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Futurabond M+ is intended for use as:

• [A1] Adhesive for direct restorations of all classes of cavities using light-curing . composite /compomer / OrmocerR materials with a methacrylate base.
• [A2] Adhesive for core build-ups made of light-curing composite materials. .
• [A3] Adhesive for indirect restorations with light-curing luting composites. .
• [B] Intraoral repair of composite, compomer or OrmocerR restorations, ceramic veneers and allceramic restorations without an additional primer.
• [C] Treatment of hypersensitive tooth necks. .
• [D] Protective varnish for glass ionomer cement restorations. .
• [E1] Sealing of cavities prior to amalgam restorations. .
• [E2] Sealing of cavities and core preparations prior to the temporary luting of . indirect restorations. In combination with Futurabond M+ DCA (Dual Cure Activator):
• [F1] Adhesive for direct self-curing or dual-curing composite restorations of all . classes of cavities and for core build-ups.
• [F2] Adhesive for indirect restorations using dual-curing or self-curing luting . composites.
• [G] Luting of root posts with dual-curing or self-curing luting composites. .
• [H] Primer for surface preparation of adhesively luted indirect restoration materials . and root posts.

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This document is a 510(k) clearance letter from the FDA for a dental bonding agent called "Futurabond M+". It does not contain any information about acceptance criteria or specific study data showing device performance.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on substantial equivalence to existing devices, rather than through a new clinical effectiveness study demonstrating specific performance metrics against pre-defined acceptance criteria.

The document is purely an FDA clearance letter and an "Indications for Use Statement."

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Futurabond Universal is intended for use as:

• Adhesive for direct restorations of all classes of cavities using light-curing composite/compomer/Ormocer materials with a methacrylate base
• Adhesive for core build-ups made of light-curing composite materials
• Adhesive for indirect restorations with light-curing luting composites .
• Intracral repair of composite, compomer or Ormocer restorations, ceramic veneers and all ceramic restorations without an additional primer
• Treatment of hypersensitive tooth necks
• Protective vamish for glass ionomer cement restorations
• Sealing of cavities prior to amalgam restorations
• Sealing of cavities and core preparations prior to the temporary luting of indirect restorations
• Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups
• Adhesive for indirect restorations using dual-curing or self-curing luting composites
• Luting of root posts with dual-curing or self-curing luting composites

Not Found

This FDA 510(k) clearance letter for the Futurabond U device does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The document is a clearance letter, confirming that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices for the specified indications for use. It outlines administrative details like regulation numbers, product codes, and general controls provisions of the Act.

Therefore, I cannot provide the requested information as it is not present in the provided text.

To illustrate, if the document had contained information about a study, it might have looked something like this (this is a hypothetical example of what one would look for):

Hypothetical Section from a different document (NOT from the provided text):

"Clinical Study Results for Futurabond U

A prospective, randomized, controlled clinical trial was conducted to evaluate the bond strength and clinical longevity of Futurabond U compared to a predicate device.

Acceptance Criteria:

• Shear Bond Strength (SBS) to Enamel: Mean SBS ≥ 15 MPa
• Shear Bond Strength (SBS) to Dentin: Mean SBS ≥ 10 MPa
• Retention Rate at 12 Months: ≥ 95%
• Marginal Adaptation: No significant deterioration (score 0 or 1 on a 0-3 scale) in >90% of restorations at 12 months.

Reported Device Performance:

Study Details:

• Test Set Sample Size: 250 patients, with a total of 500 restorations (250 Futurabond U, 250 predicate).
• Data Provenance: Prospective, multi-center study conducted in the USA, Germany, and Japan.
• Experts for Ground Truth: 5 board-certified restorative dentists, each with an average of 15 years of clinical experience.
• Adjudication Method: 3+1 (three dentists independently evaluated each restoration; in case of disagreement, a fourth senior dentist adjudicated).
• MRMC Comparative Effectiveness Study: No, this was a direct comparison of device performance, not a reader study.
• Standalone Performance: Yes, the above metrics represent the performance of the algorithm (device) itself.
• Type of Ground Truth: Clinical outcome data (retention, marginal adaptation) and ex vivo laboratory measurements (bond strength).
• Training Set Sample Size: Not applicable for a dental bonding agent; performance is based on material properties and clinical application.
• Ground Truth for Training Set: Not applicable. Material properties are established through chemical and physical testing during product development.

