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Synchfix™ EVT is intended for soft tissue and bone fixation for ankle syndesmosis disruptions with or without ankle fractures and as an adjunct in connection with hardware for ankle fractures such as Weber B, Weber C and Maisonneuve in adult and adolescent patient populations.

The subject device, Synchfix™ EVT, is a sterile, single-use, suture-button system intended to stabilize syndesmotic disruptions in the ankle. The subject system consists of a UHMWPE suture tensioned between two titanium alloy buttons and single use instruments to assist in implantation, including a pre-loaded inserter.

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The intended use of the VenAir Sequential Compression System (hereby referenced as "VenAir system") is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism. The garments are single patient use - do not reuse. The VenAir system is intended for use only in professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment. The VenAir system should be used as part of a prescribed plan of care.

The VenAir system is a sequential pneumatic compression system by applying sequential and gradient pressure to increase venous blood flow and circulation in at-risk patients to help prevent deep vein thrombosis and pulmonary embolism. The product consists of the pump, tubing sets, and disposable (single patient use) garments (thigh, calf, and foot optional purchase) and focuses on compressing the limbs to enhance better blood circulation.

The VenAir system has digital sensors to check the garment connections, pressure output and power supply. On the other hand, operator can follow this manual to check the error code and action as advised.

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Atalante X is intended to perform ambulatory functions and mobility exercises, hands‐free, in rehabilitation institutions under the supervision of a trained operator for the following populations:

• Individuals with hemiplegia due to cerebrovascular accident (CVA)
• Individuals with spinal cord injuries at levels C4 to L5 (SCI)
• Individuals with multiple sclerosis (MS)

The operator must complete a training program prior to use of the device.

Atalante X is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand‐up position.

The device is not intended for sports or stair climbing.

Atalante X is a completely self‐balancing walking system for people with mobility disabilities. It is a fully powered hip‐knee‐ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self‐balancing and includes dynamic‐walking control. Dynamic‐walking allows the Atalante X to consume significantly less power and have a more natural gait.

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Indications for Use (Describe)

Prescription Use

Collagen Wound Dressing is indicated for the management of exuding wounds including:

• Full thickness and partial thickness wounds
• Pressure and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• Partial thickness burns
• Donor sites and other bleeding surface wounds
• Abrasions
• Traumatic wound healing by secondary intention
• Dehisced surgical incisions

Over-The-Counter Use

Intended for the management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.

Collagen Wound Dressing is a wound care device composed of pure freeze-dried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing that can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable. Please reapply the dressing as needed based on the patient's wound healing situation.

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Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device, is intended to provide 50 Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body.

Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device is intended to provide 100Hz shear wave speed measurements and estimates of tissue stiffness in spleen.

Shear Wave Quantificational Ultrasound Diagnostic System is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile.

Shear Wave Quantificational Ultrasound Diagnostic System is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis in the human body (including abdominal applications) in B, M, CFM, PWD, B/B, 4B, B+M, B+CFM, B+PWD, and B+CFM+PWD modes.

The system must be operated by qualified and appropriately trained medical professionals in a professional healthcare facility environment.

The subject system is a general purpose, software-controlled, diagnostic ultrasound system. It is composed of a complex probe, an imaging probe, a main unit, a power cord, a foot switch, two fuses and a protective earth wire. The complex probe is a convex array probe used for elasticity measurement and ultrasound imaging, and the imaging probe is also a convex array probe used for ultrasound imaging. The system uses transient elastography to measure shear wave speed non-invasively and estimate tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. A mechanical vibrator in the complex probe produces low-frequency shear waves at 50 Hz or 100HZ that travel through the skin and intercostal space into the liver or spleen respectively. The propagation speed of the shear wave is captured by complex probe using ultrasound at 2.5 MHz. Under imaging mode, the system acquires and displays ultrasound images in B, M, CFM, PWD modes. The system uses imaging probe and complex probe with a frequency range of 2.5MHz to 5.0 MHz on abdomen for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. The ultrasonic imaging also helps to find a proper location for the Transient Elastography examination.

There are a total of 6 models in this product, all of which share the same intended use, physical design and principle of technology. The only differences among these models are software functions configuration and availability of imaging probe.

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Allomatrix® Injectable Putty, Allomatrix C, and Allomatrix® DR products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Allomatrix® products are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

AlloMatrix® Custom Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of bony structure. AlloMatrix® Custom Putty is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine), and as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

The Allomatrix® family of bone void fillers are comprised of demineralized bone matrix (DBM), a range of cancellous bone matrix (CBM) granules, and a binder of surgical-grade calcium sulfate and carboxymethylcellulose (CMC). Allomatrix® is available in four formulations and various volumes to accommodate surgeon needs. After mixing, the resultant putty can then be handled and placed in the appropriate bone voids.

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This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

The SureTome™ SW Sphincterotome with DomeTip ® are sterile, single use devices compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing high frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.

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LoFric Origo is indicated for short- and long-term bladder management with intermittent urinary catheterization.

The subject device: LoFric® Origo™ is a range of sterile, single-use, urinary catheters designed as an intermittent pathway for drainage of the bladder. The catheters, designed to accommodate the individual anatomy of male users, are available in various lengths and French sizes, and come in three tip designs: Nelaton (straight tip), Flexible (straight ball-shaped tip), and Tiemann (Coudé tip). Each catheter is individually packaged together with an adjustable insertion grip, or an extendable protective sleeve attached to the catheter along with a sterile water sachet (packet). The adjustable insertion grip or the extendable protective sleeve are provided to minimize touching the catheter shaft directly during insertion and retraction. The water sachet is provided for wetting of the hydrophilic surface and is to be broken immediately before use in order to soak the tubing.

