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510(k) Data Aggregation
(121 days)
The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural. This system provides high-quality ultrasound images in the following modes: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or appropriately trained healthcare professionals.
In addition to the aforementioned indications for use, when EUS transducer GF-UCT180 and BF-UC190F are connected, Aplio i800 Model TUS-AI800/E3 provides image information for diagnosis of the upper gastrointestinal tract and surrounding organs, airways, tracheobronchial tree and esophagus.
The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V9.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 33MHz.
This FDA 510(k) clearance letter details the substantial equivalence of the Aplio i900, Aplio i800, and Aplio i700 Software V9.0 Diagnostic Ultrasound System to its predicate device. The information provided specifically focuses on the validation of new and improved features, with particular attention to the 3rd Harmonic Imaging (3-HI), a new deep learning (DL) enabled filtering process.
Acceptance Criteria and Device Performance for 3rd Harmonic Imaging (3-HI)
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (3-HI) | Study Details to Support Performance |
|---|---|---|---|
| Clinical Improvement | Spatial Resolution: Demonstrate improvement relative to conventional 2nd harmonic imaging. Contrast Resolution: Demonstrate improvement relative to conventional 2nd harmonic imaging. Artifact Suppression: Demonstrate improvement relative to conventional 2nd harmonic imaging. | Scores for 3-HI were higher than the middle score of 3 (on a 5-point ordinal scale) for spatial resolution, contrast resolution, and artifact suppression, as rated by radiologists in a blinded observer study. | Test Set Size: 30 patients Data Provenance: U.S. clinical site, previously acquired data (retrospective). Ground Truth: Clinical images with representative abdominal organs, anatomical structures, and focal pathologies. Experts: Three (3) U.S. board-certified radiologists. Adjudication Method: Blinded observer study (comparison to images without 3-HI). MRMC Study: Yes, human readers (radiologists) compared images with and without 3-HI. The effect size is indicated by "scores for 3-HI were higher than the middle score of 3". |
| Phantom Study Objectives | Lateral Resolution: Demonstrate capability to visualize abdominal images better than conventional 2nd harmonic imaging. Axial Resolution: Demonstrate capability to visualize abdominal images better than conventional 2nd harmonic imaging. Slice Resolution: Demonstrate capability to visualize abdominal images better than conventional 2nd harmonic imaging. Contrast-to-Noise Ratio (CNR): Demonstrate capability to visualize abdominal images better than conventional 2nd harmonic imaging. Reverberation Artifact Suppression: Demonstrate capability to visualize abdominal images better than conventional 2nd harmonic imaging. Frequency Spectra: Demonstrate capability to visualize abdominal images better than conventional 2nd harmonic imaging. | All prespecified performance criteria were achieved. The phantom studies demonstrated the capability of 3-HI to visualize abdominal images better than conventional 2nd harmonic imaging across all specified metrics. | Test Set Size: Not explicitly stated for each metric but "five abdominal phantoms with various physical properties". Data Provenance: Phantom data. Ground Truth: Controlled phantom targets with varying depths, sizes, and contrasts. Experts: Not applicable (objective measurements). Adjudication Method: Not applicable (objective measurements compared to prespecified criteria). |
Detailed Study Information
1. Acceptance Criteria and Reported Device Performance
(See table above)
2. Sample Size Used for the Test Set and Data Provenance
- 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
- Sample Size: 30 patients.
- Data Provenance: Previously acquired data from a U.S. clinical site (retrospective). Patients were selected to ensure diverse demographic characteristics representative of the intended U.S. patient population, including a wide range of body mass indices (18.5-36.3 kg/m²), roughly equivalent numbers of males and females, and ages ranging from 23-89 years old.
- 3rd Harmonic Imaging (3-HI) Phantom Study:
- Sample Size: Five abdominal phantoms.
- Data Provenance: Phantom data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
- Number of Experts: Three (3).
- Qualifications: U.S. board-certified radiologists.
4. Adjudication Method for the Test Set
- 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
- Adjudication Method: Blinded observer study. The three radiologists compared images with 3-HI to images without 3-HI (predicate functionality) using a 5-point ordinal scale. The median score was then compared with the middle score of 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Yes, a MRMC-like comparative effectiveness study was done for 3-HI's clinical evaluation.
