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510(k) Data Aggregation
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The Hand Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health.
The Hand Massager is indicated for temporary relief of minor muscle aches and pains and for a temporary increase in circulation to the treated areas in generally healthy adults.
This hand massager is intended for use by healthy adults to temporarily relieve minor muscle aches and pains in the hand and wrist and to temporarily increase local circulation. It is particularly suitable for relaxing hand muscles after repetitive activities.
Charge this product using the supplied USB cable and a 5 V USB power adapter (1 A or 2 A). Do not use rapid/fast charging or a power adapter that outputs more than 6 V. The power indicator flashes during charging and turns off when fully charged. This product cannot be turned on or operated while it is being charged.
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(163 days)
The HIGHERDOSE BODY SCULPTOR (Model: GS-03) is an over-the-counter device that is intended to improve the appearance of wrinkles.
The HIGHERDOSE Body Sculptor (Model: GS-03) is a home-use light-emitting diode phototherapy device with two proven wavelengths of light 650nm Red light and 850nm Near infrared red light, both of these lights are known to reducing the wrinkle.
The main device is made of black plastic (ABS+PC) and silicone button cup, and contain light emitting diode (LED) which will emit red light and infrared light. The device is a handheld device.
The device contains a rechargeable Lithium battery, which can be charged by charging disk. The HIGHERDOSE Body Sculptor cannot be operated while charging.
Press and hold the power button to turn the product on/off. Press the power button briefly to turn the LED light therapy on/off.
The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.
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(66 days)
Holmium Laser Therapeutic Apparatus are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and stone fragmentation in use in medical specialties including: Urology, Gastroenterology, ENT, Gynecology and general surgery.
The HZ-40 Holmium Laser Therapeutic Apparatus is a family of pulsed solid-state Holmium:YAG laser systems that deliver energy at a wavelength of 2100 nm through optical fibers for soft tissue surgery and stone fragmentation. The system utilizes a flashlamp-pumped Ho:YAG laser medium, and the laser energy is transmitted to the target site via SMA905-compatible optical fibers. The system includes a touchscreen interface, single-pedal footswitch, integrated liquid cooling, and multiple built-in safety features such as an emergency stop, door interlock, and real-time monitoring of laser output.
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(59 days)
The HydroMARK™ Plus Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least six (6) weeks, and be permanently visible by x-ray and MRI.
The HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly and Hummingbird shapes) is a two-component marker that provides permanent marking of a breast biopsy or axillary lymph node biopsy site following a breast biopsy procedure. The implantable marker is made of a highly expandable solid cylinder of polymerized and desiccated hydrogel that has the permanent titanium marker embedded. Upon fluid contact (e.g., water, blood, etc.), the hydrogel material expands to an equilibrium point. Once the material hydrates, it is visible under ultrasound. Over time, the hydrogel is resorbed by the patient's body. The titanium wire is permanently visible under x-ray and MRI even after the hydrogel is resorbed.
The HydroMARK™ Plus Breast Biopsy Site Marker is a permanent implant and is not intended to be removed unless the marked tissue requires surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is designed to fit into specified commercially available breast biopsy devices. During a breast biopsy procedure, the marker is deployed through a compatible introducer into the biopsy cavity created by the breast biopsy device.
The focus of this submission is a modification to the applicator of the marker, which has been modified to enhance compatibility of use in the MR Environment. The markers themselves remain unchanged from the predicate device.
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(126 days)
Halcyon and Ethos radiotherapy system are indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.
Halcyon and Ethos radiotherapy system with the HyperSight imaging feature produce kV CBCT anatomical images that can be used in the simulation and planning of radiation therapy.
Halcyon and Ethos Radiotherapy System are single energy medical linear accelerators (linacs) designed to deliver Image Guided Radiation Therapy and radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. They consist of the accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room.
An electron gun generates electrons which are accelerated by radio frequency (RF) power from a magnetron. The electrons strike a tungsten target producing photons (X-rays) for treatment and MV Imaging. The photons produced by the target are monitored and controlled by a pressurized ion chamber.
A beam collimation subsystem consisting of a primary and secondary collimator and two stacked multileaf collimators (MLCs) shapes the photon beam to define the treatment area.
X-Ray images of the patient are used by the treater to verify the correct treatment location. MV Imaging uses the treatment beam and a flat panel imager whereas kV imaging uses a high-capacity kV X-ray tube, a kV collimation system with full fan bowtie filter with movable y-blades to define the imaging beam size and to capture the image, a kV imager.
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(252 days)
High-speed air turbine handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
High-speed Turbine Air Handpiece is an instrument for drilling, grinding, repairing utilized in dental clinics. It composed of a head, a handle and a connector.
