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Genadyne UNO Negative Pressure Wound Therapy System is in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed Surgical Incision
  Genadyne UNO Negative Pressure Wound Therapy System is a single patient use device.

The Genadyne UNO Negative Pressure Wound Therapy System is a single patient use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO Negative Pressure Wound Therapy System has a pre-determined lifespan. The unit has an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and has selections of Continuous Mode at 80mmHg/ 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Negative Pressure Wound Therapy System Therapy Kits include a therapy unit. 200 ml and 300 mL canisters, and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO Negative Pressure Wound Therapy System can be provided separately. The dressing is intended to be used for a maximum of 3 days. Therapy duration of the dressing may be less than indicated if clinical practice or other factors such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes. Disposable components of the Genadyne UNO Negative Pressure Wound Therapy System, including the foam dressing and drape, are packaged sterile (Ethylene Oxide) and not made with natural rubber latex. All disposable components of the Genadyne UNO Negative Pressure Wound Therapy System are for single use only. The Genadyne UNO Negative Pressure Wound Therapy System dressings are to be used only with the Genadyne UNO Negative Pressure Wound Therapy System.

This document is a 510(k) Summary for the Genadyne UNO Negative Pressure Wound Therapy System, seeking FDA clearance for a modified version of an existing device (K190028). The submission focuses on demonstrating substantial equivalence to the predicate device, primarily through non-clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with detailed performance metrics. Instead, it relies on demonstrating compliance with recognized electrical safety and electromagnetic compatibility standards, and on a comparison of technical specifications with a legally marketed predicate device.

However, based on the non-clinical testing mentioned and the comparison table, we can infer the acceptance criteria are met by demonstrating conformity to relevant standards and maintaining equivalent performance to the predicate device for critical specifications.

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

• Sample Size for Test Set: The document does not specify a "test set" in terms of patient data or a specific number of devices tested for performance. The testing involved compliance with IEC standards for electrical safety and EMC. These standards typically involve a defined set of tests on representative units of the device rather than a "sample size" in the statistical sense for clinical studies. The number of devices used for these engineering tests is not disclosed.
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. The tests are described as "non-clinical" and implicitly prospective as they were performed on the new device model to demonstrate compliance.

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

This information is not applicable as the submission relies solely on non-clinical testing (electrical safety, EMC) and comparison to a predicate device's specifications. There was no "ground truth" derived from expert consensus on medical images or clinical outcomes for this submission.

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

This information is not applicable as there was no clinical study with a test set requiring adjudication of findings. The assessment was based on engineering test results against established compliance standards.

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:

This information is not applicable. No MRMC comparative effectiveness study was performed as this is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic imaging device. The changes relate to the pump's power source and housing, not its interaction with clinical interpretation.

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

This information is not applicable. This device is a Negative Pressure Wound Therapy System, which is a physical medical device, not an algorithm or software. No standalone algorithm performance was evaluated.

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

The concept of "ground truth" as typically understood in the context of diagnostic AI or clinical studies (e.g., pathology, expert consensus) is not applicable to this submission. The "ground truth" for the non-clinical tests would be the established requirements and limits defined by the IEC 60601-1 and IEC 60601-1-2 standards. The device's performance (e.g., maintaining 125 mmHg vacuum) is directly measured and compared against its own specifications and the predicate device's specifications.

8. The sample size for the training set:

This information is not applicable. This device is a physical medical device. It does not use machine learning or AI, and therefore does not have a "training set."

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

This information is not applicable for the reasons stated in point 8.

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UNO 30 is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include: Chronic, Acute, Traumatic, Subacute and dehisced wounds, Ulcers (such as diabetic or pressure), Flaps and grafts, Closed surgical incision. UNO 30 is a single patient use device.

The UNO 30 is portable, battery powered wound suction pump with the intention to deliver negative pressure wound therapy to the wound. The unit provides negative pressure at either 80mmHg or 125mmHg in continuous mode and 80mmHg/30mmHg or 125mmHg/30mmHg in variable mode. The UNO 30 NPWT system includes dressing and canister.

