Search Results
Found 51 results
510(k) Data Aggregation
(107 days)
The Red Light Hair Growth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.
The Red Light Hair Growth Cap is an over the counter (OTC) home-use, non-invasive device indicated to treat androgenetic alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.
The Red Light Hair Growth Cap is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (660nm red light) produced by LEDs to treat androgenetic alopecia and promote hair grown.
The device comprises of a wearable soft textile cap, a controller, an AC adaptor and a USB cable. The device can be powered by the AC adaptor which connected to the mains directly, also it can be powered by a power bank. The device is operated by the controller. There are 2 buttons on controller, ON/Off button is used to turn on/off the device, time button is used for setting treatment time from 10 to 30 minutes, each press in 5-minute increments./decrements. The device will shut off automatically after reach treatment time.
The provided FDA 510(k) clearance letter and summary for the "Red Light Hair Growth Cap" do not contain the detailed clinical study information typically associated with acceptance criteria, reported device performance for clinical endpoints, sample sizes for test/training sets, expert qualifications, or adjudication methods for AI/software devices. This is because the device, an "Infrared Lamp" (a physical medical device), was cleared based on its substantial equivalence to predicate devices and extensive non-clinical (electrical safety, EMC, software verification/validation) testing, rather than a clinical effectiveness study.
The summary clearly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."
Therefore, I cannot directly extract the requested information (points 1-9) in the manner typically expected for an AI/software medical device that undergoes rigorous clinical validation with specific performance metrics against a ground truth.
However, I can describe the acceptance criteria and study type that proves the device meets those criteria based on the provided document:
Acceptance Criteria and Study for the Red Light Hair Growth Cap
The Red Light Hair Growth Cap (LP-RJVGRW-BLK) received FDA 510(k) clearance based on its substantial equivalence to legally marketed predicate devices, combined with comprehensive non-clinical performance testing. The core "acceptance criteria" for this specific submission were centered around safety and effectiveness being comparable to existing devices and meeting established electrical and software safety standards.
1. A table of acceptance criteria and the reported device performance
Since this was a 510(k) based on substantial equivalence and non-clinical testing, the "acceptance criteria" are primarily related to safety standards and comparison to predicate device characteristics. There are no specific clinical performance metrics for "hair growth" reported in this document.
| Acceptance Criteria Category | Specific Criteria/Standard Met | Reported Device Performance/Compliance |
|---|---|---|
| Electrical Safety | IEC 60601-1: 2020 | Conforms to standard |
| IEC 60601-1-2: 2020 (EMC) | Conforms to standard | |
| IEC 60601-1-11: 2020 (Home Healthcare) | Conforms to standard | |
| IEC 60601-2-57: 2011 (Non-Laser Light Source) | Conforms to standard | |
| Photobiological Safety | IEC 62471: 2006 | Conforms to standard |
| Software Verification & Validation | FDA Guidance for Industry and Staff: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Basic Documentation Level) | Software verification and validation conducted; documentation provided. |
| Substantial Equivalence (Indications for Use) | Treat Androgenetic Alopecia and promote hair growth in specific male (Norwood-Hamilton IIa-V) and female (Ludwig-Savin I-1 to I-4, II-1, II-2 or frontal) hair loss patterns, with Fitzpatrick Skin Types I-IV. | Same as predicate devices (CurrentBody Skin™ Led Hair Regrowth and Biophotas Celluma RESTORE). |
| Substantial Equivalence (Technical Characteristics) | Similar design principle, energy type (LED red light), peak wavelength, intensity, treatment dose, treatment time, control mechanisms, and electrical power. | Similar to predicate devices. Differences in intensity, treatment dose (Note 1) and treatment time (Note 2) were deemed not to affect safety or effectiveness. Electrical power differences (Note 3) met safety standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (Clinical): Not applicable. Clinical testing was explicitly stated as "not needed" for this 510(k). The evaluation relied on non-clinical engineering and software testing.
- Data Provenance: The document does not specify country of origin for any safety testing data, only that the sponsor is Shenzhen Idea Light Limited, China. The testing itself is non-clinical (lab-based engineering/software V&V).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There was no clinical "test set" requiring expert ground truth establishment for clinical endpoints.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 not an AI/software diagnostic tool; it is a therapeutic device that does not involve human readers interpreting output or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical therapeutic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical testing, the "ground truth" refers to the established requirements and specifications of the referenced IEC standards (e.g., IEC 60601-1 for electrical safety) and FDA software guidance. Compliance with these standards served as the "ground truth" for safety and performance.
- For substantial equivalence for indications for use, the "ground truth" was the cleared indications for use of the predicate devices.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in the context of data-driven algorithm development.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
Ask a specific question about this device
(123 days)
RED is used to evaluate the neuromuscular function of the patient's ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity. RED helps identify patients with rectal hypersensitivity who experience desire or urge-to-defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations.
RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The RED catheter consists of an open-cell foam ball encased inside of a balloon, coupled to a hollow catheter. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume of air it displaces when inflated in room air is 52ml. This passive expansion provides the same function as filling an empty balloon with water or air. When expanded, the volume of material inside the patient's rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate. This is measured by asking patients the questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually.
