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Administration of local anesthesia for dental procedures.

The Dentalhitec QuickSleeper 5 (QS5) is indicated for the administration of local anesthesia for dental procedures using computer-controlled handpiece and wireless foot pedal. The QuickSleeper5 is a reusable injection device, allowing intraosseous and mucosal injection of anesthetic within the oral cavity. The QS5 functionality includes injection, aspiration, and rotation. The handheld syringe device's electronic interface provides the user with information on selected injection speed and injection site resistance. The rotational movement allows the needle to pass through dense tissue.

The provided FDA 510(k) clearance letter for the QuickSleeper 5 device indicates that it is a spring-powered jet injector for administering local anesthesia in dental procedures. The document primarily focuses on demonstrating substantial equivalence to a predicate device (RA-5 ANESTO Handpiece) and a reference device (The WAND STA System) through a comparison of technological characteristics and non-clinical performance testing.

However, the provided text does not contain the detailed acceptance criteria and study data typically associated with proving the AI/software component of a device meets specific performance metrics. The document mentions "Software Verification testing" as one of the non-clinical tests performed, but it only lists the categories of tests (Injection testing, Audio indicators, Option selection, Standby function, Conformance to IEC 62304) without providing:

• Specific quantitative acceptance criteria (e.g., "injection volume must be within X% of target").
• Reported device performance values against those criteria.
• Details on the test set, data provenance, ground truth establishment, or human expert involvement often seen in AI/software clinical validation studies.
• Any information about training sets for an AI system.

This suggests that the QuickSleeper 5, while having "computer-controlled" elements and "firmware with programmable settings," is being cleared as a mechanical/electronic device for drug delivery, not as a device heavily reliant on AI for diagnostic or decision-making purposes that would necessitate the kind of rigorous AI/ML performance validation outlined in your request. The "Software Verification testing" appears to relate more to functional safety and performance of the device's control software rather than a sophisticated AI algorithm making "decisions."

Therefore, based solely on the provided text, I cannot complete most of the requested fields because the information is not present. The document focuses on showing the device functions as intended mechanically and electronically and is safe and effective when used by a human practitioner, rather than demonstrating complex AI performance.

For completeness, I will extract what little information is available related to "acceptance criteria" and "study" details, while noting the significant gaps.

Acceptance Criteria and Reported Device Performance

The document states, "To demonstrate substantial equivalence, the subject device met the acceptance criteria for the following non-clinical testing." While it lists categories of tests, it does not provide specific quantitative acceptance criteria or the reported performance metrics of the device against those criteria.

Study Details (Based on provided text)

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

   • Sample Size: Not specified. The document refers to "non-clinical testing" and "simulated use" but does not provide specific sample sizes (e.g., number of injections, number of test runs, number of users in usability).
   • Data Provenance: Not specified. The manufacturer is Dentalhitec, located in France. The testing location or data origin is not mentioned. The studies were "non-clinical" and "simulated use," implying lab/bench testing rather than patient data.
   • Retrospective or Prospective: N/A for this type of non-clinical, simulated use testing.

2. 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/not specified. For "Software Verification testing" and "Device safety and performance testing" of a mechanical/electronic device, ground truth is typically established by engineering specifications, calibration standards, and established test methodologies, not human expert consensus. Usability testing involved "collecting user feedback through direct input and observations," implying users (dental professionals) participated, but details on their number or qualifications as "ground truth experts" are not given.

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

   • Not applicable/not specified. Adjudication methods are typically used when subjective expert review is required to establish ground truth for complex tasks like image interpretation, which is not the primary subject of these tests.

4. 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 MRMC study was described. This is expected given the device's function as a drug delivery system, not an AI diagnostic/interpretive tool.

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

   • Not applicable in the context of an "AI" algorithm as you might expect for an image analysis tool. The "Software Verification testing" would implicitly include standalone algorithm (firmware) performance checks, but these are for the control functions of the device (injection, audio, etc.), not for an independent AI diagnostic output.

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

   • For functional and safety testing, ground truth is based on engineering specifications, physical/electrical measurements, established industry standards (e.g., ISO, IEC), and successful completion of pre-defined test protocols. It is not derived from expert consensus, pathology, or outcomes data in the way an AI diagnostic would require.

7. The sample size for the training set:

   • Not applicable/not specified. The document does not describe the use of machine learning or AI that would require a "training set" in the conventional sense. The "firmware" likely contains programmed logic and presets, not a model trained on data.