The subject device is intended to be used for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). The user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).
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(30 days)
HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.
SCT Screen and SCT Confirm are reagents intended to simplify and standardize the detection of LA in clinical evaluations. SCT Screen is poor in phospholipid making it sensitive to LA. The additional amount of phospholipid in SCT Confirm neutralizes LA to give shorter clotting times.
Silica Clotting Time in the presence of calcium, directly activates the intrinsic pathway of coagulation. SCT Screen and SCT Confirm are therefore unaffected by factor VII deficiencies or inhibitors. Using a ratio of screen and confirm allows the SCT to be insensitive to warfarin treated samples. As a result, SCT Screen and SCT Confirm are more specific tests for the evaluation of LA than APTT or dilute PT. Per CLSI Guideline H-60, patient samples containing heparin may exhibit falsely prolonged clotting times which could lead to incorrect results.
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(189 days)
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System and probes are designed to obtain ultrasound images and analyze body fluids.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac), Peripheral vessel and Ophthalmic.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, M mode, Color Doppler mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, MV-Flow Mode, Multi Image mode(Dual, Quad), Combined modes, 3D/4D mode.
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System are a general purpose, mobile, software controlled, diagnostic ultrasound system. Their function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, MV-Flow mode, Multi-Image mode(Dual, Quad), 3D/4D mode.
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System also give the operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a diagnosis by competent health care professionals. HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Here's a breakdown of the acceptance criteria and the study details for each AI-ML based software feature described in the FDA 510(k) summary:
Overview of Acceptance Criteria and Device Performance (AI-ML Features)
The provided document details the testing and performance for several new and updated AI-ML based software features. The information given for each feature constitutes the acceptance criteria and the device's reported performance against those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| AI/ML Feature | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| AbdomenAssist - Kidney Length Measurement | Success Rate: Within a pre-specified clinical error margin compared to reference standard. | 100% [94.17%, 100.00%] (Success Rate) |
| Bland-Altman mean difference (Bias) / 95% Limits of Agreement (LoA). | 1.5% (Bias); [-4.53%, 7.64%] (95% LoA) | |
| AbdomenAssist - Spleen Length Measurement | Success Rate: Within a pre-specified clinical error margin compared to reference standard. | 96.77% [88.98%, 99.11%] (Success Rate) |
| Bland-Altman mean difference (Bias) / 95% Limits of Agreement (LoA). | 2.8% (Bias); [-7.02%, 12.61%] (95% LoA) | |
| BladderAssist - Bladder Width Measurement (First Instance) | Success Rate: Within a pre-specified clinical error margin compared to reference standard. | 95.24% [86.91%, 98.37%] (Success Rate) |
| Bland-Altman mean difference (Bias) / 95% Limits of Agreement (LoA). | -4.81% (Bias); [-12.94%, 3.31%] (95% LoA) | |
| BladderAssist - Bladder Width Measurement (Second Instance) | Success Rate: Within a pre-specified clinical error margin compared to reference standard. | 96.83% [89.14%, 99.13%] (Success Rate) |
| Bland-Altman mean difference (Bias) / 95% Limits of Agreement (LoA). | -3.2% (Bias); [-11.86%, 5.47%] (95% LoA) | |
| QualityCheck - View Classification (Manual Images) | Sensitivity: > 0.80 (implied, by meeting 0.85-1.00 range) | Ranged from 0.85 to 1.00 |
| Specificity: > 0.80 (implied, by meeting 0.85-1.00 range) | Ranged from 0.85 to 1.00 | |
| Positive Predictive Value (PPV): > 0.80 (implied, by meeting 0.80-1.00 range) | Ranged from 0.80 to 1.00 | |
| Negative Predictive Value (NPV): > 0.90 (implied, by meeting 0.90-1.00 range) | Ranged from 0.90 to 1.00 | |
| QualityCheck - Structure Detection (Manual Images) | Sensitivity: > 0.80 (implied, by meeting 0.81-1.00 range) | Ranged from 0.81 to 1.00 |
| Specificity: > 0.99 (implied, by meeting 0.99-1.00 range) | Ranged from 0.99 to 1.00 | |
| Positive Predictive Value (PPV): > 0.89 (implied, by meeting 0.89-1.00 range) | Ranged from 0.89 to 1.00 | |
| Negative Predictive Value (NPV): > 0.99 (implied, by meeting 0.99-1.00 range) | Ranged from 0.99 to 1.00 | |
