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UpDoc is a software as a medical device (SaMD) intended to provide medication management for patients aged 18 years and older who have been diagnosed with type 2 diabetes.

UpDoc provides patients with insulin treatment plan instructions based on a healthcare provider (HCP)-specified treatment plan.

UpDoc contains two user-interactive software components:

• Patient User Interface (UpDoc mobile application): Intended for use by patients with type 2 diabetes as an aid in optimizing insulin management. Patients use the mobile application to log blood glucose, meal, symptom, and medication adherence data, and receive treatment plan instructions. Data may be entered manually or reported via voice or text-based interactions. The application may also receive blood glucose data via a Bluetooth-enabled glucometer or continuous glucose monitor.

• HCP User Interface (UpDoc web portal): Intended for use by trained healthcare providers to configure and manage the patient-specific insulin treatment plan. This includes insulin dosing instructions (type, starting and maximum doses, adjustment algorithm, and blood glucose targets) and safety protocols to address non-emergency hypoglycemia, hyperglycemia, and related symptoms.

Insulin instructions are computed in UpDoc's cloud-based application based on the HCP-defined treatment parameters.

UpDoc is a software as a medical device (SaMD) designed to assist patients aged 18 years and older with insulin management for type 2 diabetes. Healthcare providers (HCPs) set an individualized treatment plan for their patients that includes monitoring and insulin titration instructions. UpDoc engages with patients to help them follow their designated treatment plan and supports HCPs in monitoring reported health data, medication adherence, and treatment progress.

UpDoc is composed of three modular software components: a provider-facing web portal (UpDoc Provider Portal), a patient mobile application (UpDoc Patient App), and a cloud-based application consisting of a Conversation Service (UpDoc Agent) and a Clinical Service. These components work together to support safe and effective provider-directed insulin therapy.

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Chiavaye personal moisturizer is a lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Chiavaye personal moisturizer is not compatible with natural rubber latex, polyurethane, or polyisoprene condoms.

Chiavaye Personal Moisturizer is a clear to slightly yellow and odorless oil-based personal lubricant that is not compatible with condoms made of natural rubber latex, polyisoprene, or polyurethane. This device is a non-sterile personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This device is sold as an over-the-counter (OTC) product in 30 mL and 100 mL sizes provided in black 'MIRON' glass, with a Polypropylene (PP) protective cap. The pump cap is made of Polypropylene (actuator), Nitrile (seal), and Polyethylene (tube).

The device is composed of Almond Oil, Coconut Oil, Grape Seed Oil, Sunflower Oil, Evening Primrose Oil, and Vitamin E.

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The PVAD IQ software is intended for non-invasive analysis of ultrasound images to detect and measure structures from cardiac ultrasound of patients 18 years old and above, with a Percutaneous Ventricular Assist Device (PVAD). Such use is typically utilized for clinical decision support by a qualified physician.

PVAD IQ is a Software as a Medical Device (SaMD) solution designed to support clinicians in the positioning of Percutaneous Ventricular Assist devices (PVADs) through ultrasound image-based assessment. Percutaneous Ventricular Assist device is a temporary device used to provide hemodynamic support for patients experiencing cardiogenic shock or undergoing high-risk percutaneous coronary interventions (PCI).

The PVAD IQ software is a machine learning model (MLM) based software, that operates on ultrasound clips (as the system input) and provides two outputs with regards to PVAD patients:

1. Landmark identification and measurement - provides the two landmarks position detection, and computation of the mean distance between the two landmarks- the aortic annulus and the PVAD inlet.

2. Acceptability classification, which is a binary classification of ultrasound clips that are "acceptable" or "non-acceptable", in terms of visibility of the two landmarks. A clip is defined as acceptable when both landmarks are simultaneously visible in a manner suitable for quantitative imaging.

The User Interface (UI) enables the user to review or hide the mean distance measurement, annotate desired images, and add manual measurement, while keeping the raw data for further review as needed.

The software output is shown on the screen either as the mean distance measurement, or as a notification related to non-acceptable clips.

The PVAD IQ Software, a machine learning model (MLM) based software, provides two primary outputs for patients with Percutaneous Ventricular Assist Devices (PVADs): landmark identification and measurement (specifically, the distance between the aortic annulus and the PVAD inlet) and acceptability classification of ultrasound clips.

