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The SD500 High Speed Handpiece Series is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.

The SD500 High-Speed Handpiece Series includes a fiber optic high speed handpiece, to be marketed as a SD500 Elite Handpiece and a non-fiber optic handpiece, to be marketed as a SD500 Pro Handpiece. Both the Elite and the Pro versions are available as lubefree or lubricated turbine handpieces. Each is a pneumatically driven handheld device with multiport water spray that is capable of reaching rotational speeds of 367,200 – 448,800 rpms at a recommended air pressure of 38 to 43 PSI. The series delivers a range of 39 - 50 watts of power providing .28 oz.-in. of stall torque at 43 psi. The handpieces are constructed of stainless steel, including the internal air and water tubes, which provide drive air to the turbine assembly and cooling water to the work site. The handpiece also uses PEEK in its construction. The handpieces incorporate either a lubefree ceramic bearing turbine assembly or a lubricated ceramic bearing turbine assembly. Both versions of the turbine assembly use a push button autochuck. The stainless steel and aluminum air driven turbine assembly provides rotation to the bur. The SD500 High-Speed Handpiece Series uses a quick disconnect coupler that allows easy connection to the dental line delivery tubing. This coupler allows for easy rotation of the handpieces when attached to the tubing. These couplers include both fiber optic and nonfiber optic versions with Type 3 or 2 connections. The fiber optic version uses LED technology to deliver the light to the handpiece. All couplers are autoclavable. The burs used with the SD500 High Speed Handpiece Series are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used. All handpieces in this series incorporate RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag will allow the practitioner to track the device within the office only if the practitioner has a separate reader. A reader will enable the practitioner to track such things as usage and maintenance.

This document describes a 510(k) premarket notification for the SD500 High Speed Handpiece Series. It is a submission for a dental handpiece, which is a Class I reserved device. As such, the information provided focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and material characteristic comparisons and adherence to relevant industry standards, rather than clinical study results establishing diagnostic accuracy or comparative effectiveness with human readers.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, organized according to your request:

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

The provided document doesn't explicitly state numerical "acceptance criteria" in the way one might see for a diagnostic device (e.g., "sensitivity > 90%"). Instead, the performance evaluation is based on meeting the requirements of recognized industry standards and demonstrating comparable performance to predicate devices. The "reported device performance" is largely described qualitatively or by reference to meeting these standards.

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 refers to "bench testing" and "test results" to demonstrate conformity with standards like ISO 14457 and IEC 60601-1.

• Sample Size: No specific numerical sample size is provided for these bench tests. This is typical for engineering performance testing of mechanical devices where testing is often done on a representative number of units to ensure consistency and compliance with specifications.
• Data Provenance: The tests were "conducted to evaluate the functional performance and safety." Given this is a 510(k) submission by DentalEZ Inc., located in Lancaster, Pennsylvania, USA, the testing was likely conducted in-house or by a contracted laboratory within the US or a region adhering to these international standards. The data is prospective as it was generated specifically for this submission.

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 product is a dental handpiece, not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" and "experts used to establish ground truth" with qualifications like "radiologist with 10 years of experience" does not apply in the context of this submission. The performance of the device is assessed against engineering specifications and industry standards, not against expert interpretations of diagnostic outputs.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human judgment (e.g., expert review of medical images). Since this submission pertains to a mechanical device and its performance against engineering standards, no adjudication method as described would be applicable or necessary. Performance is measured objectively through physical 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

No MRMC comparative effectiveness study was done. This type of study is relevant for AI-powered diagnostic tools where human readers are involved in interpreting results, with or without AI assistance. The SD500 High Speed Handpiece Series is a direct therapy/procedural device, not a diagnostic or AI-assisted system.

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

No standalone algorithm performance study was done. This device does not involve any algorithms or AI for diagnostic or interpretive purposes. Its performance is entirely mechanical and physical.