| QualityCheck - View Classification (LVA Images) | Sensitivity: > 0.80 (implied, by meeting 0.86-1.00 range) | Ranged from 0.86 to 1.00 |
| Specificity: > 0.80 (implied, by meeting 0.85-1.00 range) | Ranged from 0.85 to 1.00 | |
| Positive Predictive Value (PPV): > 0.80 (implied, by meeting 0.80-1.00 range) | Ranged from 0.80 to 1.00 | |
| Negative Predictive Value (NPV): > 0.91 (implied, by meeting 0.91-1.00 range) | Ranged from 0.91 to 1.00 | |
| QualityCheck - Structure Detection (LVA Images) | Sensitivity: > 0.80 (implied, by meeting 0.82-1.00 range) | Ranged from 0.82 to 1.00 |
| Specificity: = 1.00 (implied, by meeting 1.00-1.00 range) | Ranged from 1.00 to 1.00 | |
| Positive Predictive Value (PPV): > 0.89 (implied, by meeting 0.89-1.00 range) | Ranged from 0.89 to 1.00 | |
| Negative Predictive Value (NPV): > 0.99 (implied, by meeting 0.99-1.00 range) | Ranged from 0.99 to 1.00 | |
| PelvicAssist - Volume Alignment | Acceptance rate | 96.67% |
| PelvicAssist - LH Measurement (ICC) | Intraclass Correlation Coefficient (ICC) for six measurements. | LH Area (0.9802), LH Circ. (0.9837), LH AP (0.9910), LH Lat. (0.9536), Right LUG (0.9423), Left LUG (0.9596) |
| PelvicAssist - LH Measurement (Bland-Altman) | Mean difference near zero; majority of data points within 95% LoA. | Mean difference near zero (up to 1.1cm² and 0.53cm); 95.8% of data points fell within 95% LoA. |
| EzVolume - Measurement Test | Bias (Mean Difference) for each label: Does not exceed ±2%. | Did not exceed ±2% |
| 95% confidence interval for mean error includes zero. | Included zero | |
| 95% Limits of Agreement (LoA) for all labels: fell within ±15%. | Fell within ±15% | |
| UterineAssist - Segmentation (Sagittal) | Average Dice-score of uterus. | 96.7% |
| UterineAssist - Segmentation (Transverse) | Average Dice-score of uterus. | 95.8% |
| UterineAssist - Segmentation (Endometrium) | Average Dice-score of endometrium. | 86.8% |
| UterineAssist - Feature Points Extraction (Uterus) | Average error range of uterus feature points. | 1.5 – 2.6 mm |
| UterineAssist - Feature Points Extraction (Endometrium) | Average error range of endometrium feature points. | 0.9 - 1.7 mm |
| UterineAssist - Size Measurement (Uterus) | Average error range of Measurements. | 0.87 – 1.79 mm |
| Widest 95% LoA range for uterus measurements; Largest Mean difference. | [-2.96, 4.04] (widest 95% LoA); 1.23 mm (largest Mean difference) | |
| UterineAssist - Size Measurement (Endometrium) | 95% LoA range for endometrium measurements; Mean difference. | [-1.59, 2.09] (95% LoA); 0.25 mm (mean difference) |
| NerveTrack - Detection | Localization accuracy success rate (95% CI); Processing speed. | 92.19% (95% CI: [90.03%, 94.34%]) (Success Rate); ~3.98 FPS |
2. Sample Sizes and Data Provenance
| AI/ML Feature | Sample Size (Test Set) | Data Provenance |
|---|---|---|
| AbdomenAssist | 62 individual patients; 124 ultrasound images (62 kidney, 62 spleen) | United States and Germany; Mix of retrospective and prospective |
| BladderAssist | 63 individual patients; 63 ultrasound bladder transverse images | United States and Germany; Mix of retrospective and prospective |
| QualityCheck | 283 individual patients; 43,737 static 2D B-mode images (25,786 manual, 17,951 Live ViewAssist) | United States; Mix of retrospective and prospective |
| PelvicAssist | 40 individual patients; 120 volumes (40 rest, 40 contraction, 40 Valsalva) | United States and Italy; Mix of retrospective and prospective |
| EzVolume | 200 individual patients/3D volumes (100 1st trimester, 100 2nd/3rd trimesters) | South Korea and United States; Mix of retrospective and prospective |
| UterineAssist | 60 individual patients; 120 static images (60 sagittal, 60 transverse) | South Korea and United States; Mix of retrospective and prospective |
| NerveTrack | 46 individual patients; At least two nerve views per patient, with 2D sequences of at least 10 images. At least 24 and up to 42 ultrasound images for each of the 10 nerves. | South Korea and United States; Mix of retrospective and prospective |
3. Number and Qualifications of Experts for Ground Truth (Test Set)
| AI/ML Feature | Number of Experts | Qualifications of Experts |
|---|---|---|
| AbdomenAssist | 3 | Two sonographers (one with >20 years exp., one with >10 years exp.); One senior expert radiologist (>20 years exp.) |
| BladderAssist | 3 | Two sonographers (one with >20 years exp., one with >10 years exp.); One senior expert radiologist (>20 years exp.) |
| QualityCheck | 3 | Two sonographers (each with >20 years exp.); One Obstetrician-Gynecologist (>10 years exp.) |
| PelvicAssist | 3 | Three clinical experts (each with >20 years exp.) |
| EzVolume | 3 | Three clinical experts (each with >10 years exp.) |
| UterineAssist | (At least) 2 | One sonographer (>10 years exp.) for view classification; Two sonographers (>10 years exp.) for manual drawing of anatomy areas/ground truth for validation images. |
