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510(k) Data Aggregation
(25 days)
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
The Computed Oral Radiology System is intended for intra-oral x-ray examinations and indicated for dental patients. It produces instant, digital, intraoral x-ray images of a patient's mouth while reducing the necessary x-ray dosage. This device modification in no way alters the indications for use of this machine beyond what was most recently cleared in K072134.
The Computed Oral Radiography 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.
The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. A new scintillation material differs from the predicate in that in that it affords higher resolution and lower noise. Direct triggering via an x-ray tube continues to be supported as was cleared in K072134 and K041385. The modification offers an improvement in image quality.
The provided text describes a 510(k) premarket notification for a modification to the Schick Computed Oral Radiology System. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.
Therefore, much of the requested information, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, number and qualifications of experts, adjudication methods, details of comparative effectiveness studies, and specific ground truth methodologies for training and test sets, is not available in the provided text.
However, I can extract the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: While no explicit numerical or qualitative acceptance criteria are listed, the document states: "All validation activities have demonstrated that the predetermined acceptance criteria were met." The principal risk identified was "unintended x-ray exposure."
- Reported Device Performance:
- "A new scintillation material differs from the predicate in that that it affords higher resolution and lower noise."
- "The modification offers an improvement in image quality."
- "It produces instant, digital, intraoral x-ray images of a patient's mouth while reducing the necessary x-ray dosage." (This statement is about the overall system's capability, not specific performance metrics of the modification).
Since specific metrics and thresholds for "higher resolution," "lower noise," and "improvement in image quality" are not provided, a detailed table cannot be constructed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text. The document mentions "validation studies" but does not specify sample sizes or 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)
- Not available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text.
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 and not available. This device is an imaging system (hardware modification), not an AI algorithm for interpretation. Therefore, a multi-reader multi-case study comparing human readers with AI assistance would not be relevant to this specific device modification.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This relates to an imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated for the validation study. The document implies that the validation focused on "imaging, software validation, and third-party safety testing" to address the risk of "unintended x-ray exposure" and demonstrate "higher resolution and lower noise." The ground truth for these types of evaluations would likely involve physical measurements (e.g., MTF, DQE for resolution/noise, dosimeter readings for x-ray exposure) rather than clinical expert consensus or pathology, as this is a hardware modification improving image capture, not diagnostic interpretation.
8. The sample size for the training set
- Not applicable and not available. This device represents a hardware modification to an X-ray imager, not an AI model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As a hardware modification, there is no "training set" in the context of machine learning.
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(13 days)
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predetermined acceptance criteria were met. (General statement for risk analysis and validation) | Not explicitly detailed beyond the statement that criteria were met. The context implies that the device maintained its previously cleared performance characteristics despite the hardware/firmware modification. |
| Principal risk of unintended x-ray exposure evaluated; all validation activities demonstrated criteria were met. | "Bench, and third-party safety testing" was conducted. Specific results are not provided. |
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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(27 days)
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
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 is a small digital imaging receptor that may be used in place of dental x-ray film. The proposed device modification alters the method of communication between the sensor and computer from a wired to wireless interface, introducing a radio frequency transmitter. The wireless sensor is powered via a battery. Image acquisition is mediated through hardware rather than software components. The sensor encapsulation material has been modified from aluminum to a thermoplastic resin. The existing firmware has been altered to support the modified and additional hardware, with firmware installed on both the remote module and the sensor. The firmware on the sensor facilitates unidirectional communication of image and sensor status data to the remote module.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Schick Computed Oral Radiology System, structured to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K022953) is a 510(k) summary for a modification to an already cleared device. As such, it primarily focuses on demonstrating substantial equivalence to the predicate device, rather than defining new, specific acceptance criteria for performance metrics like sensitivity or specificity. The "acceptance criteria" here implicitly revolve around demonstrating that the modifications did not negatively impact the established performance or safety of the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintain Substantial Equivalence to Predicate Device (K933455): Ensure that the modified device (wireless communication, hardware-mediated image acquisition, thermoplastic resin encapsulation, updated firmware) retains the intended use and fundamental scientific technology governing image acquisition of the original, cleared Computed Oral Radiology System. This implies no degradation in image quality, diagnostic accuracy, or safety compared to the wired version. | The device's intended use and fundamental scientific technology governing image acquisition remain unchanged. "Those imaging parameters that could be potentially affected by the modification as are outlined generally in the document, 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' were found to be substantially equivalent to the predicate." The risk analysis determined the effect of the proposed changes to be negligible. The FDA concurred with the substantial equivalence determination. |
| Safety - Introduction of New Energy Type (Radio Frequency Transmitter): Demonstrate that the new wireless interface and associated power source (battery) do not introduce unacceptable risks. | A risk analysis was performed in conformance with ISO9001 quality program. Bench-lab measurements also supported negligible effect. The FDA cleared the device, indicating satisfaction with the safety profile of the modifications. |
| Safety - Change in Sensor Encapsulation Material: Demonstrate that the thermoplastic resin is safe for its intended use and does not pose new biocompatibility or other safety concerns. | "Thermoplastic resins are utilized in other FDA-approved dental sensors. The specific thermoplastic resin chosen for this application has been approved for incidental food contact. The duration and nature of body contact with materials in that discipline is greater than what a patient would endure with a sheath encapsulated sensor." This comparison indicates the material is deemed safe for a lesser contact duration than already approved uses. |
| Performance - Image Acquisition and Processing: Ensure that the changes to the image acquisition method (hardware vs. software polling) and firmware updates do not negatively impact the quality or speed of image acquisition. | "The operating principle differs in that image acquisition is mediated through hardware rather than software components... This modification is necessary to reduce the sensor's idle state power to a minimum." While the mechanism changed, this was done for a functional improvement (power efficiency) and the claim of substantial equivalence implies no negative impact on image quality or acquisition performance. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a distinct "test set" sample size for evaluating clinical image performance, nor does it provide details on data provenance (country of origin, retrospective/prospective).
The study described is primarily a risk analysis and validation study focused on the changes introduced by the modification. This type of study (for a 510(k) modification) would typically involve engineering tests, bench-top measurements, and consideration of regulatory standards to ensure the modified device functions as intended and remains safe and effective, rather than a large-scale clinical image evaluation comparing diagnostic accuracy against a new, independent test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Given the nature of the study as presented (risk analysis and demonstration of substantial equivalence for a device modification), there is no mention of experts establishing ground truth for a clinical image test set. The reliance is placed on demonstrating that the modified device's technical characteristics and performance are "substantially equivalent" to the previously cleared predicate.
4. Adjudication Method for the Test Set
As there is no clearly defined clinical "test set" and associated ground truth establishment described, there is no adjudication method mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or described in this document. This document pertains to the sensor technology itself, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done or described. This submission is for a dental x-ray sensor, an imaging device, not an AI algorithm.
7. The Type of Ground Truth Used
For the specific modifications described, the "ground truth" implicitly refers to:
- Engineering specifications and performance characteristics of the predicate device (e.g., imaging parameters as per the "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices").
- Safety standards and biocompatibility data for materials (thermoplastic resin).
- Risk analysis methodology (ISO9001).
There is no mention of pathology, expert consensus on clinical images, or outcomes data being used as ground truth for evaluating the changes introduced by this specific modification, because the core imaging capability was assumed to be maintained from the predicate device.
8. The Sample Size for the Training Set
This document describes a device modification, not the development of an AI algorithm based on a training set of data. Therefore, there is no concept of a "training set" sample size mentioned.
9. How the Ground Truth for the Training Set was Established
As there is no training set mentioned, there is no description of how its ground truth was established.
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