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OTTO is intended for use on swabbable needlefree connectors as a cover to protect the needlefree connectors from potential contamination. OTTO acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access.

OTTO will disinfect the connector thirty (30) seconds after application and maintains a disinfected connector surface for up to seven (7) days if not removed.

The OTTO™ Disinfecting Cap is a sterile disposable cap designed to disinfect swabbable needlefree female connectors with 70% isopropyl alcohol (IPA) when attached to an intravenous (IV) catheter. The OTTO™ product line complements the ICU Medical Clave family of needlefree connectors; however, it is designed to work with other on-market swabbable needlefree female connectors used in peripheral intravenous catheters, indwelling central venous or arterial access catheters.

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The OptiMap™ Catheter is indicated for use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e. linear mapping catheters). The OptiMap™ Catheter may also be used for delivery of externally generated pacing stimuli.

The OptiMap™ Catheter is a sterile, single use device used to detect electrical potentials from the endocardial surfaces of the heart. It may also be used to deliver externally generated pacing stimuli. These signals may be used for analysis with a 3-D mapping system.

The catheter's distal end is an expandable basket with eight (8) longitudinal splines each having eight (8) electrodes spaced equal distance along the length of the spline. When expanded it forms a spherical or basket shape. An integrated Introducer Tool collapses the basket for insertion into a minimum 8.5 F sheath. The OptiMap Catheter is available in one model number representing its basket size.

• OPTI-CATH2-50 is the 50 mm basket size

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SleepMap system is intended for use as an aid for physicians in the diagnosis of sleep and respiratory related disorders in adult patients (aged 18 and up), who have been prescribed a sleep study by their doctor.

SleepMap is a software-only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study recordings, including the staging of sleep, detection of arousals, leg movements, desaturations, obstructive apneas and obstructive hypopneas.

Respiratory event subtypes (central and mixed apneas; central hypopneas), RERA, Cheyne Stokes Breathing, Snoring Events, and Arrhythmia Events are not automatically detected and must be manually marked within records.

All automatically scored stages and detected events can be manually marked or edited within records during review.

All automatically scored stages, detected events and physiological signals which are retrieved, analyzed, displayed, and summarized are subject to verification by a qualified clinician.

Onera SleepMap is a software-only medical device that analyses previously recorded physiological signals obtained during sleep through a polysomnography sleep test with the Onera STS I device. SleepMap can analyze at-home or in-lab sleep study recordings of adult patients.

Automated algorithms are applied to the raw input signals (read from a measurement file in the EDF file format originating from the Onera STS I device) in order to derive additional signals:

• a heartrate (HR) signal from the raw ECG signal. The heartrate algorithm does not include any automated arrhythmia analysis.
• a quantized position signal from the raw continuous value position signal.

Additionally, multiple algorithms are used to interpret the raw and derived signals by classifying sleep stages, sleep events and artifacts. The software automates recognition of the following sleep events: obstructive apnea and obstructive hypopnea events, arousal events, desaturation events, leg movement and PLM events.

The Onera SleepMap contains the following algorithms:

• Sleep staging algorithm, a deep learning model (AI-model) which classifies sleep stages, based on EEG, EOG and EMG inputs.
• Arousals algorithm, a Convolutional Neural Network (AI-model) which predicts arousals, based on sleep stages, EEG, EOG, EMG, ECG and nasal pressure inputs.
• Desaturation algorithm, a rule-based algorithm which detects events of minimum 3% or 4% oxygenation drop based on sleep stages and SpO2 signal inputs.
• Apnea (obstructive) detection, a rule-based algorithm which detects ≥90% nasal pressure drops, based on sleep stages and nasal pressure signal inputs.
• Hypopneas (obstructive) detection, a rule-based algorithm which detects ≥30% nasal pressure drops based on sleep stages, nasal pressure signal, arousal events, and desaturation event inputs.
• Leg Movement algorithm, a rule-based algorithm which detects (repetitive) EMG amplitude increasements, based on sleep stages, EMG signal and respiratory event inputs.
• Artifact algorithms, rule-based algorithms which detect artifacts, based on SpO2, EEG, EOG, EMG and heart rate inputs.

Additionally, clinical users can manually annotate: respiratory event subtypes (central and mixed apneas and central hypopneas), RERA, Cheyne Stokes Breathing, Snoring Events, and Arrhythmia Events.

The raw signals, derived signals and all automated analysis results (annotations) must be visually inspected and reviewed by sleep analysts and physicians prior to the results being integrated into a sleep study report.

SleepMap calculates aggregated metrics and indexes on the set of annotations resulting from the sleep analyst or physician review and integrates these into a technical sleep report that can be previewed.

The technical sleep study report summarizes the sleep stage annotations in a hypnogram, provides the aggregated metrics and indexes, and the technician notes into a PDF document which is the main output of SleepMap. The technical sleep study report is transferred to the Onera Digital Health Platform for storage and is used by the physician to diagnose the sleep disorder.

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

Onera SleepMap Acceptance Criteria and Study Summary

The Onera SleepMap is a software-only medical device intended as an aid for physicians in the diagnosis of sleep and respiratory related disorders in adult patients (18 and up) who have been prescribed a sleep study. It analyzes physiological signals and automatically scores sleep study recordings for sleep staging and the detection of arousals, leg movements, desaturations, obstructive apneas, and obstructive hypopneas.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Onera SleepMap's automated scoring algorithms are implicitly defined by the reported performance metrics (Positive Agreement, Negative Agreement, Overall Agreement, False Discovery Rate) against a 2/3 majority ground truth from expert scorers. The performance metrics are presented with 95% bootstrap confidence intervals. The device is deemed acceptable if these metrics demonstrate sufficient agreement with human expert consensus, indicating it can serve as a reliable aid for physicians.