Here's an analysis of the provided text regarding the acceptance criteria and study for the UNO 30 device:

The provided text is a 510(k) Premarket Notification for the UNO 30, a Negative Pressure Wound Therapy (NPWT) system. It focuses on demonstrating substantial equivalence to predicate devices, rather than a novel claim requiring extensive clinical trials or an AI's performance evaluation. Therefore, the information you're asking for, particularly concerning AI performance metrics, clinical study design, and expert adjudication, is not present in this document. The device is a physical medical device (pump, dressings, canister), not an AI-powered diagnostic or assistive tool.

However, I can extract the relevant information available for the device as described.

Acceptance Criteria and Device Performance (Based on "Technological Characteristics" and "Discussion of nonclinical and clinical testing" sections)

This document doesn't present "acceptance criteria" in the typical sense of performance thresholds for an AI or diagnostic device. Instead, it focuses on demonstrating that the UNO 30 maintains similar technical characteristics and safety/effectiveness as its predicate devices, primarily the Genadyne UNO (K180840) with an extended use-life.

The key "performance" aspect evaluated here is the extended device lifespan to 30 days while maintaining the functionality of the predicate.

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

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

This document describes bench testing, not a clinical study involving patients or data sets. Therefore, there's no "sample size for the test set" in the context of patient data, nor a country of origin for such data. The tests were performed on the device itself.

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)

Not applicable. This device is a physical pump, not an AI or diagnostic tool requiring ground truth established by experts for performance evaluation. The "ground truth" here is the expected physical performance of the device (e.g., maintaining pressure, battery life, proper shutdown).

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

Not applicable. As this is bench testing of a physical device, there's no expert adjudication involved in the sense of reviewing outputs or diagnoses.

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

Not applicable. This document is about a physical NPWT device, not an AI or diagnostic tool. No MRMC study was performed, and thus no effect size related to AI assistance is provided.

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

Not applicable. This is not an algorithm or AI. The software component mentioned is for device control and functionality, not for standalone diagnostic or assistive performance.

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

The "ground truth" for the bench tests was the engineering specifications and expected functional performance of the device (e.g., a pressure reading close to 125 mmHg, battery lasting for a certain duration, a specific alert triggering correctly). This is based on established engineering principles and the device's design requirements.

8. The sample size for the training set

Not applicable. There is no AI or machine learning model that requires a "training set" described in this document.

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

Not applicable, as there is no training set for an AI model.

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Genadyne UNO is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include: Chronic, Acute, Traumatic, Subacute and dehisced wounds, Partial-thickness burns, Ulcers (such as diabetic or pressure), Flaps and grafts, Closed surgical incision. Genadyne UNO is a single patient use device.

The UNO Negative Pressure Wound Therapy System is portable, battery powered wound suction pump with the intention to deliver negative pressure wound therapy to the wound.

This looks like a 510(k) premarket notification for a medical device. Based on the provided text, here's a breakdown of the acceptance criteria and study information for the Genadyne UNO Negative Pressure Wound Therapy System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" for performance tests in a tabular format with corresponding reported values. Instead, it states that "The results were within the acceptable limit of the criteria that were set prior the experiment." However, based on the non-clinical testing discussion, we can infer the types of performance aspects tested.

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

The document mentions "A clinical case series from 15 patients with closed surgical incisions were provided as supplementary performance data in support of the safety of the device."

• Sample Size for Test Set: 15 patients
• Data Provenance: Not explicitly stated, but clinical case series generally imply prospective or retrospective data from a clinical setting.
  • Retrospective/Prospective: Not specified, but "case series" can be either.

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

This information is not provided in the document. The document refers to a "clinical case series" as "supplementary performance data," but it does not describe how the outcomes for these 15 patients were adjudicated or evaluated by experts to establish a 'ground truth' for device performance in the context of an AI/algorithm. This device is a physical pump, not an AI diagnostic tool, therefore, the concept of "ground truth" as typically applied to image analysis or diagnostic algorithms doesn't directly apply in the same way. The "ground truth" here would relate to the patient's actual wound healing and safety outcomes, which would likely have been determined by the treating clinicians.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As noted above, this isn't an AI diagnostic device where expert adjudication of outputs would typically be required. The "clinical case series" would involve patient follow-up and clinical assessment by healthcare professionals.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation where multiple readers evaluate cases with and without AI assistance). The Genadyne UNO is a Negative Pressure Wound Therapy System, which is a therapeutic device, not a diagnostic one.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Genadyne UNO is a physical medical device (a powered suction pump for wound therapy), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