End Hypothetical Section

The provided document {0}, {1}, {2} is purely an FDA clearance letter and does not include any of the detailed study information or acceptance criteria for performance metrics.

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MUSCLE STIMULATOR
INDICATIONS FOR USE:

1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
6. Maintaining or increasing range of motion
   Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

ULTRASOUND
INDICATIONS FOR USE:
Application of deep heat for:

1. Temporary relief of minor pain
2. Muscle spasm relief
3. Joint contracture relief
   Not for treatment of malignancies. Not for use on the face.

The Futura Pro (US Specification) is a 10 channel Electronic Muscle Stimulator system with a diathermic ultrasound attachment.
The main muscle stimulation part consists of a main control unit which powers and controls a separate stimulator that repetitively contracts skeletal muscles by applying transcutaneous electrical pulses to areas of the body that require therapy for the indicated conditions. These pulses for muscle stimulation are applied via self adhesive electrodes applied on the skin.
The ultrasound attachment is also powered by the main control unit. The diathermic ultrasound signal is delivered via an acoustic coupling gel. The ultrasound applicator has all the necessary controls (on/off amplitude) in the handset and derives only a time controlled power source from the main control unit.
Set programs, with predetermined parameters, are selectable by the operator. On screen instructions guide the user, displaying numbered programs, indication of intensity levels, adjustments, and treatment use. The output leads have indicator LEDs identifying each output as the electrodes are positioned and the intensity adjusted.
The system is powered either internally from a 12V rechargeable sealed battery within the main control unit or via an external12VDC power supply.
Not part of this submission: Electrodes and Conductive gel. Dr. Wenker shall purchase and distribute the FDA-cleared electrodes and coupling gel, which have been specified by Ultratone Scientific Instruments to ensure proper operation of their equipment. Initially, Ultratone Scientific Instruments has specified electrodes and coupling gel from the respective manufacturers, Axelgaard and Parker. Dr. Wenker shall be purchasing and distributing these two items separately.
The stimulator contains safe-start electronic output interlock circuits to ensure stimulation is not suddenly applied to the patient at turn on. The stimulation outputs can subsequently be adjusted by a master output control.

The provided 510(k) summary for the Futura Pro (US Specification) does not contain specific acceptance criteria with corresponding performance metrics from a dedicated study. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized safety and performance standards.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present a formal table of acceptance criteria with measured device performance. Instead, it relies on a comparison with predicate devices and compliance with international standards. The "performance" is implicitly demonstrated by the device's technical specifications falling within acceptable ranges or being comparable to the predicates, as well as by meeting safety standards.

The document highlights some differences where the Futura Pro (US Specification) exceeds the predicate in certain aspects (e.g., current density, which is still "well within accepted levels," and power density), and improvements in user interface and control. These are presented as benefits rather than failures to meet specific quantified criteria.

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

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) related to clinical efficacy is mentioned. The submission states, "No clinical tests were performed." Non-clinical tests were for compliance with standards.

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

Since no clinical tests were performed, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study was done. The submission explicitly states, "No clinical tests were performed."

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

The Futura Pro is a physical medical device (muscle stimulator and ultrasound), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop does not directly apply in this context. The operational performance of the device itself (e.g., electrical outputs, ultrasound parameters) was likely assessed during non-clinical testing to ensure it met design specifications and safety standards.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was compliance with established national and international safety and performance standards (e.g., BS EN 60601 series, BS EN 55022, BS EN 61000 series). The device's technical specifications and outputs were measured against the requirements of these standards.

8. The Sample Size for the Training Set

Not applicable, as this device does not involve an AI algorithm that would require a 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 the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets "acceptance criteria" (understood here as regulatory requirements for substantial equivalence and safety) is primarily a non-clinical testing and comparison study.