The acceptance criteria and study proving the device meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Device can safely be used to evaluate neuromuscular function of the patient's ability to expel its contents from the rectum in adults with functional constipation. | Clinical evidence from a prospective trial of 60 adults "clearly supports product safety and performance and the indications for use in that RED can safely be used to evaluate neuromuscular function of the patient's ability to expel its contents from the rectum in adults with functional constipation (defined by Rome IV criteria)." The specific quantitative measure for "safely" is not explicitly defined here but is inferred to be the absence of reported adverse events or complications during the study. The ability to evaluate neuromuscular function is indirectly supported by the fact that the device is analogous to traditional balloon expulsion tests. |
| Device can be safely and effectively used as a qualitative test for rectal hypersensitivity. | The study "demonstrates that RED can be safely and effectively used as a device for qualitative testing for rectal hypersensitivity, whereas 31.0% of patients experienced rectal hypersensitivity with RED distended when queried on the patient perception to defecate." Safety is again inferred from the absence of reported adverse events. Effectiveness for qualitative testing for rectal hypersensitivity is demonstrated by the ability to identify a significant percentage of patients (31.0%) exhibiting this condition as per patient perception to defecate when the RED device is distended. |
| RED offers benefits with respect to assessing hypersensitivity compared to primary predicate. | "RED offers benefits... Firstly, the equipment and complexities required to use the primary predicate greatly limits the access to hypersensitivity testing. As such, the large subpopulation of individuals who are hypersensitive to lower volumes, but are never tested due to testing complexities of the predicate, are likely to benefit greatly through referral to physical therapy. Further, as the sensitivity evaluation simply requires asking a question about urge to defecate for individuals who are already undergoing rectal expulsion testing, it provides that added benefit at no additional risk than rectal expulsion testing alone with RED would provide." This criterion is met by detailing the advantages of RED in terms of accessibility and ease of use, leading to increased detection of hypersensitivity. |
2. Sample size used for the test set and the data provenance:
- Sample Size: 60 adults
- Data Provenance: Prospective clinical trial. The country of origin is not explicitly stated in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the clinical trial. However, it mentions that patients with functional constipation were "defined by Rome IV criteria," which are internationally recognized diagnostic criteria established by experts in gastroenterology. The evaluation for rectified hypersensitivity also involved "querying on the patient perception to defecate," suggesting reliance on patient self-report interpreted within clinical guidelines.
4. Adjudication method for the test set:
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "ground truth" for functional constipation was based on Rome IV criteria, and rectal hypersensitivity was determined by patient perception to defecate when the RED device was distended. This suggests reliance on established diagnostic criteria and patient report rather than an expert adjudication process for image or data interpretation.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. The RED device is described as operating without electronics or software, and is not an AI-assisted device. The study focused on the device's standalone performance and its comparison to traditional methods in terms of accessibility and ease of use.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done for the device in the context of its intended use. The RED device itself is a mechanical device, and its "standalone performance" refers to its ability to perform the balloon expulsion test and facilitate the qualitative assessment of rectal hypersensitivity as described, without additional electronic or software components. The clinical trial evaluated its performance in these applications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For functional constipation: Expert consensus-based diagnostic criteria (Rome IV criteria).
- For rectal hypersensitivity: Primarily patient perception/self-report regarding the desire or urge-to-defecate at lower volumes of distension, interpreted qualitatively.
8. The sample size for the training set:
The provided text describes a clinical trial for performance evaluation, not a machine learning model, therefore, there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
As there is no machine learning model or training set, this question is not applicable.
Ask a specific question about this device
(272 days)
The REDEMPTION™ Charcot Plating System bone plates and screws are indicated for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, and digits. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for patients with osteopenic bone in neuropathic osteoarthropathy (Charcot).
The REDEMPTION™ Charcot Plating System contains bone plates, screws, and accompanying instruments to aid in the surgical procedures. The system is a multi-indication reconstruction solution providing polyaxial locking technology and low-profile design. The system is optimized for use in osteopenic bone, such as those of neuropathic osteoarthropathy (Charcot) patients.
The system contains poly-axial locking and non-locking 4.0mm and 5.5mm diameter screws with threads optimized for osteopenic bone purchase.
All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136).
Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The REDEMPTION™ instruments are manufactured from stainless steel, with a few Aluminum and Silicone components.
I am sorry, but the provided text from the FDA 510(k) K233816 document for the "REDEMPTION™ Charcot Plating System" does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.
The document describes a traditional 510(k) submission for a metallic bone fixation system (plates and screws), not an AI/ML-driven diagnostic or therapeutic device. The "Performance Data" section details mechanical and material testing for the bone fixation system, such as:
- Static four-point bend testing per ASTM F382-17
- Screw Torsional Properties per ASTM F543-17 A1
- Screw Insertion and Removal Torque per ASTM F543-17 A2
- Screw Pullout Testing per ASTM F543-17 A3
- Cleaning and sterilization validations
These tests are standard for orthopedic implants to demonstrate structural integrity, and biocompatibility, and ensure the device can be properly cleaned and sterilized.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are concepts applicable to AI/ML software validation, not the mechanical testing of orthopedic hardware described in this document.