For the clinical case series, the "ground truth" would be the clinical outcomes observed in the 15 patients regarding wound healing, removal of exudates/infectious material, and absence of adverse events associated with the device's use. This would be based on clinical assessment and patient follow-up by healthcare professionals. For the bench tests, the ground truth would be based on objective measurements of physical parameters (pressure, absorbance, alert function) against predefined engineering specifications.

8. The Sample Size for the Training Set

Not applicable. As the Genadyne UNO is a physical medical device and not an AI/Machine Learning algorithm, there is no "training set." The device's performance is established through bench testing and clinical observations, not through a learning process from data.

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

Not applicable, as there is no training set for this device.

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The Unomedical Comfort™ Subcutaneous Infusion Set and Unomedical Comfort Short™ Subcutaneous Infusion Set are indicated for subcutaneous infusion of insulin administered by an external pump.

The Unomedical Neria Soft Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.

The Medtronic Silhouette® Subcutaneous (Luer Lock) Infusion Set is indicated for subcutaneous infusion of insulin from and infusion pump.

The Medtronic Silhouette Paradigm® Subcutaneous Infusion Set is indicated for use with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.

The Roche Accu-Chek Tender™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered with microdosage insulin pumps.

The Asante Comfort™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered by the Snap™ Insulin Pump System.

The Abbott Comfort™ Subcutaneous Infusion Set is indicated for infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir of a compatible Abbott pump.

The Comfort Subcutaneous Infusion Sets are sterile, non-pyrogenic, single use subcutaneous infusion sets. The current sets are designed to be used with commercially available infusion devices or are indicated for a specific pump where the set has a proprietary pump reservoir connection (e.g. Medtronic, Asante). Each has two basic components provided for each device. The first is a stand-alone subcutaneous indwelling Soft Cannula. This component of the set is provided as an integral assembly with a PFOA-Free PTFE soft cannula, adhesive backed fixation tape, an injection port and the female portion of a proprietary plastic "click-lock" connector. The assembly comes with a stainless-steel insertion needle. The insertion needle is mounted to a male portion of the proprietary plastic "click-lock" connector. The insertion needle comes to the user inserted through the injection port and the inner lumen of the soft cannula with the needle end protruding past the tip of the soft cannula. The male connector is locked to the female connector on the indwelling soft cannula. A needle protector is assembled over the soft cannula and the insertion needle. A separate male portion of the proprietary connector without the insertion needle is provided in the package. This component is used to attach to the female connector after the indwelling soft cannula has been inserted and the steel insertion needle has been withdrawn and protects the indwelling cannula when the infusion set is not attached. Each Soft cannula set comes individually packaged in its own blister pack sealed with paper lid stock.

The second component is the infusion tubing set. The infusion tubing set for all sets are comprised of a co-extruded tube with a stainless-steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient end. The proximal end of the current Comfort set terminates in either a standard luer lock connector or a proprietary connector compatible with the specified pump. The sets come individually packaged in blister packs sealed with paper lid stock.

This document describes the 510(k) premarket notification for several subcutaneous infusion sets. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly concerning a change in the sterilization facility and the adoption of a PFOA-free PTFE soft cannula.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states "The following verification testing was performed" but does not provide specific sample sizes for each test. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

Not applicable in this context. The study is a series of engineering/performance verification tests for a medical device (infusion sets), not a clinical study requiring expert assessment of medical images or patient outcomes to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements (e.g., flow rate, leak detection, pull force, bend cycles) with clear pass/fail criteria, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or AI-assisted clinical decision support systems, which is not the nature of this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical medical device (infusion set), not an algorithm or AI system. Its performance is inherent to the device itself.

