Search Results

The LeEject 2 Syringe and Needle System is indicated to be used in conjunction with LeEject Needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

The LeEject 2 Syringe and Needle System is a side-loading dental syringe with a plastic guard "Safeguard" to secure the needle. After inserting the LeEject Needle hub into the opening of the plastic Safeguard, rotating the "Safeguard" guard clockwise secures the dental needle. The system gives the user the option of recapping the dental needle prior to disposal or unlocking the "Safeguard" and allowing the needle to fall into the sharps container without recapping. The LeEject 2 Syringe's main body is shaped like a standard syringe, apart from having a tapered end with a plastic "safeguard" attached, but has no threads on the tip to screw on the needle. The LeEject 2 Syringe is mostly made of chrome plated brass with the exception of the harpoon and piston rod, which is made of stainless steel. The LeEject 2 Syringe is sold non-sterile, uses a standard 1.8mL anesthetic cartridge. The LeEject needles are EO sterilized, single use and sold separately. Only the LeEject Needle can be used with the LeEject 2 Syringe.

The provided text describes a 510(k) premarket notification for a dental syringe and needle system (LeEject 2). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document are primarily related to non-clinical performance testing against recognized standards and a comparison to predicate devices, not a clinical study to assess human-in-the-loop performance or algorithm-only performance as might be seen for AI/ML medical devices.

Based on the information provided in the document:

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 exact sample sizes used for each non-clinical test. It only lists the standards to which the device was tested. The data provenance is implied to be from laboratory testing conducted by the manufacturer or a contracted lab to meet the specified international and national standards. This testing is not based on patient data provenance (e.g., country of origin) but rather on engineering and material performance tests. These are prospective tests performed specifically for this submission.

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

This type of information (number of experts, qualifications, ground truth establishment) is not applicable to this 510(k) submission. The "ground truth" for non-clinical performance refers to the objective pass/fail criteria of the specified engineering and biocompatibility tests and comparison to the predicate device's characteristics. No clinical "ground truth" established by medical experts is discussed.

4. Adjudication Method for the Test Set

This is not applicable as there is no human review or classification of data points in this non-clinical testing context. The "adjudication" is based on meeting the quantitative or qualitative requirements of the listed 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

A MRMC study is not applicable as this is a traditional medical device (dental syringe and needle system), not an AI/ML-driven device. No AI assistance or human reader performance improvement is being evaluated.

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

This is not applicable as the device is not an algorithm. It is a physical dental syringe and needle system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this submission is based on established international and national standards for medical device performance, materials, sterilization, and biocompatibility. The comparison to the predicate device also serves as a form of "ground truth" for substantial equivalence. There is no expert consensus, pathology, or outcomes data presented as a basis for ground truth in this non-clinical submission.

8. The Sample Size for the Training Set

This is not applicable as there is no "training set" involved. This is a traditional medical device, not an AI/ML device that requires machine learning training data.

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

This is not applicable for the same reason as point 8.

Ask a specific question about this device

Integra® Miltex® N-Tralig® Intraligamentary Syringe is indicated to be used in conjunction with anesthetic needles and cartridges for injection of anesthetic into the periodontal ligament.

The Integra® Miltex® N-Traligamentary Syringe is a cartridge syringe intended to inject anesthetic agents into the intraligamentary space (i.e., periodontal ligament). The device consists of a stainless steel syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the barrel cap, the device is used to administer an injection to the patient. The Integra® Miltex® N-Tralig® Intraligamentary Syringe delivers 0.2cc of anesthetic with each ratchet. The ratchet action of the syringe allows for the slow infiltration of anesthetic during the Periodontal Ligament Injection (PDL injection) to help minimize patient discomfort. The 30° adapter helps provide a better angle with difficult-to-reach injections. The syringe comes with a solid barrel and a window barrel.

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Based on the provided text, the device is the Integra® Miltex® N-Tralig® Intraligamentary Syringe. This document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed performance metrics and acceptance criteria as might be found in a De Novo or PMA submission.

Therefore, the "acceptance criteria" discussed here are primarily related to meeting recognized standards and validating specific processes, rather than performance metrics of an AI algorithm or a clinical effectiveness study.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a medical device like a syringe, the "acceptance criteria" are typically related to standards compliance and validation of operational aspects (like cleaning and sterilization) rather than clinical performance metrics in the way one might evaluate an AI algorithm's diagnostic accuracy.

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

The document describes non-clinical technical testing (cleaning, sterilization validation). It does not mention a "test set" in the context of patient data or clinical performance. Therefore, there is no information provided regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set.

