Search Results
Found 36 results
510(k) Data Aggregation
(76 days)
308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System
(UV-Y); 308nm UV Phototherapy System (UV-Z)
The 308nm UV Phototherapy System is intended to be used for the treatment of psorrasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is used on intact skin only.
The 308nm UV Phototherapy System is available in four models, UV-K , UV-Y and UV-Z. It is a portable medical device, which consists of LED light board, heat dissipation module, control circuit, drive circuit, battery (applicable to UV-X, UV-Z), and power adapter. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders, which can be used in hospital, clinics and households.
The device is mainly composed of a host and a power adapter. The LED light board of the device host contains light emitting diodes (LEDs), which create narrowband UVB light centered at a wavelength 308nm(±2nm) for the purpose of phototherapy. They are intended to be use in localized phototherapeutic treatment of dermatologic conditions(excluding eyes), such as psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is for the partial treatment and is intended to be used on intact skin only.
The materials of the parts of the 308nm UV Phototherapy System that come into contact with the human body are mainly: PC, ABS.
This document describes the 510(k) summary for the Boston Aesthetics INC 308nm UV Phototherapy System (UV-K; UV-X; UV-Y; UV-Z). Below is a summary of the acceptance criteria and the study that proves the device meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (K172273 - 308nm Excimer System) and reference devices (K170489 - Clarify Phototherapy System, K191571 - UV Radiation Treatment System). The "acceptance criteria" are not explicitly listed with numerical thresholds in the provided document, but rather are implied by the demonstration that the subject device's characteristics are similar or comparable and that non-clinical performance testing meets established standards.
| Feature / Criteria (Implied) | Acceptance Criteria (Implied by Predicate/Reference) | Reported Device Performance (Subject Device K244022) | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Treatment of specific dermatologic conditions on intact skin, under prescription. (Predicate: psoriasis, vitiligo; Reference: adds atopic dermatitis, seborrheic dermatitis, leukoderma) | Intended for treatment of psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. Used on intact skin only. (Prescription use in hospitals, clinics, and households). | Similar & Comparable |
| Light Source | Xenon-Chlorine (XeCI) excimer lamp or LED UV lamps (Predicate: XeCI excimer lamp; Reference 1 & 2: LED UV lamps) | LED UV lamps | Same |
| UV Spectral Output | UVB (Predicate: UVB; Reference 1: UVB; Reference 2: UVA&UVB) | UVB | Same |
| UV Light Wavelength | 308nm±2nm (Predicate and Reference 2 UVB: 308nm±2nm or 300nm-320nm; Reference 1: 300nm-320nm) | 308nm±2nm | Same |
| Max Power Output | Comparable to predicate/reference devices (Predicate: 50mW/cm²; Reference 1: 3-15mW/cm²; Reference 2: 10mW/cm²) | UV-K&UV-X: 30 mW/cm²; UV-Y&UV-Z: 50 mW/cm² | Comparable |
| Maximum Treatment Dose | ≤ 5J/cm² (Predicate: 2J/cm²) | ≤ 5J/cm² | Comparable |
| Action Area | Partial treatment excluding eyes (Predicate and Reference 2: Partial treatment excluding eyes) | Partial treatment excluding eyes | Same |
| Treatment Area | Comparable to predicate/reference devices (Predicate: 16cm²; Reference 1: 4.5cm²; Reference 2: Max 15cm²) | 3cm² ~ 3.41cm² | Comparable |
| Treatment Time | Comparable to predicate/reference devices (Predicate: 140s; Reference 2: 520 min) | UV-K&UV-X: 1140s; UV-Y&UV-Z: 1100s | Comparable |
| User-Contacting Materials| Safe and biocompatible materials (Predicate: ABS; PC; Reference 1: ABS; Reference 2: ABS) | ABS; PC (demonstrated non-cytotoxic, non-irritating, non-sensitizing via ISO 10993-5, -10, -23) | Same |
| Safety and Performance | Compliance with recognized electrical safety, EMC, and photobiological safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471 generally common across predicates/references) | Compliance with: AAMI/IEC 60601-1:2005/(R)2012+A1+A2, ANSI AAMI IEC 60601-1-2: 2014, IEC 60601-1-11:2015, IEC 60601-2-57:2011, IEC 60601-2-83:2019, IEC 62471:2006. Biocompatibility testing per ISO 10993-5, -10, -23. Software documentation compliant with FDA guidance. | Same |
Study Proving Device Meets Acceptance Criteria:
The provided document describes a non-clinical performance testing approach to demonstrate substantial equivalence, rather than a clinical study with patient outcomes.
- Study Type: Non-clinical (bench testing, biocompatibility, and software documentation).
- Objective: To demonstrate that the 308nm UV Phototherapy System is as safe and effective as the predicate device (K172273) and reference devices by meeting recognized performance standards and having comparable technological characteristics.
2. Sample Size Used for the Test Set and Data Provenance
This is not a clinical study involving a "test set" of patients or data in the typical sense for performance metrics like sensitivity/specificity. Instead, it relies on:
- Bench Test Samples: The device units themselves (UV-K, UV-X, UV-Y, UV-Z models) are the "samples" for electrical safety, EMC, and photobiological safety testing. The number of units tested is not specified but is assumed to be sufficient for compliance with the relevant standards.
