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510(k) Data Aggregation
(234 days)
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(1 days)
CHROMA PRINT PREMIUM REGULAR AND FAST SET:
Indications:
Chroma Print Premium is indicated for total or partial impressions of dentate or edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.
HYDRO PRINT PREMIUM REGULAR AND FAST SET
Indications:
Hydro Print Premium is indicated for total or partial impressions of dentate or edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.
PERFIL PRO
Indications:
Perfil Pro is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.
PERFIL PRO CHROMA
Indications:
Perfil Pro Chroma is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.
PERFIL PRO +
Indications:
Perfil Pro+ is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.
Device Description – Principle of Operation
The Vigodent Alginate Impression Materials are irreversible hydrocolloid powders intended to be mixed with water to form a paste that sets by gelation. The material is placed in a standard dental impression tray and introduced into the patient's oral cavity to capture the anatomical details of teeth and soft tissues. Once set, the impression is removed from the mouth and poured with dental gypsum to obtain a working model.
Conditions of Use
The products are used in dental clinics and laboratories for total or partial impressions in the fabrication of study models, provisional prostheses, orthodontic appliances, and other preliminary dental applications. The device directly contacts the oral cavity tissues for a short duration (minutes) and does not remain in the body.
Interaction with Patient and Other Devices
The alginate material only interacts with oral tissues during impression taking and does not require any surgical procedure. The material interfaces with standard dental trays and dental gypsum products, with which it is compatible. No electronic components, implants, or additional medical devices are involved.
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(30 days)
The HANAROSTENT® Esophagus Upper (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
This self-expanding tubular prosthesis is designed to maintain patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and an over the wire (OTW) delivery device.
The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, radiopaque markers made of gold wire, fully covered silicone membrane, and one repositioning lasso at each end of the stent made of polymeric materials. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device and expanded in the body by pulling the outer sheath of the delivery device. The HANAROSTENT® Esophagus Upper (CCC) is intended for single use only.
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(135 days)
The Hushd Pro Z-Link device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The Hushd Pro Z-Link device series are removable intraoral patient-specific device intended for the treatment of snoring and mild to moderate obstructive sleep apnea. The device consists of custom-made maxillary and mandibular splints that fit over the upper and lower teeth, and are connected via a pair of detachable rigid connectors. When linked, the splints function as a mandibular repositioner by holding the lower jaw in a forward position during sleep, thereby preventing the tongue and soft tissues from collapsing into the airway.
Each device consists of one maxillary and one mandibular splint, designed and manufactured using 3D printing technology. The splints incorporate a pair of integrated studs that are located around the canine area for the maxillary splint and around the first molar area for the mandibular splint. These studs interface with slots on the detachable connectors to securely link the two splints together. This configuration permits the mandible to advance from the baseline position, offering improved patient comfort.
Titration is achieved by replacing the connectors with another pair of a different size. The connectors are available in 1.0 mm incremental lengths, allowing progressive mandibular advancement according to patient tolerance and clinical need. A standard set includes six pairs of connectors, ranging from -1 mm to +5 mm protrusion, while an extended set ranging from +6 mm to +10 mm is available upon request, providing a maximum mandibular protrusion of 10 mm.
The connectors are not elastic and do not contain adjustment mechanisms such as pistons, screws, straps, or repositioning elastics. The rigid connectors are manufactured with medical grade nylon PA12 using commercial injection molding process and are marked for easy identification.
The splints of this device are manufactured using selective laser sintering (SLS) 3D printing with EOS PA2200 polyamide (nylon) PA12 material. This material offers excellent mechanical properties, long-term stability, and has a history of safe use in oral medical devices. The manufacturing process includes mechanical or chemical polishing, cleaning, and rigorous quality control prior to packaging.
The Hushd Pro Z-Link is available for prescription only and designed based on optical or physical impressions taken by a licensed healthcare provider. The splints and connectors are designed exclusively by the device manufacturer and its authorized partners to ensure consistent quality and performance.
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(89 days)
Hair Growth Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.
Hair Growth Laser Cap is a dome-shaped low level laser therapy (LLLT) device is designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of laser diodes at 650nm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included battery pack.
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(29 days)
The HemoSphere Stream™ Module when used with a Smart Pressure Controller (PC1Q) and VitaWave™ Plus Finger Cuff is indicated for use in adult patients to provide continuous, non-invasive arterial pressure waveform output to a compatible multi-parameter patient monitor. The device is designed for use in clinical environments requiring continuous assessment of blood pressure waveform morphology, without the need for an invasive catheter.