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

Not applicable. This device is a mechanical syringe, not an AI diagnostic tool. Ground truth in the context described (cleaning and sterilization validation) would be established by the adherence to specified quality and safety standards and documented validation protocols, likely involving lab technicians and engineers, not clinical experts for ground truth.

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

Not applicable, as there is no clinical "test set" or diagnostic evaluation that would require an adjudication method.

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 a medical device (syringe), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (syringe), not an algorithm.

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

For the technical tests (cleaning and sterilization validation), the "ground truth" is adherence to established, recognized international and national standards (e.g., ISO, AAMI). For biocompatibility, the ground truth is based on the long-standing safety record and material specifications of stainless steel.

8. The sample size for the training set

Not applicable. This is a medical device (syringe), not an AI algorithm requiring 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.

Ask a specific question about this device

These devices are intended for use by dental professionals only. The devices are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

Hu-Friedy dental cartridge syringes are made from chrome-plated brass and stainless steel. Syringes are reusable, sterilizable and packaged non-sterile.

Here's an analysis of the acceptance criteria and study information for the Hu-Friedy Dental Cartridge Syringes, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative or objective pass/fail manner with corresponding numerical results. Instead, it describes performance characteristics that were demonstrated to be "within recommended specifications" of various ISO standards. Therefore, I will derive the acceptance criteria from the mentioned ISO standards and summarize the finding as "Conforms to applicable clauses."

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

The document does not specify the sample size (number of syringes) used for the in-house performance testing. It also does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given it was "in-house testing," it's prospective testing conducted by the manufacturer.

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

This type of information is not applicable to the device described. The "test set" here refers to the physical dental syringes undergoing engineering and performance testing against established international standards (ISO standards). The "ground truth" is determined by measurements and observations as per the test methodologies outlined in those standards, not by expert consensus on clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. Testing against ISO standards typically involves objective measurements and predefined pass/fail criteria, not consensus-based adjudication from multiple human reviewers.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of data/images (e.g., radiologists reading scans), which is not relevant to a dental cartridge syringe.

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

Yes, the performance testing described is a standalone evaluation of the device's physical and functional characteristics against established standards. There is no "algorithm" involved, and the human role is in conducting the tests and verifying compliance, not in interpreting the device's output within a clinical context.

7. The Type of Ground Truth Used

The ground truth used for establishing the performance of the device comprises:

• International Standards: Specifically, ISO 9997:1999, ISO 11499:2007, and ISO 13402:1995 provide the "truth" or benchmark for acceptable performance.
• ANSI/AAMI ST79: This standard serves as the ground truth for establishing successful steam sterilization cycles.
• Manufacturer's Recommended Specifications: The document states that performance was "within recommended specifications of the applicable clauses," implying that the manufacturer's internal specifications, aligned with the ISO standards, were used as the benchmark for "ground truth."

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or algorithm that requires a "training set."

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

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

Ask a specific question about this device

The device is indicated for the injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedures.

KI works' Anesthesia Injection Tool Set (KIW-1000) is a device for injecting local anesthetic for anesthesia prior to, or in conjunction with, dental procedures. This device consists of Main body, Hand-piece, Battery pack and Adapter. All operating displays and the majority of the operator controls are located on front panel of the control unit.

The provided text describes the KI works' Anesthesia Injection Tool Set (KIW-1000) and its submission for 510(k) clearance, asserting substantial equivalence to a predicate device. However, the document does not contain explicit "acceptance criteria" presented as quantitative thresholds or specific performance metrics that the device had to achieve. Instead, the document focuses on demonstrating that the KIW-1000 is "substantially equivalent" to a legally marketed predicate device (Comfort Control Syringe System) based on intended use, technological characteristics, and safety/effectiveness considerations, primarily relying on non-clinical performance and electrical testing.

The study presented is a non-clinical performance test, not a clinical trial evaluating effectiveness against specific acceptance criteria.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating similarity to a predicate device and adherence to safety standards. The performance aspects discussed are comparative and qualitative/descriptive, rather than explicitly defined acceptance thresholds.

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

• Sample Size for Test Set: Not explicitly stated as a number of devices or injections. The "performance test" mentions evaluating "initial slow injection time" for Auto 1 (adult) and Auto 2 (children) settings of the KIW-1000 and comparing it to the predicate device's "first 10 seconds." It implies direct comparison, but the number of tests performed is not quantified.
• Data Provenance: The testing was "non-clinical" (bench testing) performed by KIWORKS Co., Ltd. (Korea). The data is retrospective in the sense that it's reported after the testing, but it's not patient data.

