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Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are airpowered highspeed dental handpieces with intended use of preparing dental cavities for restorations, such as fillings, reducing hard tooth structure, and cleaning teeth. Karam STD, Karam Mini, AeroBreeze STD, and AeroBreeze Mini can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling. Karam ECN model connects directly to either Type A or Type B hose connectors and does not require a coupling.

Karam45 and Dexor45 are air-powered highspeed dental handpieces with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used. Both models can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling.

The devices are an air-powered dental handpieces intended for use with a friction-grip bur that conforms to ISO 1797-1 standard. Recommended air pressure is 29 ~ 36 psig (gage pressure) to produce high-speed bur rotation ranging between 380,000 and 450,000 RPM. Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are straight-headed. Karam45 and Dexor45 models are designed with a 45-degree back angle. The devices include a water line that directs water mist/jet to the cutting area for cooling and irrigation.

Aerobine line of handpieces employs a cartridge type air turbine with a common core design across the product line. All models employ a friction-grip push button chuck, a drive air line, a discharge air egress line, a water delivery line to supply cooling water. With the exception of Karam ECN, all models can be used with either Karam 4B or Karam 2A coupling. Karam ECN connects directly to Type A or Type B hose connectors without a coupling.

The provided text describes Aerobine Line of Dental Handpieces and compares them to predicate devices for a 510(k) submission. It does not contain a detailed study with acceptance criteria and reported device performance in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics.

Therefore, many sections of your request cannot be fully answered.

Here's a breakdown of what can be extracted and what cannot:

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

The document lists "Minimum Performance requirements" as a technological characteristic and states that the Aerobine devices are "Identical" to the predicate devices for these requirements. However, it does not specify the quantitative acceptance criteria or the actual reported performance values for the Aerobine devices.

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

This information is not provided in the document. The document refers to "engineering analysis results obtained in support of the sterilization validation effort (section 14)," but section 14 is not included, and no details about specific test sets, sample sizes, or data provenance are mentioned for performance criteria.

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)

This information is not provided. The document does not describe a study involving expert assessment or ground truth establishment.

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

This information is not provided.

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/not provided. The device is an air-powered dental handpiece, not an AI-assisted diagnostic tool.

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

This information is not applicable/not provided.

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

This information is not applicable/not provided. The document indicates that substantial equivalence was determined based on "technological profile comparisons (Table 1) and engineering analysis results."

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not provided. There is no mention of a "training set" or ground truth establishment in this context.

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High Speed Air Turbine Handpiece series: This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.

Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece Series: This device is an air-powered hand-held device. intended for removing curious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and polishing teeth for use by a trained professional in general dentistry.

High Speed Air Turbine Handpiece series: There are two series (total 12 models) handpieces in this high speed hanhpiece series as A and B series. A series means the initial of model is "A", which include Quick Coupling, B series means the initial of model is "B", which doesn't include Quick Coupling. The High Speed Air Turbine Handpiece series device is reusable device, but they should be sterilized before use. In the A series, there are 2 models (AZL-4 and ADZ-4) device have one especial different from other model. These two model device have illumination function implemented via LED, the power supply of which is 3.3V d.c. and supplied by Therapy Machine. All the variant types follow the same principle with the same intended use and are made of same materials. The applicant device is not for life-supporting or life-sustaining, not for implant. The device is for prescription. The device does not contain drug or biological product. The device are not provided as sterile, they can be reusable and re-sterilized by the user. The device is not software-driven device.

Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece series: This series devices is the low speed handpiece device which includes 2 air motors (model 0222 is two hole motor; model 0224 is four hole motor), one straight head (model 043) and one contra angle head (model 058E). the two air motor can be matched with the straight or contra angle head discretional for different condition. The Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece series device is reusable device, but they should be sterilized before use. All the variant types follow the same principle with the same intended use and are made of same materials. The applicant device is not for life-supporting or life-sustaining, not for implant. The device is for prescription. The device does not contain drug or biological product. The device are not provided as sterile, they can be reusable and re-sterilized by the user. The device is not software-driven device.

This submission details the K093971 Premarket Notification for High Speed Air Turbine Handpiece series and Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece series. The document asserts substantial equivalence to predicate devices based on safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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 or prospective). It simply states that "The performance of device following [relevant ISO and IEC standards] were conducted."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth was established through compliance with recognized international and national standards for device performance, not through expert human evaluation of outcomes.

4. Adjudication Method for the Test Set

Not applicable. Device performance was assessed against established technical standards, not through a process requiring human adjudication.

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

Not applicable. This device is a dental handpiece, not an AI/imaging diagnostic device that would typically involve an MRMC study comparing human readers with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states that "The performance of device following [relevant ISO and IEC standards] were conducted," implying that the device's technical specifications and functional capabilities were assessed independently against these standards. This is a standalone evaluation of the device's adherence to engineering and safety benchmarks.