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

As this is a mechanical device, the "ground truth" for its performance is established by:

• Compliance with Industry Standards: E.g., ISO 14457 (Dentistry Handpieces and Motors), IEC 60601-1 (Medical Electrical Equipment), ANSI/AAMI ST79, ISO 14937, ANSI/AAMI ST81 (for sterilization), FDA Guidance for "Reprocessing Medical Devices."
• Engineering Specifications: Meeting predefined rotational speed, power, and torque outputs.
• Material Compatibility: Use of materials with established safety profiles (Stainless steel, PEEK, Ceramic bearings) from existing industry knowledge.

These standards and specifications serve as the "ground truth" against which the device's physical and functional performance is measured.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth for it to be established.

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The SD5 Ultrasonic TableTop Doppler (hereinafter called "SDS") and SD6 Ultrasonic TableTop Doppler (hereinafter called "SD6") are intended to be used by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription in hospitals, clinics and private offices.

The 2 MHz and/or 3 MHz obstetrical probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal heart well being. They can also be used to verify fetal heart viability.

The SD5&SD6 Ultrasonic Tabletop Doppler is a hand-held device for non-invasive measurement and display of fetal heart rate utilizing the principle of Doppler shift of an ultrasound. The ultrasound is transmitted from the probe to patient body (maternal abdominal wall), and moves through biophysical objects. The acoustic ultrasound is reflected by blood and moving objects such as the fetal heart. The reflected ultrasound is received by the probe and is converted into electric signals. The waveform data are applied to the CPU for all the digital processing on LED Display, operation keys. The audio signal is taken off for the routing to the speaker to generate the analogue signals before digital processing. The system is compatible with 2 MHz or 3 MHz for fetal heart rate. The signal acquired can be transferred to SD5 by wired method, and by Bluetooth to SD6.
The main unit can be powered by main supply (100 V-240 V~) or Ni-MH Battery (7.2 V/2000 mAh). And transducers are powered by 3.7 V/800 mAh Lithium Battery only.

The provided document is a 510(k) Premarket Notification from the FDA for the Edan Instruments, Inc. SD5 & SD6 Ultrasonic Tabletop Doppler. This document describes the device, its intended use, and compares it to a predicate device. It also briefly mentions performance testing.

However, the document does not contain the specific acceptance criteria or the detailed study results that prove the device meets these criteria in a quantitative manner, which is typical for a clinical performance study. The primary focus of this document is to demonstrate substantial equivalence to a previously cleared device (K102138, also an SD5/SD6 Ultrasonic Tabletop Doppler from Edan Instruments).

Based on the information available in the document, here's what can be extracted and inferred, along with the information that is not present:

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

Note: The above table is derived directly from the "FHR Specifications" comparison with the predicate device (K102138). The current device (SD5/SD6) actually specifies a better performance for FHR measuring range and accuracy than its predicate, which supports its substantial equivalence claim. However, these are technical specifications and not necessarily acceptance criteria from a specific clinical performance study. The document states that "all testing passed pre-specified criteria," but does not explicitly list these criteria.

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

• Not provided. The document states "Clinical test: Not applicable." This indicates that no new clinical study (with a test set of patients) was conducted for this 510(k) submission to assess the device's performance in a clinical setting. The substantial equivalence is based on technical comparisons, safety, and performance bench testing.

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. As no clinical test data is provided, there is no mention of experts or ground truth establishment for a patient test set.

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

• Not applicable. No clinical test data is provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. The device is a fetal ultrasonic monitor (Doppler) for detecting fetal heart rate. It is a standalone measurement device, not an AI-powered image analysis tool that assists human readers. Therefore, an MRMC study and AI assistance effect size are not relevant to this device type.

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

• Yes, effectively. The performance data related to FHR measuring range, accuracy, and resolution (as shown in the table above) represent the standalone technical performance of the device. This performance is assessed through bench testing and compliance with standards (e.g., IEC 60601-2-37). The device, by its nature, provides a direct measurement (fetal heart rate) rather than involving an "algorithm only" in the sense of image interpretation, but its core function is performed independently to provide the output.