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

• Number of Experts: Not applicable. This was a non-clinical bench test. There were no human experts establishing ground truth for performance. The comparison was to a predicate device's known characteristics and general engineering principles.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No human adjudication was involved in this non-clinical bench testing.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an anesthetic delivery tool, not an AI-assisted diagnostic or interpretation system.

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

• Standalone Performance: Not applicable in the context of AI. This device is a physical, automated-assist medical tool, not an algorithm for diagnosis or interpretation. The device's "standalone" performance was assessed via bench testing, as described in point 2.

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

• Type of Ground Truth: For the performance test, the "ground truth" was the performance characteristics of the predicate device (Comfort Control Syringe System) and engineering standards/specifications (e.g., EN60601-1) for safety. There was no clinical ground truth (like pathology or outcomes data) established.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is not an AI/machine learning system that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there was no training set for this device.

Ask a specific question about this device

MORPHEUS is an instrument intended solely to be used for anesthetic applications inside the oral region in human beings by dentistry professionals certified by local laws.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device named "Morpheus," which is a cartridge syringe intended for anesthetic applications in dentistry. This document does not describe any acceptance criteria or a study that proves the device meets specific performance criteria.

The information typically requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is related to the evaluation of AI/ML or diagnostic devices. The "Morpheus" device, as described, is a cartridge syringe, which is a mechanical device, not a diagnostic or AI-powered one. Therefore, the type of performance evaluation and acceptance criteria for such a device would focus on aspects like materials biocompatibility, sterility, dimensions, force required for delivery, leakage, and other physical/mechanical properties, rather than diagnostic accuracy metrics.

The FDA letter essentially states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics, and raises no new questions of safety or effectiveness. This determination is based on the information provided in the 510(k) submission, which would include testing results relevant to the device's function as a cartridge syringe, but these specific details are not present in the provided FDA letter.

Therefore, I cannot provide the requested information based on the given input. The document does not contain the study details, acceptance criteria, or performance metrics typically associated with the evaluation of AI or diagnostic devices.

Ask a specific question about this device

Cartridge Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

Dental Aspirating Syringes/Self Aspirating Syringes include standard, petite and medium sizes. All syringes are made of stainless steel and have aluminum handles. Syringes are reusable, sterilizable and packaged non-sterile.

This document is a 510(k) Premarket Submission for a Cartridge Dental Syringe (K092943). It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as it's a premarket notification document for a medical device seeking market clearance, not a study report.

The document indicates that the device is a simple cartridge syringe for dental anesthetic injections and is being found "substantially equivalent" to existing devices on the market. This type of submission relies on demonstrating that the new device has similar technological characteristics and intended use as a legally marketed predicate device, rather than requiring new clinical performance data against specific, quantitative acceptance criteria.

Therefore, it is not possible to fill out the requested table and information points from the provided text.

Explanation of what this document is (and isn't):

• 510(k) Premarket Submission: This is a regulatory pathway in the US for medical devices that are substantially equivalent to a legally marketed predicate device. It demonstrates that the new device is as safe and effective as the predicate.
• Substantial Equivalence: This means the device has the same intended use and the same technological characteristics as the predicate, or it has different technological characteristics but does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the predicate device.
• Absence of Acceptance Criteria and Performance Study: For many Class I and Class II devices seeking 510(k) clearance, extensive clinical studies with quantifiable acceptance criteria are not required if substantial equivalence can be established through technological comparison, design features, and material properties. The FDA letter confirms the device classification (Class II) and that it's subject to general controls, indicating that a full PMA (Premarket Approval) with extensive clinical trial data was not necessary.

Ask a specific question about this device

Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

Miltex® Dental Aspirating Syringes include Standard Aspirating Syringes, Petite Aspirating Syringes, Self-Aspirating Syringe, Lightweight Self-Aspirating Syringe, Articulating Barrel Syringe and GripRite™ Standard and Petite Aspirating Syringes. All syringes are made of chrome-plated brass and stainless steel; Lightweight Self-Aspirating Syringe has aluminum handle. Syringes are reusable, sterilizable and packaged non-sterile.

This document is a 510(k) summary for the Miltex® Dental Aspirating Syringes, which is a traditional medical device (not an AI/ML powered device). Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics (like MRMC studies or standalone algorithm performance) is not applicable or available in this submission.

