Search Results
Found 4 results
510(k) Data Aggregation
(28 days)
The STARband® 3D™ 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 to improve cranial symmetry and/or shape.
The STARband® 3D™ redirects the head growth to improve proportion and symmetry. The practitioner takes a 3-dimensional captured image of the infant's head to acquire the existing shape. The 3-dimensional positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® 3D™ 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 STARband® 3D™ directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
This document is an FDA 510(k) clearance letter and summary for a medical device called STARband 3D. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific studies conducted to prove acceptance criteria for a new, independent device.
Therefore, the information required to accurately answer the prompt (acceptance criteria, specific study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text. The document states that:
- "Nonclinical performance testing performed for the predicate device and reference device remains applicable as there was no design change to the device."
- "Validation was conducted to evaluate one potential risk identified during design control activities and no impact on safety or effectiveness was identified."
- "These tests are referenced in the submission." (But the submission itself is not provided).
Without the actual submission that details the non-clinical performance tests and their results, I cannot provide the specific information requested in the prompt regarding the device's acceptance criteria and the study that proves it meets them.
Ask a specific question about this device
(182 days)
The STARband 3D is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, 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 STARband® redirects the head growth to improve proportion and symmetry. The practitioner takes a 3-dimensional captured image of the infant's head to acquire the existing shape. The 3-dimensional positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® 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 STARband® directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The STARband® 3D™ cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K211376. The difference with this proposed device is a structural change with a bilateral side opening design and two latch closure mechanisms at each opening. The indications for use, the intended use, and the underlying principles of operation of the STARband® cranial orthosis remain the same.
The provided text is a 510(k) summary for the STARband 3D cranial orthosis, which is a medical device for treating infants with abnormal head shapes. This document does not include information about a study that proves the device meets acceptance criteria related to AI/algorithm performance or human reader improvement, as it is not an AI-powered device.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the non-clinical performance testing conducted for the STARband 3D. The device is a physical cranial orthosis, and its evaluation revolves around its physical characteristics, manufacturing process, and safety, not AI diagnostic performance.
Therefore, many of the requested points regarding AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for AI, and sample sizes for training sets of AI models are not applicable to this device and the provided document.
However, I can extract information related to the physical device's performance testing and "acceptance criteria" from the document.
Here's the relevant information from the provided text, adapted to the closest interpretations of your questions for a non-AI device:
Acceptance Criteria and Device Performance (for a physical medical device)
The device is a cranial orthosis (a helmet) designed to improve cranial symmetry and/or shape in infants. The "acceptance criteria" for a physical device like this are met through demonstrating that its design, manufacturing process, and materials are safe and perform as intended, comparable to a predicate device.
Here's a table summarizing the non-clinical performance and acceptance criteria for the STARband 3D, as reported in the 510(k) summary:
| Test Type | Test Name | Acceptance Criteria (Implicit from Test Results) | Reported Device Performance |
|---|---|---|---|
| Dimensional Analysis | Dimensional Analysis | Acceptable part consistency and reproducibility across build cycles for both controlled and random sample populations. The dimensional differences between 3D printed parts and computer design files must be within acceptable limits (implied by "acceptable part consistency and reproducibility"). | "Dimensional analysis of the additively manufactured Starband® 3D orthoses resulted in acceptable part consistency and reproducibility across build cycles for both controlled and random sample population." |
| Fit Analysis | Fit Assessment | Proper fit, form, and function when 3/16" pads are installed and the device is fit to an unmodified patient-matched mold. All helmets must align and secure properly, and total contact (appropriate hold) must be achieved at the prominent or bossed areas of the unmodified patient model. | "The fit assessment of the additively manufactured Starband® 3D orthoses was successful for all parts evaluated. All helmets aligned and secured properly and total contact (appropriate hold) was achieved at the prominent or bossed areas of the unmodified patient model." |
| Pressure Test | Pressure Test | Pressure distribution for the Starband 3D design, when fit on patient (or model), must be equivalent to or better than the predicate device. | "The Starband® 3D orthoses design successfully showed that the pressure force is comparable to the predicate device." |
| Mechanical Analysis | Latch Closure Cyclic Test | The latch closure must successfully exceed the established don & doff cycles without fatigue or failure impacting function during normal utilization. The design must maintain operational criteria of latching and successfully securing the anterior and posterior shells on the patient model throughout the duration of the cyclic fatigue testing. | "The latch closure design successfully exceeded the established don & doff cycles without fatigue or failure impacting function during normal utilization. The design maintained operational criteria of latching and successfully securing the anterior and posterior shells on the patient model throughout the duration of the cyclic fatigue testing." |
| Mechanical Analysis | Latch Closure Destructive Testing | The maximum force required to fail the latch must exceed a maximum average pull strength of 9.18 lbf for an adult using defined pinch grips (Razza et al., 2022). This demonstrates it can withstand and surpass the pull forces of Don & Doff throughout the entire treatment. | "Destructive testing successfully proved that the STARband 3D latch closure design exceeds the average pull strength of an adult when using various pinch grips in application. It was concluded that the latch closure mechanism can withstand and surpass the pull forces of Don & Doff throughout the entire treatment." |
| Biocompatibility Analysis | Material Biocompatibility Test | All biocompatibility testing must successfully meet the acceptance criteria of ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization, Irritation). | "Biocompatibility test reports demonstrate that all biocompatibility testing successfully met the acceptance criteria." |
Here are the answers to your specific questions, indicating where the information is not applicable (N/A) for this type of device submission:
-
A table of acceptance criteria and the reported device performance
- See the table above.