Ask a specific question about this device
(90 days)
The RedDrop ONE is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
The RedDrop ONE Lancet is a single-use blood lancing device with an integral sharps injury prevention feature intended for producing microliter capillary whole blood samples. The device is adhered to the skin in the selected position on the upper arm. The device is actuated by sliding the actuator causing an energized spring to release and deploy the lancet array. The lancet array is deployed to a maximum depth of 2 mm to access capillaries. The lancet array is then automatically retracted to a safe position that prevents sharps injury and re-activation. Sliding the actuator also releases two spring loaded pistons that create a gentle vacuum to the skin to facilitate the emergence of capillary blood from the sample site.
The RedDrop ONE (One) device, a single-use blood lancing device, underwent clinical testing to demonstrate its performance and meet acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Total Success Rate | Over 95.0% |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample size for the test set is not explicitly stated as a number of participants. However, the summary mentions that "Subjects produced their blood samples following the instructions for use."
The data provenance is prospective, as indicated by the "actual-use study" and subjects actively producing blood samples. The country of origin for the data is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The study focuses on the device's ability to produce blood samples rather than a diagnostic interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the device (producing blood samples), adjudication by experts for ground truth is unlikely in the same way it would be for an AI diagnostic device. The "success" was likely objectively measured based on whether a blood sample was successfully produced.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study involving human readers and AI assistance was not conducted. This device is a lancing device for obtaining blood samples, not an AI diagnostic algorithm.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The RedDrop ONE is a physical medical device, not an algorithm. Its performance inherently involves a "human-in-the-loop" to operate it.
7. Type of Ground Truth Used
The ground truth used was the ability of the device to "produce blood samples from the upper arm of human subjects according to the device labeling." This implies an objective measurement of whether a sufficient micro-liter capillary whole blood sample was successfully obtained after using the device as instructed.
8. Sample Size for the Training Set
Not applicable. This device is a physical lancing device and does not involve AI algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used for this physical medical device.
Ask a specific question about this device
(266 days)
The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalcaneal arthrodesis (fusion)
Specific indications include:
- · Post-traumatic or degenerative arthritis
- · Previously infected arthrosis
- Revision ankle arthrodesis
- Failed total ankle arthroplasty
- · Avascular necrosis of the talus
- · Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- Rheumatoid arthritis
- · Osteoarthritis
- Pseudarthrosis
- · Trauma (malunited tibial pilon fracture)
- · Charcot foot
- · Severe endstage degenerative arthritis
- Severe defects after tumor resection
- Pantalar arthrodesis
- · Post-traumatic arthrosis
- · Neuroarthropathy
The Vilex Redemption Duo system consists of implantable intramedullary nails, endcaps, and locking screws manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and PEEK per ASTM F2026) that are implanted into the talocrural region to facilitate tibiotalocalcaneal arthrodesis (fusion). A variety of implant sizes are provided to accommodate individual patient anatomy. The Vilex Redemption Duo system includes device specific instrumentation for use in site preparation, implantation, and removal of the implants and instruments are packaged clean and non-sterile in a sterilization tray with instructions for sterilization prior to surgery.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Vilex Redemption Duo Hindfoot Nail System." This type of document does not typically contain information about AI/ML device performance, acceptance criteria, or a study specifically designed to demonstrate meeting such criteria as it would for an AI/ML diagnostic or prognostic system.
Instead, this clearance letter is for a physical orthopedic implant system (intramedullary nail) that facilitates tibiotalocalcaneal arthrodesis (fusion). The "performance data" referred to in Section VII relates to mechanical testing of the implant's physical properties, not diagnostic accuracy or AI algorithm performance.
Therefore, I cannot provide the requested information about acceptance criteria, AI/ML device performance, sample sizes, ground truth establishment, or expert involvement, as these concepts are not applicable to the type of device described in this FDA clearance.
The document describes the device's technical characteristics and provides references to the following:
Device Name: Vilex Redemption Duo Hindfoot Nail System
Regulation Number: 21 CFR 888.3020
Regulation Name: Intramedullary fixation rod
Regulatory Class: Class II
Product Code: HSB
Performance Data (Mechanical Testing):
The performance data provided supports the mechanical integrity and safety of the implant, not the performance of an AI algorithm. The tests performed are standard for orthopedic implants and include:
- Bending Fatigue per ASTM F1264-16e1
- Static Torsion per ASTM F543-17
- Driving Torque per ASTM F543-17
- Removal Torque per ASTM F543-17
- Axial Pullout Strength per ASTM F543-17
- Static Four-Point Bending per ASTM F1264-16e1
- Static Torsion per ASTM F1264-16e1
- Dynamic Four-Point Bending per ASTM F1264-16e1
The conclusion states that "Although minor differences in the design exist between the subject and predicate devices, the testing supports that these differences do not raise any different questions of safety and effectiveness. Therefore, it is concluded that the Vilex Redemption Duo Hindfoot Nail System is substantially equivalent to the predicate device." This indicates that the mechanical tests demonstrated equivalent performance to predicate devices, satisfying the FDA's requirements for 510(k) clearance for this type of physical implant.
