaluating the orthosis's performance is presented in this 510(k). For the OMEGA scanner, the evaluation was against "predetermined acceptable criteria," implying a comparison to established metric values rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done or reported for the Cranial Remolding Orthosis. This type of study is typically done for diagnostic devices where human interpretation is involved.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• The device is a physical orthosis, not an algorithm. The OMEGA scanner, which is a component of the workflow, had a standalone technical validation for its accuracy, reproducibility, and repeatability in measuring physical objects (cylindrical shapes). This is an "algorithm only" type of test in the sense that the scanner's output (3D digital image) was tested for its fidelity, independent of human interpretation or intervention in the measurement process itself.

7. Type of Ground Truth Used

• For the orthosis: The ground truth for effectiveness is implicitly tied to the established clinical outcomes and safety profile of the predicate device (STARband). The clinical literature referenced (Littlefield et al., 1988) speaks to the treatment of craniofacial asymmetry with dynamic orthotic cranioplasty in general, supporting the concept of this type of device.
• For the OMEGA Scanner validation: The ground truth was the known dimensions of the "three cylindrical shapes."

8. Sample Size for the Training Set

• For the orthosis: There is no mention of a "training set" in the context of this device because it is a physical medical device manufactured based on patient-specific molds, not a machine learning model.
• For the OMEGA Scanner: No specific "training set" is mentioned for the scanner's underlying algorithms either. The scanner validation study is a performance evaluation of a pre-existing system.

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

• Not applicable, as no training set (in the context of machine learning) is described for this device or its related components.

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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.

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The O&P Bivalve Cranial Molding Helmet 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 sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic shaped heads.

O&P Bivalve Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up and made round creating a void. As the child's head grows, the skull is slowly reshaped and rounded by growing into the open voids created in the helmet for this purpose. The finished helmet has a foam-lined interior and has rigid plastic exterior. The helmet is bivalve with the anterior section overlapping the posterior section. The helmet is secured by means of a rivet on one side and an elasticized Velcro closure on the opposite side.

The provided 510(k) summary for the O&P Bivalve Cranial Molding Helmet (K063395) describes the device's substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance data for the new device. Therefore, much of the requested information regarding acceptance criteria and a dedicated study proving performance for this specific device is not present in the provided text.

However, I can extract information related to the predicate device and the general evidence used to support the effectiveness of cranial orthoses.

1. Table of Acceptance Criteria and Reported Device Performance

As this submission relies on substantial equivalence and does not establish new acceptance criteria for the O&P Bivalve Cranial Molding Helmet, a direct table of acceptance criteria and performance for this device cannot be generated.

Instead, the submission refers to the performance of its predicate device and the general effectiveness of cranial orthoses. The "performance" in this context refers to clinical outcomes observed with similar devices.

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

• Test Set Sample Size: Not applicable. There was no specific "test set" for the O&P Bivalve Cranial Molding Helmet, as its performance was not evaluated through a new clinical study.
• Data Provenance: The submission references:
  • Retrospective clinical experience with the predicate device (Precision Prosthetics' Orthotic Molding Helmet), stating "Precision Prosthetics treated over 2,340 children with their orthotic molding helmet" over nine years. No specific country of origin is mentioned for this experience, but given the company's location (Missouri, USA), it's highly likely to be US-based.
  • Published scientific literature on cranial orthoses by Clarren et al. (1979, 1981, 1977), Persing et al. (1986), Kane et al. (1996), and especially Littlefield et al. (1998). These studies describe general findings on the effectiveness of cranial orthoses. The Littlefield et al. study described monitoring "more than 750 infants." Specific country of origin for these studies is not detailed in the summary, but given the journals and authors often published in English, they are likely from Western countries (e.g., USA).

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

Not applicable. No specific test set was created for this device where expert ground truth was established. The effectiveness claims are based on prior clinical experience with a substantially equivalent device and existing scientific literature on the general class of devices.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated test set was used for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This submission does not describe an MRMC comparative effectiveness study, as it is centered on substantial equivalence rather than a new clinical trial comparing human readers with and without AI assistance. This device is a physical medical device, not an AI/software device that would involve human readers.

