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The Boston PICO is indicated for surgical and cosmetic use in dermatology department, general surgery department and plastic surgery department, details are as follows:

1064 nm wavelength:

• Remove tattoos of all skin types (Fitzpatrick skin type I-VI) in the following colors: black, brown, green, blue and purple.
• Treat benign pigmented skin lesions of Fitzpatrick I-IV types.

532 nm wavelength:

• Remove tattoos of Fitzpatrick skin type I-III in the following colors: red, yellow and orange.
• Treat benign pigmented skin lesions of Fitzpatrick I-IV types.

Microbeam handpieces (1064nm and 532nm) are used for the treatment of wrinkles for skin types I-IV.

The Boston PICO is a multi-wavelength, pulsed laser system, and a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in 250ps(± 20%). The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed. The 1064 nm wavelength can be frequency-doubled to 532nm as desired. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064 nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.

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The Access anti-HAV IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human pediatric (2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, and tripotassium (K3) EDTA] using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HAV IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis A virus (HAV) infection in individuals with signs and symptoms of hepatitis A virus, when used in conjunction with other serological and clinical information.

This assay is not intended for use for screening donors of blood or blood products or human cells, tissues, or cellular or tissue-based products (HCT/Ps).

The Access anti-HAV IgM assay requires Access anti-HAV IgM (reagent packs), Access anti-HAV IgM Calibrator (C1), and Access anti-HAV IgM QC (QC1-QC2). The Access anti-HAV IgM assay is a two-step sandwich immunoassay. Paramagnetic particles coated with anti-human IgM monoclonal antibody and prediluted sample are added to a reaction vessel. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. HAV antigen and anti-HAV monoclonal antibody alkaline phosphatase conjugate are added. HAV antigen complexed to the conjugate binds to the IgM antibodies captured on the particles. A second separation and wash step removes unbound conjugate.

A chemiluminescent substrate is then added to the vessel and light generated by the reaction is measured with a luminometer. The light production is compared to the cut-off value defined during calibration of the instrument. The qualitative assessment is automatically determined from a stored calibration.

Quality control (QC) materials simulate the characteristics of patient samples and are essential for monitoring the system performance of the Access anti-HAV IgM immunoassay. In addition, they are an integral part of good laboratory practices. When performing assays with Access reagents for anti-HAV IgM, include quality control materials to validate the integrity of the assay. The assayed values should fall within the acceptable range if the test system is working properly.

The Access anti-HAV IgM reagents are provided in liquid ready-to-use format designed for optimal performance on the Beckman Coulter DxI 9000 Access Immunoassay Analyzer only. Each reagent kit contains two reagent packs. The Access anti-HAV IgM Calibrator kit contains one vial, and the Access anti-HAV IgM QC kit contains three vials each of anti-HAV IgM positive control and anti-HAV IgM negative control. Other items needed to run the assay include Lumi-Phos PRO (chemiluminescent substrate) and UniCel DxI Wash Buffer II.

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

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The BodyGuardian™ Remote Monitoring System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional.

The BodyGuardian Remote Monitoring System is intended for use with adult and pediatric patients who are at least 29 days old in clinical and non-clinical settings to collect and transmit electrocardiogram (ECG) and other health parameters to healthcare professionals for monitoring and evaluation. Health parameters, such as heart rate and ECG data, are collected from external devices such as ECG sensors.

The BodyGuardian Remote Monitoring System does not provide any diagnosis.

The BodyGuardian Remote Monitoring System (BGRMS) is a system for recording and analyzing ECG data for cardiac arrhythmias to assist healthcare professionals, including ECG technicians at 24/7 attended analysis centers in evaluating a patient's cardiac health. Reports are generated for clinician review, that provide analysis and summary of the ECG data collected during a patient's monitoring study. Both the predicate and proposed devices, feature a modular design inclusive of outpatient cardiac telemetry (commonly called mobile cardiac telemetry (MCT)), cardiac event monitor and connected/non-connected Holter modalities. Components in the system external to the software include ECG monitors, electrodes, mobile phones and apps.

The BGRMS System includes the following main components:

• ECG monitor – a patient worn device for ECG waveform data collection and transmission, utilized with compatible electrodes
• Mobile App – applications that execute on an off-the-shelf (OTS) smartphone to communicate with the ECG monitor and the PatientCare Server for collection and transmission of data
• PatientCare – server software responsible for receiving, storing, analyzing, and displaying and reporting data gathered from the ECG monitors; includes the ECG analysis algorithm BeatLogic™
• AI-Based Device Software Functionality (AI-DSF) – Automated classification of continuous
  ECG based on the proprietary BeatLogic™ AI algorithm. BeatLogic consists of an ensemble of deep neural networks (DNNs), trained on real-world patient data and post-processing logic that combines the DNN output to produce individual beat, rhythm, and waveform classifications. This output is intended to be reviewed and confirmed by healthcare professionals to assist in diagnosis.

The provided FDA 510(k) clearance letter and summary for the BodyGuardian Remote Monitoring System (BGRMS v3.0) contains information on the device's acceptance criteria and study to prove it.

Acceptance Criteria and Reported Device Performance

The clinical validation results met all predefined acceptance criteria, though the specific criteria are not explicitly detailed in the provided document beyond "substantially equivalent performance for BeatLogic." The performance was assessed by evaluating the Sensitivity and Positive Predictive Value (PPV) for key rhythms. While specific numerical values for the acceptance criteria are not given, the reported device performance is stated as meeting these unspecified criteria.

