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The Splashwire Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

The Splashwire Hydrophilic guide wire consists of a nitinol core wire with a ground tapered distal section. A polyurethane jacket which contains tungsten for radiopacity is applied over the core wire and a hydrophilic coating is applied over the polyurethane jacket. The surface of the jacket is uniform with both the distal and proximal ends fully coated. The wire is placed inside a multiple loop flush dispenser, also referred to as a hoop. The dispenser has a flush port which facilitates solution flushing through the hoop to hydrate the guide wire. The wire is placed so that the distal end of the wire comes out of the outer portion of the hoop. A J-straightener is placed on the other end of the hoop to introduce the wire into the catheter. The wire is sold sterile and is a single use device. The subject Splashwire Hydrophilic Guide Wire Line Extensions and the predicate Splashwire Hydrophilic Guide Wire share the device characteristics described above, with the subject guide wire incorporating the following additional modifications:

J-Tip Guide Wires:
The J Tip devices incorporate a distal tip formed into a J shape. These guide wires are provided with a 3.0 mm J Tip.

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The Sterilization Pouch/Roll is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature.

The Sterilization Pouch/Roll is made with medical grade paper and medical compound film. The Sterilization Pouch/Roll maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from Pink before sterilization to Yellow after sterilization. The steam sterilization indicator color change from Blue before sterilization to Black after sterilization.

The Sterilization Pouch/Roll is composed of medical grade paper(60g/m2) and medical compound film(50μm), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process.

The recommended sterilization cycle parameter is:

Steam: 4 minutes at 132°C(270°F); 20 minutes dry time.

Ethylene oxide: 4 hours at 50 °C(122°F); relative humidity between 30%- 90%; ethylene oxide concentration is 695 mg/L, 7 days aeration time at room temperature.

The medical devices are inserted into the Pouch/ Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The pouch is self-sealed prior to sterilization processing. The roll is heat-sealed by a plastic sealing machine. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.

The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to yellow (EtO) or Blue to Black (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.

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Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition) and to detect patient presence and body movements.

The Sleepiz One+ hardware unit is intended to be used by a healthcare professional when the recordings are performed in a clinical setting, or by patients or their caregivers when the recordings are performed in a home environment. The Sleepiz One+ cloud software is intended for use by healthcare professionals. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not indicated for use on pregnant women.

Sleepiz One+ is a contactless medical device that uses radar technology to measure respiration rate and heart rate from a resting or sleeping patient.

The Sleepiz One+ consists of a hardware unit and cloud-based software. The hardware unit can be positioned on a bedside table, mounted on a stand, or attached to the wall behind the patient's bed. It is designed to monitor physiological signals by detecting small body movements, such as those caused by breathing and heartbeat, using Doppler radar. The recorded signals are then transmitted via Wi-Fi to cloud-based software, where they are analyzed to obtain respiration rate, heart rate, and body movement. These outputs can be exposed via the Application Programming Interfaces (APIs) to allow healthcare professionals the review and annotation of the data and compilation of results into reports.

Outputs:

• Breathing pattern
• Instantaneous breathing rate [breaths per minute]
• Breathing rate statistics (10th, 50th, and 90th quantiles) [breaths per minute]
• Body movement
• Time in bed [hours]
• Presence detection
• Heart rate [beats per minute]
• Heart rate statistics (10th, 50th, and 90th quantiles) [beats per minute]

The overall system can be grouped into 4 major components, which are classified on the basis of the logical component interfaces where data exchange is occurring:

• Sleepiz Hardware - This is a hardware component serving as primary data acquisition device.

• Embedded Software - This encompasses the firmware running of the Sleepiz Hardware. This, together with Sleepiz hardware, is responsible for data acquisition. The embedded software forms the crux of the Sleepiz hardware such that it defines and controls the data acquisition process. The security aspects related to the operation of the device are incorporated in the design and implementation of embedded software.