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

Not applicable. This is a physical cranial orthosis, not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the effectiveness claims cited comes from:

• Clinical outcomes data: From the past 9 years of treating over 2,340 children with the predicate device, implying observed improvement in cranial shape.
• Published clinical studies: Which documented "complete or near complete correction of asymmetry" based on measurements or assessments of infants' head shapes over time (e.g., Littlefield et al. 1998 study). This would typically involve clinical assessment and anthropometric measurements by medical professionals.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. If interpreted as the "experience" pool for the predicate device, it would be "over 2,340 children" and "more than 750 infants" from the cited studies.

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

Not applicable, as there is no training set in the context of an AI/ML device. For the clinical experience and studies cited, the "ground truth" (i.e., whether the treatment was effective) was established through clinical observation, anthropometric measurements, and follow-up assessments by medical professionals involved in the treatment of positional plagiocephaly.

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The COPC Band 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 initiating treatment from three to 14 months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic patterned head shapes.

The COPC Band is a cranial orthosis used to treat abnormally shaped craniums in infants three to 14 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 COPC Band is only available through a prescription issued by a physician. The orthosis is custom designed for each patient from a modified model and measurements of the infant's head. The mold is prepared for fabrication using advanced plaster modification techniques. Each orthosis is composed of an outer shell of thermoformable plastic, an inner lining of hypoallergenic foam, and a strap for securing Optimum fit and alignment is insured and monitored by the clinical the orthosis. practitioner.

The COPC Band is a cranial orthosis designed to treat positional or deformational plagiocephaly in infants aged three to 14 months. The device works by passively holding prominent cranial regions to guide the growth of flattened areas of the skull, thereby improving cranial symmetry and/or shape.

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable table format. Instead, it argues for substantial equivalence to a predicate device (DOC™ Band) based on several factors:

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

No explicit test set or specific sample size for a clinical study is mentioned. The safety and performance data presented relies on material biocompatibility assessments and a limited mechanical test using a cranial model.

• Data Provenance: Not explicitly stated, but the description of the pressure sensor analysis implies it was conducted in a lab setting, likely within the United States. It is an engineering/bench test, not human clinical data.
• Retrospective/Prospective: Not applicable, as this is primarily based on bench testing and material characteristics, and comparison to existing data for the predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The provided data does not describe a study involving expert assessment or ground truth establishment in a clinical context (e.g., diagnosis of plagiocephaly or assessment of treatment outcomes by human experts). The "performance data" section focuses on material safety and mechanical characteristics.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a test set requiring adjudication in the common sense of clinical data review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done or mentioned. The submission focuses on substantial equivalence to the predicate device based on design, materials, and safety features.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The COPC Band is a physical medical device, not an algorithm or AI-driven system. Therefore, no standalone algorithm performance study was conducted.

7. Type of Ground Truth Used:

The "ground truth" for the device's acceptable performance is primarily established through:

• Material Specifications and Biocompatibility Standards: MSDS sheets and standard biocompatibility assessments for the materials used.
• Bench Testing/Mechanical Analysis: Pressure sensor analysis on a cranial model to demonstrate pressure distribution and the function of the corrugated stop.
• Comparison to Predicate Device: The effectiveness and safety are largely inferred by demonstrating analogous characteristics to the legally marketed DOC™ Band, which already has established effectiveness.

8. Sample Size for the Training Set:

Not applicable. The COPC Band is a physical medical device; there is no "training set" in the context of machine learning or algorithms. Its design and manufacturing process are based on established practices for cranial orthoses.

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

Not applicable, as there is no training set for this device.

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The Providence Molding Helmet is used for treatment of children from three (3) to eighteen (18) months with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is prescribed by a physician to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.