• Non-Clinical Tests:

  • Purpose: To demonstrate that the Futura Pro (US Specification) performs as intended and conforms to the specified safety and performance standards.
  • Methods: Comparison of outputs (electrical stimulation and ultrasound parameters) with predicate devices and independent testing against a comprehensive list of European (BS EN) and international standards for medical electrical equipment, including general safety, particular requirements for stimulators and ultrasonic physiotherapy equipment, and electromagnetic compatibility (EMC).
  • Key Findings (as reported): "Comparisons of the outputs for the Futura Pro (US Specification) and the predicates show similar results that are suitable for transcutaneous electrical muscle stimulation and the application of deep heat using ultrasound." The device also successfully passed all listed BS EN standards.
  • Data Provenance: Testing carried out by the manufacturer (Ultratone Scientific Instruments) and independent laboratories (implicitly, for certification to BS EN standards). Location of these labs is not specified.
  • Design: This was a series of engineering and performance verification tests rather than a clinical study.

• Substantial Equivalence Argument:

  • The submission argues that the Futura Pro is substantially equivalent to legally marketed predicate devices (Ultratone 20, K926410, and Ultrasonic Therapy Appliance, K050410).
  • This is supported by detailed technological comparisons in tables for both the muscle stimulator and ultrasound parts, highlighting similarities in intended use, power source (with minor variations), number of output modes/channels, channel isolation, software control, design, frequency, mode, waveform type, applicator size, effective radiating area, temporal max power, temporal max effective intensity, and beam nonconformity ratio.
  • Differences are acknowledged and explained as not raising new safety or effectiveness issues, often being presented as benefits (e.g., illuminated connectors, self-adhesive electrodes that result in higher but acceptable current density, graphical display, sophisticated control circuitry, integrated power for ultrasound).

In essence, the "study" for this device was a combination of engineering design validation, verification testing against recognized standards, and a comprehensive comparison of technical characteristics to already cleared predicate devices, all performed in a non-clinical setting. No human subjects were involved.

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• Futurabond M/Futurabond M Single Dose is suited as adhesive for direct restoration with light-curing filling materials in all cavity classes.
• Futurabond M/Futurabond M Single Dose is also suited for cavity sealing as a pretreatment for indirect restorations
• Futurabond M/Futurabond M Single Dose is also suited for the treatment of exposed root surfaces
• Futurabond M/Futurabond M Single Dose can be used for core build-ups using light-cured or dual-cured filling materials.

Futurabond M/Futurabond M Single Dose is a single-component, light-curing, self-etch-bond reinforced with nano-particles to build a durable bond between tooth substance and light-curing filling materials without marginal leakage.

Futurabond M/Futurabond M Single Dose displays the same adhesive properties of totaletch preparations without separate etching of the tooth substance.

Futurabond M/Futurabond M Single Dose tolerates residual moisture.

Futurabond M/Futurabond M Single Dose is an all-purpose adhesive for use with all lightcuring composites, compomers and Ormocer®s.

Futurabond M/Futurabond M Single Dose is offered in 5 ml plastic bottles (Futurabond M) and in 0.06 ml Single Dose blisters (Futurabond M Single Dose).

This document is a 510(k) summary for the dental adhesive device, "Futurabond M/Futurabond M Single Dose". It does not describe an AI or machine learning device, nor does it provide a study that proves the device meets acceptance criteria in the format requested. Instead, it details the device's characteristics, intended use, and argues for substantial equivalence to predicate devices based on identical composition and performance characteristics.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document as it pertains to a different type of device and regulatory submission.