7. Type of Ground Truth Used

The ground truth used was compliance with established international and national standards for dental handpieces:

• ISO7785-1:1997
• ISO9168:1991
• IEC 60601-1 (for specific models with illumination)
• IEC60601-1-2 (for specific models with illumination)
• ISO7785-2:1995
• ISO13294:1997

8. Sample Size for the Training Set

Not applicable. This device is a mechanical dental instrument, not a machine learning or AI-driven device that requires a training set.

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

Not applicable. There is no training set for this type of device.

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AS ALL OTHER DENTAL HANDPIECES, WILL THIS DENTAL HANDPIECE, BE USED INTRA AND EXTRA ORALLY TO CENTAL DEVICES CRIND AND POLISH TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH.

THE DENTAL HANDPIECE, PATENT NUMBER 5575647, WAS DESIGNED TO INTRA-ORALLY, ALIGNED WITH THE LONG AXIS OF EACH TOOTH. THIS EASE OF ALIGNMENT IN ALL AREAS OF THE MOUTH DECIDEDLY GIVES THE HANDPIECE A SAFETY MARGIN OVER ANY EXISTING HIGHSPEED HANDPIECE, UPON WHICH THE SUBSTANTIAL EQUIVALENCE IS BASED. ALL DENTAL HANDPIECES, SINCE THEIR INCEPTION IN THE LATE 1800'S, HAVE BEEN CONSRUCTED OF THE SAME MATERIALS: BRASS AND CHROME,OR STAINLESS, OR A COMBINATION OF BOTH. AALL DENTAL HANDPIECES HAVE BEEN BOTH DURABLE AND SAFE.

The provided text describes a 510(k) submission for a dental handpiece (K971732). However, it does not contain any information regarding acceptance criteria, study methodologies, performance metrics, sample sizes, expert qualifications, or ground truth establishment.

The document is a 510(k) summary/statement and the FDA's response letter indicating substantial equivalence to a predicate device. This type of regulatory submission typically focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, often by highlighting similar design, materials, and intended use, rather than presenting detailed clinical study data with specific acceptance criteria and performance outcomes.

Therefore, I cannot populate the requested table or answer most of the questions based on the provided text.

Here's what I can extract, and why the other information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Quantitative acceptance criteria (e.g., specific thresholds for durability, ergonomic benefits, or any other performance aspect) are not mentioned. Corresponding quantitative performance results are also absent.

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

Missing Information: The document does not describe any specific test set, clinical study, or data.

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

Missing Information: No information about expert involvement in establishing ground truth is provided, as no test set or study is detailed.

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

Missing Information: No adjudication method is mentioned, as there is no description of a test set requiring adjudication.

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

Missing Information: This device is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effectiveness are irrelevant and not mentioned.

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

Missing Information: This is not an algorithm or software device. No standalone performance data is relevant or provided.

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

Missing Information: No ground truth information is provided, as no specific study or clinical data is presented. The substantial equivalence relies on the comparison to predicate devices' known safety and efficacy, often inferred from long-standing market use (as implied by the statement "All dental handpieces, since their inception in the late 1800's, have been consructed of the same materials: brass and chrome, or stainless, or a combination of both. AALL dental handpieces have been both durable and safe.")

8. The sample size for the training set

Missing Information: No training set is mentioned or applicable to this device type and submission.

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

Missing Information: No training set or ground truth for such a set is discussed.

Summary of Document Content:

The provided documents are a 510(k) "Substantial Equivalence" submission and the FDA's clearance letter for a dental handpiece (K971732). The basis for substantial equivalence is primarily:

• Similar materials: "Constructed of the same materials: brass and chrome, or stainless, or a combination of both" as other dental handpieces.
• Historical safety: "All dental handpieces... have been both durable and safe."
• Design feature leading to safety margin: The new handpiece's "ease of alignment in all areas of the mouth" is presented as a safety improvement over existing designs.
• Intended use: "To grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth," identical to other dental handpieces.

This type of submission often leverages known safety and performance of predicate devices without requiring new, specific clinical studies with detailed acceptance criteria or performance metrics for the new device.

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Brixton Infection Control Barrier is intended as a single use, transparent plastic, disposable, nonsterile barrier that will help reduce gross contamination and provide equipment surface protection for devices used within the dental/ clinical treatment setting. Brixton Infection Control Barriers are available in an assortment of sizes and shapes, designed to accommodate the following types of equipment: Light Handles, Chairs, Headrests, Air and Water Syringe sleeves (ties included), Stools, X-Ray Heads, Trays

The Brixton Infection Control Barrier manufactured by Filmtech. Inc. is intended as a single use, disposable, transparent, polyethylene plastic equipment cover that will help provide surface protection and reduce cross contamination of equipment used in the dental/ clinical setting. The barriers are available in a variety of sizes and shapes, dispensed in boxes containing 200, 250 or 500 covers,

This document is a 510(k) summary for a medical device called the Brixton Infection Control Barrier. It details its intended use, device description, and claims of substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory submission requirements for demonstrating substantial equivalence based on device characteristics rather than reporting detailed performance studies.

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