The 510(k) summary establishes substantial equivalence to predicate devices based on:

• Intended Use: "Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity." This is the same as the predicate devices.
• Fundamental Technology, Design, and Materials: The document states the Miltex® syringes are substantially equivalent to the legally marketed predicate devices in these aspects. The devices consist of chrome-plated brass and stainless steel (and aluminum for one specific model), are reusable and sterilizable, and are packaged non-sterile, consistent with standard dental aspirating syringes.

The FDA's review confirms substantial equivalence, allowing the device to be marketed, subject to general controls and applicable additional controls for Class II devices.

Ask a specific question about this device

Indicated for the use of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with dental procedures.

Denjector is a gun type electronic dental anesthetic cartridge syringe. This device is used with injectable local anesthetics packaged in cartridge form. The device consists of: Injector gun, battery, battery charger stand, DC adapter for battery charger stand, Cartridge holder and Cartridge pushing/pulling pin. Standard needles may be used with the device.

This document is a 510(k) summary for the Denjector, an electronic dental anesthetic cartridge syringe. It indicates that no clinical tests were performed to establish its safety and effectiveness. Instead, the submission relies on non-clinical tests and a comparison to a predicate device to claim substantial equivalence. Therefore, the information requested regarding acceptance criteria and a study proving those criteria cannot be extracted from this document, as such a study was not conducted.

Here is a summary of the information that can be extracted, along with explanations for the missing data:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document explicitly states, "Clinical testing was not conducted." Therefore, there are no acceptance criteria derived from clinical performance and no reported device performance against such criteria. The substantial equivalence claim is based on non-clinical standards and comparison to a predicate.

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

• Sample Size: Not applicable (No clinical test set was used).
• Data Provenance: Not applicable (No clinical data was used).

Explanation: As no clinical testing was performed, there is no test set or associated data provenance.

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

• Number of Experts: Not applicable (No clinical test set requiring ground truth established by experts).
• Qualifications: Not applicable.

Explanation: Without clinical testing, there was no need for experts to establish ground truth for a test set.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable.

Explanation: No clinical test set means no adjudication method was necessary.

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

• MRMC Study Done: No.
• Effect Size: Not applicable.

Explanation: An MRMC comparative effectiveness study involves human readers and clinical cases. Since no clinical testing was done, no such study was conducted.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study Done: No.

Explanation: The "Denjector" is a hardware device (an electronic dental anesthetic cartridge syringe), not a software algorithm. Therefore, a standalone algorithm-only performance study is not relevant. The testing mentioned (EN 60601-1, EN 61000-3-2, and EN 61000-3-3) refers to electrical safety and electromagnetic compatibility standards for medical devices, which are not performance studies in the clinical sense.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable.

Explanation: There are no clinical outcomes or diagnostic assessments to establish ground truth for, as no clinical study was performed.

8. Sample Size for the Training Set:

• Sample Size: Not applicable.

Explanation: The Denjector is a hardware device, not an AI/ML algorithm that requires a training set.

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

• Method: Not applicable.

Explanation: As no training set was used, no ground truth needed to be established for it.

In summary, the provided 510(k) submission for the Denjector explicitly states that no clinical trials were conducted. The device's safety and effectiveness were established through non-clinical testing against recognized standards (EN 60601-1, EN 61000-3-2, EN 61000-3-3) and a comparison to a predicate device (CC:3; computer controlled syringe by DENTSPLY Midwest Professional Ltd., K983105) to demonstrate substantial equivalence.

Ask a specific question about this device

To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.

The CompuDent STA™ Syringe is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes. The device provides audible and visible status indicators of injection rate, amount of anesthetic remaining in the carpule, and pressure at the tip of the needle. It is substantially equivalent to the company's currently marketed CompuDent™ computer controlled syringe.

This 510(k) summary for the CompuDent STA™ Syringe indicates that it is substantially equivalent to a previously marketed device (CompuDent™ computer controlled syringe). As such, it relies on the predicate device's performance and does not describe a new study with acceptance criteria and device performance. Device performance for substantial equivalence is often established through detailed comparisons to the predicate device's specifications and existing performance data, rather than new, stand-alone clinical trials with explicitly stated acceptance criteria.

Therefore, many of the requested elements (like sample size, number of experts, ground truth, MRMC study, and training set details) are not explicitly present in the provided text because the submission is for substantial equivalence to an existing device rather than a de novo approval requiring extensive new clinical validation.

However, based on the provided text, I can infer what would typically be considered "acceptance criteria" for a device of this nature and the "study" demonstrating performance, which in this case is the substantial equivalence comparison.

