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Disposable Barrier Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

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The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Barrier Sleeves." This document is a regulatory clearance for a physical medical device (barrier sleeves), not an AI/software as a medical device (SaMD).

Therefore, the document does not contain any of the information requested in your prompt regarding acceptance criteria and study details for an AI/SaMD. Specifically:

• No AI/SaMD Performance: The device is a physical barrier sleeve, completely unrelated to AI performance metrics.
• No Test Set/Ground Truth: There is no mention of a test set, data provenance, expert ground truth, adjudication, or MRMC studies because these concepts are not applicable to the clearance of a disposable physical barrier.
• No Training Set: Similarly, there is no training set for a physical product.

The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance. The focus of the regulatory review for this product would have been on material safety, physical dimensions, intended use, and substantial equivalence to existing devices, not on algorithmic performance.

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Minitube Dentasleeve Protective Barrier Sleeves are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only

Minitube Dentasleeve Protective Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment of those parts of the devices used during dental procedures. Barrier Sleeves act as a physical barrier, augmenting existing infection control techniques, and facilitate clean up. The Minitube Dentasleeve Protective Barrier Sleeves are available in below sizes. All sizes below are provided in millimeters (mm, approx.) and excluding paper liner, i.e. actual sleeve only:

• . 1 ml Width: 29 mm Length: 148 mm
• 5 ml Width: 43 mm Length: 195 mm
• 50ml Width: 63 mm Length: 126 mm

This document, a 510(k) Premarket Notification from the FDA, details the equivalence of the Minitube Dentasleeve Protective Barrier Sleeves to a predicate device. The information provided is for a medical device (dental barrier sleeves), not an AI/algorithm-based device. Therefore, a significant portion of your request regarding AI model validation (e.g., training set, test set, ground truth for AI, MRMC studies, expert consensus, etc.) is not applicable to this document.

The acceptance criteria and study proving the device meets them are based on bench testing and material property comparisons rather than clinical performance or AI algorithm assessment.

Here's an attempt to answer your questions based on the provided document, highlighting where the information is not applicable (N/A) due to the nature of the device:

Device Name: Minitube Dentasleeve Protective Barrier Sleeves
Regulation Number: 21 CFR 878.4370 (Surgical Drape and Drape Accessories)
Regulatory Class: Class II
Product Code: PEM

1. Table of Acceptance Criteria and Reported Device Performance

This device is cleared based on substantial equivalence to a predicate device (Barrier Sleeves, K191448). The "acceptance criteria" are implied by the performance characteristics of the predicate device, which the new device must match or perform equivalently.

Note on Dimensions: While the predicate device had sizes 29x148mm and 36x279mm, the subject device offers 29x148mm, 43x195mm, and 63x126mm, stating these "will fit perfectly over a 1ml, 5ml and 50ml syringe, respectively." This is deemed "SE" (Substantially Equivalent) as it still fulfills the same barrier function for dental instruments, albeit with different specific sizes.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each mechanical or biocompatibility test. It indicates that "samples of the proposed devices" were tested and that the "results are included in this submission."
• Data Provenance: The tests were conducted to support the 510(k) submission. The supplier (Minitube AB, Sweden) manufactures both the predicate and subject devices. This implies the bench testing was done by or for the manufacturer. The data is prospective as it's generated specifically for this premarket notification.

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

• N/A. This is a physical barrier device, and its "ground truth" is established through standardized laboratory bench tests, not through expert human interpretation of medical images or data. The standards (ASTM, ISO) themselves define the methodology and "ground truth" for material performance.

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

• N/A. Adjudication methods like 2+1 are relevant for subjective evaluations, typically in clinical studies or AI performance assessment. Here, the assessment is based on objective, quantitative measurements from standardized laboratory tests.

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

• N/A. This device is a physical barrier, not an AI or imaging device. Therefore, MRMC studies are not applicable.

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

• N/A. This is not an algorithm or AI device.

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

• Bench Testing Standards and Predicate Device Performance: The "ground truth" is established by compliance with recognized international standards (e.g., ISO 10993 for biocompatibility, ASTM F1670, F1671, D882, F1342, D1004 for material properties) and by demonstrating identical or equivalent performance to the legally marketed predicate device.

8. The sample size for the training set

• N/A. This is not an AI/machine learning device; therefore, there is no training set in that context.

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

• N/A. As above, no training set for an AI model. For the device itself, the manufacturing process is regulated by Quality Systems (21 CFR Part 820), ensuring consistency and adherence to product specifications, which can be thought of as the "ground truth" for uniform product characteristics.

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Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient one time use only.