- Biocompatibility Samples: Samples of the user-contacting materials (PC, ABS) were tested. The number of samples is not specified but is assumed to follow the requirements of ISO 10993 standards.
- Data Provenance: Not applicable in the context of clinical data. The data comes from internal testing and validation against international and national standards.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This information is not applicable. The assessment is based on objective testing against predetermined engineering and safety standards, not on expert interpretations of clinical images or outcomes.
4. Adjudication Method for the Test Set
Not applicable, as this is objective non-clinical testing against standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a phototherapy system, not an AI-assisted diagnostic tool where human reader performance would be a primary metric.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a medical device for therapeutic use, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" for demonstrating safety and effectiveness in this context is:
- Compliance with Recognized Standards: Meeting the requirements of international and national standards for medical electrical equipment (IEC 60601 series), photobiological safety (IEC 62471), and biocompatibility (ISO 10993 series).
- Comparison to Predicate Device: Demonstrating that the subject device's technological characteristics and intended use are similar or comparable to a legally marketed predicate device cleared by the FDA, without raising new questions of safety or effectiveness.
8. Sample Size for the Training Set
Not applicable. This is a hardware therapeutic device, not an AI/ML device 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 this type of device.
Ask a specific question about this device
(189 days)
Phototherapy System (OL-PDT950)
The Phototherapy System use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The blue light (469mm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The red light (633nm wavelength) indicated to treatment of superficial, benign vascular, and pigmented lesions.
The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The Phototherapy System OL-PDT950 is a vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions.
The device produces light in the red light region of the spectrum (633±15nm), in the blue light regions of the light spectrum (469±15nm) and infrared light region of light spectrum (835±15nm).
Five sets of LEDs panels are available for the device.
Based on the provided FDA 510(k) summary for the Phototherapy System (OL-PDT950) (K230342), here's an analysis of the acceptance criteria and the study proving the device meets them:
Important Note: This document is a 510(k) summary for a premarket notification, which demonstrates substantial equivalence to existing devices. It is not a clinical study report that would typically detail the comprehensive acceptance criteria and performance data for a novel device or a device requiring de novo classification. Therefore, the information related to clinical performance is limited, and many of the requested items (e.g., sample size for test set, expert qualifications, MRMC study, ground truth establishment) are generally not part of a 510(k) submission for this type of device.
Acceptance Criteria and Device Performance for Phototherapy System (OL-PDT950)
The device, a Phototherapy System, is intended to emit energy to treat dermatological conditions using red, blue, and infrared light. For a 510(k) submission of this nature, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved through a comparison of technological characteristics and performance specifications. Clinical efficacy is typically established through a combination of the predicate device's history of safe and effective use and non-clinical performance testing of the new device.
The study proving the device meets acceptance criteria is primarily composed of non-clinical tests and a comparison of technical specifications to predicate devices. Clinical testing was not performed for this specific submission as stated in Section 6.1.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for substantial equivalence based on non-clinical data, the "acceptance criteria" are the demonstration of comparable technical specifications and compliance with relevant safety and performance standards. The "reported device performance" are the results of these non-clinical tests and the listed specifications of the subject device.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Subject Device (OL-PDT950) Reported Performance/Specifications | Reference Predicate Devices (K200751, K2227551, K200104) |
|---|---|---|
| Compliance with Electrical Safety Standard | Comply with IEC 60601-1 and IEC 60601-1-2 | Predicates also comply with IEC 60601-1 and IEC 60601-1-2 |
| Compliance with Non-Laser Light Source Equipment Safety Standard | Comply with IEC 60601-2-57 | Predicates also comply with IEC 60601-2-57 |
| Compliance with Photobiological Safety Standard | Comply with IEC 62471 | Predicates also comply with IEC 62471 |
| Software Verification and Validation (if applicable) | Software testing conducted in accordance with FDA guidance. | (Implicit in general controls for all medical devices with software) |
| Wavelengths | Red light: 633nm ± 15nm | |
| Blue light: 469nm ± 15nm | ||
| Infrared light: 835nm ± 15nm | Predicate 1: Red 630±15nm, Blue 415±15nm, IR 835±15nm | |
| Predicate 2: Red 633±15nm, Blue 417±15nm, IR 835±15nm | ||
| Predicate 3: Red 625nm±5nm, Blue 465nm±5nm, Yellow 590nm±5nm (note: Yellow not on subject device) | ||
| Maximum Power Density (Irradiance) | Red light: 75 mW/cm² | |
| Blue light: 35 mW/cm² | ||
| IR: 120 mW/cm² | Predicate 1: Red 115 mW/cm², Blue 120 mW/cm², IR 70 mW/cm² | |
| Predicate 2: Red 20-96 mW/cm², Blue 10-120 mW/cm², IR ≤ 70 mW/cm² | ||
| Predicate 3: Red 100 mW/cm², Blue 45 mW/cm², Yellow 35 mW/cm² | ||
| Treatment Area | 1228 cm² | Predicate 1: 1410 cm² |
| Predicate 2: 900 cm² ± 10% | ||
| Predicate 3: 500cm² and 860cm² | ||
| Recommended Treatment Time | 20 minutes | Predicates all list 20 minutes |
| Working Distance | 10-15cm | Predicate 1: 10-15cm |
| Predicate 2 & 3: Unknown |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for clinical data, as stated in Section 6.1: "Clinical testing was not performed for the subject device as part of the submission."