- Effect Size: The statistical analysis demonstrated that scores for 3-HI were higher than the middle score of 3 for spatial resolution, contrast resolution, and artifact suppression. This indicates that human readers (radiologists) rated images with 3-HI as improved compared to those without.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, a standalone study was performed for 3-HI in the phantom study. The phantom studies objectively examined lateral and axial resolution, slice resolution, contrast-to-noise ratio (CNR), reverberation artifact suppression, and frequency spectra without human interpretation.
7. The Type of Ground Truth Used
- 3rd Harmonic Imaging (3-HI) Clinical Evaluation:
- Type of Ground Truth: Expert consensus (from the three board-certified radiologists) on image quality metrics (spatial resolution, contrast resolution, artifact suppression) through a blinded comparison against predicate functionality. The initial selection of patient images included "representative focal pathologies" suggesting clinical relevance in the images themselves.
- 3rd Harmonic Imaging (3-HI) Phantom Study:
- Type of Ground Truth: Objective measurements against known physical properties and targets within the phantoms.
8. The Sample Size for the Training Set (for 3-HI)
- The document explicitly states that the "The validation data set [30 patients] was entirely independent of the data set used to train the algorithm during its development." However, the actual sample size for the training set is not provided in the given text.
9. How the Ground Truth for the Training Set Was Established (for 3-HI)
- This information is not provided in the given text, beyond the statement that the algorithm was "locked upon completion of development" and had "no post-market, continuous learning capability."
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(182 days)
The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. The headcap shall be placed on the head of infants, including newborns and preterm babies.
The Ceribell Instant EEG Headcap is a single-use, non-sterile, disposable EEG electrode device that includes a minimum of 9 EEG electrodes that are placed on the subject's scalp. The Headcap is intended to collect and provide EEG signals to an EEG recording or monitoring device.
The Ceribell Headcap includes the following components:
- An elastic fabric headcap
- An elastic fabric chin strap
- Nine (9) silver/silver chloride (Ag/AgCl) electrodes
- A cable attached to the headcap to allow connection to an EEG acquisition/recording device
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(267 days)
The BD Alaris™ Pump Infusion Set is indicated for pump use by experienced healthcare professionals within healthcare facilities through intravenous, intra arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults. Based on clinical discretion these sets can be used for temporary intravenous gravity infusion.
The subject BD Alaris™ Pump Infusion Set is a single-use infusion set incorporating a spiked drip chamber on the proximal end, which is inserted into a fluid container, and a male luer lock connector on the distal end which connects to a patient's access device. The spike cap and the male luer lock cap maintain sterility of the fluid path prior to use. The BD Alaris™ Pump Infusion Set is supplied fluid-path sterile using gamma irradiation and is non-pyrogenic. The subject BD Alaris™ Pump Infusion Set incorporates a pump segment designed to interface with the BD Alaris™ Pump Module for administration of fluids, medications, and parenteral nutrition through clinically acceptable routes of administration.
The BD Alaris™ Pump Infusion Set is available in six (6) configurations incorporating variations of the following components: roller clamp, pinch clamp, slide clamp, SmartSite™ Y-site(s), back check valve, and inline filter.
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(62 days)
The ellacor System with Micro-Coring Technology is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. It is further indicated for Fractional Skin Resurfacing.
The ellacor System with Micro-Coring Technology removes unwanted skin by rapidly excising full thickness micro-columns of the dermal and epidermal tissue via specially designed hollow coring needles. The needles are controlled to precise coring depths and positions by the device console and handpiece. The system provides a range of skin removal percentages (treatment densities) and needle depths settings to customize the user needs that is controlled by the LCD touch display on the console. The treatment is applied in 1cm² areas of the skin at a time by the handpiece, which has a vacuum assisted disposable in order to help with alignment between treatment areas. The ellacor System with Micro-Coring Technology mechanically removes full thickness sections of skin without evidence of scarring or need for surgical procedure. As much as 7.9% of the surface area of the skin is removed in columns that are the size of the inner diameter of the needle which is too small to cause visible scarring. The holes quickly close because of the natural elastin of the skin as they start to heal. This wound response, combined with the mechanical removal of the skin's surface area, leads to a reduction in the appearance of wrinkles.
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(91 days)
The UniSpace® TPLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The UniSpace® TPLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the UniSpace® TPLIF Cage is to be used with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.