-
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document refers to "test samples" for Dimensional Analysis, Fit Assessment, and Mechanical Testing, and "test samples" or "finished, fully assembled additively manufactured device" for Biocompatibility. However, specific numerical sample sizes for these tests are not provided in this 510(k) summary.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that these are non-clinical (bench/lab) tests for a physical device, the concepts of retrospective/prospective clinical data are not directly applicable. These appear to be laboratory-based validation studies.
-
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)
- N/A. This device does not involve "ground truth" derived from expert interpretation of medical images or patient data in the typical sense of AI/diagnostic device evaluation. The "ground truth" for these tests comes from engineering specifications, known dimensions, mechanical properties of materials, and successful operation based on design intent. For example, the "unmodified patient matched mold" serves as a reference for the fit assessment.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically relevant for clinical studies or studies where multiple human readers interpret data to establish a consensus "ground truth." This is a non-clinical, bench testing report for a physical device.
-
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
- N/A. This is not an AI-powered diagnostic device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical cranial orthosis, not a software algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A in the typical AI sense. For this physical device, "ground truth" is established by:
- Engineering Specifications/Design Files: For Dimensional Analysis (comparison of 3D printed part to original design file).
- Physical Models/Molds: For Fit Assessment (fitting to an "unmodified patient matched mold").
- Predicate Device Performance: For Pressure Test (comparing pressure force to the predicate device).
- Defined Mechanical Criteria: For Latch Closure tests (e.g., specific cycle counts, exceeding a defined pull strength threshold).
- International Standards: For Biocompatibility (conformance to ISO 10993-5 and ISO 10993-10).
- N/A in the typical AI sense. For this physical device, "ground truth" is established by:
-
The sample size for the training set
- N/A. This device does not involve machine learning or a "training set."
-
How the ground truth for the training set was established
- N/A. This device does not involve machine learning or a "training set."
Ask a specific question about this device
(105 days)
The STARband is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, 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 will have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic- shaped heads.
The STARband® redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3dimensional image 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 STARband® 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 STARband® directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The STARband® Side Opening design and STARband® Bi-Valve design are made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARband® Side Opening design has a top opening and a side opening. The band is held in place by a Velcro® strap (1½" for STARband® Side Opening) across the side opening. The STARband® Bi-Valve design consists 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 STARband® Plus cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K082950. The difference with this proposed device is a structural change to a dual side opening design with a living hinge at the top. The indications for use, the intended use, and the underlying principles of operation of the STARband® cranial orthosis remain exactly the same.
The provided document describes materials testing and durability testing for the STARband® Plus cranial orthosis. It does not contain information about a study that assesses the device's performance in improving cranial symmetry or shape in infants, which would typically involve clinical outcomes or efficacy data related to the device's intended use. The provided information focuses on the physical properties and structural integrity of the device itself.
Based on the provided text, here's what can be extracted regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Durability) | Reported Device Performance |
|---|---|
| Living hinge to achieve or exceed 1440 cycles without experiencing failure (fatigue/fracture/yield) when donned and doffed roughly 4 times a day for 6 months. | All STARband Plus configurations (1/2" Aliplast, (4) 1/8" Aliplast, and ½" Pelite) successfully completed 1440 cycles without fatigue/failure impacting the living hinge. |
2. Sample size used for the test set and the data provenance
The document states that the "sample population included both deformational and post-operative patients" for the STARband Plus durability test, but it does not specify the exact number of devices (sample size) or the provenance of the data (e.g., country of origin, retrospective or prospective).
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 as the described study is a non-clinical, mechanical durability test and does not involve human expert assessment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the described study is a non-clinical, mechanical durability test and does not involve adjudication by multiple reviewers. The assessment involved visual inspection for wear or failure.
