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The dental delivery system is a device intended to support the instruments used by the dental practitioner, delivering those instruments to an accessible position during a dental procedure. This device may control and be the means of delivering compressed air, water, vacuum and low voltage electricity to a variety of instruments commonly used in dental practice.

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The provided text is a 510(k) clearance letter from the FDA for a Dental Delivery System Series 5 and 5 Plus.

This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) letter primarily addresses the substantial equivalence of the device to legally marketed predicates and outlines regulatory requirements. It does not delve into specific performance metrics, clinical study design, or ground truth establishment for a medical device that relies on diagnostic performance (like an AI algorithm).

Therefore, based solely on the provided text, it is impossible to answer the questions regarding acceptance criteria and the study that proves the device meets them. The device described (Dental Delivery System Series 5 and 5 Plus) is a physical piece of dental equipment, not a diagnostic algorithm or AI software for which the requested performance metrics and study details would be relevant.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data for a diagnostic device, or a clinical study report.

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The DCI Edge Dental Chair with operative unit is a device intended to position the patient in such a manner to provide to the dental practitioner visual and manual access to the oral cavity. This device should provide for the ergonomic necessities of most patients, both adults and children, throughout its range of movement. The device shall also be the means of supporting delivery systems for the purpose of standard dental procedures.

The DCI Edge Chair with Operative Unit is a dental chair with an operative unit attached. There are three main parts to the proposed device: a dental chair, dental light and dental chair has adjustable headrest, backrest, seat height and armrests. The dental chair unit consists of a floor box to which are attached a number of operative units: lights, cuspidor, cup filling device, control panel, and foot control. The instrument panel also includes a 3-way syringe and salvia ejector.

The provided documents describe a DCI Edge Dental Chair with Operative Unit (K151987), which is a medical device. However, the information provided does not contain acceptance criteria related to device performance in terms of diagnostic accuracy or a study proving it meets such criteria.

The context of this document is a 510(k) premarket notification for a Class I dental chair. Class I devices are generally low-risk and subject to general controls. The review process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy or performance studies like those typically required for artificial intelligence (AI) or diagnostic devices.

Here's why the requested information cannot be fully provided based on the given text:

• Type of Device: A dental chair and operative unit is a mechanical device designed for positioning patients and supporting dental tools. It does not perform diagnostic functions, analyze data, or make clinical interpretations that would require metrics like sensitivity, specificity, accuracy, or a comparison to a "ground truth" derived from expert consensus or pathology.
• Regulatory Focus: The 510(k) summary (pages 3-5) and the FDA letter (pages 0-1) explicitly state the focus is on "substantial equivalence" to a predicate device (Foshion Chair Mounted Dental Unit K071353). This involves comparing intended use, technological characteristics, and safety standards, not diagnostic performance metrics.
• "Acceptance Criteria" in this context: For this device, "acceptance criteria" primarily relate to compliance with recognized performance standards for medical electrical equipment, biological evaluation, risk management, and usability engineering, as listed in Section 8 "Non Clinical Testing" (page 5). It does not refer to clinical performance metrics for diagnosis or prediction.
• "Study that proves the device meets the acceptance criteria": The "study" here is the non-clinical testing demonstrating compliance with the listed ISO/AAMI/IEC standards. This is a demonstration of safety and basic functionality, not clinical performance.

Therefore, many of the requested fields are not applicable to the information provided about this specific device.

However, I can extract the relevant information that is present in the document.

Summary of Information from the Document (where applicable):

Since the device is a dental chair and not an AI or diagnostic device, the requested table and many of the questions related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. The "testing" referred to is compliance with engineering and safety standards, not clinical performance testing with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth for diagnostic or clinical performance was established, as this is a mechanical dental chair, not a diagnostic device.

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

• Not Applicable.

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-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm. The software controls the chair's mechanical movements.

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

• Not Applicable.

8. The sample size for the training set

• Not Applicable. Training data for an AI algorithm is not relevant to this device.

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

• Not Applicable.

In conclusion, the provided documentation focuses on the safety and functional equivalence of a dental chair to existing products, rather than the performance metrics of a diagnostic or AI-driven device.

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The LectraJet Needle-Free Injection System is intended to deliver subcutaneous (SQ) or intramuscular (IM) injections of vaccines and other injectable medications.

The LectraJet Needle-Free Injection System may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections.