Ask a specific question about this device
(90 days)
The ReddyPort Elbow is intended to provide an interface for application of CPAP or bi-level therapy to the patient including while the patient is simultaneously undergoing another care procedure (e.g. oral care, suctioning, bronchoscopy) by hospital/institutional clinicians. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients (> 40 lbs/ 18.2 kg) for whom CPAP or bi-level therapy has been prescribed. The elbow can be used with Philips Respironics AF541 masks and AF531 masks with the clip-style connection.
The ReddyPort Elbow is an NIV elbow that replaces the elements AF541 style masks and AF531 masks with a clip-style comection and provides oral access for clinicians to the patient's airway during CPAP and bi-level therapy. The ReddyPort Elbow is compatible with both Over the Nose (OTN) cushion ((S, M, L, XL sizes) and an Under the Nose (UTN) cushion (A, B, C sizes) configurations of the AF541 EE Mask and AF531 mask with clip-style connection. ReddyPort permanently replaces the conventional elbow on the mask and maintains positive pressure. This elbow allows for respiratory care procedures (e.g. oral care, suctioning, bronchoscopy) to be performed on a patient while the patient is receiving non-invasive ventilation. The elbow contains a duckbill valve that allows the patient's airway and that seals with similar leak rates to conventional NIV elbows. In addition, the elbow includes an anti-asphysia valve to ensure safety of the patient.
Here's an analysis of the provided FDA 510(k) summary regarding the ReddyPort Elbow, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary for a medical device that interfaces with respiratory therapy equipment. It is not an AI/ML medical device. Therefore, many of the requested elements for AI/ML device studies (like sample size of test/training sets, expert ground truth, MRMC studies, etc.) are not applicable to this type of traditional medical device submission. This document focuses on the physical and functional equivalence to predicate devices through bench testing and biocompatibility testing, not on algorithmic performance.
I will address the applicable sections of your request based on the provided text.
Device Name: ReddyPort Elbow
Regulation Name: Continuous Ventilator (specifically an accessory/interface)
Regulatory Class: Class II
Product Code: MNS
Applicant: SMD Manufacturing LLC
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't present a formal table of "acceptance criteria" against "reported performance" in the way one might see for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, for this type of mechanical device, the acceptance criteria are generally implied by meeting the requirements of recognized standards (ISO 17510, ISO 5356-1) and demonstrating performance (e.g., leak rates, resistance to flow). The device is deemed acceptable if it meets these standards and is substantially equivalent to predicate devices.
However, based on the "Substantial Equivalence Comparison Table" (pages 4-5) and "Performance Testing" section (page 6), here's an attempt to structure the information in a table format, focusing on quantitative metrics where available:
| Characteristic/Test | Acceptance Criteria (Implied/Standard) | Reported Device Performance (ReddyPort Elbow - Subject Device) | Substantial Equivalence Remarks |
|---|---|---|---|
| Indications for Use | Consistent with predicate devices for CPAP/bi-level therapy interface during other procedures (e.g., oral care, suctioning, bronchoscopy). | Provides interface for CPAP/bi-level therapy during oral care, suctioning, bronchoscopy. | Similar |
| Patient Population | Patients > 40 lbs / 18.2 kg (similar to predicates). | Patients (> 40 lbs / 18.2 kg). | Similar |
| Environment of Use | Hospital/Institutional Environment Only. | Hospital/Institutional Environment Only. | Same |
| Sterility | Provided Non-Sterile (Clean). | Provided Non-Sterile (Clean). | Same |
| Patient Usage Type | Single patient use in hospital/institutional environment. | Single patient use in hospital/institutional environment. | Same |
| Design | Permanent replacement elbow with duckbill and anti-asphyxia valve, clip-style connection (similar to predicate/reference). | Permanent replacement elbow with duckbill and anti-asphyxia valve, clip-style connection. | Similar |
| Valve Type | Duckbill Valve for access (similar to predicate). | Duckbill Valve. | Similar |
| Body Material | Biocompatible material (e.g., Polycarbonate or Polypropylene). | Polypropylene. | Similar (to Philips Respironics) |
| Access Valve Material | Silicone Elastomer. | Silicone Elastomer. | Similar |
| Anti-Asphyxia Valve Material | Silicone Elastomer. | Silicone Elastomer. | Same |
| Elbow Deadspace | Comparable to traditional NIV elbows (implied by "streamlined, low dead-space design"). | 37.59 mL (Predicate: 50.9 mL). Subject device has lower dead space. | Similar (and improved) |
| Leak Rates (4 cmH2O) | Comparable to predicate (e.g., 8.46 L/min for predicate). | 0.6 L/min. (Predicate: 8.46 L/min). Subject device has significantly lower leak rates. | Similar (and improved) |
| Leak Rates (10 cmH2O) | Comparable to predicate (e.g., 7.26 L/min for predicate). | 0.65 L/min. (Predicate: 7.26 L/min). | Similar (and improved) |
| Leak Rates (17 cmH2O) | Comparable to predicate (e.g., 7.65 L/min for predicate). | 0.89 L/min. (Predicate: 7.65 L/min). | Similar (and improved) |
| Leak Rates (24 cmH2O) | Comparable to predicate (e.g., 7.56 L/min for predicate). | 1.11 L/min. (Predicate: 7.56 L/min). | Similar (and improved) |