8. How the ground truth for the training set was established:

   • Not applicable. No training set for an AI model is described.

Summary of Limitations Based on Provided Text:

The provided FDA letter and 510(k) summary are for a medical device (spring-powered jet injector) with some electronic and software controls, but it does not represent a typical AI/ML-driven device that would require validation against complex "ground truth" derived from patient data or human expert interpretation. The "software verification testing" mentioned refers to the functional software controlling the mechanical aspects of the device, not an AI algorithm performing complex analytical tasks. Therefore, most of the detailed information requested for an AI system's validation is not present in this document.

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Drilling system to perforate cortical bone in order to administer local anesthesia in spongiosa. Application in dentistry.

RA-5 "ANESTO" is a handpiece, which, on the one hand, is provided with a coupling system according to ISO 3964. This coupling allows the handpiece's attachment onto a corresponding dental motor, for transmitting the motor's rotational movement to the attached intraosseous injection needle, intended to perforate cortical bone. On the other hand, it was designed for being equipped with an anesthetic cartridge acc. ISO 11499, volume 1.7 or 1.8ml. After having perforated the bone, this cartridge's anesthesia can be administered locally in the spongiosa by means of a manually-operated dosage lever. "ANESTO's" application is intended in dentistry.

The provided text describes the 510(k) summary for the "Handpiece RA-5 'ANESTO'" and its substantial equivalence determination. However, it explicitly states:

• "Clinical data were not needed for this new product."
• "Bench testing results demonstrate substantially equivalence."

This means that a formal clinical study with acceptance criteria, human readers, ground truth establishment, and training/test sets as typically understood for an AI/ML device was not conducted for this specific medical device submission. The substantial equivalence was based on bench testing.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance, ground truth types, or training set details because this information is not present in the provided document.

Instead, the submission relies on the device being "substantially equivalent" to predicate devices based on:

• Intended Use: Drilling system to perforate cortical bone to administer local anesthesia in spongiosa; application in dentistry.
• Technological Characteristics: Similar to the predicate, but designed to be attached to and driven by a dental micro motor (air or electric motor) instead of an integrated air-supplied driving system. Handpiece shape and ease of operation were improved.
• Performance Parameter: Stated as "very similar to the predicate device."
• Material: Stated as "very similar to the predicate device."
• Performance Testing: Bench testing results were used to demonstrate substantial equivalence.

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• Administration of intraosseous anesthesia for dental indications.

The Cyberjet™ is a dental device intended for intraosseous injection of local anesthetics. Intraosseous injection requires the dentist to drill a small hole in the bone adjacent to the problem tooth. The dentist then uses a standard anesthesia needle and svringe to inject the local anesthetic solution into the previously drilled hole to numb the nerve of the tooth. The Cyberjet™ combines the dental drill and the injection needle into one device and performs both the drilling and injection functions with the same device. After an appropriate injection site has been identified, a topical anesthetic is applied to the gum, followed by a few minutes wait to allow the topical anesthetic to take effect. The previously selected injection site is located and the injection motor and the injection motor are turned on. The tip of the drill/needle is placed on the overlying gum and pressure is applied. The drill/needle passes through the soft tissue and starts to perforate the cortical plate. After the penetration of the cortical plate, the drill motor is turned off by releasing the momentary-switch on the foot-pedal. Local anesthetic is continuously dispensed into the tissue during and after the drilling process through the Infuser. Use of the Cyberjet™ will result in a simple one-step intraosseous injection for dental anesthesia. The system includes 5 components: 1. A Hollow Tubing Needle referred to as a drill/needle or Infuser that serves as a drill as well as a hypodermic iniection needle.

The provided document is a 510(k) Premarket Notification Summary of Safety and Effectiveness Information for the Cyberjet™ Local Anesthesia System. It focuses on regulatory classifications and substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them based on the text provided. The document primarily addresses regulatory approval based on demonstrating substantial equivalence to a legally marketed predicate device.

Specifically, the document does not contain:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes for test sets, data provenance, or details about the experts establishing ground truth.
• Adjudication methods.
• Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set or how ground truth for the training set was established.

The document's purpose is to outline the device's classification, intended use, and its substantial equivalence to the predicate device Stabident System Intraosseous Local Anesthesia K910446.

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