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The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage.

The device and its predicate are small digital imaging receptors that may be used in place of dental x-ray film. The new control mechanism differs from the predicate in that image acquisition may additionally be triggered through a hardwire to an x-ray tube. This modification allows for a quicker x-ray response time and may improve ergonomics as it eliminates the need for a standalone remote module. The existing firmware has been altered to support the modified and additional hardware. The new remote module may be housed within a specified x-ray source. The modification in no way effects the fundamental technology governing image acquisition.

Based on the provided document, here's an analysis of the acceptance criteria and the study (or lack thereof) to prove the device meets them:

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

The document does not provide specific, quantifiable acceptance criteria or reported device performance in a table format. It states generally:

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

The document does not specify the sample size used for any test set or the data provenance.

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)

The document does not provide information about any experts used to establish ground truth or their qualifications.

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

The document does not describe any adjudication method for a test set.

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 multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. The device in question is a digital X-ray imager, not an AI-assisted diagnostic tool.

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

This document describes a modification to a digital dental X-ray imaging system, which is a hardware and firmware update to improve image acquisition and ergonomics. It is not an algorithm-only or AI device, so a standalone performance study in that context is not applicable and was not performed. The "standalone" aspect in this context refers to the elimination of a "standalone remote module."

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

The document does not describe the type of ground truth used, as it doesn't detail specific performance studies where ground truth would be established for diagnostic accuracy. The focus of this 510(k) submission is on demonstrating that a modification to an existing system maintains its safety and effectiveness relative to its predicate, rather than establishing primary diagnostic efficacy with new clinical data. The "ground truth" implicitly would be that the modified system continues to produce images suitable for dental x-ray examination without increased risk of unintended x-ray exposure.

8. The sample size for the training set

The document does not discuss a training set. This is not an AI/machine learning device that would require such data.

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

Not applicable, as there is no training set for an AI/machine learning model mentioned in the document.

Summary of the Document's Focus:

This 510(k) submission focuses on a device modification to an already cleared Computed Oral Radiology System. The modification involves a change in the control mechanism (allowing image acquisition to be triggered via a hardwire to an x-ray tube rather than a standalone remote module) and corresponding firmware alterations.

The document emphasizes demonstrating substantial equivalence to the predicate device. The "studies" mentioned are risk analysis, bench testing, and third-party safety testing, which focused on ensuring the modification did not introduce new risks (specifically unintended X-ray exposure) or alter the fundamental technology or indications for use. The acceptance criteria were therefore primarily related to safety and the maintenance of equivalence to the predicate, rather than new performance benchmarks for diagnostic accuracy.

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The Apex HRI Digital Radiography System is designed to replace standard intraoral xray film and film development chemicals used for patient diagnostics in dental practices.

Digital dental Intraoral Xray sensor

The provided text is a 510(k) summary for the Apex HRI Digital Radiography System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and study results for device performance. As such, much of the requested information regarding acceptance criteria, specific performance metrics, and study details is not available in the provided document.

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria or a formal study demonstrating the device meets these criteria in terms of image quality or diagnostic accuracy. Instead, the entire submission is based on the premise of substantial equivalence to predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Based on Substantial Equivalence Claim)

The document does not describe a specific clinical study undertaken to establish the device's performance against predefined acceptance criteria. Instead, it relies on demonstrating substantial equivalence to pre-existing, legally marketed devices.

1. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of an independent performance study is described. The comparison is against predicate devices based on their established characteristics and intended use.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No independent ground truth establishment for a test set is described.

3. Adjudication method for the test set: Not applicable. No "test set" and corresponding adjudication process are described.

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: Not applicable. The device is an intraoral digital X-ray sensor, not an AI-assisted diagnostic tool for which MRMC studies assessing reader improvement would be relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a digital X-ray sensor, which is a hardware component with associated imaging software, not an algorithm, and intrinsically involves a human operator (dentist/radiographer) in its use.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an independent performance study. The "ground truth" for the substantial equivalence claim is the performance and regulatory acceptance of the predicate devices.

7. The sample size for the training set: Not applicable. The device is a digital X-ray sensor; it does not explicitly describe an algorithm that requires a "training set" in the machine learning sense.

8. How the ground truth for the training set was established: Not applicable, for the same reasons as point 7.

Summary of the K023292 Submission:

The K023292 submission for the Apex HRI Digital Radiography System is a 510(k) Premarket Notification. This regulatory pathway is used to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use and the same technological characteristics, or, if it has different technological characteristics, the differences do not raise different questions of safety and effectiveness.

The core of this submission is the statement: "The Apex HRI Digital Radiography sensor is identical to the Mediadent HDXMMD HDX SP xray sensor in size, type, and materials used to manufacture the product... The Apex HRI Digital Radiography sensor is virtually identical to the Trophy Radiologie RVG Portable Radiovisiography sensor in size, manufacture and materials. The only difference between these and the Computed Oral Radiology System is the type of sensor employed... This is a minor difference in design. All four products are used in exactly the same manner and circumstances."