However, I can extract the following relevant information:

1. Acceptance Criteria and Reported Device Performance (Implied):

The document implies that the "acceptance criteria" revolve around demonstrating that Futurabond M/Futurabond M Single Dose has "the same adhesive properties" and is "identical in composition and performance characteristics" to the legally marketed predicate devices. This is not a quantitative acceptance criterion with specific thresholds as would be expected for an AI device.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a test set of data. The claims are based on material composition and established performance of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method for the test set: Not applicable. No adjudication method for a test set 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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/ML device. The "ground truth" for this submission is implicitly the established safety and effectiveness of the identified predicate devices, based on their prior regulatory clearance and market history.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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Futurabond DC/Single Dose is intended for direct self- or dual curing composite restaurations and core build-ups, direct light-curing composite/compomer/ormocer-based restaurations, fixing root pins/posts with dual- or self-curing composite cements, indirect restaurations with the application of dual-curing composite cements for bonding inlays, onlays, crowns and bridges.

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The provided text is an FDA 510(k) clearance letter for a dental bonding agent (Futurabond DC/Single Dose). It states that the device is substantially equivalent to a legally marketed predicate device but does not contain any information regarding specific acceptance criteria, study details, performance data, or ground truth establishment.

Therefore, I cannot answer your specific questions about acceptance criteria and the study that proves the device meets them because the information is not present in the provided document. The letter only confirms that the device has received 510(k) clearance based on substantial equivalence, implying that the manufacturer conducted studies to demonstrate this equivalence, but the details of those studies are not included in this FDA correspondence.

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Futurabond NR Single Dose is intended to be applied onto the interior of a prepared Futurabond NR Single Dood is internation of a restoration.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental bonding agent, Futurabond NR Single Dose. It does not contain the acceptance criteria or reported device performance data. Therefore, I cannot provide the requested information.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the clearance is based on substantial equivalence to existing devices, not necessarily a new study proving the device meets specific acceptance criteria outlined in the letter itself.

To find the information you're looking for, you would typically need to refer to the 510(k) submission document itself, or potentially a separate clinical study report if one was conducted and referenced within the submission.

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Cold-curing, methyl methacrylate resin for adding the saddles to cobalt chrome denture bases, repairs, additions and relines, and relines. Cold-curing, methyl methacrylate resin for the completion of full and partial dentures. Cold-curing, methyl methacrylate resin for adding saddles to cobalt chrome dentures bases, repairs, additions and other repairs. Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e. g. Unipress). Cold-curing repair resin for additions, replacing teeth and relining dentures. Heat-curing, methyl methacrylate resin for fabricating partial and full dentures using flasks and clamps or injection moulding systems. Heat-curing, methyl methacrylate resin, with liquid phase, for adding the saddles to cobalt chrome denture bases and other repairs.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for several dental resins. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

The document does not contain any information about:

• Acceptance criteria table or reported device performance for a study.
• Sample sizes used for test sets or data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance studies.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

Therefore, I cannot fulfill your request for this information based on the provided text.

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Futurabond NR is intended to be applied onto the interior of a prepared cavity of a tooth to improve retention of a restoration.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent, Futurabond NR. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI comparative effectiveness studies.

This document is a regulatory approval notice, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

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The device is intended to be used for subcutaneous and intramuscular use. The function of the Futura® Safety Syringe is designed to provide safe and reliable method of injecting medication and fluids into patients and also helps protect the healthcare worker from potential needle sticks.

The Futura® Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle safely inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism.

This document is a 510(k) premarket notification FDA letter for the Futura® Safety Syringe. It confirms the device is substantially equivalent to legally marketed predicate devices. Unfortunately, the provided text does not contain the acceptance criteria, details of a study that proves the device meets acceptance criteria, or any of the specific information requested in your numbered list.

The letter focuses on the regulatory approval for marketing the device based on substantial equivalence, and the "Indications for Use Statement" mentions the device's intended use and mechanism. It does not include performance metrics or study results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input.

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FUTURA TOPCAP non gamma-2 is to be used as a filling material for restoring function to teeth which have lost portions to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue.

Single surface cavities such as Class I

Two surface cavities such as MO, DO, FO, LO

Three surface cavities such as MOD, FOD.

Pinned onlays and half crowns.

Core build-ups for cast half and full crowns.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

Labels will bear this caution.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental filling material called "Futura Topcap Non Gamma-2". It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information and indications for use. Therefore, I cannot extract the requested information from the provided text.

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