The LectraJet Needle-Free Injection System may also be used by patients to self inject or to have other individuals administer injections of prescribed medications.

The components of the LectraJet® Needle-Free Injection System include the needle-free single-use syringes with disposable vial adapter and cap with plunger rod attached and the injector handpiece with manual reset mechanism.

The LectraJet® handpiece and reset mechanism are sold as a complete injection system contained within a carrying case. The carrying case is an accessory of convenience that provides for portability, organization, and ease of use for the practitioner.

The LectraJet® syringes are packaged sterile and designed to be filled by the end user at the time of use. The polycarbonate syringes have a molded orifice at the front end. The syringe orifice is available in sizes 0.006", 0.008", 0.010" and 0.012" diameter, which allows the user to choose the syringe appropriate for the desired depth of penetration (IM/SQ) and patient selection (child/adult).

The syringes have a flange at the back end that is held by the injector handpiece when delivering the injection. Syringes are designed to be used immediately upon filling, similar to a traditional needle and syringe, and identical to the Biojector 2000® and Medi-Jector Vision® syringe filling philosophy. After the syringes are filled, they are inserted directly into the LectraJet® handpiece.

The LectraJet® handpiece contains a spring drive system that, when compressed, provides the energy to deliver the injection. To compress the spring, the handpiece is placed in a manual reset mechanism and hand pressure is applied to the reset mechanism lever. In the Medi-Jector Vision®, the manual power source used to compress the spring is a hand-twist knob. In the Biojector 2000®, the power source is either a gas cartridge or a gas cylinder.

When the LectraJet® handpiece is actuated, the spring drive system is released, and the handpiece ram contacts the syringe piston to drive the injectate out through the syringe orifice, creating a jet stream with enough energy to penetrate the tissue. This is identical in principle to the Biojector 2000® and the spring powered Medi-Jector Vision®.

After the injection, the used syringe is released into an appropriate trash container.

Little maintenance is required for the LectraJet® handpiece. There are no o-rings or seals to change. No sterilization of the handpiece is required.

All of the above features are similar to the Biojector 2000® and the Medi-Jector Vision®, predicate devices and accessories.

The LectraJet® Needle-Free Injection System demonstrates substantial equivalence to predicate devices (Biojector 2000® and Medi-Jector Vision®) based on a non-clinical study evaluating injection force profile, injection duration, and depth/dispersion into a homogeneous substrate.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly define "acceptance criteria" in a quantitative sense with specific thresholds. Instead, the study's conclusion is that the LectraJet® is substantially equivalent to the predicate devices based on the test results. The device performance is reported in a comparative manner against these predicates.

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

• Sample Size: The document does not specify the exact sample size for the test set (number of injections performed or devices tested).
• Data Provenance: The study is reported within a 510(k) submission to the FDA, suggesting it was likely conducted by or for D'Antonio Consultants International, Inc. (DCI, Inc.) at their facility or a contracted lab. The country of origin of the data is not explicitly stated but can be inferred as the USA, given the submitter's location (East Syracuse, NY) and the FDA submission context. The study is non-clinical (bench testing), not referring to patient data, therefore the terms retrospective or prospective do not apply in the typical sense.

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

This section is not applicable as the study described is a non-clinical bench test comparing physical characteristics of the device against predicate devices. There is no "ground truth" established by experts in the context of clinical outcomes or imaging interpretation. The ground truth for the comparison is the measured performance of the predicate devices themselves.

4. Adjudication Method for the Test Set

This section is not applicable. As a non-clinical bench test, there is no need for adjudication by experts in the way clinical studies or image interpretation studies would. The measurements of force, duration, depth, and dispersion are objective physical measurements.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The described study is a non-clinical performance evaluation of the device itself, not a comparative study of human readers' performance with and without AI assistance.

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

This section is not applicable. The LectraJet® is a physical medical device (a needle-free injection system), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant. The study evaluates the standalone performance of the physical device.

7. The Type of Ground Truth Used

The ground truth for this non-clinical study is the measured physical performance of the predicate devices (Biojector 2000® and Medi-Jector Vision®) for the parameters of injection force profile, injection duration, and depth/dispersion into a homogeneous substrate. The LectraJet®'s performance was then compared to these established predicate device measurements to determine substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" for this type of non-clinical device performance study. The LectraJet® is a mechanical device, not an AI model that requires training data.

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

This section is not applicable as there is no training set for a mechanical device.

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