| NerveTrack | 3 | Two clinical experts (extensive experience in musculoskeletal ultrasound); One senior clinical expert (extensive experience in the field) |
4. Adjudication Method for the Test Set
| AI/ML Feature | Adjudication Method |
|---|---|
| AbdomenAssist | 2+1 (2 independent measurements, 1 senior expert adjudication). The third senior expert reviewed and adjudicated the two measurements to determine the final value. |
| BladderAssist | 2+1 (2 independent measurements, 1 senior expert adjudication). The third senior expert reviewed and adjudicated the two measurements to determine the final value. |
| QualityCheck | The expert panel for the validation ground truth consisted of two sonographers, who performed the annotation, and an Obstetrician-Gynecologist, who provided the review and final confirmation. (Implies a 2+1 model, where the third expert reviews and confirms). |
| PelvicAssist | GTs were permuted and sent to the experts for peer review. Rejected data were re-labeled by the initial assigned expert, and the process is repeated. (This suggests an iterative consensus approach rather than a strict 2+1 or 3+1 structure initially, but aims for consensus among the 3 experts.) |
| EzVolume | Consensus process of 3 experts. Initial annotation by one expert, then reviewed independently and blindly by the other two. If both accept, it's final. If any propose modifications, all three convene for unanimous agreement. |
| UterineAssist | For images, two sonographers manually drew anatomy areas. (Implies agreement or an internal process, but not explicitly stated as 2+1 or 3+1. Ground truth was "made by sonographer" and then "manually drawn for each of the image by two sonographers" - implies dual annotation to establish GT.) |
| NerveTrack | 2+1 (2 independent manual segmentations, 1 senior clinical expert adjudication). The senior expert resolved any discrepancies to establish the definitive ground truth. |
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance for any of the features described. The studies focused on the standalone performance of the AI algorithms.
6. Standalone (Algorithm Only) Performance
Yes, standalone (algorithm only without human-in-the-loop performance) was done for all the AI/ML features described.
- AbdomenAssist: Evaluated success rate and Bland-Altman agreement of the algorithm's measurements.
- BladderAssist: Evaluated success rate and Bland-Altman agreement of the algorithm's measurements.
- QualityCheck: Evaluated sensitivity, specificity, PPV, and NPV of the algorithm's view classification and structure detection.
- PelvicAssist: Evaluated acceptance rate for volume alignment and ICC/Bland-Altman for LH measurement of the algorithm.
- EzVolume: Evaluated error rate, bias, and LoA for the algorithm's measurements based on its segmentation results.
- UterineAssist: Evaluated Dice-score for segmentation, average error range for feature point extraction, and error range/Bland-Altman for size measurements of the algorithm.
- NerveTrack: Evaluated localization accuracy success rate and processing speed of the algorithm's detection.
7. Type of Ground Truth Used
| AI/ML Feature | Type of Ground Truth |
|---|---|
| AbdomenAssist | Expert consensus / manual measurement by clinical experts |
| BladderAssist | Expert consensus / manual measurement by clinical experts |
| QualityCheck | Expert consensus / classifications and annotations by clinical experts |
| PelvicAssist | Expert consensus / annotations by clinical experts |
| EzVolume | Expert consensus / 3D segmentation annotation by clinical experts |
| UterineAssist | Expert consensus / manual segmentation and feature point annotation by sonographers |
| NerveTrack | Expert consensus / manual segmentation (ROI drawing) by clinical experts |
8. Sample Size for the Training Set
The document explicitly states for each feature that "Data used for test and training/tuning purpose are completely separated from the ones during training process and there is no overlap between the two." or "Data used for training, tuning and validation purpose are completely separated from the ones during training process and there is no overlap between the three."
However, the specific sample sizes for the training sets are not provided in this FDA 510(k) summary document.
9. How the Ground Truth for the Training Set was Established
Similar to the training set size, the document does not explicitly describe how the ground truth for the training set was established. It only details the process for establishing the ground truth for the test/validation sets. The inference is that a similar expert-driven annotation process would have been used for training data, but the specifics are absent from this document.
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