Therefore, the "proof" that the device meets acceptance criteria is the argument that it is the same or substantially similar to devices already accepted as safe and effective by the FDA. The submission does not detail independent studies with new performance data.

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The accuDEXA is a dual-energy x-ray device indicated for use in measuring an index of the bone density of the middle finger of the nondominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. The measurement is compared to similar measurements from patients of the same gender and ethnicity to provide t-scores (number of standard deviations above or below the mean for a reference group of young healthy individuals) and z-scores (number of standard deviations above or below the mean for a cohort of the same age). A t-score or a z-score may be used by a physician as one factor, in conjunction with other clinical indicators, to diagnose osteoporosis and other bone disorders. When a normative database of the same ethnicity and gender is not available, the BMD value may still be used to compare to the patient's own baseline value, for example in following the patient's response to treatment for osteoporosis.

Below normal bone density can be associated with a variety of conditions or disorders of bone. For example, the Society of Nuclear Medicine and American College of Nuclear Physicians has identified specific medical indications for measurement of a patient's bone mass: for patients with premenopausal oophorectomy, spontaneous menopause, or estrogen deficiency conditions; for treatment-related osteopenia; when the diagnosis of osteopenia is suggested or established by other means, such as x-ray; during long-term immobilization; for endocrinopathies known to be associated with osteopenia; for post-gastrectomy and other malabsorption states leading to osteopenia: during long-term corticosteroid therapy; for chronic renal disease, particularly in childhood or adolescence; and to monitor treatment programs for osteoporosis.

The accuDEXA device is a Dual Energy X-Ray Absorptiometer (DEXA) device. The device is intended to calculate an index of bone mineral density in the middle finger of the non-dominant hand. By changing the high voltage on the X-ray tube, two energies are produced. Each of the two settings produces an image of the finger and each image is analyzed using various algorithms to produce a value of bone mineral density (BMD) and bone mineral content (BMC). These values are compared with a normative database, yielding a t-score and a z-score. The t-score is the number of standard deviations that the patient is above or below the mean of a reference sample of young healthy individuals. The zscore is the number of standard deviations that the patient is above or below the mean of a reference sample of individuals of the same age as the patient.

Here's an analysis of the provided text regarding the Schick accuDEXA Bone Densitometer, focusing on acceptance criteria and the supporting study:

Schick accuDEXA Bone Densitometer Acceptance Criteria and Study

The provided document, a 510(k) Summary for the Schick accuDEXA Bone Densitometer, describes the device's performance characteristics through a study to demonstrate substantial equivalence to predicate devices. While explicit "acceptance criteria" in a numerical or threshold format are not directly stated, the document implies them through its claims of precision, accuracy, and correlation with predicate devices and ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, the "acceptance criteria" are implied by the demonstration of performance that supports substantial equivalence to existing devices. The document highlights key performance characteristics rather than specific pass/fail values.

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

• Sample Size for Test Set: The document states the study was conducted "on cadavers" for precision and accuracy testing. It does not specify the exact number of cadavers or bone samples used in this study.
• Data Provenance: Retrospective, as it involves cadaveric tissue. The country of origin of the data is not specified.

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

• The document does not mention the number or qualifications of experts used to establish ground truth. The ground truth (ashed bone weights) is an objective physical measurement, not an expert interpretation.

4. Adjudication Method for the Test Set

• None specified. For the "ashed bone weights" ground truth, adjudication by experts would not be applicable, as it's a direct physical measurement.

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

• No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. The study focuses on the device's intrinsic performance (precision and accuracy) and its correlation with predicate devices.

6. Standalone Performance Study

• Yes. The primary study described evaluates the "precision and accuracy of the accuDEXA device" and its correlation with ashed bone weights. This is a standalone assessment of the algorithmic performance in determining bone density.

7. Type of Ground Truth Used

• For the accuracy evaluation, the ground truth used was "ashed bone weights." This is an objective, quantitative physical measurement of true bone mineral content.

8. Sample Size for the Training Set

• The document mentions "A reference data base has been developed in a clinical study which allows the calculation of t-scores and z-scores for each patient." However, it does not specify the sample size of this clinical study that formed the normative database.

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

• The ground truth for the "reference data base" (which acts as a training set for norm-based scoring) was established through "a clinical study." It is assumed that this clinical study involved measuring BMD in a population to derive mean and standard deviation values for different age, gender, and potentially ethnic groups, thereby establishing the normative data for t-scores and z-scores. The specific methods for establishing the "ground truth" (i.e., true bone density measurements in this clinical cohort) are not detailed beyond "measurements."

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