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WELLlife Flu A&B Home Test:
The WELLlife Flu A&B Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing other individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

WELLlife Influenza A&B Test:
The WELLlife Influenza A&B Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. This test is for use by individuals aged 14 years or older testing themselves, or adults testing other individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare providers.

Positive results do not rule out co-infection with other respiratory pathogens.

Test results should not be used as the sole basis for treatment or other patient management decisions.

The WELLlife Flu A&B Home Test and WELLlife Influenza A&B Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B protein antigens. The test has two versions, one for over the counter (OTC) use (WELLlife Flu A&B Home Test) and one for professional use (WELLlife Influenza A&B Test). Both versions of the WELLlife Influenza A&B Test that have an identical general design and are intended for the qualitative detection of protein antigens directly in anterior nasal swab specimens from individuals with respiratory signs and symptoms. Results are for the identification and differentiation of nucleoprotein antigen from influenza A virus, and nucleoprotein antigen from influenza B virus. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with three lines: two test lines (Flu A line, Flu B line) and a control line (C line). The device is for in vitro diagnostic use only.

The provided FDA Clearance Letter for the WELLlife Flu A&B Home Test includes details on the device's performance based on non-clinical and clinical studies. Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for performance are generally implicit in these types of submissions, aiming for high agreement with a comparative method. The reported performance is presented through Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).

Table 1: Acceptance Criteria and Reported Device Performance (Implicit Criteria)

Study Details

1. A table of acceptance criteria and the reported device performance

• See Table 1 above. The acceptance criteria are inferred from what is typically expected for a diagnostic device of this type seeking FDA clearance (e.g., high sensitivity and specificity, consistent performance).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • Clinical Study: 680 evaluable subjects (from 766 enrolled) were used for clinical performance evaluation.
  • Non-clinical Studies: Sample sizes vary by study:
    • Lot-to-Lot Precision: 180 results per sample type (3 lots x 3 operators x 2 replicates x 2 runs per day x 5 days).
    • Site-to-Site Reproducibility: 135 replicates per sample type (3 sites x 3 operators x 5 days).
    • LoD: 20 replicates for confirmatory testing.
    • Analytical Reactivity: Triplicates for initial range finding, then triplicates for two-fold dilutions.
    • Cross-Reactivity/Microbial Interference: 3 replicates per organism/virus.
    • Endogenous Interfering Substances: 3 replicates per substance.
    • High Dose Hook Effect: 9 replicates (across 3 lots).
    • Competitive Interference: 9 replicates for each combination.
• Data Provenance:
  • Clinical Study: "A prospective study was performed... between January 2025 and March 2025... at six (6) clinical sites." The country of origin is not explicitly stated, but the FDA clearance implies US-based or FDA-accepted international clinical trials. It's a prospective study.
  • Non-clinical Studies: Performed internally at one site (Lot-to-Lot Precision) or at three external sites (Site-to-Site Reproducibility). These are also prospective experimental studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• The ground truth for the clinical test set was established using an "FDA-cleared molecular comparator method." This is a laboratory-based, highly sensitive, and specific molecular test, which serves as the gold standard for detecting influenza RNA/DNA.
• There is no mention of human experts (e.g., radiologists, pathologists) being used to establish the ground truth for this in vitro diagnostic device. The comparator method itself is the "expert" ground truth.

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

• The document does not describe an adjudication method for conflicting results between the investigational device and the comparator method. Results from the WELLlife Flu A&B Home Test were compared directly to the FDA-cleared molecular comparator method. For an in-vitro diagnostic, typically the molecular comparator is considered the definitive 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

• No MRMC study was performed. This device is a lateral flow immunochromatographic assay, a rapid antigen test that produces visible lines interpreted directly by the user (either a lay user at home or a professional user). It does not involve "human readers" interpreting complex images or AI assistance in the interpretation of results in the way an imaging AI device would. Therefore, this question is not applicable to the WELLlife Flu A&B Home Test.

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

• This question is primarily relevant for AI/ML-driven software as a medical device (SaMD) where an algorithm provides an output. The WELLlife Flu A&B Home Test is a rapid diagnostic test interpreted visually. Its performance is inherent to the chemical reactions on the test strip, and it's designed for human interpretation (either self-testing or professional use). Therefore, a "standalone algorithm-only" performance study is not applicable in the context of this device's technology. The "device performance" metrics (PPA, NPA) are effectively its standalone performance as interpreted by a human user following instructions.

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

• The ground truth for the clinical study was an FDA-cleared molecular comparator method (e.g., PCR or equivalent), considered the gold standard for influenza detection.

8. The sample size for the training set

• The provided document describes clinical and non-clinical performance evaluation studies. For IVD devices like this one, it's common that the "training set" is not a distinct, formally defined dataset as it would be for a machine learning model. Instead, the device's design, reagent formulation, and manufacturing processes are optimized and validated through iterative development and verification testing (analogue to "training" and "internal validation"). The studies described in this summary are primarily validation studies demonstrating the final product's performance. Therefore, a specific "training set sample size" as one might see for an AI model is not applicable/not explicitly defined in this context.

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

• As mentioned above, for a rapid diagnostic test, there isn't a "training set" in the sense of a machine learning model. Instead, the development process involves:
  • Analytical Validation: Establishing LoD, reactivity, specificity (cross-reactivity, interference) using reference strains, cultured microorganisms, and purified substances with known concentrations and characteristics. This essentially acts as the "ground truth" during the development phase.
  • Design Iteration: The test components (antibodies, membrane, buffer) are optimized to achieve desired sensitivity and specificity against known influenza strains and potential interferents. This iterative process, using well-characterized samples, ensures the device learns (is developed) to correctly identify targets.
  • The FDA-cleared molecular comparator assays serve as the ultimate "ground truth" against which the device's overall clinical performance is measured.

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