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The safety lancet is intended for capillary blood sampling.

The safety lancet is single use medical device, which is designed to collect capillary blood sample.

The intended users include Healthcare personnel, patients and lay persons.

Model XXXVII, the safety lancets consist of needle core, button, housing, ring and spring. The sterile part of the safety lancet is the needle tip.

The sterile barrier is the needle sleeve and sterilized to a SAL of 10⁻⁶ by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

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Ryurei (1.5 mm) is indicated for:

• Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
• Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.

Ryurei (2.0–4.0 mm) is indicated for:

• Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
• Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
• Balloon post-deployment expansion of balloon expandable stents (bare metal and drug-eluting).

The tip of the catheter is equipped with a balloon inflatable to a specific diameter and length at recommended pressures.
One or two radiopaque markers inside the balloon.
On the shaft, there are two depth markers.
Double-lumen structure, with a guidewire lumen and an inflation lumen.
A hub is attached to the balloon for inflation/deflation.
The surface of catheter is coated with hydrophilic polymer coating.

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HyperSuture™ All Green Extension sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

The Threadstone HyperSuture All Green Extension cables, loops, and tapes are nonabsorbable, sterile, surgical sutures composed of multiple multifilament strands of ultrahigh molecular weight polyethylene (UHMWPE) braided together to form the implant.

HyperSuture All Green Extension cables and tapes are available in 36 inches and 40 inches in length. The loop configurations are available in 24" or 2" loop configurations. HyperSuture All Green Extension cable, loops, and tape sizes include USP #2-0, USP #0, USP #1, USP #2, USP #3, USP #5, and 1.0mm tape, 1.2mm tape, 1.5mm tape, 1.8mm tape, 2.0mm tape. All variations of the suture, cables, loops, and tapes, are available with or without pre-attached needles.

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Tyto Insights for Eardrum Bulging Detection is an over-the-counter web-based AI-enabled software analytics device intended to automatically detect the bulging of the eardrum in Otoscopic video recordings acquired by the compatible electronic otoscope, as identified in the product labeling, in patients aged 6 months and older. The device is not intended for diagnosis. A healthcare provider's advice is required to understand the meaning of the Tyto Insights for Eardrum Bulging Detection result. Healthcare providers should consider the device result in conjunction with otoscopic recordings and other relevant patient data. The device is not intended to detect other abnormal otoscopic findings.

Tyto Insights for Eardrum Bulging Detection is a web-based AI enabled software analytics device intended to automatically detect the bulging of the Eardrum in Otoscopic video recordings acquired by the compatible Tyto Otoscope in pediatrics and adults. The device is intended to process recordings only from the compatible Tyto Otoscope (Class I medical device, exempt from premarket notification procedures), manufactured by TytoCare Ltd. The acquisition of the video otoscopy data (recordings) is carried out by a professional user in a clinical environment or by a lay user in a non-clinical environment.

Bulging is a medical characteristic of the tympanic membrane that is commonly used for the diagnosis of Acute Otitis Media, but is also observed in ear trauma, barotrauma, bullous myringitis, etc. Therefore, the device can provide an aid to diagnosis when used in conjunction with otoscopic ear examinations and when considering all patient symptoms and medical history.

The Tyto Insights for Eardrum Bulging Detection system is a processing service and has an interface with a Telehealth system which is not part of this product. The Tyto Insights for Eardrum Bulging Detection device is responsible for the data transfer, store and read-only display of device output (otoscopic video analysis results).

Here's a breakdown of the acceptance criteria and the study that demonstrates the device's adherence to those criteria, based on the provided document:

Acceptance Criteria and Device Performance Study for Tyto Insights for Eardrum Bulging Detection

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the Tyto Insights for Eardrum Bulging Detection device were defined in a comparative effectiveness study, comparing the device's performance against a panel of non-ENT clinical readers. The criteria focused on demonstrating superiority in both sensitivity and specificity.

Acceptance Criteria for Primary Endpoint (Comparative Clinical Performance):

Standalone Performance (Against Expert GT)

While not explicitly stated as acceptance criteria in the same manner as the comparative study, the standalone performance against the expert ground truth provides the baseline for the device's accuracy.

Note: PPV and NPV are calculated based on Bayes theorem to account for eardrum prevalence of 8.06%.

Secondary Endpoint (Eardrum Quality Filter Performance):

No success criteria was applied to the secondary endpoint.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: 857 otoscopic recordings (857 patients).
• Data Provenance: Retrospective validation dataset sourced from real-world use of the Tyto Otoscope recordings. While specific countries are not mentioned for the test set, the training data originates from the TytoCare RWD (Real-World Data) Database, implying a similar origin of real-world telehealth use. The comparative human performance study specifically states the non-ENT clinicians were U.S.-licensed, suggesting the data may represent typical U.S. patient populations.

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

• Number of Experts: For the standalone performance (bench study) against expert ground truth, the document states the external ground truth was established by "a panel of ENTs." For the comparative clinical performance study (human reader comparison), the ground truth for the device's standalone performance within that study was also established by a panel of ENTs. The exact number of ENTs for the test set ground truth is not explicitly stated, but the training set ground truth process provides insight (see point 9).
• Qualifications of Experts: ENT (Ear Nose Throat) specialists (otolaryngologists) for establishing the primary ground truth. For the comparative study, the human reader panel consisted of two pediatricians and one general practitioner (U.S.-licensed), who were chosen to represent the intended clinical users of the device in U.S. primary care settings.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set. However, for the training set, it describes a process where 3 ENTs annotated data, and the "final ground truth is determined by majority vote among the three truthers," suggesting a 3+1 (majority vote) approach was likely used for expert ground truth establishment for the test set as well, or at least a consensus-based approach among a panel.