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

• For the technical specifications (FHR measuring range, accuracy, resolution), the ground truth would typically be established by reference measurement techniques using calibrated equipment and simulated fetal heart rate signals during bench testing. The document states "Bench testing was conducted on the SD5&SD6 Ultrasonic Tabletop Doppler, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-2-37: 2007." This standard specifies requirements for the safety and essential performance of ultrasonic diagnostic and monitoring equipment, including accuracy of measurements.

8. The sample size for the training set

• Not applicable. This device is a hardware-based fetal Doppler. It does not appear to employ machine learning or AI algorithms that would require a "training set" of data in the conventional sense. Its functionality relies on established Doppler physics and signal processing techniques.

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

• Not applicable. (See point 8).

Summary of what the document focuses on for acceptance:

The primary method for demonstrating acceptance and substantial equivalence in this 510(k) submission relies on:

• Predicate Device Comparison: Showing that the new device has the same intended use, similar product design, and comparable performance and safety characteristics to a legally marketed predicate device.
• Compliance with Recognized Standards: Mentioning compliance with standards such as IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic equipment safety/performance), IEC 62304 (software life cycle), ISO 10993-1, -5, -10 (biocompatibility), and NEMA UD-2 (acoustic output). Passing these tests implicitly means meeting the criteria outlined within those standards.
• Bench Testing: Conducted to ensure the system meets specified technical performance.
• Software Verification and Validation: Performed for the "moderate" level of concern software.

The absence of clinical study data is explicitly noted as "Not applicable," suggesting that the FDA deemed the technical and bench testing sufficient to establish substantial equivalence for this type of device based on its intended use and comparison to the predicate.

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The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.

Ultrasonic TableTop Doppler (Models SD5, SD6) provides the following primary features:

• Basic parameters: FHR
• 240 seconds fetal heart sound record and playback
• Infrared communication(for SD6 only)
• Ni-MH battery for 20 hours continuous working of main unit
• Li-ion battery for 2.5 hours continuous working of SD6 probe
• Charge the SD6 probe battery by main unit
• Continuous wave Doppler transducer for FHR detection

Here's a breakdown of the acceptance criteria and the study information for the Edan Instruments, Inc. Ultrasonic TableTop Doppler (Models SD5 and SD6), based on the provided text:

Based on the provided text, the submission is a 510(k) Summary of Safety and Effectiveness, which aims to demonstrate substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with detailed performance metrics. Therefore, the "acceptance criteria" here refer to the regulatory standard of substantial equivalence, and the "study" is the overall verification and validation testing, not a traditional clinical trial with a test set, ground truth, and statistical analysis of performance metrics.

Acceptance Criteria and Reported Device Performance

Study Details (Based on the provided 510(k) summary)

The provided document describes a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to previously cleared devices rather than a standalone clinical performance study with explicit acceptance criteria for diagnostic accuracy. Therefore, many of the typical elements of a clinical study, such as specific sample sizes for test sets, expert-established ground truth, adjudication methods, or MRMC studies, are not detailed in this summary.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided summary.
   • Data Provenance: Not specified. The document only mentions "Verification and validation testing."

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

   • Not specified. The 510(k) summary does not detail the methodology for establishing ground truth for any specific performance metrics.

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

   • Not specified.

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 comparative effectiveness study was mentioned. This device is a fetal heart rate Doppler, not an AI-assisted diagnostic tool for image interpretation by human readers.

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

   • The document implies general "Hardware testing" and "Software testing," but it does not specify a standalone performance study in the context of an algorithm's diagnostic accuracy. The device itself is a standalone fetal Doppler used by healthcare professionals.

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

   • Not specified. The "Test Summary" only lists generic quality assurance measures like "Software testing," "Hardware testing," "Safety testing," "Environment test," and "Risk analysis." For a fetal Doppler, ground truth might involve comparisons against other established methods for FHR detection, but the details are not provided.

7. The sample size for the training set:

   • Not applicable as this documentation pertains to a traditional medical device (fetal Doppler) and not an AI/ML algorithm that requires a training set.

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

   • Not applicable.

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