| Leak Rates (30 cmH2O) | Comparable to predicate (e.g., 7.35 L/min for predicate). | 1.34 L/min. (Predicate: 7.35 L/min). | Similar (and improved) |
| Resistance to Flow (50 L/min) | Low resistance (e.g., 0.223 cmH2O for predicate). | 0.23 cmH2O. (Predicate: 0.223 cmH2O). | Similar |
| Resistance to Flow (100 L/min) | Low resistance (e.g., 0.217 cmH2O for predicate). | 0.13 cmH2O. (Predicate: 0.217 cmH2O). Subject device has lower resistance. | Similar (and improved) |
| Resistance Under Single Fault (Inspiratory) | Acceptable (e.g., 0.6 cmH2O for predicate). | 1.23 cmH2O. (Predicate: 0.6 cmH2O). This shows higher resistance compared to the predicate, but is still considered acceptable under ISO standards. | Similar |
| Resistance Under Single Fault (Expiratory) | Acceptable (e.g., 0.5 cmH2O for predicate). | 0.43 cmH2O. (Predicate: 0.5 cmH2O). | Similar |
| Safety Valve | Includes anti-asphyxia valve (similar to predicate). | Includes anti-asphyxia valve. | Same |
| Duration of Replacement | In place for entirety of NIV therapy (similar to predicate). | In place for entirety of NIV therapy. | Similar |
| Intentional Vent Holes | No vent holes (similar to predicate). | No vent holes. | Same |
| Pressure Range | 4 to 30 cmH2O (similar to predicate). | 4 to 30 cmH2O. | Same |
| Patient Circuit Connection | 22mm Connection. | 22mm Connection. | Same |
Conclusion from section "Performance Testing": "The ReddyPort Elbow met all applicable requirements and acceptance criteria."
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. For this type of device, "test set" refers to physical samples of the device undergoing bench testing, not a dataset of patient cases. The number of physical units tested is not specified but is assumed to be sufficient for engineering and regulatory standards (e.g., multiple units to ensure consistency and robustness, per standard requirements like ISO).
- Data Provenance: Not applicable. This is not clinical data. The data comes from bench testing performed by the manufacturer, likely in a controlled laboratory setting (e.g., specific to the manufacturing facility or a third-party testing lab). The document does not specify a country of origin for the testing, but it is for a US regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. "Ground truth" in the context of an AI/ML device refers to a definitive 'correct answer' for a diagnostic task, often established by expert consensus or pathology results. For this mechanical device, the "truth" is established by physical measurement against engineering standards and specifications. Engineers and technicians, not medical experts as defined in the prompt, perform these tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers in diagnostic tasks, which is characteristic of AI/ML performance studies. This device's evaluation is based on objective physical measurements via bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. This device is a mechanical accessory, not a diagnostic AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No. There is no algorithm or AI component in this device. The performance data presented (leak rates, resistance, dead space) is indeed "standalone" in the sense that it's the raw physical performance of the device without human interaction being assessed as part of the primary outcome, but this is standard bench testing, not AI standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is defined by:
- Engineering Specifications and Design Requirements: What the device is designed to do.
- Recognized International Standards: Such as ISO 17510 (Medical devices -- Sleep apnoea breathing therapy Masks and application accessories) and ISO 5356-1 (Anaesthetic and respiratory equipment Conical connections). These standards specify acceptable ranges for performance characteristics like leak rates and resistance.
- Performance of Legally Marketed Predicate Devices: Especially the primary predicate (ReddyPort NIV Access Elbow, K171827) and reference devices (AF541 EE Full Face Mask, K150639; BRONCHOSCOPY ELBOW, K132168). The subject device must perform as well as or better than these predicates to prove substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a manufactured physical device, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a mechanical device.
Summary of Acceptance and Proof for ReddyPort Elbow:
The ReddyPort Elbow's acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices. This is proven through:
- Bench Testing: As detailed in the table above, the device's physical performance characteristics (dead space, leak rates, resistance to flow) are measured and shown to be comparable to, and in some cases better than, the predicate devices, while meeting the requirements of relevant ISO standards. The document explicitly states: "The ReddyPort Elbow met all applicable requirements and acceptance criteria."
- Biocompatibility Testing: The materials used in the device meet the requirements of ISO 10993 series and ISO 18562 series, indicating the device is biologically safe for its intended use and contact duration.
- No Clinical Testing: The FDA determined that no clinical testing was required, implying that the bench testing and comparison to predicates provided sufficient evidence of safety and effectiveness for a 510(k) clearance.
In essence, the "study" proving the device meets acceptance criteria consists of these comprehensive engineering, performance, and biocompatibility tests conducted according to recognized standards, demonstrating the device's functional and safety equivalence to previously cleared devices.