The Providence Molding Helmet is a cranial orthosis used to treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age. This includes infants with plagiocephalic-, brachyecephalic-, and scaphocephalic- shaped heads. This device works by applying gentle holding pressure to the prominent regions of the infant's skull while leaving room for growth in the adjacent flattened regions. The Providence Molding Helmet consists of a 5/32 polypropylene outer shell and two (2) layers of 3/16 volara foam inner lining. The helmet is split posteriorly and an elastic Velcro strap is attached to the back of the helmet to keep it securely in place. The device allows for growth of the flattened areas of the infant's skull into the voids of the shell/foam lining, thus correcting the plagiocephaly and giving the infant's skull a more symmetrical shape. The Providence Molding Helmet is custom designed and custom fitted for each patient from a plaster mold of the infants' head.

The provided text is a 510(k) summary and FDA clearance letter for the Providence Molding Helmet. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about any specific study that proves the device meets acceptance criteria.

The 510(k) clearance process for this type of device (Class II, Cranial Orthosis) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and performance metrics as might be seen for novel high-risk devices or software.

Therefore, I cannot populate the requested table or answer most of the questions because the information is not present in the provided document.

Here's a breakdown of what can be extracted based on the input:

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

• Cannot be provided. The document states "Performance Standards: None, Special Controls required". The 510(k) process for this device focused on substantial equivalence, not on specific performance metrics or acceptance criteria from a study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be provided. No test set or study data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Cannot be provided. No test set or ground truth establishment is described.

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

• Cannot be provided. No test set or adjudication is mentioned.

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. This device is a physical cranial orthosis, not an AI software. An MRMC study is not relevant.

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

• No. This is a physical device, not an algorithm.

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

• Cannot be provided. No ground truth is mentioned in the context of device performance evaluation. The device corrects shape, and its effectiveness would likely be assessed by clinical observation and anthropometric measurements, but no such study is detailed here.

8. The sample size for the training set:

• Cannot be provided. No training set is mentioned as this is a physical device, not a machine learning algorithm.

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

• Cannot be provided. No training set or ground truth establishment is mentioned.

Summary based on the provided text:

The Providence Molding Helmet received 510(k) clearance based on its substantial equivalence to the Ballert Molding Helmet (K011433). The clearance letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the device was found to be as safe and effective as a legally marketed predicate device, and did not require new clinical performance studies with specific acceptance criteria to demonstrate its safety and effectiveness. The document lists "Performance Standards: None, Special Controls required," indicating that the regulatory pathway did not involve adherence to quantitative performance standards for clearance.

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The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants' with plagiocephalic and brachycephalic shaped heads.

The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' 3 to 18 months of age, with plagiocephalic and brachycephalic shaped heads.

The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109

The Cranial Symmetry System provides passive pressure to the prominent areas of the infants' skull while allowing for growth into the flattened areas. There are no exceeding pressures that could put restrictions on brain growth. The cranial orthosis helmet is custom fabricated with lightweight materials. The outer shell consists of a sheet of three-sixteenths inch thick polypropylene. The padded inner liner consists of three-sixteenths Aliplast. These materials are vacuumed formed over the modified plaster cast mold of the infants' skull. There is a Velcro chinstrap that is used as a method of suspension. The chinstrap is fastened securely through the Dacron loops at the cut out section for the infants' ears. The chinstrap holds the helmet in place eliminating the risk of slippage. There are air holes drilled into the helmet for ventilation.

The provided text describes a 510(k) submission for the Cranial Symmetry System helmet. However, it does not include detailed acceptance criteria or a dedicated study section with specific performance data to prove the device meets such criteria. Instead, it relies on substantial equivalence to a predicate device and references two existing medical journal articles as "Performance Data."

Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or provide specific details for points 2 through 9 as they are not present in the document.

Here's a breakdown of what is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated or quantified in terms of specific performance metrics (e.g., percentage improvement in cranial symmetry, time to achieve symmetry).
• Reported Device Performance: The document does not report performance metrics for the Cranial Symmetry System itself. It references two articles by Clarren et al. (1979 and 1981) for the general concept of helmet treatment for plagiocephaly and torticollis, implying that the methodology and technique are "gleaned" from this work. However, no specific data from these studies are presented to establish performance criteria or compare with the Cranial Symmetry System's performance.