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

• Was it done? Yes, a comparative effectiveness study was performed, comparing the device's standalone performance against a panel of human readers (two pediatricians and one general practitioner). This implicitly functions similar to an "AI vs. human" comparative study, although the AI was standalone and not assistive.

• Effect Size (Device vs. Human Readers):

  • Sensitivity Improvement: The device had a sensitivity improvement of 0.1989 (LCI: 0.1691, UCI: 0.2315) compared to the human readers. (Device Sensitivity: 0.9231 vs. Readers Sensitivity: 0.7242)
  • Specificity Improvement: The device had a specificity improvement of 0.2087 (LCI: 0.1756, UCI: 0.2442) compared to the human readers. (Device Specificity: 0.9463 vs. Readers Specificity: 0.7325)
  • PPV Improvement (Prevalence-adjusted): 0.4038 (0.3161 – 0.5070) in favor of the device.
  • NPV Improvement (Prevalence-adjusted): 0.0250 (0.0215 – 0.0288) in favor of the device.

  The study demonstrated that the device exhibited "higher sensitivity and specificity" compared to the non-ENT reader panel. This "effect size" highlights how much better the AI performed alone compared to the human readers alone for the detection task. It's not an AI-assisted human performance metric.

6. Standalone Performance (Algorithm Only)

• Was it done? Yes. The "Performance Testing - Bench" section (Page 8) explicitly details the standalone performance and accuracy (Sensitivity, Specificity, PPV, NPV) of the Tyto Insights for Eardrum Bulging Detection device.

7. Type of Ground Truth Used

• Expert Consensus: For both training and validation (test) sets, the ground truth for eardrum bulging detection was established by a panel of ENT (Ear Nose Throat) specialists (otolaryngologists) through a consensus or majority vote process.

8. Sample Size for the Training Set

• Total Training Dataset: 3,102 otoscopic recordings.
  • Bulging Positive: 606 recordings
  • Bulging Negative: 1,510 recordings
  • Tympanic Membrane Position Not Sufficiently Captured: 986 recordings

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

The ground truth for the training set was established through a multi-step process involving multiple ENT specialists:

• Step 1 (Initial Screening): Recordings were systematically annotated by one ENT specialist into "Ear Abnormal Recording" and "Ear Normal Recording." This step aimed to address the low prevalence of bulging in real-world data by enriching the "abnormal" pool.
• Step 2 (Detailed Annotation & Majority Vote): All data marked "Abnormal" from Step 1, plus a randomly selected portion of "Normal" data, were then annotated by three ENTs. They categorized recordings as "Bulging Positive," "Bulging Negative," or "Tympanic Membrane Position was not sufficiently Captured." The final ground truth for these recordings was determined by a majority vote among the three ENTs.
• Step 3 (Frame-level Annotation): Randomly selected recordings from Step 2 were further annotated on a frame level by an ENT. This highly granular annotation was used to train both the Eardrum Bulging Detection and Quality Filter Algorithms.

This comprehensive approach leveraged multiple expert opinions and a tiered annotation process to establish robust ground truth labels for training the AI algorithms.

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Disposable Concentric Needle Electrodes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyography (EMG) and nerve potential signal.

The Disposable Concentric Needle Electrode (DCNE) is a recording electrode used for recording of bio-electric, electromyography (EMG) or electroencephalography (EEG) signals in patients undergoing clinical neurophysiological testing. It is inserted into muscle tissue of patient, acting as an interface between the EMG equipment and the patient. It is connected to the EMG cable (not in this submission), which is connected to the EMG equipment to detect bio-electric signals distally.
The subject devices are invasive, single-use and supplied sterile. It is used by healthcare professionals, specifically trained and certified in electrophysiology and recording/monitoring techniques.
The subject devices consist of 6 variants. The differences between the variants are the diameter, length of the needle and the color of the handle.

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8mm×20mm stents:
The Niti-S SPAXUS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution.

10mm×20mm and 16mm×20mm stents:
The Niti-S SPAXUS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size and walled-off necrosis ≥ 6 cm in size that are adherent to the gastric or bowel wall. Once placed, the Niti-S SPAXUS™ Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution. The Niti-S SPAXUS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.

The Niti-S SPAXUS™ Stent is a fully covered, self-expanding metallic stent. The stent is constructed from nickel-titanium alloy (nitinol), which provides flexibility, durability, and self-expansion properties. Its bi-flange design provides stable lumen apposition and helps mitigate migration risk. The complete silicone coating helps prevent leakage during drainage and facilitates the safe removal of the device. Radiopaque markers made of platinum/iridium and stainless steel enhance visibility under fluoroscopic guidance, aiding precise placement and monitoring.

The Stent Delivery System (SDS) is a disposable, non-electrocautery system for the delivery and deployment of the stent at the target position. It is similar in design to the SDS used for the Esophageal TTS Stent (K240522).

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The Zionic Pro Max EMS function of the device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Zionic Pro Max programs is not suitable for rehabilitation or physiotherapy.

The ZIONIC Pro Max is an innovative electrical impulse generator that generates electrical muscle stimulation (EMS) energy to subcutaneous tissue by way of contact with intact skin. The device includes and console and user interface that power a selection of handpieces that deliver EMS to intact skin. The device is intended for use by medical professionals.

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