Ask a specific question about this device
(218 days)
The REDEMPTION Beaming System is indicated for fracture fixation, osteotomies, reconstruction procedures, and fusions of bones in the foot and ankle including the Metatarsals, Cuboid, Navicular, Calcaneus and Talus. Specific examples include: Medial Column Fusion and Lateral Column Fusion resulting from neuropathic osteoarthropathy (Charcot).
The REDEMPTION Ø3.5mm Headless Screws are indicated for small bone fragments fracture and osteotomy in the lower extremities primarily the foot.
The REDEMPTION™ Beaming System, consisting of the REDEMPTION™ Beams and the REDEMPTION™ Nails, is a reconstruction solution providing various diameters of cannulated screws.
The REDEMPTION™ Beams are provided in diameters of Ø5.0 mm, Ø6.5 mm, and Ø8.0 mm, and are cannulated and either partially or fully threaded. The Ø5.0 mm beams are available in 35 mm to 130 mm lengths (5 mm increments) and the Ø6.5 mm and Ø8.0 mm beams are available in 40 mm to 160 mm lengths (5 mm increments).
The REDEMPTION™ Nails are provided in diameters of Ø7.5 mm and Ø8.2 mm and are partially threaded. The nails range in length from 50 mm (5 mm increments).
The REDEMPTION™ Headless 3.5 mm screw can be used as a cross screw with the nail and are offered in lengths from 12 mm to 60 mm.
All implant components are manufactured from titanium (Ti-6A1-4V, ASTM F136).
Specific instrumentation including wires, drills, torx drivers, drill guides, implant inserters, implant drivers, and a targeting guide are required for use with the system. The REDEMPTION™ instruments are manufactured from stainless steel and radel (plastic).
The provided text is a 510(k) summary for the REDEMPTION™ Beaming System, a medical device for bone fixation. It details the device's description, indications for use, comparison to predicate devices, and performance data submitted in support of substantial equivalence.
However, the provided document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML device performance. The content is focused on the mechanical and material properties of a traditional medical device (bone fixation fastener), not an AI/ML powered device.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance (for AI/ML)
- Sample size and data provenance for a test set (for AI/ML)
- Number and qualifications of experts for ground truth (for AI/ML)
- Adjudication method (for AI/ML)
- MRMC comparative effectiveness study or effect size (for AI/ML)
- Stand-alone (algorithm only) performance (for AI/ML)
- Type of ground truth used (for AI/ML)
- Sample size for training set (for AI/ML)
- How ground truth for training set was established (for AI/ML)
The "Performance Data" section in the document lists:
- Static Four Point Bend Testing per ASTM F1264-16
- Mechanical testing per ASTM F543-17 (Insertion Torque, Removal Torque, Pull-out Force, Ultimate Torque)
- Computational Analysis
- Cleaning and sterilization validations
These are all standard engineering and biocompatibility tests for traditional medical implants, not for the evaluation of AI/ML algorithms.
In summary, the provided document does not describe an AI/ML-driven device or study its performance against the criteria typically associated with AI/ML medical devices.
Ask a specific question about this device
(90 days)
The Better Bunion System is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot and ankle for adult and pediatric patients 12 years of age and older. Better Bunion cutting guides are intended for single use only.
The RedPoint Medical Better Bunion system includes single use, patient specific bone resection guides designed from DICOM files from a patients' CT scans and a surgeon's prescription. The Better Bunion system includes single use and reusable instruments to facilitate surgery. The Better Bunion patient specific bone resection guides assist the surgeon in cutting bone in the foot and ankle according to the pre-surgical plan. The quides are individually manufactured for each patient using a validated design and manufacturing process with strict procedures for transfer and conversion of patient images from DICOM files to digital models (STL files), and in turn to patient specific bone resection guides that are additively manufactured with titanium alloy conforming to ASTM F3001. The bone cutting guides are single use devices and provided clean, not sterile to the end user.
Here's a breakdown of the acceptance criteria and study information for the RedPoint Medical Better Bunion System, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance (Simulated Surgical Studies) |
|---|---|---|
| Accuracy of Guide Placement | The guides should accurately facilitate the planned osteotomies, specifically for hallux valgus deformities, resulting in acceptable angular corrections. | Simulated surgeries for correction of hallux valgus deformities demonstrated the Better Bunion guides to provide:A final average intermetatarsal (IM) angle of ±2º relative to planAn IM angle of <4º for all guidesAn average deviation of 0.91º relative to plan |
| Fit and Usability | The patient-specific cutting guides should fit correctly and be usable for their intended surgical procedures. | Verification of fit and usability of the Better Bunion patient specific cutting guides for the Lapidus procedure, and Akin, Calcaneal, and Met-Traverse Metadductus osteotomies was demonstrated. |
| Biocompatibility | The single-use and reusable instruments must be biologically safe for patient contact. | The single-use and reusable instruments were determined to be biocompatible per ISO 10993-1. |
| Sterilization | The device, if intended to be sterilized (or provided clean for user sterilization), must meet appropriate sterility assurance levels. | Sterilization validation with sterility assurance level (SAL) of 10^-6^ using the overkill method per AAMI/ISO 14927. (Note: The guides are provided clean, not sterile, so this likely refers to user sterilization validation or the sterilization of the reusable components if applicable). |
As an AI, I need to point out that the provided text is an FDA 510(k) summary, which often provides a high-level overview of performance data rather than a detailed study protocol. Therefore, some of the requested information (like specific sample sizes for test sets, expert qualifications, or details about comparative effectiveness studies) is not explicitly stated in this document. I will extract what is available and note when information is not present.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for the "simulated surgical studies." The text mentions "all guides" when referring to the IM angle performance, but doesn't quantify the number of guides or cases.