• Sleep Analytics Software - The sleep analytics software is responsible for processing data from the Sleepiz Hardware and returning its analytics (e.g., breathing rate, heart rate), as well as its statistics (e.g., mean breathing rate, total recording time, etc.). This refers to the ML model deployed within the cloud software. By itself, the Sleep Analytics Software does not have an external interface. It is wholly encapsulated by the cloud software component Data Processing Layer.

• Cloud Software - The cloud software can be divided into the backend service and the analytics service. The backend service includes modules for data ingestion, a public API, a private API, and a module for sending analysis process requests. The analytics service is responsible for receiving analysis requests and interacting with the sleep analytics software.

The provided FDA 510(k) clearance letter for the Sleepiz One+ (Model 2.5) indicates that no new non-clinical or clinical testing was required for this specific submission (K253388). The device is stated to be identical in design, materials, intended use, and technological characteristics to its predicate device (Sleepiz One+, K251364). Therefore, the information regarding acceptance criteria and a study to prove the device meets these criteria would pertain to the predicate device's clearance.

Based on the provided text, we can infer the following about acceptance criteria and the study that would have supported the predicate device (Sleepiz One+, K251364):

Since the current clearance states "The previous testing and clinical evidence supporting the predicate remain applicable," the information requested relates to what would have been submitted for the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list the acceptance criteria or reported device performance for the predicate device. However, based on the stated intended use and functionality, the performance would likely be evaluated based on the accuracy of:

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

This information is not provided in the current 510(k) document. For the predicate device, a clinical study would have been conducted to validate the accuracy of heart rate and respiration rate measurements against a gold standard. The sample size would depend on statistical power requirements to demonstrate equivalence or non-inferiority to the reference device. The data provenance (e.g., country of origin, retrospective/prospective) would also be detailed in the predicate's submission.

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

This information is not provided in the current 510(k) document. For the predicate device, if ground truth involved human interpretation (e.g., for certain types of sleep events, though unlikely for automated HR/RR), the number and qualifications of experts would be specified (e.g., board-certified pulmonologists or sleep specialists with X years of experience). For HR/RR, the "ground truth" would more likely come from concurrent measurements from established medical devices.

4. Adjudication Method for the Test Set

This information is not provided in the current 510(k) document. For the predicate device, if multiple experts were involved in establishing ground truth (which is less likely for direct physiological measurements like HR/RR), the adjudication method (e.g., 2+1, 3+1 consensus, majority vote) would be detailed. For physiological measurements, adjudication typically involves comparing automated readings against a validated reference device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided in the current 510(k) document. An MRMC study is typically performed for AI devices that assist human readers in interpreting complex images or signals. Since the Sleepiz One+ is a direct measurement device (heart rate, respiration rate, presence, movement), an MRMC study comparing human readers with and without AI assistance is unlikely to be relevant for its primary functions. The device directly outputs physiological parameters, not interpretations for human review.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Based on the device description, where "recorded signals are then transmitted via Wi-Fi to cloud-based software, where they are analyzed to obtain respiration rate, heart rate, and body movement," a standalone performance study would have been conducted for the predicate device. The study would evaluate the algorithm's accuracy in autonomously determining heart rate, respiration rate, presence, and movement against a ground truth.

7. Type of Ground Truth Used

For the predicate device, the ground truth for heart rate and respiration rate measurements would most likely be established using validated medical-grade reference devices (e.g., electrocardiogram (ECG) for heart rate, capnography or pneumotachograph for respiration rate) concurrently with the Sleepiz One+ device. For presence and body movement, the ground truth could be established by observation, video recording, or other motion sensors.

8. Sample Size for the Training Set

This information is not provided in the current 510(k) document. For the predicate device, data from human subjects would have been collected to train the machine learning models (specifically the "Sleep Analytics Software / ML model deployed within the cloud software"). The size and diversity of this training set are critical for the model's generalizability and accuracy.