The HemoSphere Stream™ Module when used with the Smart Pressure Controller (PC1Q) and VitaWave™ Plus Finger Cuff is indicated for use in adult patients to provide continuous, non-invasive arterial pressure waveform output to a compatible multi-parameter patient monitor.
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(271 days)
The Hemastyl Wound Gel is indicated for use as follows:
Hemastyl Wound Gel
Rx: Management of wounds such
- 1st degree burns and 2nd degree superficial burns
- stasis ulcers
- pressure ulcers
- diabetic ulcers
- lacerations
- abrasions
- skin tears
- surgical incision sites
- device insertion site wounds
- graft sites
- donor sites
OTC: Management of minor cuts, minor abrasions, minor lacerations and minor scalds.
Hemastyl™ Wound Dressing is a repeat use, amorphous hydrogel containing silver chloride (AgCl), cupric chloride (CuCl2) and ferric chloride (FeCl3) as preservatives and HA and fish collagen for use in the management of wounds.
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(184 days)
The HYDROS Robotic System is indicated for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.
The HYDROS Robotic System has three components – the HYDROS Robotic System, HYDROS TRUS Probe, and HYDROS Handpiece.
- HYDROS Robotic System
The HYDROS Robotic System, consists of the following nine components:
- HYDROS Tower
- Touchscreen Interfaces - Monitor that supports the Tower Monitor (Tmon) and Surgeon Monitor (Smon)
- HYDROS Software
- HYDROS Operating System
- Embedded Software
- Motorpack
- Handpiece Arm
- TRUS Probe Arm
- Foot Pedal
The HYDROS Robotic System is provided non-sterile, and no sterilization is required prior to each use. The Tower, Foot Pedal, Roll Stand, Articulating Arms, and Motorpack are reprocessed per instructions provided with the device after each use. The HYDROS Robotic System does not come in contact with the patients during the procedure.
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HYDROS TRUS Probe
The HYDROS TRUS Probe is a biplane transrectal ultrasound probe that is used in the conjunction with the HYDROS Robotic System and HYDROS Handpiece to provide ultrasound imaging to deliver the AQUABLATION procedure. The HYDROS TRUS Probe is re-usable and provided non-sterile. It is reprocessed prior to each use as per the instructions provided in the IFU. -
HYDROS Handpiece
The HYDROS Handpiece is the single-use sterile surgical device introduced to the surgical site within the prostate through the urethra to visualize, resect and remove prostatic tissue. The HYDROS Handpiece is integrated with a digital CMOS Scope and is terminally sterilized by EtO.
The provided document is a 510(k) Clearance Letter and 510(k) Summary for the HYDROS Robotic System. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results and acceptance criteria for specific AI/ML components as one might find in a De Novo or PMA submission.
Therefore, the document does not contain all the requested information for the acceptance criteria and the study proving the device meets those criteria, particularly for the AI/ML aspects. It only states that the AI/ML component "Passes" FDA guidance.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in quantitative terms for the AI/ML features. Instead, it indicates that the AI/ML component passed relevant FDA guidance.
| Feature Area | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| FirstAssist AI™ | Complies with FDA Guidance for AI/ML in Medical Device Development. | "Pass" (referring to compliance with FDA Guidance: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions; Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions; Good Machine Learning Practice for Medical Device Development: Guiding Principles) |
| Overall System | Meets applicable standards and guidance documents for non-clinical tests. | "Pass" for all listed non-clinical bench tests (System Verification, Usability, EMC, Basic Safety, Wireless, Sterilization, Biocompatibility, Packaging, Shelf Life, Reliability, Labeling, Reprocessing, Corrosion, Cystoscope Imaging, Ultrasound Imaging, Cybersecurity, Software). |
Limitations: The document does not provide specific performance metrics (e.g., accuracy, sensitivity, specificity, or localization error thresholds) as acceptance criteria for the FirstAssist AI™ feature, nor does it present quantitative results. The "Pass" indicates general compliance with regulatory expectations for a 510(k) AI/ML submission.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the AI/ML components. It only mentions "non-clinical performance data" and "simulated use testing and cadaver testing" for overall system validation, but these don't specifically refer to the AI/ML test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications for the AI/ML test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set, particularly for the AI/ML component.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. It also does not provide any effect size for human readers improving with AI assistance. The AI feature ("FirstAssist AI™") is described as "optional" assistance during the PLAN step for displaying nozzle position, prostate capsule boundary, and placing landmarks, implying it's a tool for surgeons rather than a primary diagnostic AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
The document implicitly suggests a standalone component analysis for the AI/ML feature by stating it "provides the handpiece nozzle position and the prostate capsule boundary" and "will place the 4 landmarks." However, detailed standalone performance metrics (e.g., how accurate the AI's landmark placement is without human correction, or the performance of the AI in identifying boundaries) are not provided. The description focuses on its function as an assistive tool, implying human review and adjustment.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the AI/ML component. Given the nature of prostate anatomy and procedural planning in a surgical context, it could involve expert anatomical annotation on imaging data, but this is not specified.