Plasdent Disposable Barrier Sleeves and Barrier Film are made of polyethylene film (PE), and come in various shapes and sizes as dental accessories intended to fit over and cover dental instruments and equipment. The Disposable Barrier Sleeves cover small hand-held dental instruments such as air/water syringes, curing lights, hand pieces, computers, sensors, dental instrument trays, and other similar handheld instruments to provide as a physical barrier or cover during a dental procedure. In other forms, the Disposable Barrier Film Covers are used to cover equipment, such as dental chairs, headrests, X-Ray heads, and other devices. The device is non-sterile, prepackaged, and is disposable, for single patient and one time use only.

This document is a 510(k) Premarket Notification from the FDA for a medical device: "Plasdent Disposable Barrier Sleeves and Barrier Film." It is primarily focused on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

It is important to note that this document does NOT describe the validation of an AI/ML powered medical device. It describes the testing of a physical barrier device. Therefore, many of the requested elements for an AI/ML device validation (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, sample size for training set, ground truth for training set) are not applicable or present in this context.

However, I can extract the relevant information for the physical device based on the provided text, focusing on acceptance criteria and performance data from the non-clinical testing.

Acceptance Criteria and Device Performance (for a physical barrier device)

The document presents non-clinical testing results to demonstrate that the Plasdent Disposable Barrier Sleeves and Barrier Film are substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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Barrier Sleeves are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment of the devices used during dental procedures. Barrier Sleeves act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.

The provided text describes the 510(k) premarket notification for "Barrier Sleeves" by Ivoclar Vivadent, AG. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's independent efficacy through a "study that proves the device meets the acceptance criteria" in the context of, for example, an AI/ML medical device.

The "acceptance criteria" here are based on the similarity to the predicate device and meeting established performance standards for surgical drapes/barrier materials. The study described is a series of non-clinical bench tests and biocompatibility assessments.

Here's how to structure the information based on your request, with the understanding that this is not an AI/ML device study, but rather a traditional medical device submission for substantial equivalence:

Device: Barrier Sleeves (K191448)

Intended Use: "Barrier Sleeves are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only."

The claim of substantial equivalence is supported by demonstrating that the Barrier Sleeves have the same intended use, fundamental technology, working principle, material composition, and comparable performance properties to the predicate device (Disposable Barrier Sleeves and Covers, K160232) manufactured by the same supplier.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are implied by demonstrating equivalence to a legally marketed predicate device and meeting relevant industry standards for barrier materials. The study is a series of physical and biological tests.

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

The document does not explicitly state specific sample sizes for each non-clinical test (e.g., how many sleeves were tested for blood penetration). It refers to "the samples" for mechanical properties.

• Sample Size: Not explicitly stated for each test, generally referred to as "the samples."
• Data Provenance: Non-clinical bench testing conducted by the manufacturer for the purpose of this 510(k) submission. The document doesn't specify country of origin for the testing itself, but the submitter (Ivoclar Vivadent) is based in New York, USA, and the parent company in Liechtenstein. The material supplier is Minitube AB, Sweden. The tests are prospective, conducted specifically for this submission.

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

This section is not applicable for this type of medical device submission. Ground truth, in the context of AI/ML or diagnostic devices, is typically established by medical professionals reviewing images or patient data. For a barrier sleeve, "ground truth" refers to meeting the chemical, physical, and biological performance standards, which are evaluated by laboratory testing under defined ASTM and ISO standards, not by expert medical review of "cases."

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human reviewers of medical data (e.g., radiologists interpreting images). The "test set" here involves laboratory measurements against established standards.

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

No. MRMC studies are performed to assess the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical barrier and does not involve human interpretation or AI assistance.

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

Not applicable. This is not an algorithmic or software device.

7. The Type of Ground Truth Used

For this device, the "ground truth" is defined by established engineering and biocompatibility standards (e.g., ASTM F1670/F1670M for synthetic blood penetration, ISO 10993-5 for cytotoxicity). The device performance is measured against these standards and compared to the predicate device. It is not based on medical outcomes data or expert consensus in the diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As per point 8, there is no training set for this device.

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BH Medical Dental Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

BH Medical Dental Barrier Sleeves and Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.

The provided text is an FDA 510(k) Premarket Notification letter for BH Medical Dental Barrier Sleeves and Barrier Film. This document does not describe an AI or algorithm-based medical device therefore, it does not contain the information requested regarding acceptance criteria and study details for an AI/ML device.

The document describes the regulatory clearance process for physical medical devices—dental barrier sleeves and film—which are used as disposable barriers for dental instruments and equipment. The performance testing mentioned (e.g., resistance to penetration, tear resistance, biocompatibility) relates to the physical properties of these barrier products, not an AI/ML algorithm's performance.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies, as these concepts are not applicable to the device described in the provided text.