1. Acceptance Criteria and Reported Device Performance

The study established pre-specified acceptance criteria for the PVAD IQ software's performance, which it met.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 963 clips
• Number of Patients: 186 patients
• Data Provenance: Geographically distinct test datasets. While specific countries are not mentioned, the ground truth annotations were provided by US (United States) board certified cardiac sonographers. The timing (retrospective or prospective) is not specified, but the data was used for evaluating a previously trained model, which often implies a retrospective application to a held-out test set.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

• Number of Experts: Not explicitly stated as a specific number of individual experts. The document refers to "US (United States) board certified cardiac sonographers."
• Qualifications of Experts: "US (United States) board certified cardiac sonographers experienced in PVAD/Impella® echocardiographic imaging."

4. Adjudication Method for Test Set

The adjudication method is not explicitly stated in the provided document. It only mentions that ground truth annotations were "provided by US (United States) board certified cardiac sonographers." It does not specify if multiple sonographers reviewed each case, how disagreements were resolved, or if a consensus mechanism (like 2+1 or 3+1) was used.

5. MRMC Comparative Effectiveness Study

An MRMC (Multi-Reader Multi-Case) comparative effectiveness study comparing AI assistance with unassisted human readers was not mentioned in the provided document. The study focused on the standalone performance of the PVAD IQ software.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted. The reported performance metrics (MAE, Cohen's Kappa, AUC) directly assess the algorithm's performance against the established ground truth.

7. Type of Ground Truth Used

The ground truth used was expert consensus/annotations. Specifically, "Ground truth annotations for the distance between the aortic annulus and the PVAD inlet were provided by US (United States) board certified cardiac sonographers experienced in PVAD/Impella® echocardiographic imaging." This implies human experts manually defining the "correct" measurements and classifications.

8. Sample Size for the Training Set

The sample size for the training set is not provided in this document. The document states that the PVAD IQ software is "trained with clinical data" but does not specify the volume or characteristics of this training data.

9. How Ground Truth for Training Set Was Established

The method for establishing ground truth for the training set is not explicitly detailed in this document. It broadly states that the software uses "non-adaptive machine learning algorithms trained with clinical data" and "refining annotations" is part of model retraining (under PCCP). While it can be inferred that ground truth for training data would also involve expert annotations, similar to the test set, the specific process, number of experts, or their qualifications for the training data are not provided.

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The UltraSight Guidance is intended to assist medical professionals (not including expert sonographers) in acquiring cardiac ultrasound images. UltraSight Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems. UltraSight Guidance is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).

UltraSight Guidance is a software application based on machine learning that uses artificial intelligence to provide dynamic real-time guidance on the position and/or orientation of the transducer to help non-expert users acquire diagnostic quality tomographic views of the heart. The system provides guidance for ten standard cardiac views.

Main features:
• Quality Bar: The system displays an image quality bar that is continuously updated while the user scans the subject, while attempting to find the maximal quality. The quality bar is a score for image diagnosability. It represents the classification between high and low quality images, where high quality images are defined as grade 3 or more based on American College of Emergency Physicians (ACEP) guidelines (Rachel B. Liu et al., "Emergency Ultrasound Standard Reporting Guidelines", 2018, American College of Emergency Physicians)
• Probe Guidance: The probe guidance feature provides graphic on-screen instructions for the user to emulate how a sonographer would manipulate the transducer to acquire the target cardiac view. The five possible guidance cues are rotation, tilt, rock, and slides in the lateral-medial and up/down directions (with respect to the subjects' head).

The guidance user interface (UI) is composed of a 3D probe display that shows orientation guidance cues (rotations, tilts and rocks) and a cross that shows slide guidance cues (slides in x and y directions). The users infer the maneuver they should perform from viewing the 3D probe display and the slides cross. Supporting text messages appear on the screen regarding guidance cues.

This device is a modification of a previously marketed device, where the main modification introduced is the addition of a pre-processing step done prior to feeding images as an input to the device. This modification is aimed to enable future compatibility with potentially additional ultrasound probes that meet pre-requisites as part of a pre-determined change control plan.