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

• Automated Scoring Service (Sleep Staging & Events):
  • Sample Size: 98 PSG night studies from 98 unique patients.
  • Data Provenance:
    • N=72 studies from the United States (home environment), acquired August 2023 to August 2025.
    • N=26 studies from Germany (clinic environment), acquired September 2022 to April 2024.
• Heartrate (HR) Algorithm:
  • Sample Size: 249 PSG night studies from 215 unique patients. The validation used 5-minute time intervals from these studies.
  • Data Provenance:
    • N=171 studies from the United States (home environment), acquired August 2023 to August 2025.
    • N=78 studies from Germany (clinic environment), acquired September 2022 to April 2024.

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

• Automated Scoring Service (Sleep Staging & Events):
  • Number of Experts: 3
  • Qualifications: Independent, US-based certified sleep professionals.
• Heartrate (HR) Algorithm:
  • Number of Experts: 2 independent cardiac technologists initially for manual annotation, and an expert board-certified cardiologist for adjudication.
  • Qualifications: Independent cardiac technologists and an expert board-certified cardiologist from Florida, USA.

4. Adjudication method for the test set

• Automated Scoring Service (Sleep Staging & Events): A 2 out of 3 (2/3) majority scoring was constructed as the ground truth reference. Epochs where a 2/3 majority agreement was not reached (n=3282 for sleep staging) were excluded from validation.
• Heartrate (HR) Algorithm: Disagreements in annotations between the 2 cardiac technologists were adjudicated by an expert board-certified cardiologist.

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

The provided document does not indicate that an MRMC comparative effectiveness study was performed to evaluate human readers' improvement with AI assistance. The study focuses on the standalone performance of the AI algorithms against expert consensus.

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

Yes, a standalone performance study was done. The reported performance metrics (Positive Agreement, Negative Agreement, Overall Agreement, False Discovery Rate, and absolute error for HR) describe the Onera SleepMap algorithms' performance independently against the established ground truth. The device is designed for use "under the supervision of a clinician," and all automatically scored stages and events "are subject to verification by a qualified clinician," indicating that the reported standalone performance is intended as an aid for, not a replacement of, human review.

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

• Automated Scoring Service (Sleep Staging & Events): Expert consensus, specifically a 2/3 majority agreement from 3 independent, US-based certified sleep professionals, in compliance with AASM scoring guidelines.
• Heartrate (HR) Algorithm: Expert consensus derived from manual annotations by 2 independent cardiac technologists, with disagreements adjudicated by an expert board-certified cardiologist.

8. The sample size for the training set

The document does not specify the sample size used for the training set for any of the algorithms. It only describes the validation data sets.

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 details the ground truth establishment for the validation data set.

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One-Stop is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation, and cavity preparation.

One-Stop is a paste-type topical pre-impression agent intended to provide gingival retraction and hemostasis. The product contains aluminum chloride, which functions as an astringent. Its paste consistency allows controlled placement in the target area, and it can be removed by rinsing with water after use.

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The Owl Night Guard is Indicated for protection of teeth and restorations against grinding and clenching, and as an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing.

The Owl Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).

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The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation, in the following procedures:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
• Knee: Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair and Meniscal Root Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 Anchors only).
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).

The OSSIOfiber® Suture Anchor consists of an eyelet and anchor body preloaded on an inserter. The anchor body and eyelet are made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration.

The OSSIOfiber® Suture Anchors are sterile, single-use, and non-pyrogenic.

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Osteomni Spinal Fixation System is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the Osteomni Spinal Fixation System is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• Spondylolisthesis.
• Trauma (i.e. fracture or dislocation)
• Spinal stenosis
• Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis; and failed previous fusion

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Osteomni Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Osteomni Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Osteomni Spinal Fixation System is intended to be used with autograft and/or allograft.

Osteomni Spinal fixation system is a top-loading, multiple components, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (straight and curved), connectors, hooks, and setscrews. It allows surgeons and functions for use in spinal implant construction to stabilize and promote spinal fusion. The system components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available to be used by a professional in a healthcare facility/ hospital.

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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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Pedicle Screw System: The OLYMPIC Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Olympic Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Olympic Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Sublaminar Band System: The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma surgery, used in sublaminar or facet wiring techniques.
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis.
• Spinal degenerative surgery, as an adjunct to spinal fusions.

The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

Fenestrated Screw System: Fenestrated Screw System: When used in conjunction with the listed compatible bone cements the OLYMPIC Fenestrated spinal implants are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement fusion. The OLYMPIC Fenestrated Screws augmented with the listed compatible bone cements are limited to use in spinal levels where the structural integrity of the spine is not severely compromised. Compatible bone cements include G21 V-STEADY, G21 V-FAST, Teknimed F20, and Teknimed HIGH V+.

Navigated Instrument System: The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease ( defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

Fenestrated Screw System: Fenestrated Screw System: When used in conjunction with the listed compatible bone cements the OLYMPIC Fenestrated spinal implants are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement fusion. The OLYMPIC Fenestrated Screws augmented with the listed compatible bone cements are limited to use in spinal levels where the structural integrity of the spine is not severely compromised. Compatible bone cements include G21 V-STEADY, G21 V-FAST, Teknimed F20, and Teknimed HIGH V+.

Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system.

The MASADA Modular Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of modular polyaxial screws, and rods. The system is supported by a comprehensive set of instruments to install the implants within the system for percutaneous and minimally invasive access. All implant components are manufactured from the materials listed in the table below.

Materials: Ti-6Al-4V ELI (ASTM F136), CP Titanium Grade 4 (ASTM F67), CoCrMo Alloy (ASTM F1537), Elgiloy CoCrNi Alloy (ASTM F1058), Nitinol #1 (ASTM F2063)

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