8. The Sample Size for the Training Set
The document does not provide the sample size used for the training set of the AI/ML model.
9. How the Ground Truth for the Training Set was Established
The document does not describe how the ground truth for the training set was established for the AI/ML model.
Summary of AI/ML Specifics from the Document:
- Feature Name: FirstAssist AI™ (previously Assisted Planning)
- Functionality:
- Transverse view: Provides handpiece nozzle position and prostate capsule boundary.
- Sagittal view: Places 4 landmarks (treatment start (TS), bladder neck (BN), mid-prostate (MP), and treatment end (TE)).
- User Interaction: The surgeon has the option to adjust the landmarks as needed.
- Change from Predicate: The subject device has an "updated AI model for the same functionality of landmark identification."
- Regulatory Status: "Passes" FDA Guidance for AI/ML.
In conclusion, while the document confirms the HYDROS Robotic System has an AI/ML component ("FirstAssist AI™") and was cleared based on non-clinical performance and equivalence to a predicate, it lacks the detailed quantitative acceptance criteria and study particulars for the AI/ML model itself that would typically be found in a more comprehensive clinical validation report. The "Pass" for AI/ML indicates compliance with the regulatory requirements pertinent to a 510(k) submission, which often rely on demonstration of similar performance to a predicate or adherence to recognized performance standards rather than extensive de novo clinical studies specifically for the AI component's accuracy.
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(375 days)
The HexaPLUS S OneDrill Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement-retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. The system is intended for delayed loading.
The HexaPLUS S OneDrill Implant System is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the indications for use, the technology used, the material compositions and performance characteristics. The surface of the implants are treated by SLA method. Implants with 4.50mm and 5.25mm body diameter are provided in lengths of 8.5, 10, 11.5, 13.0, 14.5, and 16 mm. Implants with 6.5mm and 7.5mm body diameter are provided in lengths of 8.5, 10, 11.5, 13.0, and 14.5.
The system includes the following components.
Fixtures
- Size: 4.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5/16.0mm (L)
- 5.25mm (Dia.) x 8.5/10.0/11.5/13.0/14.5/16.0mm (L)
- 6.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5
- 7.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5
Abutments
- Healing Abutment
- One-Step Abutment
- Final Cement Abutment
- Straight Abutment
- Angled Abutment
- Temporary Abutment
- Ball Abutment
Cover Screw
- Size: 3.45mm (Dia.) x 4.9
Abutment Screw
- Size: 2.30mm (Dia.) x 8.25
Multi Angle Abutment Screw
- Size: 2.30mm (Dia.) x 8.20
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(90 days)
Heylo™ System is indicated to allow detection of ostomy appliance leakage for people with an ileostomy or colostomy, giving them an opportunity to take preventative measures. Heylo™ System is comprised of a protective adhesive barrier with integrated sensors that detect occurrences of leakage of output from the wearer's stoma and a transmitter that translates leakage data and sends notifications to the user's Heylo™ app. Heylo™ System and its components are for individuals with an ostomy 12 years and older.
Heylo™ System is a leakage notification system designed to monitor for leakage of stoma output in patients with an ileostomy or colostomy. Heylo™ System is comprised of a protective adhesive barrier with integrated sensors that detect occurrences of leakage of output and a transmitter that translates leakage data and sends notifications to the user's Heylo App.
The Heylo™ System is considered an accessory to the ostomy bag/pouch. It is intended to be used together with an ostomy barrier (synonymous with ostomy pouch, ostomy baseplate and bag) and designed for compatibility with most baseplates and supporting products. It can be worn wherever patients normally wear their ostomy appliance.
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