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 information is not applicable. The device is a cranial orthosis, not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device (cranial orthosis), not an algorithm or software. The testing described is for the physical durability of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the durability test, the "ground truth" was the physical integrity of the device's living hinge after repeated cycling, assessed by visual inspection for signs of wear or failure.
8. The sample size for the training set
This information is not applicable. There is no "training set" mentioned or implied as this is a non-clinical, mechanical durability test of a physical device, not an algorithm that requires training.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set involved.
Ask a specific question about this device
(195 days)
The STARband, STARlight, and St. Louis Band are 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. These devices are also indicated 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-, brachycephalic- and scaphocephalic-shaped heads.
The STARband and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured inage of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image 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 STARband and STARlight provide 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 STARband and 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 STARband and STARlight product families as it was last cleared in K180109 are essentially still the same devices. The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). 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. 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 STARband Side Opening design and the STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap (1½" for STARband Side Opening and 1" for STARlight Side Opening) 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 St. Louis Band (formally known as the O&P Bivalve Molding Helmet in K063395) was last cleared in K180109 by Orthomerica Products Inc. The St. Louis Band is a Bi-Valve design made with an outer shell of 1/4" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/4" Aliplast foam (closed cell polyethylene). The Bi-Valve design consists of two plastic shells that overlap and are held together with rivet fasteners. The St. Louis Band utilizes a Velcro strap with chafe and loop for a secure fit.
The Cranial Comparison Utility (CCU) is a software component for a previously cleared shape capture method, the STARscanner Data Acquisition System, distributed by Orthomerica Products, Inc. The CCU is a separate software program that is designed to present specific measurements derived from a three-dimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.
The proposed addition is a new software component for a previously cleared shape capture method, the NetVirta SmartSoc Data Acquisition System, distributed by Orthomerica Products, Inc. The new software component is the Measurement Comparison Utility (MCU). The MCU is a separate software program, not used in manufacturing, which is designed to present specific measurements derived from a threedimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.
The provided document describes a 510(k) premarket notification for Orthomerica Products Inc.'s cranial orthoses (STARband, STARlight, and St. Louis Band) with the addition of a new software component, the Measurement Comparison Utility (MCU). The acceptance criteria and supporting study details are primarily focused on the MCU Accuracy and Capabilities Study.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the MCU's performance was evaluated against the predicate Cranial Comparison Utility (CCU) and manual/3D-CAD software measurements. The reported device performance is that the MCU was determined to be substantially equivalent to the predicate CCU.
| Feature | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Measurement Accuracy & Capabilities | To be comparable to manual measurements and 3D-CAD software, and substantially equivalent to the predicate CCU in terms of model alignment, differential maps, calculations, and reporting. | MCU was determined to be substantially equivalent to the predicate CCU regarding accuracy of measurements and capabilities of model alignment, differential maps, calculations, and reporting. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states that the MCU Accuracy and Capabilities Study "Utilized representative cranial shapes that reflect symmetrical and asymmetrical cranial shapes." However, it does not specify the exact number (sample size) of these cranial shapes used in the test set.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It refers to "representative cranial shapes," which could be phantom models or de-identified patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document states that the MCU was "Compared... to manual measurements and 3D-CAD software." This implies that the ground truth for some measurements was established through manual methods and potentially by experts using 3D-CAD software. However, the document does not specify the number of experts used or their qualifications.
4. Adjudication Method
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth of the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in this submission. The focus was on the performance of the software (MCU) in comparison to established methods (manual measurements, 3D-CAD, and predicate software).
6. Standalone (Algorithm Only) Performance
A standalone performance study was performed. The "MCU Accuracy and Capabilities Study" evaluates the MCU software program itself, without human intervention in its measurement calculations or reporting. It compares the MCU's outputs to manual measurements and 3D-CAD software.
7. Type of Ground Truth Used
The ground truth used for the MCU Accuracy and Capabilities Study was:
- Manual measurements
- 3D-CAD software measurements
This combination provided a reference for assessing the accuracy of the MCU's measurements and capabilities.
8. Sample Size for the Training Set
The document does not mention a training set sample size. The MCU is described as a software component designed to present specific measurements from 3D digital models. It seems to function as a measurement and comparison tool rather than a machine learning algorithm that requires a traditional training set for model development in this context. The study focuses on its accuracy for processing existing 3D models.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not explicitly mentioned as relevant for this type of software (a measurement utility rather than a predictive model), the document does not describe how ground truth for a training set was established.
Ask a specific question about this device
Page 1 of 1