7. The Type of Ground Truth Used:

The ground truth or reference standard for these tests are the established engineering specifications and physical properties of the materials and assembled device. For example:

• Flow/Leak/Pull Tests: Engineering specifications for flow rates, pressure resistance, and tensile strength.
• Bend Test: Durability and integrity requirements under mechanical stress.
• Biocompatibility: Established ISO standards (ISO 10993) for material safety and equivalence.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context would refer to internal manufacturing process optimization and quality control, not data for an algorithm.

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

Not applicable, as there is no training set for an algorithm. The "ground truth" for manufacturing and quality (if considered analogous) would be established through industry standards, regulatory requirements, and internal design specifications, often validated by extensive testing and risk analysis during the device development lifecycle.

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Genadyne UNO is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material.

Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts

Genadyne UNO is a single patient use device.

The UNO Wound Vacuum System is portable, battery powered wound suction pump with the intention to apply negative pressure to the wound.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Genadyne UNO Negative Pressure Wound Therapy System:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a full clinical trial. As such, detailed human clinical study data proving the device meets acceptance criteria in the same way a new drug or novel device might is not typically included in these summaries. The "acceptance criteria" here largely refer to comparison against the predicate device's characteristics and meeting relevant safety standards.

Acceptance Criteria and Reported Device Performance

The core of the "acceptance criteria" for this 510(k) submission is demonstrating that the Genadyne UNO is substantially equivalent to the predicate device, the Pico Single Use Negative Pressure Wound Therapy System (K151436), and that it meets applicable safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The document primarily describes non-clinical testing to support substantial equivalence.

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

• Test Set Sample Size: Not specified for individual tests. For the non-clinical testing, sample sizes would typically refer to the number of units tested per bench test (e.g., n=3, n=5, n=10 devices). The document states "Bench testing was done with in house protocol to establish ensure the performance and outcome."
• Data Provenance: The testing appears to be prospective bench testing conducted in-house by Genadyne Biotechnologies, Inc., and potentially by third-party labs for standards compliance (e.g., biocompatibility, IEC). The country of origin for the data generation would likely be the USA, as this is a US-based company submitting to the FDA.

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

• This information is not provided in the document. For bench/non-clinical testing, "ground truth" is typically established by engineering specifications, recognized standards (e.g., ISO, IEC), and scientific principles, not by expert medical consensus on individual cases.

4. Adjudication method for the test set:

• This is not applicable to the type of non-clinical, bench testing described. Adjudication methods like 2+1 or 3+1 are used for reviewing patient cases, often in diagnostic studies to establish a consensus 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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, where human readers (e.g., radiologists) interpret images with and without AI assistance. The Genadyne UNO is a therapeutic negative pressure wound therapy system, not a diagnostic imaging device with AI interpretation.

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

• No, this is not applicable. The Genadyne UNO is a medical device (a powered suction pump) used directly on patients for wound therapy, not an algorithm, and does not have a "standalone" algorithmic performance. Its performance is its functional operation (e.g., maintaining negative pressure, managing exudate).

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

• For the non-clinical testing described, the "ground truth" or reference standards used would be:
  • Engineering specifications for device function (e.g., vacuum pressure, battery life).
  • International standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and electromagnetic compatibility).
  • Predicate device characteristics as a benchmark for comparison.

8. The sample size for the training set:

• Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."

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

• Not applicable. As there is no training set for an AI algorithm.

Summary of Device Meeting Acceptance Criteria:

The document concludes that the Genadyne UNO meets its acceptance criteria by demonstrating substantial equivalence to the predicate device and by passing relevant safety and performance non-clinical tests.

• Biocompatibility Testing: The dressing kit (silicone foam dressing, PU film strips) met accepted criteria.
• Electrical Safety & EMC Testing: The pump successfully met acceptance criteria for all applicable IEC testing.
• Bench Testing: In-house protocols were used to ensure the device's performance and outcome were as expected.
• Design & Function Comparison: While some technical specifications differ (e.g., max vacuum, battery type, canister use), these differences are highlighted and determined not to raise new issues of safety or effectiveness. The fundamental intended use, indications, and contraindications are presented as similar to the predicate.

The basis for acceptance is that the device is as safe and effective as a legally marketed predicate device, as evidenced by these non-clinical comparisons and standard compliance.