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Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

The proposed devices. Disposable Barrier Sleeves and Covers, are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves and covers are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The Disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment and/or protrusion (where applicable) of those parts of the devices used during dental procedures. The Disposable Barrier Cover is placed over equipment, such as dental chair head rests and trays, to cover those parts.

The proposed devices, Disposable Barrier Sleeves and Covers, act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.

The document provided is a 510(k) premarket notification for "Disposable Barrier Sleeves and Covers" (K160232) by DENTSPLY International. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, the information requested regarding acceptance criteria and studies proving a device meets them for a complex AI/ML device is largely not applicable in this context.

However, I can extract the relevant information from the provided document as it pertains to the substantial equivalence determination for this non-AI medical device.

Here's a breakdown based on the provided document and the nature of a 510(k) submission for a non-AI device:

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

The acceptance criteria are generally established by recognized standards for medical device materials and performance. The document defines the "Proposed Device" as "Disposable Barrier Sleeves and Covers" and compares its performance against a "Predicate Device," "TIDIShield™ Curing Light Sleeve (K132953)".

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

The document does not explicitly state the sample sizes for the mechanical and performance tests. It refers to "samples" being tested. For biocompatibility, it states "the proposed devices, Disposable Barrier Sleeves and Covers" underwent testing.
The data provenance is not specified beyond "testing conducted to support substantial equivalence." It's common for such bench testing to be conducted in-house by the manufacturer or by contract labs. There is no indication of country of origin or whether it was retrospective or prospective, as these are typically not relevant for a 510(k) submission for this type of device.

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 is not applicable. For a physical barrier device like this, ground truth is established by standardized material and performance testing against recognized industry standards (e.g., ASTM, ISO). There are no "experts" establishing a subjective "ground truth" in the way one would for diagnostic imaging.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data in clinical studies, typically for diagnostic devices. This device is a physical barrier, and its performance is evaluated by objective laboratory tests, not by expert adjudication of subjective assessments.

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 is entirely not applicable.
* This device is a disposable physical barrier, not an AI/ML-powered diagnostic device.
* No human "readers" are involved.
* No "cases" are being interpreted.
* No AI assistance is provided or claimed.
* No MRMC study was conducted or is relevant for this device.

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

This is entirely not applicable.
* This device is a physical product, not an algorithm.
* There is no "human-in-the-loop" concept for this device's function.

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

The "ground truth" for this device's performance is based on the objective outcomes of standardized laboratory tests as defined by international standards (e.g., ISO, ASTM). For example:

• Biocompatibility: Demonstrated non-cytotoxicity, non-sensitization, and non-irritation as per ISO 10993 series.
• Performance (Barrier): Demonstrated resistance to synthetic blood and viral penetration as per ASTM F1670/F1670M and ASTM F1671/F1671M.
• Mechanical Properties: Measured tensile strength, puncture resistance, and tear resistance as per ASTM D882, F1342/F1342M, and D1004.

These are quantitative measurements against defined criteria, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

This is not applicable. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

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

This is not applicable, as there is no training set for this type of device.

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This product is intended for use by dental professionals only. This device is an accessory to the EI DownPak Endodontic Obturator Handpiece which is used in the oral cavity for root canal therapy. The barrier sleeve will be used to cover the hand piece thereby reducing the risk of cross infection while in use.

The EI® brand DownPak Barrier Sleeves are similar to the TIDI Product (SaniTherm) Disposable Thermometer Sheaths listed above. The El DownPak Barrier sleeve and the predicate TIDI Products Disposable Thermometer Sheaths are intended for use by medical professionals in the oral cavity as infection control devices. The EI DownPak Barrier Sleeve will be use to cover the El DownPak Endodontive Obturator Handpiece which is used for root canal therapy. The CDC Guidelines for Infection Control in Dental Healt Care Settings (Vol. 52, No. RR-17, ng 20, December 19, 2003) references the use of disposable barrier protection. The El DownPak Barrier sleeves will be used in combination with the cleaning instructions for the EI DownPak Obturator handpiece which recommends wiping the surface of the handpiece with a soft cloth dampened with pH neutral surface disinfection solution or mild detergent (not containing phenols). Hu-Friedy will purchase the barrier sleeves from TIDI Products, formerly Banta Healthcare Products, as an own brand private label device. The EI DownPak Barrier Sleeves are identical to the TIDI Products Disposable Sheaths in shape, material, and design. All of the technical specifications are identical to the marketed TIDI Products device. EI has 510k (K070246) approval to market the marketed device in the US. The EI DownPak barrier sleeves are compatible with the EI DownPak handpiece. The El DownPak barrier sleeves are identical to the TIDI Products Disposable Thermometer Sheaths. All of TIDI Products probe cover products (i.e. thermometer sheath, instrument sheaths, and dental camera covers) arc manufactured to ASTM E1104-98. The material construction meets the requirements for poly products, referenced in Part 177 21 CFR (specifically 177.1340 and 177.1520). These sheaths have been tested and certified to be in compliance for sensitization, cytoxicity, and irritation as specified in ISO 10993 eomphally, these sheaths have been tested and certified to be in compliance for viral penetration in accordance with ASTM F1671.