- Data Provenance: The reported performance data for the subject device comes from non-clinical tests (e.g., electrical safety, electromagnetic compatibility, photobiological safety, and performance specifications adherence). The location of these tests is not explicitly stated but can be inferred to be China, given the manufacturer's location (Shanghai, China). The data is inherently prospective in terms of the specific device's specifications and test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As clinical testing was not performed, there was no "ground truth" derived from expert consensus on medical conditions for a test set. Normative data for device specifications and compliance with standards are established through engineering and testing professionals, not medical experts.
4. Adjudication method for the test set
- Not applicable. There was no clinical test set 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
- Not applicable. This device is a phototherapy system, not an AI-powered diagnostic or assistive tool for human readers (like radiologists interpreting images). Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithmic device. Its performance is based on its physical light emission characteristics.
7. The type of ground truth used
- For the non-clinical tests and technical specifications, the "ground truth" is established through objective measurements (e.g., power meters for irradiance, spectrophotometers for wavelength verification) and compliance with internationally recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471). There is no "pathology" or "outcomes data" ground truth used for this type of 510(k) submission.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for this device.
Ask a specific question about this device
(272 days)
Neonatal Phototherapy System
The Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age ≥38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed.
The Neonatal Phototherapy System, Model: KANGALITE is a wearable phototherapy system that consists of six components: Light Source with AC Power Cord, Dual Fiber Optic Panels (Standard accessory) /Single Fiber Optic Panel (optional accessory), Swaddle, Strap, Disposable Covers and Table Mounting Clip (optional accessory). The Neonatal Phototherapy System, Model: KANGALITE delivers a narrow band of high-intensity blue light emitting diode (LED), in order to provide phototherapy treatment for neonatal hyperbilirubinemia.
The Neonatal Phototherapy System, Model: KANGALITE Light Source contains a blue LED which emits light in the range 400-500 nm (peak wavelength 455±10 nm). The system gives only one blue light irradiance output level which is not adjustable. This blue light is directed through the optical fiber bundle to the illuminating area of the Fiber Optic Panel where the newborn receives blue light therapy.
The Fiber Optic Panel is inserted into the Disposable Cover and is placed in a soft and comfortable Swaddle, while the baby is wrapped inside to receive phototherapy. Baby is allowed to receive kangaroo care. Besides, compare to conventional phototherapy, no eye protection for the baby is required as blue light will not leak out when properly set up.
The light output (>30 µW/cm²/nm) is sufficient to provide intensive phototherapy which is defined as in the American Academy of Pediatrics (AAP) standard.
Average irradiance for:
Dual Fiber Optic Panels: 50 µW/cm2/nm (±25%);
Single Fiber Optic Panel: 60 uW/cm2/nm (±25%).
The spectrum range of the blue LED light matches with the spectral absorption of bilirubin. Under blue light irradiation, subcutaneous bilirubin absorbs strongly in the blue region of the light spectrum and converts into less lipophilic waste products which can be excreted through the bile or urine without the need for conjugation.
The Neonatal Phototherapy System, Model: KANGALITE can be directly connected to nominal voltages readily available throughout the world as the Light Source is affixed with a wide-range medical adaptor, rated from 100-240 VAC and 50/60 Hz. It converts the power to 15 VDC to power up the Light Source.
The provided text describes a 510(k) premarket notification for a medical device, the Neonatal Phototherapy System, Model: KANGALITE. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI/device.
Therefore, many of the requested details regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI models or new clinical devices, are not explicitly provided in this 510(k) submission.
Here's a breakdown of what can be inferred or stated based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of explicit acceptance criteria with numerical performance targets typical for clinical efficacy studies (e.g., sensitivity, specificity, or improvement in bilirubin levels). Instead, the "acceptance criteria" for this 510(k) submission are met by demonstrating substantial equivalence to a previously cleared predicate device (Bili-Tx, K070180) through various non-clinical tests and comparisons of technological characteristics.
The "reported device performance" is largely qualitative, asserting that the device meets relevant safety and performance standards established for such phototherapy systems.