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The UNO Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by adjacent teeth and roots, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more Ø3.0 mm implants adjacent to one another. The UNO Narrow Implant is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

The UNO Narrow Implant is a self tapping, root-form, two piece screw type dental implant, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The UNO Narrow Implant is provided in one diameter (3 mm) in the following lengths: 10mm, 11.5 mm, 13mm and 16mm. The implants are tapered with double thread (2mm pitch) for fast insertion. The implants surface is sand blasted and acid etched. The UNO Narrow Implant is a two piece device whereas the implant is to be used in combination with replaceable ball attachments anchor screws and healing caps. The Uno implants and healing caps are supplied sterile and are intended for single use only. The ball attachment anchor screws are supplied non-sterile since immediately after their placement the ball attachments are used for impression coping in plastic materials. The UNO Narrow Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-02- Standard Specification for Wrought Titanium-6Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

This document is a 510(k) summary for the UNO Narrow Implant, a dental device. It asserts substantial equivalence to a predicate device, the OsseoSpeed™ Narrow from Astra Tech AB. The summary does not describe an AI/ML device, nor does it present any studies or data related to AI/ML device performance. Therefore, I cannot provide the requested information about acceptance criteria or study details from this document.

The document discusses the following:

• Company Name: MIS Implants Technologies Ltd.
• Device Name: UNO Narrow Implant
• Predicate Device: OsseoSpeed™ Narrow from Astra Tech AB (K080396)
• Description of the device: Self-tapping, root-form, two-piece screw-type dental implant, made of Ti6AL4V ELI.
• Indications for Use: Placement in specific regions of partially edentulous jaws where horizontal space is limited, to support prosthetic devices.
• Substantial Equivalence: Claimed due to same intended use and equivalent performance characteristics, manufactured from the same Titanium alloy.
• Conclusion: The device is substantially equivalent to its predicate.

There is no mention of acceptance criteria, device performance metrics, sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance studies, training sets, or how ground truth was established, as these are concepts relevant to AI/ML device testing, which is not applicable to this 510(k) submission.

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The Uno - One Piece Screw-Type 3.0 mm Dental Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices of partificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised of the implant and abutment one piose bend Mandibular central and lateral incisors must be splinted if using two or more 3.0 mm implants adjacent to one another. The If acting on a can factured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.

The Uno - One Piece Screw-Type 3.5 mm Dental Implants are indicated for use in surgical and restorative applications for placement in the premolar, cuspid and incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are made of one piece solid material comprised of the implant and abutment one piooo oone matting are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.

The Uno - One Piece Screw-Type Dental Implant is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type Dental Implant is made of one piece solid material comprised of the implant and abutment combination.

The Uno implants are provided in two diameters. The Uno 3.0 mm dental implant is indicated for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions. The Uno 3.5 mm dental implant is indicated for placement in the premolar, cuspid and incisor regions.

The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02. The Implants are provided in several lengths of 10mm, 13mm and 16mm with diameters of 3.0mm, 3.5mm. The implants surface is sand blasted and acid etched to improve the osseointegration. The implants are tapered with double thread (2mm pitch) for fast insertion.

The Uno implants are supplied sterile and are intended for single use only.

This 510(k) submission for the "Uno - One Piece Screw-Type Dental Implant" does not describe a study to prove the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set, training set details) are not applicable or cannot be extracted from the provided text.

The document primarily details the device description, intended use, and argues for its equivalence to a previously cleared device.

Here's an analysis based on the information available:

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

• Not Applicable. The submission does not define specific "acceptance criteria" for performance that would be met through testing. Instead, it relies on demonstrating that the device is manufactured from the same material and has similar technological characteristics to the predicate device, implying equivalent performance.

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

• Not Applicable. No test set data is described. The submission relies on a comparison to a predicate device, not new clinical or performance testing data.

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)

• Not Applicable. No test set requiring ground truth establishment is described.

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

• Not Applicable. No test set requiring adjudication is described.

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

• Not Applicable. This device is a dental implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to "human readers improving with AI" is irrelevant to this submission.

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

• Not Applicable. This is a physical medical device (dental implant), not a standalone algorithm.

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

• Not Applicable. No new clinical or performance data requiring ground truth is presented in this submission. The "ground truth" for the submission is the established safety and effectiveness of the predicate device based on its prior clearance.