Here's a breakdown of the acceptance criteria and study details for the UltraSight Guidance device, based on the provided FDA 510(k) clearance letter:

UltraSight Guidance: Acceptance Criteria and Study Details

The UltraSight Guidance device focuses on two main features: the "Quality Bar" and "Probe Guidance." The performance testing for each is described below.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Quality Bar: 134 patients, comprising 26,362 ultrasound clips.
  • Probe Guidance: 134 patients, comprising 2.4 million ultrasound frames.
• Data Provenance: The test dataset was collected from clinical sites geographically distinct from those used for the development dataset.
  • Countries of Origin: 111 patients from the US and 23 patients from Israel.
  • Retrospective/Prospective: Not explicitly stated as retrospective or prospective, but the description of "collected from clinical sites" and "comprising [number] ultrasound clips/frames" suggests it was likely retrospective collection of existing data or data collected for the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Quality Bar: Two expert cardiologists initially annotated the clips for diagnosability.
• Probe Guidance: Ground truth was established by expert sonographers and/or cardiologists.
• Qualifications of Experts: The document explicitly states "expert cardiologists" and "expert sonographers and/or cardiologists," implying recognized professionals in their respective fields, but does not provide specific details on years of experience or board certifications.

4. Adjudication Method for the Test Set

• Quality Bar: 2+1 Adjudication. Initially, two expert cardiologists provided annotations. In case of disagreement, a third cardiologist provided additional annotation, and the final label was determined by majority vote among the three experts. (p. 9-10)
• Probe Guidance: Not explicitly detailed. The statement "Ground truth was established by expert sonographers and/or cardiologists" (p. 13) does not specify an adjudication method for potential disagreements among multiple experts, or if a single expert reviewed each case.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No MRMC comparative effectiveness study was specifically described for the initial clearance in the provided text. The testing focuses on the standalone performance of the algorithm (AI model) for the Quality Bar and Probe Guidance features.
• It does mention a "Clinical utility test" as a potential future testing method as part of the PCCP for "Expanded list of cardiac views": "Clinical utility test will evaluate the ability of non-expert users to obtain diagnostic-quality cardiac images using UltraSight software for the newly added cardiac views." (p. 12). This might involve comparing performance with and without the device, but it is for future modifications, not the current clearance, and details are scarce.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Yes, standalone performance (algorithm only) was done for both the Quality Bar and Probe Guidance features. The studies describe the classification performance of the algorithm against expert-established ground truth without human users interacting with the device for the testing itself. For example, for the Quality Bar, the device's classification of "diagnosable/non-diagnosable" was compared to expert labels. For Probe Guidance, the algorithm's prediction of guidance cues was compared to expert-defined optimal probe positions.

7. The Type of Ground Truth Used

• Quality Bar: Expert Consensus (diagnosability label). The ground truth ("diagnosable / non-diagnosable") was established by two expert cardiologists, with a third cardiologist resolving disagreements through majority vote. (p. 9-10)
• Probe Guidance: Expert-established optimal probe position/orientation. Ground truth was established by "expert sonographers and/or cardiologists using the recorded probe position during ultrasound acquisition." This defined the "required rotation, tilt, rock and slides adjustments" against which the algorithm's guidance was compared. (p. 13)

8. The Sample Size for the Training Set

• The document states that the test dataset was "collected from clinical sites geographically distinct from those used for the development dataset" (p. 9). However, the specific sample size of the training (development) set is not provided in the clearance letter summary.

9. How the Ground Truth for the Training Set Was Established

• Similar to the training set sample size, the method for establishing ground truth for the training (development) set is not explicitly detailed in the provided text. It is generally assumed that similar expert annotation processes would have been followed for the training data, but the document does not specify this.

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The Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual discharge.

The proposed unscented menstrual tampons are cylindrical devices designed to absorb menstrual blood during a women's period. They consist of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (except for the digital style). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip for ease of insertion. According to different composition materials and design styles, the unscented menstrual tampons of this submission are divided into 3 categories (Unscented menstrual long applicator tampon, Unscented menstrual Cardboard Applicator Tampon, Unscented menstrual Digital Tampons) and 7 sub-categories (Cotton + cardboard tube, Organic cotton + cardboard tube, Cotton (digital style), Organic cotton(digital style), viscose (digital style), Cotton + plastic tube and Viscose + cardboard tube). For applicator-style tampons, they feature a built-in applicator made of plastic or cardboard that helps the users insert the tampons into the vagina by pushing the tampon out of the applicator. The digital style tampons consist of a plain tampon designed to be inserted manually using the fingers.

The tampons are provided in 4 absorbencies: Light(L) (≤6g), Regular(R) (6-9g), Super (S)(9-12g) and Super Plus (SP)(12-15g). For Cotton + cardboard tube and Organic cotton + cardboard tube, L and SP are applicable for this application. For Cotton (digital style), Organic cotton (digital style) and Viscose (digital style), only L is applicable. For Cotton + plastic tube and Viscose + cardboard tube, all those four absorbencies are applicable for this application.

Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

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Unimed Reusable SpO₂ Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused, when applied to the finger. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.

The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with Mindray M12, and are supplied non-sterile.
Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in finger clip type.
The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.

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Unimed Reusable SpO₂ Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused, when applied to the finger. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.

The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with Nonin 9847, and are supplied non-sterile.

Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in multiple configurations, including finger clip, wrap, and soft-tip types, to accommodate various patient needs and anatomical sites.

The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.

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The Spectra Platinum is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

The Spectra Platinum is an electrically powered breast pump intended for use by lactating women to stimulate lactation and express breast milk. The device is intended for single-user, home use. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time.

The Spectra Platinum operate using an AC adapter (100-240V AC, 50/60Hz, DC 12V) or a rechargeable Li-Polymer battery (11.1V, 2,000mAh).

The Spectra Platinum is comprised of the following components: Main unit, Power adapter, Tubing, Backflow protector, Wide breast shield, Milk bottle, Screw ring, Cap, Sealing cap for milk bottle, Silicone nipple, Silicone valve. The device is provided non-sterile.

The Spectra Platinum support a single pumping mode in which only one breast is expressed and a dual pumping mode in which both breasts are expressed. The user can switch between Massage Mode and Expression Mode using designated buttons and adjust the vacuum level and cycle speed within each mode.

Spectra Platinum includes the following features:

• Expression can be performed on one breast only (single mode), on both sides simultaneously (dual mode).
• Expression mode: 1-15 level (90-270 mmHg), cycle speeds (38, 42, 46, 50, 54)
• Massage mode: 1-5 level (60-100 mmHg), cycle speeds (70, 80, 90, 100, 105)

The Spectra Platinum operates within these specified parameters.

When the backflow protector is assembled between the pump unit and the wide breast shield, the silicone membrane inside the backflow protector creates a hygienic barrier by preventing air and milk from flowing back into the pump unit. This not only enables safe and hygienic breast pumping, but also protects the pump unit from contamination and potential damage caused by backflow of milk.

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ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150)

ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of the following contrast media:

• Gadobutrol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
• Gadopiclenol Injection in SD container or IBP
• Gadobenate dimeglumine Injection in SD container
• Gadoterate meglumine Injection in SD container

Easy-Click-Cassette – flex Max 2M and Easy-Click-Cassette – flex Max 3 are used for a maximum time of twenty-four (24) hours or a maximum of 96 bottles of contrast media, whichever comes first.

Use time expiration per SD container is a maximum of four (4) hours, unless otherwise stated by the contrast media labeling.

Use time expiration per IBP or saline container is a maximum of twenty-four (24) hours, unless otherwise stated by the media labeling.

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.

The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is not intended for injection of contrast media (CM) for high-pressure angiography.

ulricheasyINJECT Max 3 (XD 10180)

ulricheasyINJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of the following contrast media:

• Gadobutrol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
• Gadopiclenol Injection in SD container or IBP
• Gadobenate dimeglumine Injection in SD container
• Gadoterate meglumine Injection in SD container

ulricheasyINJECT Max is a syringeless contrast media management system that is designed for the controlled, automatic venous administration of contrast media in conjunction with physiological saline solution to human subjects undergoing diagnostic examinations in Magnetic Resonance Imaging (MRI or PET MRI).

The ulricheasyINJECT Max device consists of a terminal, injector, and tubing system. The injector is a mobile pedestal device that consists of an injector head and injector base with rechargeable battery. The tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The tubing system consists of the following three components:

• Spikes,
• Easy-Click-Cassette – flex
• Patient Tubing

The ulricheasyINJECT Max uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the tubing system (spikes, cassette, and patient tubing). ulricheasyINJECT Max is intended to be used with the following components that are not supplied with the system:

• Saline containers,
• Single-dose contrast media bottles,
• Imaging Bulk Package (IBP) contrast media containers, and
• Cannula.

ulricheasyINJECT Max is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the system. Controls include air detectors to detect the presence of air in the tubing system without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.

The ulricheasyINJECT Max is provided in three models:

• ulricheasyINJECT Max 2M (XD 10140),
• ulricheasyINJECT Max 3 (XD 10150), and
• ulricheasyINJECT Max 3 (XD 10180).

The Max 3 models have 3 media connection points: 1 NaCl and 2 Contrast Media connections. The Max 2M has 2 media connection points: 1 NaCl and 1 Contrast Media connections. Max 2M and Max 3 are technically identical except the different available media connection points.

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