Here's what can be extracted regarding performance and comparison:
| Characteristic | Acceptance Criteria (Implicit for Substantial Equivalence to Predicate) | Reported Device Performance (KANGALITE) |
|---|---|---|
| Intended Use | Treatment of hyperbilirubinemia in neonates (Bili-Tx) | Treatment of unconjugated hyperbilirubinemia in neonates: gestational age ≥38 weeks and weight within 2500-4500 grams |
| Principle of Operation | Blue light phototherapy converting bilirubin to excretable products (Bili-Tx) | KANGALITE uses blue light LEDs (400-500 nm, peak 455±10 nm) for bilirubin conversion |
| Light Intensity (Irradiance) | Standard Panel-Light: 30 µW/cm²/nm; Neonatal Panel-Light: 55 µW/cm²/nm; Overhead Therapy: 30 µW/cm²/nm (Bili-Tx) | Dual Fiber Optic Panels: 50 µW/cm²/nm (±25%); Single Fiber Optic Panel: 60 µW/cm²/nm (±25%). Meets AAP intensive phototherapy standard (>30 µW/cm²/nm). |
| Wavelength | Blue LEDs: 400–550 nm (peak 450–470 nm) (Bili-Tx) | Blue LED: 400-500 nm (peak: 455 ± 10 nm) |
| LED Lifetime | Minimum lifetime of 30,000 hours (Bili-Tx) | Nominal lifetime: >45,000 hours |
| Biocompatibility | Not publicly available for predicate (Bili-Tx) | Passed ISO 10993 for Cytotoxicity, Sensitization, Skin Irritation for patient-contact materials (disposable covers, Swaddle). |
| Electrical Safety | Conforms to IEC 60601-1 (Bili-Tx) | Conforms to ES60601-1 and related amendments. |
| Electromagnetic Compatibility (EMC) | Conforms to EN 60601-1-2 (2nd edition) (Bili-Tx) | Conforms to IEC 60601-1-2 (4th edition) |
| Phototherapy Safety/Performance | Conforms to IEC 60601-2-50 (Bili-Tx) | Conforms to IEC 60601-2-50. |
| Home Use Safety | Intended for home/hospital use (Bili-Tx) | Conforms to IEC 60601-1-11 for home healthcare environment. |
| Water Ingress Protection (Light Source) | IPX0 (Bili-Tx) | IP22 (KANGALITE), fulfills IEC 60601-1-11 requirement for home use. |
| Noise |
Ask a specific question about this device
(77 days)
Phototherapy System
Phototherapy Systems use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris
The red light (630mm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions
The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, atthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The Phototherapy Systems HS-770 is a vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (630±15nm), in the blue light regions of the light spectrum (415±15nm) and infrared light region of light spectrum (835±15nm). Three or four sets of LEDs panels are available for the device.
The provided text is a 510(k) Summary for a Phototherapy System, which details its specifications and compares it to a predicate device. It explicitly states that clinical testing was not applicable or performed for this submission to establish substantial equivalence.
Therefore, the document does not contain any information regarding acceptance criteria studies, device performance metrics against such criteria, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or details about training sets.
The information provided only covers non-clinical testing for electrical safety and electromagnetic compatibility to demonstrate compliance with recognized standards.
Based on the provided text, I cannot answer the questions about acceptance criteria and the study that proves the device meets them because the document states "Clinical Testing: It is not applicable."
Ask a specific question about this device
(122 days)
neoBLUE blanket LED Phototherapy System
The neoBLUE blanket LED Phototherapy System is indicated for the treatment of unconjugated hyperbilirubinemia in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver. The neoBlue blanket device provides intensive phototherapy underneath the patient and can be used with a bassinet, open bed, radiant warmer, incubator, or while holding the patient.
The neoBLUE blanket LED Phototherapy System is a portable phototherapy system that consists of five components: the neoBLUE blanket phototherapy light box, fiber optic blanket with attached cable, blanket mattress, disposable mattress covers, and power supply. The neoBLUE blanket LED Phototherapy System delivers a narrow band of high-intensity blue light via a blue light emitting diode (LED), in order to provide treatment for neonatal hyperbilirubinemia.
The portable neoBLUE blanket light box contains a blue LED which emits light in the range of 400 – 550 nm (peak wavelength 450-475 nm). This blue light is directed through an optical fiber cable to the fiber optic blanket pad. The fiber optic blanket pad is composed of high performance optical fibers enclosed in a vinyl material. A polyurethane mattress is placed on top of the fiber optic blanket, and a disposable polypropylene cover is placed around the blanket pad and mattress. The fiber optic blanket generates sufficient light output to provide intensive phototherapy which is defined as ≥30µW/cm²/nm.
The provided text describes a 510(k) premarket notification for a medical device called the "neoBLUE® blanket LED Phototherapy System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical or standalone performance studies with acceptance criteria for an AI/ML device.
Therefore, many of the requested details regarding acceptance criteria, study design for AI/ML performance, sample sizes for training/test sets, expert involvement for ground truth, and MRMC studies are not present in this document. The device in question is a phototherapy system, not an AI/ML diagnostic or therapeutic device.
Here's an analysis based on the available information and an explanation of why other requested information is not applicable:
1. A table of acceptance criteria and the reported device performance:
The document describes performance specifications that the device meets, rather than acceptance criteria for an AI/ML model's output. The criteria are related to the physical and functional characteristics of the phototherapy system.
| Acceptance Criteria (Performance Specification) | Reported Device Performance |
|---|---|
| Light Spectrum Range | 400 – 550 nm (peak wavelength 450-475 nm) |
| Light Intensity (Intensive Phototherapy definition) | ≥30 µW/cm²/nm (for both blanket sizes) |
| Factory Set Intensity | 35 ± 5 µW/cm²/nm |
| Adjustable Light Output Range | 50 to 60 µW/cm²/nm (adjustable) |
| Expected LED Life | >20,000 hours |
| Operating Temperature (Light Box) | 41° to 86° F (5 to 30°C) |
| Operating Humidity (Light Box) | 10% to 90%, non-condensing |
| Operating Temperature (Blanket) | 41° to 100° F (5 to 38°C) |
| Operating Humidity (Blanket) | 10% to 90%, non-condensing |
| Storage Temperature | 32° to 122° F (0 to 50°C) |
| Storage Humidity | 10% to 90%, non-condensing |
| Altitude / Atmospheric pressure | 700 hPa to 1060 hPa |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document explicitly states "Clinical Tests: N/A" and focuses on non-clinical engineering and performance testing of the physical medical device (phototherapy unit), not a software or AI/ML-based diagnostic system that would require a test set of data.