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

• Sample Size: Not provided for the Cranial Symmetry System.
• Data Provenance: Not provided for the Cranial Symmetry System. The referenced studies by Clarren et al. would contain this information for their studies, but not for the specific device under review.

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

• Not provided anywhere in the document.

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

• Not provided anywhere 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:

• Not applicable. This is a medical device (helmet), not an AI diagnostic or image analysis tool for human readers.

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

• Not applicable. This is a medical device (helmet), not an algorithm.

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

• Not explicitly stated for the Cranial Symmetry System. The referenced studies would likely use clinical assessments or anthropometric measurements.

8. The sample size for the training set:

• Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not provided.

Summary of the document's approach to "Performance Data":

The manufacturer, Beverly Hills Prosthetics Orthotics, Inc., largely bases its submission on substantial equivalence to the predicate device, the Clarren Helmet (K003035).

Under the "Performance Data" section, instead of presenting new study data for the Cranial Symmetry System, it references two articles:

• Clarren, Sterling, M.D., "Plagiocephaly and torticollis: Etiology, natural history, and helmet treatment, "Journal of Pediatrics, 98:1 (92-95)(Jan. 1981)
• Clarren, et al., "Helmet treatment for plagiocephaly and congenital muscular torticollis," Journal of Pediatrics, 94:1 (43-46)(Jan. 1979)

The text states that "Helmet therapy was introduced to Beverly Hills Prosthetics Orthotics, Inc. by Sterling Clarren M.D. and therefore the methodology and technique for measurements and casting gleaned is still used in practice today." This suggests that the company adopted the principles and techniques from Dr. Clarren's work, rather than conducting a new performance study on their specific device and providing its data within this 510(k) submission. The conclusion explicitly states: "Based on the foregoing and all information included in this 510(k) application, Beverly Hills Prosthetics Orthotics, Inc. believes that the performance data provides reasonable assurance of the safety and effectiveness of the Cranial Symmetry System for its proposed indications for use. Further, the Cranial Symmetry System is substantially equivalent to its claimed predicate device under the conditions of intended use."

In essence, the "study that proves the device meets the acceptance criteria" in this 510(k) is the assertion of substantial equivalence to a legally marketed predicate device, supported by the general scientific literature on the efficacy of helmet therapy for plagiocephaly using methods derived from the referenced works. Specific, quantifiable performance data for the Cranial Symmetry System itself is not provided in this document.

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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 sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.

O&P Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up and made round. The finished helmet has a hard middle layer with a padded inner and outer laver. There are ventilation holes in the top of the helmet is held in place with a chinstrap.

O&P Cranial Molding Helmets work in two ways. The first way is that the helmet fits close to the head where the head sticks out, and loosely over the flattened area. The skull will grow into the loose area of the helmet, allowing the flattened parts of the head to "catch up" with the prominent areas. This type of helmet is known as a "passive" or "Clarren style" helmet. The second way the helmet is effective is by providing a rounded surface for the infant's head to lie on, removing the worry about proper positioning.

The provided text does not contain detailed acceptance criteria and a specific study proving the device meets those criteria in the format typically used for medical device validation (e.g., sensitivity, specificity, accuracy metrics with statistical significance).

Instead, the document is a 510(k) Summary for the O&P Cranial Molding Helmet, asserting substantial equivalence to a predicate device (Orthomerica's STARband K011350). The "performance data" section primarily relies on:

• Substantial Equivalence: Claiming that since the O&P Cranial Molding Helmet is substantially equivalent to the STARband (which itself claimed substantial equivalence to the OPI Band), it meets the same standards of performance.
• Historical Use: Stating that an area hospital department in St. Louis has used O&P Cranial Molding Helmets effectively and safely for 19 years, treating an estimated 4,256 infants.
• Literature Review: Citing several published studies and a "comprehensive assessment" of cranial orthoses to support the effectiveness of such devices in correcting abnormal head shape.

Therefore, many of the requested items (sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not explicitly addressed in this 510(k) summary as it is not a direct study report for the O&P Cranial Molding Helmet's performance metrics against a predefined acceptance criterion.