Here's an attempt to answer your questions based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the primary "acceptance criterion" is that the new device performs as intended and is substantially equivalent to the predicate device. Performance is demonstrated by showing that the design, materials, principle of operation, and intended use are the same as the predicate. The document doesn't quantify specific performance metrics with numerical acceptance criteria (e.g., "flow rate must be within X% of target").

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

• Sample size: Not applicable or not specified. Substantial equivalence typically relies on design verification/validation and comparison to the predicate's established performance, rather than a new clinical "test set" in the traditional sense for a novel device.
• Data provenance: Not explicitly stated. The comparison is against the "company's currently marketed CompuDent™ computer controlled syringe," which implies internal company data and existing market performance data for the predicate.

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

• Not applicable. As this is not a study requiring medical image interpretation or complex diagnostic outcome assessment, there isn't a "ground truth" established by experts in this context. The "truth" is established by demonstrating that the device functions according to its design and industry standards, and is equivalent to the predicate.

4. Adjudication method for the test set

• Not applicable. There was no "test set" in the clinical trial sense that would require 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

• No. This device is a mechanical syringe, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• Not applicable. This is a medical device, not a software algorithm, and it always functions with human-in-the-loop operation (a dentist or other medical professional).

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

• The "ground truth" for this submission is based on the established performance and safety of the legally marketed predicate device (CompuDent™ computer controlled syringe), combined with design verification and validation testing to ensure the new device meets its specifications and performs as intended. There isn't a specific "ground truth" from a medical outcome perspective for a substantial equivalence submission of this type of device.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

• Not applicable, as there is no training set.

Ask a specific question about this device

Indicated for use with pre-filled anesthetic cartridges and press fit dental needles for the manual injection of local dental anesthetics into the oral tissues.

The cartridge syringe may aid in the reduction of needle stick injuries.

The Hagar MIRAMATIC System consists of a cartridge syringe (the MIRAMATIC) and dental needles (MIRAJECT).

The MIRAMATIC System is a manual system designed exclusively for use with MIRAJECT needles. The hub of the syringe is designed to receive the needle using a compression fit mechanism rather than a threaded screw-on motion or slip-fit. The needles have a corresponding specially designed cone to allow seating by push fit on to the hub. The syringe hub has locked and unlocked positions.

The Hager MIRAMATIC Safe Syringe System is a dental cartridge syringe system with an antistick feature, needle re-capper, and sharps container, indicated for use with pre-filled anesthetic cartridges and press-fit dental needles for the manual injection of local dental anesthetics into the oral tissues. The device is also stated to aid in the reduction of needle stick injuries.

1. Acceptance Criteria and Reported Device Performance

The provided submission does not explicitly state quantitative acceptance criteria for the Hager MIRAMATIC Safe Syringe System. However, it indicates that the device's performance and reliability characteristics were established through various tests.

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

The submission does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the mechanical testing, cleaning, sterilization efficacy, or simulated clinical evaluation.

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

The submission does not specify the number of experts used or their qualifications for establishing ground truth, particularly for the simulated clinical evaluation.

4. Adjudication Method for the Test Set

The submission does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided document. The device is a physical medical device (syringe system) rather than an AI-powered diagnostic tool, so such a study would not typically be applicable in this context.

6. Standalone Performance Study

The submission describes "Testing activities" conducted to establish the performance and reliability characteristics of the new device. This refers to the standalone performance of the device itself and its components (syringe, needles, and their interaction), rather than an algorithm. This includes mechanical testing, cleaning and sterilization efficacy, and simulated clinical evaluation.

7. Type of Ground Truth Used

The "ground truth" for this medical device would be established based on:

• Mechanical Engineering Principles and Standards: For mechanical testing (e.g., ensuring secure fit, proper ejection, durability).
• Microbiology/Sterilization Standards: For cleaning and sterilization efficacy (e.g., absence of viable microorganisms after specified processes).
• Clinical Safety and Efficacy Observations in a Simulated Environment: For the simulated clinical evaluation, focusing on the device's function as intended, particularly the "antistick feature" and ease of use. This would likely involve observing the device's operation under controlled conditions and confirming that it performs its intended functions effectively and safely.

The document does not detail specific "ground truth" methodologies beyond these general categories.

8. Sample Size for the Training Set

As this is a physical medical device and not an AI/software product, the concept of a "training set" in the context of machine learning does not apply. The development and testing process would involve iterative design, prototyping, and testing of physical components and assemblies to meet specified design requirements.

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

Since the concept of a "training set" is not applicable, there is no corresponding method for establishing a ground truth for it. The device's design and functionality would be validated against engineering specifications, user needs, and regulatory requirements through the testing activities mentioned.

Ask a specific question about this device