- Data Provenance: Not explicitly stated. The studies are described as "simulated surgeries," implying a controlled, prospective setup, but the specific origin (e.g., country) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the summary. The "simulated surgical studies" suggest an objective measurement against a plan, but the role of experts in establishing ground truth for individual cases is not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided in the summary.
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
- A MRMC comparative effectiveness study is not mentioned. The performance data focuses on the device's accuracy in achieving a planned outcome in simulated surgeries, not on how it assists or improves human reader performance or diagnostic accuracy. The device is a surgical instrument/guide, not a diagnostic AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The reported performance (simulated surgeries for correction of hallux valgus deformities) appears to be analogous to a "standalone" performance for the guide itself. The guide's accuracy is measured against the pre-surgical plan. While a surgeon would use the guide, the measurement of the guide's precision in achieving the planned angles in simulation reflects its inherent accuracy as designed, before human variability in actual surgery is introduced.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the simulated surgery results (IM angle deviation) was the pre-surgical plan. The device's performance was measured by how closely it enabled the achievement of this predefined plan (e.g., final average IM angle of ±2º relative to plan, average deviation of 0.91º relative to plan).
- For the "fit and usability" verification, the ground truth was likely observational assessment and functional testing against engineering specifications and expected surgical workflow.
- For biocompatibility and sterilization, the ground truth was adherence to international standards (ISO 10993-1, AAMI/ISO 14927) and achieving specified performance targets (e.g., SAL of 10^-6^).
8. The sample size for the training set
- The device is a patient-specific surgical guide, designed from individual patient CT scans. It is not an AI algorithm in the sense of a machine learning model that requires a "training set" of patient data in the conventional way.
- The text describes a "validated design and manufacturing process with strict procedures for transfer and conversion of patient images from DICOM files to digital models (STL files), and in turn to patient specific bone resection guides." This process itself would have been developed and validated, but there isn't a "training set" of patient images in the typical AI sense for the device itself. The "training" would be more akin to software and manufacturing process validation.
9. How the ground truth for the training set was established
- As noted above, there isn't a "training set" in the conventional AI sense for this type of device. The ground truth for the design and manufacturing process validation (which ensures accurate translation from DICOM to guide) would involve:
- Metrological assessments: Comparing digital models (STL files) derived from DICOM data to known anatomical structures or highly accurate scans.
- Prototyping and testing: Manufacturing guides and verifying their fit and accuracy on physical models or cadaveric specimens, ensuring they align with the pre-surgical plans generated.
- Software validation: Ensuring the conversion software accurately transforms DICOM data into digital bone models and then into guide designs.
Ask a specific question about this device
(131 days)
The Redline Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Redline Aligner positions teeth by way of continuous gentle force.
The Redline Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20-22 hours a day for an average of 2 weeks per aligner or as directed by the clinician and are to be removed only for eating and for cleaning.
A digital or traditional mold impression of the patient's dentition is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data of the patient's dentition. 3Shape A/S Ortho System is used to develop treatment plan. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health profession's prescription.
The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.
Once approved, the 3Shape A/S Ortho System, is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Johns dental laboratories produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The trays are provided to the dental health care professional who provides them to the patients in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment of the first aligner is delivered to when the final aligner is finished and treatment is complete. The aligners are held in place by pressure and can be removed by the patient at any time.
The provided document is a 510(k) Premarket Notification from the FDA for the Redline Aligner. It primarily demonstrates substantial equivalence to a predicate device rather than presenting a standalone study showing device performance against specific acceptance criteria in the manner one might expect for an AI/ML medical device.
Therefore, it is not possible to fully answer all aspects of your request as the document does not contain information about a study that "proves the device meets the acceptance criteria" in the context of an AI/ML device. The document focuses on showing the Redline Aligner's equivalence to existing devices based on design, materials, and manufacturing processes, rather than on its performance in a clinical trial or a specific AI-driven task.
However, I can extract the information that is present and indicate what is missing:
Description of Acceptance Criteria and Device Performance (Based on provided document)
The document describes non-clinical testing for the Redline Aligner, focusing on manufacturing accuracy and material properties, rather than clinical performance data against specific outcomes.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Manufacturing Dimensional Accuracy: | Translational measurement: Within 0.150mm (150 microns) of the target input value. There were no statistical differences in measured values among groups, indicating results were within the predefined tolerance. |
| Final Aligner Fitness: | All aligners included in the study passed and were deemed an excellent fit. |
| Biocompatibility: | Redline Aligners were concluded to be biocompatible for their intended use. Material testing was performed according to ISO 10993-1. Additional cytotoxicity testing was performed on final manufactured aligners according to ISO 10993-5:2009. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a numerical value. The document mentions an "internal manufacturing validation" where "The final aligner fitness was evaluated according to the in-house fitness acceptance criteria," and "all the aligners including in the study passed." A specific number of aligners tested is not provided.