The information provided indicates that the EI DownPak Barrier Sleeves are similar to the TIDI Products (SaniTherm) Disposable Thermometer Sheaths. The manufacturer, Hu-Friedy, intends to private label the barrier sleeves from TIDI Products. The 510(k) submission for the EI DownPak Barrier Sleeves leverages the substantial equivalence to the predicate device, emphasizing identical design, materials, and technical specifications.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Fit of the barrier sleeve onto the EI DownPak Endodontic Obturator Handpiece
• Ease of use (application and removal)
• Readability of the DownPak display through the barrier sleeve
• Activation of controls (on/off and vibration button) through the barrier sleeve
• Ease of disposal of the barrier sleeve
• Resistance to tearing of the barrier sleeve
• Tactile sensitivity through the barrier sleeve | - Evaluated in field validation study #604 by clinicians. The study successfully completed, indicating satisfactory performance across these aspects. Specific quantitative metrics or pass/fail thresholds for these criteria are not provided in the summary. |
  | Material Compliance:
• Material construction meets requirements for poly products (referenced in 21 CFR 177.1340 and 177.1520) | - The material construction meets the requirements for poly products, referenced in Part 177 21 CFR (specifically 177.1340 and 177.1520). |
  | Biocompatibility:
• Sensitization
• Cytotoxicity
• Irritation | - Tested and certified to be in compliance for sensitization, cytotoxicity, and irritation as specified in ISO 10993. |
  | Infection Control Barrier Efficacy:
• Viral penetration resistance | - Tested and certified to be in compliance for viral penetration in accordance with ASTM F1671. |
  | Compliance to Standards:
• Manufactured to ASTM E1104-98 | - All of TIDI Products probe cover products (i.e. thermometer sheath, instrument sheaths, and dental camera covers) are manufactured to ASTM E1104-98. (This is a statement about the predicate device, but since the new device is identical, it implies this applies to the new device as well). |

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

The primary study mentioned is field validation study #604.

• Sample size used for the test set: Not explicitly stated as a numerical value for patients or devices. The study involved "clinicians" evaluating the device, implying a qualitative assessment by multiple users rather than a statistically defined test set size typical for quantitative performance metrics.
• Data provenance: Prospective, as it was a field validation study where clinicians evaluated the device. The country of origin for the data is not explicitly stated, but given the submission is to the FDA for a US market device by a US-based company, it can be inferred to be from the US or a region adhering to similar clinical practices.

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

• Number of experts: Not explicitly stated as a specific number. The summary mentions "clinicians" without specifying how many.
• Qualifications of those experts: "Clinicians" are mentioned, which would typically imply dental professionals or those involved in patient care. No specific qualifications (e.g., years of experience, specialty) are provided.

4. Adjudication Method for the Test Set

The field validation study #604 appears to be a qualitative assessment by clinicians. There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus) for the results of this study. The wording "successfully completing a field validation study #604 where clinicians evaluate..." suggests a collective positive outcome rather than a formal, adjudicated reading of results.

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

No, an MRMC comparative effectiveness study was not done. The primary focus of this submission is demonstrating substantial equivalence to a predicate device and validating basic functional performance through a field study. There is no mention of comparing human readers' performance with and without AI assistance, as AI is not a component of this barrier sleeve device.

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

No, a standalone (algorithm only) performance study was not done. This device is a passive barrier sleeve, not an algorithm or an AI-powered system, so such a study would not be applicable.

7. The Type of Ground Truth Used

For the field validation study #604, the ground truth was expert assessment/consensus (from the clinicians). The criteria evaluated (fit, ease of use, readability, control activation, disposal, tearing resistance, tactile sensitivity) are subjective and based on the practical experience and judgment of the clinicians using the device.

For the material, biocompatibility, and viral penetration testing, the ground truth was established by standardized testing protocols (e.g., ASTM E1104-98, ISO 10993, ASTM F1671) and their associated pass/fail criteria.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "EI DownPak Barrier Sleeves" are physical accessories.

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

Not applicable. As stated above, this device does not involve a training set.

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