The UniSpace® TPLIF Cage is a product for lumbar spinal column stability. The implants of the UniSpace® TPLIF Cage are made of ASTM F3001 titanium alloy (Ti6Al4V ELI) and manufactured using an additive manufacturing method (3D printing), specifically Direct Metal Laser Sintering (DMLS). The UniSpace® TPLIF Cage is available in various heights, widths, lengths, and lordotic angles, and features an open architecture designed to accommodate autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft. The cages are provided in a variety of sizes to accommodate individual patients' anatomical requirements. The implants of the UniSpace® TPLIF Cage are provided as a sterile pack. The UniSpace® TPLIF Cage is implanted by using instruments manufactured from stainless steel material (ASTM F899) and/or Ti6Al4V ELI (ASTM F136).
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(208 days)
Intended Use
Viewing, post-processing, qualitative and quantitative evaluation of blood vessels and cardiovascular CT images in DICOM format.
Indications for Use
cvi42 Coronary Plaque Software Application is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format.
It enables a set of tools to assist physicians in qualitative and quantitative assessment of cardiac CT images to determine the presence and extent of coronary plaques and stenoses, in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD.
cvi42 Coronary Plaque's semi-automated machine learning algorithms are intended for an adult population.
cvi42 Coronary Plaque shall be used only for cardiac images acquired from a CT scanner. It shall be used by qualified medical professionals, experienced in examining cardiovascular CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.
Circle's cvi42 Coronary Plaque Software Application ('cvi42 Coronary Plaque' or 'Coronary Plaque Module', for short) is a Software as a Medical Device (SaMD) that enables the analysis of CT Angiography scans of the coronary arteries of the heart. It is designed to support physicians in the visualization, evaluation, and analysis of coronary vessel plaques through manual or semi-automatic segmentation of vessel lumen and wall to determine the presence and extent of coronary plaques and luminal stenoses, in patients who underwent Coronary Computed Tomography Angiography (CCTA) for the evaluation of coronary artery disease (CAD) or suspected CAD. The device is intended to be used as an aid to the existing standard of care and does not replace existing software applications that physicians use. The Coronary Plaque Module can be integrated into an image viewing software intended for visualization of cardiac images, such as Circle's FDA-cleared cvi42 Software Application. The Coronary Plaque Module does not interface directly with any data collection equipment, and its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on-screen, can be sent to report or saved for future review.
The Coronary Plaque Module consists of multiplanar reconstruction (MPR) views, curved planar reformation (CPR) and straightened views, and 3D rendering of the original CT data. The Module displays three orthogonal MPR views that the user can freely adjust to any position and orientation. Lines and regions of interest (ROIs) can be manually drawn on these MPR images for quantitative measurements.
The Coronary Plaque Module implements an Artificial Intelligence/Machine Learning (AI/ML) algorithm to detect lumen and vessel wall structures. Further, the module implements post-processing methods to convert coronary artery lumen and vessel wall structures to editable surfaces and detect the presence and type of coronary plaque in the region between the lumen and vessel wall. All surfaces generated by the system are editable and users are advised to verify and correct any errors.
The device allows users to perform the measurements listed in Table 1.
Here's a summary of the acceptance criteria and study details based on the provided FDA 510(k) Clearance Letter for the cvi42 Coronary Plaque Software Application:
1. Table of Acceptance Criteria and Reported Device Performance
| Endpoint | Acceptance Criteria (Implied) | Reported Device Performance | Pass / Fail |
|---|---|---|---|
| Lumen Mean Dice Similarity Coefficient (DSC) | Not explicitly stated but inferred as >= 0.76 with positive result | 0.76 | Pass |
| Wall Mean Dice Similarity Coefficient (DSC) | Not explicitly stated but inferred as >= 0.80 with positive result | 0.80 | Pass |
| Lumen Mean Hausdorff Distance (HD) | Not explicitly stated but inferred as <= 0.77 mm with positive result | 0.77 mm | Pass |
| Wall Mean Hausdorff Distance (HD) | Not explicitly stated but inferred as <= 0.87 mm with positive result | 0.87 mm | Pass |
| Total Plaque (TP) Pearson Correlation Coefficient (PCC) | Not explicitly stated but inferred as >= 0.97 with positive result | 0.97 | Pass |
| Calcified Plaque (CP) Pearson Correlation Coefficient (PCC) | Not explicitly stated but inferred as >= 0.99 with positive result | 0.99 | Pass |
| Non-Calcified Plaque (NCP) Pearson Correlation Coefficient (PCC) | Not explicitly stated but inferred as >= 0.93 with positive result | 0.93 | Pass |
| Low-Attenuation Plaque (LAP) Pearson Correlation Coefficient (PCC) | Not explicitly stated but inferred as >= 0.74 with positive result | 0.74 | Pass |
Note: The acceptance criteria for each endpoint are not explicitly numerical in the provided text. They are inferred to be "met Circle's pre-defined acceptance criteria" and are presented here as the numeric value reported, implying that the reported value met or exceeded the internal acceptance threshold for a 'Pass'.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "All data used for validation were not used during the development of the ML algorithms" and "Image information for all samples was anonymized and limited to ePHI-free DICOM headers." However, the specific number of cases or images in the test set is not provided.