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)
This information is not applicable. Ground truth, expert consensus, and qualifications of experts are relevant for AI/ML models that interpret medical images or data. The neoBLUE blanket LED Phototherapy System is a physical device delivering light therapy, not an interpretive AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The neoBLUE blanket LED Phototherapy System is a therapeutic device, not an diagnostic AI assistant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as there is no algorithm/AI in this medical device. Its performance is based on its physical specifications and light output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable. For this physical device, "ground truth" relates to measurable physical properties and operational performance tested against engineering specifications and recognized standards (e.g., light intensity measurements, electrical safety).
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
Summary of the Study Proving Device Meets Acceptance Criteria (Non-Clinical):
The study proving the device meets its performance specifications (which serve as "acceptance criteria" for a physical device) was based on non-clinical tests and design verification and validation.
- Type of Study: Non-clinical tests, design verification and validation.
- Purpose: To ensure the device meets performance specifications and demonstrates equivalence to the predicate device (K103589).
- Tests Performed: Specific testing for device power, electrical safety, indicators, LED performance, intensity levels, intensity range, effective area, and usability.
- Standards Applied: Where appropriate, testing was performed to recognized international and industry standards, including:
- IEC 60601-2-50:2009 +A1 / ED 2.1: 2016-04 (Particular Requirements For The Basic Safety And Essential Performance Of Infant Phototherapy Equipment)
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (General Requirements For Basic Safety And Essential Performance)
- IEC 60601-1-11:2015 (Second Edition) (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
- IEC 60601-1-6:2010, AMD1:2013 (Usability)
- IEC 60601-1-2 ED 4.0: 2014-02 (Electromagnetic disturbances)
- An AIM Standard 7351731 Rev 2.0: 2017-02-03 (Electromagnetic disturbances)
- Conclusion: The verification and validation summary and risk analysis documentation supported the conclusion that the device is as safe and effective as the predicate device and is substantially equivalent.
No human data, expert review of images, or AI/ML model performance evaluation was part of this submission, as it is for a physical phototherapy device.
Ask a specific question about this device
(294 days)
Bilicocoon Phototherapy System
The BiliCocoon™ Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home.
The BiliCocoon™ Phototherapy System is a phototherapy system designed to treat unconjugated hyperbilirubinemia in newborns and infants under 3 months old and weighing less than 10kg. It is a phototherapy device, which emits light in the absorption spectrum of the bilirubin, from 430 to 490 nm. A custom optic directs light from the LEDs into the fiberoptic Pad. The system is composed of a blue light electronic generator - the Light Box - and of a light emitting fabric – the Pad – which transmits the blue light to the newborn. The Pad is provided in two versions: Bag Pad. The Light Box has a user interface to set the session time and inform the user about eventual errors. The other parameters of the therapy (irradiance level, light wavelength, etc.) are fixed.
The BiliCocoon™ Phototherapy System is used with the BiliCocoon™ Disposable, a non-woven disposable designed to fit the Pad which interfaces between the newborn. The disposable is the only part which contacts the newborn skin.
The BiliCocoon™ Phototherapy System can be fixed on the BiliCocoon™ Fixation system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BiliCocoon™ Phototherapy System (K163526).
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily proving efficacy through a clinical trial. Therefore, the information provided primarily pertains to bench testing and comparison, rather than comprehensive clinical study data as might be expected for novel devices or PMAs.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance for a specific statistical endpoint (e.g., accuracy, sensitivity, specificity) relevant to a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the performance of the predicate device and relevant industry standards. The "reported device performance" is largely described through a comparison against the predicate and adherence to safety and performance standards.
The closest equivalent to "acceptance criteria" for a phototherapy device would be its light output specifications and safety characteristics.
| Acceptance Criteria (Implied from Predicate/Standards) | Reported Device Performance (BiliCocoon™) |
|---|---|
| Light Characteristics | |
| Peak Emission Range | Blue LED Light with peak emission between 430 and 490 nm |
| Intensity (Irradiance) average | 30 - 40 µW/cm²/nm |
| Recommended by AAP for intensive phototherapy | Meets recommendation (>30 µW/cm²/nm) |
| Safety and Electrical | |
| Leakage Current |
Ask a specific question about this device
(95 days)
Skylit Phototherapy System
The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototheraputic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and lenkoderma on all skintypes (I-VI).
The Clarify Phototherapy System is a handheld medical device that produces UVB light for the purpose of phototherapy. It was developed and will be marketed by Skylit Medical, Inc. DBA Clarify Medical, Inc. and is referred to herein as "Clarify Medical" or "Clarify". The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical device. It is indicated for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI). The system consists of the following components and accessories:
- Handheld UV light Emission device that delivers the UVB light
- Mobile Software Application that runs on smartphone (Android and iOS) platforms. This Application is the primary user interface, and provides patient guidance when phototherapy is delivered and treatment reminders
- Physician Portal Software is a cloud based software application that links the patient to the prescribing physician during home therapy.