However, based on the provided text, here's an attempt to answer the questions, indicating where information is not present or inferred from the context of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics (e.g., "must achieve X% improvement in CVA"). The implicit acceptance criterion is that the device is "safe and effective for its intended use" and "substantially equivalent" to predicate devices. This implies meeting the performance standards previously accepted for the predicate.
• Reported Device Performance:
  • Effectiveness: Corrects abnormal head shape, with evidence of relapse following treatment (from cited literature on similar devices).
  • Safety: Used effectively and safely for 19 years with 4,256 infants treated.
  • Specific Metrics: No specific quantitative performance metrics (e.g., average reduction in cranial vault asymmetry index) are provided for the O&P Cranial Molding Helmet itself. The document references a study (Littlefield et al., 1988) that documented "complete or near complete correction of asymmetry for a wide variety of head shapes" for cranial orthoses in general, but not specifically for the O&P device.

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

• Sample Size for Test Set: Not applicable/Not specified for the O&P Cranial Molding Helmet as a direct test. The document refers to:
  • Over 4,256 infants treated with O&P Cranial Molding Helmets over 19 years, but this is historical use, not a controlled test set to establish performance metrics against predefined criteria for this submission.
  • One cited study (Littlefield et al., 1988) monitored over 750 infants for cranial orthoses in general.
• Data Provenance:
  • Historical Use of O&P Helmets: An area hospital department in St. Louis (inferred to be US-based, given the submission in the US). This data appears retrospective, gathered over 19 years.
  • Cited Literature: Various studies published in journals (e.g., Journal of Pediatrics, Journal of Craniofacial Surgery). The geographical origin and whether they were retrospective or prospective are specific to each cited paper and not detailed here. The "comprehensive assessment" by Littlefield et al. monitored patients over 10 years, suggesting it was a prospective or long-term observational study.

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

• Not applicable. This information is not provided. The approach is substantial equivalence and reference to existing literature rather than a new controlled study with an explicit ground truth establishment process by experts for the test set of the O&P Cranial Molding Helmet.

4. Adjudication Method for the Test Set

• Not applicable. This information 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

• Not applicable. This device is a physical orthotic device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and "human readers" or "AI assistance" are not relevant in this context.

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

• Not applicable. This device is a physical orthotic device, not an algorithm.

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

• Implicitly based on clinical outcomes and expert judgment as documented in the cited literature for cranial orthoses. For the historical use of the O&P device, "effectiveness and safety" were determined by the hospital's long-term experience, which would involve physician assessment of infant head shape improvement (clinical outcome). The cited literature similarly relies on clinical assessments of head shape correction.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable. As above, this is not a machine learning model.

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The Precision Prosthetics and Orthotics, Inc. orthotic molding helmet is intended to apply passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

The Precision Prosthetic and Orthotics, Inc. orthotic molding helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a foam-lined, lightweight, bivalve rigid plastic helmet with the anterior section overlapping the posterior section. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other open areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the open areas.

The provided text is a 510(k) Summary for a cranial orthosis (helmet) and the accompanying FDA clearance letter. It describes the device, its intended use, and states that information was provided on biocompatibility and safety/effectiveness. However, it does not contain details about specific acceptance criteria or a study designed to prove the device meets those criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or comparative effectiveness as this information is not present in the provided text.

Here is what can be inferred from the document:

• Device Type: Cranial Orthosis (Orthotic Molding Helmet)
• Intended Use: To apply passive pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
• Predicate Device: Dynamic Orthotic Cranioplasty - DOC Band® (K964992)
• Regulatory Clearance: 510(k) clearance, indicating substantial equivalence to a legally marketed predicate device. This process typically involves demonstrating that the new device is as safe and effective as the predicate, but the specific studies and acceptance criteria used for this demonstration are not detailed in this summary.

To answer your request, a different type of document, such as a full clinical study report or a detailed submission summary, would be needed to extract the specific information about acceptance criteria and study methodologies.

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Ask a specific question about this device