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

This information is not provided in the current 510(k) document. Similar to the test set, the ground truth for the training set for the predicate device would have been established by concurrent recording with validated medical-grade reference devices for heart rate and respiration rate. This would involve recording signals from patients simultaneously with both the Sleepiz device and the reference device, allowing for the precise labeling of heartbeats, breaths, and movements in the training data.

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Seg Pro V3 is a software device intended to assist trained radiation oncology professionals, including, but not limited to, radiation oncologists, medical physicists, and dosimetrists, during their clinical workflows of radiation therapy treatment planning by providing initial contours of organs at risk on DICOM images. Seg Pro V3 is intended to be used on adult patients only.

The contours are generated by deep-learning algorithms and then transferred to radiation therapy treatment planning systems. Seg Pro V3 must be used in conjunction with a DICOM-compliant treatment planning system to review and edit results generated. Seg Pro V3 is not intended to be used for decision making or to detect lesions.

Seg Pro V3 is an adjunct tool and is not intended to replace a clinician's judgment and manual contouring of the normal organs on DICOM images. Clinicians must not use the software generated output alone without review as the primary interpretation.

The proposed device, Seg Pro V3, is a standalone software that is designed to be used by trained radiation oncology professionals to automatically delineate (segment/contour) organs-at-risk (OARs) on DICOM images. This auto-contouring of OARs is intended to facilitate radiation therapy workflows.

The device receives images in DICOM format as input and automatically generates the contours of OARs, which are stored in DICOM format and in RTSTRUCT modality. The device must be used in conjunction with a DICOM-compliant treatment planning system (TPS) to review and edit results. Once data is routed to Seg Pro V3, the data will be processed and no user interaction is required, nor provided.

The deployment environment is recommended to be in a local network with an existing hospital-grade IT system in place. Seg Pro V3 should be installed on a specialized server supporting deep learning processing. The configurations are only being operated by the manufacturer.

• Local network setting of input and output destinations.
• Presentation of labels and their color.
• Processed image management and output (RTSTRUCT) file management.

Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter for Seg Pro V3 (RT-300):

Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

2. Sample size used for the test set and the data provenance:

• Sample Size: 175 cases.
• Data Provenance: Consecutively collected from the Cancer Imaging Archive (TCIA) datasets. The data was acquired independently from product development training and internal testing. Race and ethnic distribution within the study data patient population was unavailable.
• Geographic Origin (inferred): TCIA is primarily a US-based resource, so data is likely from the United States or a diverse international collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Three.
• Qualifications of Experts: Board-certified radiation oncologists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication Method: "Each OAR contour used as ground truth (GT) was independently generated by three board-certified radiation oncologists." This implies a consensus or agreement among all three experts was used to define the ground truth, effectively a 3-way consensus. The document does not explicitly state an adjudication method like 2+1, but the independent generation by three experts suggests a high-quality, agreed-upon ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No. The study primarily evaluated the standalone performance of the AI algorithm. The clinical validation mentions that Seg Pro V3 "operates as intended within a clinical workflow and supports its intended use as an adjunct tool," but it does not present data from an MRMC study comparing human reader performance with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Yes. "a standalone performance evaluation was conducted to assess the Organ-at-Risk (OAR) contouring capabilities of Seg Pro V3. The observed results indicated that Seg Pro V3 by itself, in the absence of any interaction with a clinician, can contour developed OARs with satisfactory results." The reported DSC and HD metrics are from this standalone evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Ground Truth Type: Expert consensus. The ground truth (GT) for each OAR contour was "independently generated by three board-certified radiation oncologists."

8. The sample size for the training set:

• The document explicitly states that the 175 cases used for the standalone performance evaluation were "acquired independently from product development training and internal testing." However, the document does not specify the sample size of the training set used to develop the deep learning models.

9. How the ground truth for the training set was established:

• The document does not specify how the ground truth for the training set was established. It only describes the ground truth establishment for the test set.