The provided text describes a 510(k) premarket notification for the "Skylit Phototherapy System" (later referred to as "Clarify Medical Phototherapy System"). This device is a handheld UV light treatment system for dermatologic conditions. The submission aims to demonstrate substantial equivalence to previously marketed devices.
Based on the provided document, the device in question is a phototherapy system, not an AI/algorithm-based device. Therefore, the questions related to AI acceptance criteria, sample size for AI test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not applicable to this medical device submission.
The acceptance criteria provided focus on the electrical, optical, software, and biocompatibility safety and performance of the phototherapy device. The study proving these criteria are met consists of various performance tests and validations.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance:
| Element of Comparison | Method for Safety Assessment | Test Result Meet Design Input Specifications and Demonstrate Equivalence | Notes |
|---|---|---|---|
| UBV light Source, Max Power Output | Performance Testing (optical emissions spectrum measured at the treatment surface, biologically weighted emissions curve computed using the International Commission on Illumination accepted erythema curve, optical power at treatment surface measured). Evaluated in accordance with IEC 60601-2-57. | Yes | Verification testing demonstrated weighted peak of emissions within established therapeutic range (300-320nm) and optical power at treatment surface met specified requirements. |
| Power Source | Electrical Safety Testing, Battery Performance Testing. Evaluated in accordance with IEC 60601-1 and IEC 60601-1-4. | Yes | Not explicitly detailed in the provided text beyond "Yes." |
| Prescription Stored on the device | System Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304. | Yes | This refers to prescriptions being stored on a cloud server for the subject device, a feature that distinguishes it from some predicate devices. |
| Treatment Reminders | Software Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304. | Yes | This feature is built into the mobile software application. |
| Auto Calculation of treatment adjustment | System Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304. | Yes | This capability is built into the software in accordance with the prescribed protocol. |
| Skin Contact Materials | Performance testing. Evaluated for biocompatibility in accordance with ISO 10993-1 (cytotoxicity, sensitization, irritation) as a "surface device" with limited contact duration ( |
Ask a specific question about this device
(269 days)
neoBLUE compact LED Phototherapy System
The neoBLUE compact LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. The light can be used for infants in a bassinet, incubator, open bed, or radiant warmer.
The neoBLUE compact LED Phototherapy System utilizes a portable phototherapy light that delivers a narrow band of high-intensity blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia.
The neoBLUE compact LED Phototherapy System light consists of a lightweight plastic light enclosure which can be used independently by placing directly on top of an incubator, or with the arm, or with the arm and roll stand together. The arm can be attached to the pole mount accessory on most incubators and radiant warmers. The arm, when attached to the roll stand, can be used for infants in a bassinet, incubator, open bed, or radiant warmer.
The neoBLUE compact LED Phototherapy System light is equipped with a treatment timer to track the total number of treatment hours per patient, a device timer to track the total number of operating hours for the blue LEDs, and an exam light.
The provided text describes the neoBLUE Compact LED Phototherapy System and its substantial equivalence to predicate devices, not a study evaluating its performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested categories for a study are "Not Applicable" or "Not Provided" in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific quantitative acceptance criteria for clinical performance or a clinical study to prove the device meets them. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and compliance with safety standards.
| Feature/Test Category | Acceptance Criteria (Implied from Predicate/Standards) | Reported Device Performance (neoBLUE compact LED Phototherapy System) |
|---|---|---|
| Intended Use | Treatment of neonatal hyperbilirubinemia | Treatment of neonatal hyperbilirubinemia |
| Treatment Method | Overhead phototherapy | Overhead phototherapy |
| User | Healthcare professionals in a clinical setting | Healthcare professionals in a clinical setting |
| Sites of Use | Bassinet, incubator, open bed, radiant warmer | Bassinet, incubator, open bed, radiant warmer |
| Patient Population | Neonates | Neonates |
| Light Source | LEDs (blue) | Blue and white Light Emitting Diodes (LEDs) |
| Wavelength | Peak @ 440-470 nm (combined range of predicates) | Peak @ 450 to 470 nm |
| Intensity | Range overlapping with predicates (>20 to 50 μW/cm²/nm @ 40cm, 40-49 μW/cm²/nm @ 30-40cm) | 10 – 55 μW/cm²/nm @ 35 cm |
| Intensity Settings | 1 or 3 settings (from predicates) | 2 settings (high, low) |
| Effective Treatment Area | Range overlapping with predicates (660 to 800 cm² @ 40cm) | 700 cm² @ 35 cm height |
| Exam Light | Present on one predicate, absent on other | White Light Emitting Diodes (LEDs) (present) |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2 | Compliance with IEC 60601-1, IEC 60601-1-2 |
| Thermal Safety | Fan to cool, thermal protection circuit | Fan to cool circuitry, Thermal protection circuit |
| Radiation Safety | Minimal UV/IR light | LED light source produces minimal UV and IR light |
| Software Verification | Verified | Performed |
| Design Verification & Validation | Performed | Performed (includes device power, electrical safety, indicators, LED performance, intensity levels, intensity range, effective treatment area, usability) |
| Hazard Analysis | Performed | Performed |
| Human Factors Validation Testing | Performed | Performed |
Note: The "acceptance criteria" here are implied from the comparison to predicate devices and the mention of standards compliance for safety and performance testing. There are no explicit, quantifiable clinical efficacy acceptance criteria provided within this document for a clinical study.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not Applicable. This document describes a premarket notification (510(k)) seeking substantial equivalence, not a clinical trial with a patient test set. Performance testing mentioned (electrical safety, LED performance, etc.) would be conducted on units of the device, not a patient sample.