- Data Provenance: Sourced from multiple sites, with 100% of the data sampled from US sources. The data consisted of images acquired from major vendors of CT imaging devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Three expert annotators were used.
- Qualifications of Experts: Not explicitly stated beyond "expert annotators." The document implies they are experts in coronary vessel and lumen wall segmentation within cardiac CT images.
4. Adjudication Method for the Test Set
The ground truth was established "from three expert annotators." While it doesn't explicitly state "2+1" or "3+1", the use of three annotators suggests a consensus-based adjudication, likely majority vote (e.g., if two out of three agreed, that constituted the ground truth, or a more complex consensus process). The specific method is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document states, "No clinical studies were necessary to support substantial equivalence." The evaluation was primarily based on the performance of the ML algorithms against a reference standard established by experts, not on how human readers improved their performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes. The performance evaluation focused on the "performance of the ML-based coronary vessel and lumen wall segmentation algorithm... evaluated against pre-defined acceptance criteria and compared to a reference standard established from three expert annotators." This indicates a standalone performance assessment of the algorithm's output. The device is also described as having "semi-automated machine learning algorithms", implying the user can verify and correct.
7. The Type of Ground Truth Used
Expert Consensus. The ground truth was established "from three expert annotators," indicating that human experts' annotations formed the reference standard against which the algorithm's performance was measured.
8. The Sample Size for the Training Set
Not explicitly stated. The document mentions the ML algorithms "have been trained and tested on images acquired from major vendors of CT imaging devices," but it does not provide the specific sample size for the training set. It only clarifies that the validation data was not used for training.
9. How the Ground Truth for the Training Set Was Established
Not explicitly stated. The document describes how the ground truth for the validation/test set was established (three expert annotators). It does not provide details on how the ground truth for the training set was generated.
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(99 days)
CoroFlow is indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases.
CoroFlow is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display various physiological parameters based on the output from one or more measuring devices.
CoroFlow Cardiovascular system is used to calculate, display and store physiological parameters based on pressure and temperature measurements from Abbott Medical's PressureWire and Wi-box.
Calculated parameters include physiological indices to assess coronary lesion severity (FFR, Pd/Pa, RFR) and indices to assess coronary micro-circulation (IMR, CFR).
The system also provides indices based on the same raw pressure and temperature measurements (IMR_Corr, RRR, Absolute Flow/ Resistance, dP/dt, Tau).
CoroFlow is installed on a personal computer and receives measurement data wirelessly via the CoroHub Receiver. Information is displayed on the computer screen which can optionally be slaved to a monitor inside the coronary cathlab. Data can be stored on a local storage unit or transferred to a network location.
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(89 days)
Hair Growth Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.
Hair Growth Laser Cap is a dome-shaped low level laser therapy (LLLT) device is designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of laser diodes at 650nm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included battery pack.
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(127 days)
The Introducer Sheath set is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
The Introducer Sheath Set consists of a sheath and a dilator. The sheath is comprised of a sheath tube, a sheath hub, and a hemostatic valve. While the dilator comprises a dilator hub, a dilator tube and a rod cap. The sheath features a hydrophilic coating. Each set of products is equipped with a sheath and a dilator. The product is sterilized with ethylene oxide and is disposable.
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(267 days)
Estremo Fibular Nail is intended for use in the fixation of fibula fractures and osteotomies.
Estremo Fibular Nail includes all implants and instruments required for the fixation of fibula fractures and osteotomies. Estremo Fibular Nail includes the nails, screws, end caps and related instruments. Estremo Fibular Nail differs from traditional nails or rods as it utilizes a "Diapason wings deployment" mechanism at the proximal end of the rod to allow for proximal fixation with a screw. The implants are composed of 316L stainless steel per ASTM F138 and are provided sterile.
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