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The Sacroiliac Joint Truss System is indicated for sacroiliac joint fusion for:

• Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The Sacroiliac Joint Truss System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The SJTS is a comprehensive surgical solution for sacroiliac joint fusion procedures. The system consists of an instrument set and a wide range of threaded implants. All screws in the 4Web SJTS are cannulated, fenestrated, and made of medical grade Ti6Al4V alloy. The screws come in two distinct sterile implant offerings: a fully threaded screw with compression threads on the proximal head and a partially threaded lag screw with an accompanying washer. The implant offering includes a choice of three different diameters with a variety of lengths to accommodate the patient's anatomy.

The SJTS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

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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 SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant; in case of SMR Short Stems only if sufficient bone stock remains);
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

The PRIMA Glenoid System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.

The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patients. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Short Stem and PRIMA Short Stem Plus are intended for use in cementless and cemented applications, at the discretion of the surgeon.

The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to:

• Non-inflammatory degenerative joint disease (i.e. osteoarthritis),
• Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis,
• Avascular necrosis of the humeral head,
• Traumatic/post-traumatic arthritis,
• Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains,
• Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains,
• Cuff tear arthropathy (CTA Heads only).

The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).

Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses.

The PRIMA reverse implant is indicated for patients suffering from pain and disability due to:

• Rotator cuff tear arthropathy,
• Osteoarthritis with rotator cuff tear,
• Rheumatoid arthritis with rotator cuff tear,
• Massive irreparable rotator cuff tear,
• Avascular necrosis of the humeral head,
• Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains,
• Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains.

The subject devices consist of a line extension of the SMR Shoulder System and the PRIMA Shoulder System. The new devices introduced with this 510(k) are SMR and PRIMA Glenospheres with diam. 40 and 44mm made of Vitamin E crosslinked UHMWPE (LimaVit) and corresponding CoCrMo humeral liners.

The PRIMA Humeral System consists of the following single use components:

• Anatomic configuration:
  • Stem
  • adaptor for humeral heads.
• Reverse configuration:
  • stem
  • reverse tray and polyethylene reverse insert, or
  • metallic reverse insert.

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The Straumann Variobase Abutments XC for Bridge/Bar are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase Abutments XC for Bridge/Bar are indicated for screw-retained or cement-retained bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and shape the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed in occlusion when the implant is fully osseointegrated.

Straumann Variobase Abutments XC for Bars and Bridges are intended to be placed into Straumann implants to provide support for multi-unit restorations.

The prosthetic restoration (bar/bridge) must be cemented onto the Variobase abutments, which is then screwed onto the implants. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

The subject Variobase abutments are manufactured from Ti-6Al-7Nb (TAN) and are anodized in violet.

The Variobase Abutments for bar/bridges are non-engaging devices intended to support multiple-unit restorations.

The Variobase abutments are provided non-sterile with instructions for end user steam sterilization. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from Ti-6Al-7Nb (TAN). The subject Straumann Variobase Abutments XC for Bridge/Bar is provided in two different platform models, both available with straight and angled screw channel solutions:

Table 10.4.a - Straumann Variobase Abutments XC for Bridge/Bar characteristics

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The Sprinter Legend RX and OTW 1.25mm Balloon Dilatation Catheter is indicated as a pre dilatation catheter for enlarging coronary luminal diameters during PCI procedures.

The Sprinter Legend RX 1.5-4.0mm balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter (balloon models 2.25 mm - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is a percutaneous transluminal coronary angioplasty (PTCA) device. The proximal end comprises of a luer hub, strain relief and a hypotube and stiffening wire subassembly (proximal shaft assembly). The distal end comprises of an inflatable balloon, dual lumen tip (guidewire lumen and the inflation lumen) and radiopaque marker bands. The distal shaft includes a hydrophilic coating to aid in device advancement to the target lesion. The guidewire lumen at the distal end enables the use of a 0.014" guidewire to position the device during use. Radiopaque balloon markers enable accurate placement at the target lesion. Exit markers on the proximal shaft indicate the exit of the balloon tip out of the guide catheter for brachial and femoral approaches.

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