- Data Provenance: Not Applicable. No patient data or clinical data is mentioned for a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No clinical ground truth or expert adjudication for patient data is mentioned.
4. Adjudication method for the test set
- Not Applicable. No patient test set or adjudication process is described.
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 phototherapy system, not an AI-assisted diagnostic or interpretative tool for human readers. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device (phototherapy system), not a standalone algorithm.
7. The type of ground truth used
- Not Applicable. For the technical performance aspects, the "ground truth" would be established by reference standards, engineering specifications, and validated measurement methods, rather than clinical ground truth (pathology, expert consensus, outcomes data).
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device.
Ask a specific question about this device
(113 days)
neoBLUE® LED Phototherapy System
The neoBLUE® LED Phototherapy System is indicated for the treatment of hyperbilirubinemia for neonates and infants in a hospital environment, and administered by trained, professional medical staff, on the order of a licensed medical practitioner. The light can be used with a bassinet, incubator, open bed, or radiant warmer.
The neoBLUE® Phototherapy System consists of two products – the neoBLUE LED Phototherapy light source (light) and the neoBLUE LED Phototherapy roll stand.
The neoBLUE LED Phototherapy System is a floor-standing, mobile phototherapy light that delivers a narrow band of high-intensity blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The light can be used independently of the roll stand, and can be placed directly on an incubator with a flattopped surface.
This document describes the Natus Medical Incorporated neoBLUE® LED Phototherapy System (K160305).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present acceptance criteria in a tabular format with corresponding reported device performance metrics in the way one might see for an AI algorithm's diagnostic accuracy. Instead, the document focuses on compliance with established medical device standards and functional specifications for a phototherapy unit.
However, based on the non-clinical testing section, the implicit acceptance criteria are compliance with relevant safety and performance standards for medical electrical equipment and phototherapy devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety Standards Compliance | |
| IEC 60601-2-50:2009-03 Edition 2 (Infant Phototherapy Equipment) | Passed all testing and complies. |
| IEC 60601-1:2005/(R)2012 and C1:2009/(R)2012 (General Requirements for Basic Safety) | Passed all testing and complies. |
| IEC 60601-1-2: 2007/(R)2012 (Electromagnetic Compatibility) | Passed all testing and complies. |
| IEC 60601-1-6:2013-10 Edition 3.1 (Usability) | Passed all testing and complies. |
| Performance Specifications | |
| Intensity Setting (High) | 35 µW/cm²/nm at 12 inches (30.5 cm) |
| Intensity Setting (Low) | 15 µW/cm²/nm at 12 inches (30.5 cm) |
| Light Emission Spectrum | Blue LEDs emit 400-550 nm (peak 450-475 nm) |
| Non-significant UV/IR emission | Reduce risk of skin damage and excessive warming |
| Equivalence to Predicate Device | |
| Therapeutic Output | Same as predicate (K022196) |
| Functional Design Considerations | Separation of light source from roll stand for independent use; addition of timer for LED working hours |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the device is a phototherapy system and not a diagnostic AI algorithm that relies on a "test set" of patient data for performance evaluation in the typical sense. The testing performed was for compliance with electrical, safety, and performance standards, and for demonstrating substantial equivalence to a predicate device through engineering and design validation. The provenance in this context would refer to internal validation procedures and results.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable. The device's performance is not evaluated against a "ground truth" derived from expert consensus on patient data. Instead, it is evaluated against established engineering specifications, safety standards, and functional requirements.
4. Adjudication Method
This is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessment where discrepancies need to be resolved (e.g., in clinical trials or diagnostic accuracy studies involving multiple readers). This document describes the regulatory clearance of a medical device based on compliance with standards and functional testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The neoBLUE® LED Phototherapy System is a treatment device, not a diagnostic AI tool intended to assist human readers in interpreting medical images or data. Therefore, an MRMC study related to reader performance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a standalone phototherapy unit; it is not an algorithm, and its function does not involve human interpretation of its output in the way an AI diagnostic tool would.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Compliance with recognized international and national standards for medical electrical equipment and infant phototherapy.
- Engineering specifications for light intensity, wavelength, and safety.
- Demonstration of substantial equivalence to a legally marketed predicate device (K022196 Natus Blue Light Phototherapy Unit) in terms of intended use, operating principles, and therapeutic output.
8. The Sample Size for the Training Set
This is not applicable. The device is not an AI algorithm that undergoes a "training" phase with a dataset.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
Ask a specific question about this device
(146 days)
Applied BioPhotonics Phototherapy System ABPT1003
Applied BioPhotonics® Phototherapy System ABPT1003 is intended to provide phototherapeutic light to the body. The device emits:
- Red and infrared light to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, sprains, strains, and muscle spasm, as well as back, neck and shoulder pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The Applied BioPhotonics® Phototherapy System ABPT1003 is a light therapy device using specific wavelengths of polychromatic energy produced by super-luminous light emitting diodes (LEDs) to treat a variety of skin and body conditions.