Details of the Study Proving Device Meets Acceptance Criteria

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

• Sample Size: Not explicitly stated, but described as "real-world, randomly selected ECG records" with a demographic breakdown of 48.6% Female, 39.2% Male, 12.2% unknown gender, 50.1% < 65 years of age, 49.8% ≥ 65 years of age, and 0.1% unknown age.
• Data Provenance: "Real-world patient data" with representation across "US geographic region," indicating data from the United States. The data is retrospective as it was used to train and validate the algorithm, selected to reflect various algorithm outputs, compatible ECG device configurations, accessory types, and demographic factors.

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

This information is not provided in the document. The document states that the BeatLogic™ AI algorithm's "output is intended to be reviewed and confirmed by healthcare professionals to assist in diagnosis," but it does not specify how the ground truth for the test set was established or the number/qualifications of experts involved in this process.

3. Adjudication Method for the Test Set

This information is not provided in the document.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Was it done?: No, an MRMC comparative effectiveness study is not explicitly mentioned. The study focuses on the standalone performance of the AI algorithm (BeatLogic™).
• Effect size of human readers improvement: Not applicable, as an MRMC study was not described.

5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Was it done?: Yes. The performance measurement of the BeatLogic™ algorithm involved evaluating Sensitivity and PPV, which are metrics typically used for standalone algorithm performance against a ground truth. The document explicitly states, "Performance of the algorithm was assessed by evaluating the Sensitivity and Positive Predictive value (PPV) for key rhythms across different patient subgroups." Furthermore, it mentions that the algorithm's "output is intended to be reviewed and confirmed by healthcare professionals to assist in diagnosis," implying that the performance reported is that of the algorithm prior to human review.

6. The Type of Ground Truth Used

The ground truth annotations were established based on "ground truth annotations on real-world ECG data." The method of establishing these annotations (e.g., expert consensus, pathology, outcomes data) is not explicitly stated. However, the context of cardiac arrhythmia detection strongly suggests ground truth would be established by qualified cardiologists or electrophysiologists.

7. The Sample Size for the Training Set

• Sample Size: Not explicitly stated, but described as "real-world, randomly selected ECG records" that ensured "representation across algorithm outputs, compatible ECG device configurations and accessory types and demographic factors encompassing patient age, gender, geographic location, and indication for monitoring."

8. How the Ground Truth for the Training Set was Established

The document states that the BeatLogic™ AI algorithm consists of "deep neural networks (DNNs), trained on real-world patient data." However, the specific method for establishing the ground truth for this training data is not explicitly provided. It is implied that this involved annotations on "real-world patient data," but the process for generating these annotations (e.g., expert review, automated processes) is not detailed.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Syntex Exam Gloves is a Class I patient examination glove, that made from synthetic Butadiene-acrylonitrile latex. They are natural latex color, non-sterile, powder-free, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.

The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility.

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The Boston Pico755 is indicated for the removal of tattoos and benign pigmented lesions, including but not limited to Ota nevus, Hori spots (Hori nevus), and melasma. The Boston Pico755 with the 2 mm and 6 mm handpieces and the handpieces with Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.

The Boston Pico755 is a medical solid-state laser equipment which is indicated for the removal of tattoos and benign pigmented lesions, including but not to limited to: Ota nevus, Hori spots (Hori nevus) and melasma. It has handpieces for the treatment of acne scars and wrinkles in skin types I-IV. The device is intended to be used in professional healthcare facilities by trained physicians only.

The subject device Boston Pico755 consists of main unit (including power module, laser module, control system and cooling system), a light guide articulated arm, a footswitch, a handpiece and protective Glasses. It is connected to supply mains directly through undetachable power cord and plug. There are 8 types of replaceable handpieces - Zoom S, Zoom X, M, M6, M8, M10, 755x, 755s, and operators can choose the appropriate handpiece according to treatment needs.

When the system automatically detects the model of the installed handpiece, it will display the corresponding treatment interface specific to that handpiece. Users can view or adjust relevant parameters such as wavelength, fluence, energy, spot size, and repetition rate directly from the interface.

After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Footswitch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. The cooling system controls the heating caused by the laser output.

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The Excelsior External Fixation System is indicated for adult and pediatric (greater than 2 through 21 years of age) patients for the treatment and fixation of:

• Open and closed fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis, infected union, non-union, or malunion of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity (e.g. orthoplastic surgery)
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures
• Bone transport

The Excelsior External Fixation System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• Lisfranc dislocations
• Ankle distraction (arthrodiastasis)
• Septic fusion

The Excelsior Translation Device is not intended for weight bearing applications. Patients must remain non weight bearing on the Excelsior External Fixation frame when the Excelsior Translation Device is used for transport applications.

The Blue Ocean Global Excelsior System is a single-use modular external fixator consisting of implantable half pins and fixation wires and non-patient contact rings, telescoping struts, telescoping rods, threaded rods, posts, hinges, connection plates, twisted plates, threaded sockets, bolts, washers and nuts that are combined by the health care professional to construct different frame configurations based on patient anatomy and indicated use. The frame forms the support metalwork for the torsion wire used in fracture fixation and several other indications for long bone fixation procedures. Special wrenches and accessories are included for the proper assembly of the components. The system is manufactured from stainless steel, aluminum, and titanium.

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