- Data Provenance: The testing was "internal manufacturing validation," implying it was conducted by Johns Dental Laboratories. The country of origin of this internal data is not specified, but the applicant (Johns Dental Laboratories) is based in Terre Haute, Indiana, United States. It is a retrospective evaluation of manufacturing output.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The "in-house fitness acceptance criteria" would likely be based on internal quality control standards established by qualified personnel, but the roles and qualifications are not detailed.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. The document only states that "all the aligners including in the study passed and were deemed an excellent fit," suggesting a straightforward pass/fail assessment against defined criteria rather than a multi-reader adjudication process typically associated with AI/ML ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with/without AI Assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The Redline Aligner is a physical medical device (orthodontic plastic bracket) and not an AI/ML algorithm that assists human readers.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, a standalone performance study for an algorithm was not done. The "3Shape A/S Ortho System" software is mentioned as being used "to develop treatment plan" and "to generate standard format 3D files," but this software's performance as a standalone AI/ML device is not evaluated here. The 510(k) is for the physical aligner.
7. The Type of Ground Truth Used:
- Ground Truth: For dimensional accuracy, the "target input value" from the digital treatment plan served as the reference. For aligner fitness, "in-house fitness acceptance criteria" were used as the standard. For biocompatibility, international standards (ISO 10993-1, ISO 10993-5:2009) were the ground truth for material safety.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. The Redline Aligner is a manufactured physical device, not an AI/ML algorithm that requires a training set. The 3Shape A/S Ortho System is external software, and its training set information is not provided nor relevant to the Redline Aligner's 510(k).
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for the physical device.
Ask a specific question about this device
(80 days)
The Red Wave Hair Removal Device is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
Red Wave Hair Removal, Model: ARH001, is a small prescription-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. It is a personal Light-Based Hair Removal System. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 285g, and the size is 152.9x101.5x94.8mm (HWD). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Based on the provided text, the document is specifically a 510(k) summary for the Red Wave Hair Removal device. It mostly focuses on demonstrating substantial equivalence to predicate devices rather than detailing a direct acceptance criteria study for its performance in hair removal. Therefore, much of the requested information regarding specific acceptance criteria, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, and detailed ground truth establishment for a performance study is not present. The document mainly describes safety and electrical performance testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria for hair removal efficacy/performance. Instead, it describes a substantial equivalence comparison to predicate devices, implying that its performance is comparable.
The "Test Summary" section (on page 9) does list safety and electrical tests. For these, the acceptance criteria are generally "compliance" with the mentioned IEC standards.
| Acceptance Criteria (for Safety/Electrical) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1: 2005+COR1:2006+COR2:2007+AMD1:2012 (Electrical safety) | The device "has been evaluated the safety and performance by lab bench testing" and implicitly "complies" as per the Conclusion section indicating substantial equivalence without new safety/effectiveness issues. |
| Compliance with IEC 60601-2-57: 2011 (Specific requirements for light sources for aesthetic and therapeutic use) | Implicitly "complies" as above. |
| Compliance with IEC 60601-1-2: 2014 (Electromagnetic compatibility) | Implicitly "complies" as above. |
| Compliance with FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices" (Software verification and validation) | Implicitly "complies" as above, stating "Software verification and validation test according to the requirements of the FDA guidance." |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Test reports for ISO 10993-5 and -10 provided, indicating compliance. |
2. Sample size used for the test set and the data provenance
For the safety and electrical tests, the sample size is not specified but typically involves a small number of devices (e.g., a few units) for bench testing. The data provenance is "lab bench testing" conducted by or for Shenzhen Accompany Technology Co., Ltd. (the manufacturer). This is a prospective test for the device, not retrospective human data.
For hair removal performance, no specific test set or sample size for a clinical study is described within this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided because no clinical study for device performance is detailed in this 510(k) summary. The document does mention the device is to be used "under the direction of a physician, after training by a healthcare professional."
4. Adjudication method for the test set
Not applicable, as no clinical study for device performance with expert adjudication 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 an IPL hair removal device, not an AI-powered diagnostic system that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone hardware device that performs physical light-based treatment. There is no AI algorithm component described for standalone performance evaluation in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety and electrical tests, the "ground truth" is adherence to the specified international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57) and FDA guidance for software. For biocompatibility, it's compliance with ISO 10993-5 and -10.
For hair removal performance, the document relies on the "permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime." However, it does not explicitly state that a clinical trial was conducted for this device to establish this outcome as part of the 510(k) submission, instead implying equivalence to predicates which likely supported this claim with clinical data.
8. The sample size for the training set
Not applicable, as this is a hardware device submission, not an AI/ML software submission with a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a hardware device submission, not an AI/ML software submission with a training set.
Ask a specific question about this device
Page 1 of 6