The device can be described as a Class II Low Level Light treatment process employing the application of light and heat, which penetrates the skin surface to the underlying tissues, triggering normal cellular functions. This technology is commonly referred to as photobiostimulation, light emitting diode therapy (LEDT), LLLT, or LED's. The application of LED's to tissue is non-invasive.
Using patent pending and proprietary techniques and computational processes, the Applied BioPhotonics® Phototherapy System ABPT1003 is composed of:
- Proprietary hardware (i.e. ABLM1002 LightMachine)
- LightOS software (running in the LightMachine)
- LightPad sets (ABLP103) comprising flexible, aseptic, polymeric LED pads
- Cables (for connecting LightPads and LightMachines)
The IR and red spectrum emitted from LEDs in the ABLP103 LightPad sets is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, sprains, strains, and muscle spasm, as well as back, neck and shoulder pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The LightMachine control panel displays to the operator what treatment is being performed and provides the user with a choice of driving one or two LightPad sets with any chosen treatment protocol.
The software component of the device controls the user's selection of specific treatment protocols on the LightMachine's control panel. The treatment may be set manually by entering LED-operating conditions (i.e. wavelength, duration, and pulse frequency) or by selecting preset treatment protocols. The software is revision-controlled and can be upgraded by the manufacturer.
This is a prescription use only device. The labeling, instructions and user operations are designed for health care professionals.
This document is a 510(k) Summary for the Applied BioPhotonics® Phototherapy System ABPT1003. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study proving the device meets specific performance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not explicitly detailed in this type of submission.
Based on the provided text, here's what can be extracted and what is not available:
Acceptance Criteria and Reported Device Performance
The document states that "All the test results demonstrate that Applied BioPhotonics Phototherapy System ABPT1003 meets the requirements of its predefined acceptance criteria and intended uses." However, the specific acceptance criteria are not explicitly listed or quantified in the provided text.
The "reported device performance" is essentially that the device passed various safety and compatibility tests, and is substantially equivalent to predicate devices. No quantifiable performance metrics for "efficacy" (e.g., specific pain reduction percentages, increase in blood circulation metrics) are provided from a clinical study for this device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with Electromagnetic Compatibility Standards (e.g., IEC 60601-1-2) | Demonstrated compliance with international standards for electromagnetic compatibility. (Specific performance values not detailed, but stated as "meets the requirements"). |
| Compliance with Electrical Safety Standards (e.g., IEC 60601-1) | Demonstrated compliance with international standards for electrical safety. (Specific performance values not detailed, but stated as "meets the requirements"). |
| Compliance with Photobiological Safety Standards (e.g., IEC 62471) | Demonstrated compliance with international standards for photobiological safety. (Specific performance values not detailed, but stated as "meets the requirements"). |
| Compliance with Software Life Cycle Processes Standards (e.g., IEC 62304) | Demonstrated compliance with international standards for medical device software life cycle processes. (Specific performance values not detailed, but stated as "meets the requirements"). |
| Substantial Equivalence to Predicate Devices (in intended use, fundamental scientific technology, and technological characteristics) | Analysis of performance data (bench and safety testing) demonstrates that the device is as safe and effective as, and therefore substantially equivalent to, the listed predicate devices (IllumiMed™, LIGHTWAVE Professional Deluxe, LumiWave 1X4 Infrared Therapy Device, HealthLight™ MicroController, MiniPro, ProNeuroLight and Pro Unit). |
Additional Requested Information:
-
Sample sizes used for the test set and the data provenance:
- Test set sample size: Not applicable/not stated. The non-clinical testing appears to refer to engineering verification and validation testing of the device itself (e.g., EMC, electrical safety, software V&V) rather than a clinical "test set" of patients.
- Data provenance: The document mentions "All laboratory tests and measurements were performed by an independent test lab certified to make such assessments." The country of origin for this testing is not specified, but the device submitter is from Hong Kong, China SAR. The testing is non-clinical.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was primarily non-clinical engineering and software testing. Ground truth in the context of clinical expert review is not relevant here.
-
Adjudication method for the test set:
- Not applicable as no clinical test set requiring expert adjudication is described.
-
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- No MRMC clinical comparative effectiveness study was done. The device is a phototherapy system, not an AI diagnostic tool that assists human readers.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- While software verification and validation were performed, this relates to the device's operational software and controls, not an AI algorithm performing a specific diagnostic or clinical task. The "standalone performance" of the device is demonstrated by its compliance with safety and technical standards as an independent medical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" would be established by the specifications and standards the device was designed to meet (e.g., specific voltage tolerances, current levels, electromagnetic emissions limits, software functional requirements). It's based on engineering specifications and regulatory standards. No clinical ground truth (like pathology or outcomes data) was used or required for this type of submission.
-
The sample size for the training set:
- Not applicable. This device does not incorporate machine learning or AI that requires a "training set" in the conventional sense of data-driven model training.
-
How the ground truth for the training set was established:
- Not applicable, as there was no training set for an AI algorithm.
Ask a specific question about this device
Page 1 of 4