8. The sample size for the training set

• Not Applicable. There is no training set mentioned as this is not a machine learning device.

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

• Not Applicable. There is no training set mentioned.

Summary of what the submission does present regarding equivalence:

The submission argues for Substantial Equivalence based on the following:

• Same Intended Use: The Uno implant has the same intended use as the ZIMMER DENTAL ONE-PIECE IMPLANT (K052997). Both are for placement in the jaw to support prosthetic devices and restore chewing function.
• Equivalent Performance Characteristics: The submission states that
  • Both products are manufactured from the same material: Titanium alloy Gr. 5 complying with standard ASTM F136-02.
  • "All other technological characteristics are similar and show equivalent performance capabilities." (This is a general statement, and specific comparative data is not provided in the text.)
• Material: Titanium alloy Gr. 5 complying with ASTM F136-02 for both the Uno implant and the predicate device.

Conclusion stated in the document:
"The evaluation of the Uno - One Piece Screw-Type Dental Implants does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device."

Essentially, the "study" proving the device meets criteria is the argument for substantial equivalence to a device already deemed safe and effective by the FDA, rather than new, independent testing against pre-defined acceptance criteria.

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• All classes of fillings (according to Black) with lightcuring composite or compomer
• Cementation of indirect restorations made of composite or compomer, ceramic, and metal using RelyX™ ARC, manufactured by 3M ESPE
• Core build-ups made of light-curing composite
• Root surface desensitization
• Repair of composite or compomer fillings
• Repair of restorations veneered with composite or ceramic
• Bonding orthodontic appliances to teeth for orthodontic treatment

Uno is classified Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material). Like Adper Prompt L-Pop, 3M ESPE's well-known and well-established resin bonding agent, Uno offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Being based on methacrylate chemistry itself, Uno is well suited for bonding methacrylate based composites to dentin and enamel. Uno is also indicated to seal sensitive root surfaces as is Adper Prompt L-Pop. Furthermore, Uno is suited to bond orthodontic appliances to teeth for orthodontic treatment as is Prompt L-Pop. Like Adper Prompt L-Pop, Uno will be available in single dose applicators and in a vial version.

This document pertains to a 510(k) summary for a dental adhesive product called "Uno" and does not contain information about the acceptance criteria or a study proving its performance against such criteria in the context of an AI/ML device.

The provided text describes a "Resin Tooth Bonding Agent" and its substantial equivalence to predicate devices, focusing on its chemical composition, intended use (bonding restorative materials, sealing root surfaces, bonding orthodontic appliances), and biocompatibility.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance: This document is for a physical dental adhesive, not an AI/ML device.
• Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, or ground truth establishment for a test set: These concepts are relevant to the evaluation of AI/ML devices, not a resin tooth bonding agent.

The document states, "To provide evidence for safety biocompatibility testing was carried out. The results show that Uno is a safe device." This is the extent of any "study" mentioned, and it only addresses biocompatibility for safety, not performance against specific clinical efficacy metrics. The primary mechanism for clearance is demonstrating "substantial equivalence" to existing, legally marketed predicate devices.

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Unomedical Monica Infusion Sets are indicated for the subcutaneous infusion of medication from an external pump.

The Unomedical Monica Set is an infusion administration set, connecting to a reservoir/infusion pump and inserted in the subcutaneous tissue of a user. The administration set attaches to the reservoir by means of a "tubing connector", and subcutaneously in to the user through an indwelling catheter made of polytetrafluoroethylene (PTFE). The tubing is made of two layers: the inner layer is polyethylene; the outer is polyurethane. The indwelling catheter is introduced into the subcutaneous tissue by a removable 27 gauge introducer needle (cannula) made of AISI 304 stainless steel.

This document is a 510(k) summary for the Unomedical Monica Infusion Set, which is a submission to the FDA. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. Instead, it details the device description, its intended use, and compares it to predicate devices to establish substantial equivalence for regulatory approval.

Therefore, I cannot provide the requested information based on the provided text. The submission focuses on regulatory approval based on equivalence to existing devices, not on performance against specific acceptance criteria for a new study.

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