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Hasla is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

The product (Dental CBCT X-ray System, Model: Hasla) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dental, oral and maxillofacial areas to provides diagnostic details for the medical facilities. This product consists of Frame, X-ray generator (including Integrated X-ray source tube head, X-ray tube, Collimator), Image receptor and Image processing system (including Computer, Monitor, and Software workstation).

The provided FDA 510(k) clearance letter and summary for the Yian Medical Technology (Haining) Co., Ltd. Dental CBCT X-ray System (Model: Hasla) indicate that this is a Special 510(k) for a device modification. This means the company is asserting that the modified device is substantially equivalent to their own previously cleared predicate device (Dental Cone-beam Computed Tomography, Model: iDT901X1, K232710) and that the modifications do not raise any new safety or effectiveness concerns.

Therefore, the submission relies on the previous clearance and asserts that the current device meets the same acceptance criteria as the predicate without requiring new comprehensive studies to prove that from scratch. Instead, it demonstrates that the modifications themselves do not negatively impact the performance, safety, or efficacy previously established.

Given this context, here's a breakdown of the information requested. It's important to understand that the document does not report on a new study for the current device to explicitly prove it meets acceptance criteria with new data. Instead, it leverages the prior clearance through a demonstration of equivalence.

Acceptance Criteria and Device Performance (as related to the predicate device and the claim of equivalence)

The document states: "The subject device and the predicate device are equivalent in the model name, same in the indications for use, patient population, use environment, software functions, and software level of documentation, performance characteristics and technical specification." It further specifies that "Any difference between the predicate device and the subject device have no impact on safety or efficacy of the subject device and do not raise any new potential or increased safety risks."

Therefore, the "acceptance criteria" for the current device are implicitly met by demonstrating that its performance and safety characteristics are unchanged from the predicate device, which had previously met its own acceptance criteria during its clearance process (K232710).

The summary provides a detailed comparison table (Table 1) between the subject device (Hasla) and the predicate device (iDT901X1). Essentially, all listed specifications and performance characteristics are presented as identical between the two.

Table 1: Acceptance Criteria (Implied from Predicate Equivalence) and Reported Device Performance

Study Details (Based on the provided document for the current 510(k) submission)

It's crucial to reiterate that this is a Special 510(k). The document explicitly states: "The modifications of the device have no impact on the product's design, working principle, software function, software documentation level, performance characteristic and technical specification indication for use, patient population, environment of use, user needs, thus no impact on the previously conducted Bench Testing and validation. No new bench testing or validation was needed. The previously conducted and submitted verification and validation test results are still valid for the modified device..."

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

   • Test Set Sample Size: Not applicable/Not specified as new data. The submission relies on the testing of the predicate device (K232710) and general compliance with standards.
   • Data Provenance: Not applicable/Not specified, as no new clinical or standalone performance studies were explicitly conducted for this submission beyond bench testing to confirm compliance with recognized standards. The submitter is Yian Medical Technology (Haining) Co., Ltd. in China.

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

   • Not applicable. This submission does not detail a study involving expert readers or ground truth establishment, as it's a Special 510(k) relying on equivalence to a previously cleared device.

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

   • Not applicable. No such study or adjudication method is 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:

   • No. This device is a Dental CBCT X-ray System, which is an imaging acquisition device, not an AI-based diagnostic tool for human reader interpretation improvement. The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence."

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

   • No. This device is an imaging system, not a standalone algorithm. The clearance is based on the device's ability to produce images compliant with established standards, not on an algorithm's diagnostic performance. The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." The bench testing cited ("Bench Testing Summary") confirms the physical and technical specifications against standards (e.g., spatial resolution, focal spot size, etc.), which are standalone performance characteristics of the device (hardware/software combined for image generation), but not a "standalone algorithm" in the typical sense of AI performance.

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

   • Not applicable. No new clinical studies requiring external ground truth were conducted for this Special 510(k). The evaluation revolves around compliance with engineering and radiation safety standards, and performance characteristics (like spatial resolution, scan time) derived from bench testing using phantoms or calibrated equipment.

7. The sample size for the training set:

   • Not applicable. This is not an AI algorithm requiring a training set in the conventional sense. The "software functions" mentioned are for image acquisition, data management, display, processing, and system settings, which are intrinsic to the operation of the imaging device itself.

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

   • Not applicable, as there is no specific training set described for an algorithm in this context.

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KP-View 3D is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

The product ( Dental Cone-beam Computed Tomography, Model: KP-View 3D) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dental, oral and maxillofacial areas to provides diagnostic details for the medical facilities. This product consists of Frame, X-ray generator (including Integrated X-ray source tube head, X-ray tube, Collimator), Image receptor and Image processing system (including Computer, Monitor, and Software workstation).

The provided document is a 510(k) summary for the Yian Medical Technology (Haining) Co., Ltd. KP-View 3D Dental Cone-beam Computed Tomography system.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format for the device's performance in the way a clinical study might. Instead, it demonstrates substantial equivalence to a predicate device (iDT901X1 Dental Cone-beam Computed Tomography, K232710) by comparing technical specifications and performance characteristics. The acceptance is based on meeting safety and performance standards relevant to dental X-ray equipment.

Here's a table summarizing key comparable technical and performance characteristics, as presented in the document, which implicitly serve as a basis for acceptance by showing equivalence to the already-cleared predicate:

The "acceptance criteria" can be inferred to be that the subject device's performance characteristics, as demonstrated through non-clinical bench testing, are equivalent to those of the predicate device, and that it complies with relevant recognized standards for safety and performance (e.g., IEC 60601 series for electrical and radiation safety, IEC 62366 for usability, IEC 62304 for software lifecycle, ISO 14971 for risk management).

2. Sample Size for the Test Set and Data Provenance

The document states, "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." Therefore, there is no test set of patient data from clinical studies. The testing relies on non-clinical bench testing to demonstrate equivalence. The provenance of any underlying data that informed the predicate device's clearance is not mentioned here, as this is a Special 510(k) focused on modifications to an already cleared device.

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

Not applicable, as no clinical study with a test set requiring expert-established ground truth was conducted. The assessment is based on technical equivalence and compliance with standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical study with a test set was conducted.

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 device is a dental cone-beam CT system, not an AI-powered diagnostic software. The submission focuses on hardware and software equivalence for image acquisition and processing.

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

Not applicable. This is not an algorithm-only device. It is a medical imaging system. Its performance is assessed through its ability to produce images that meet quality and safety standards, as demonstrated through bench testing.

7. The Type of Ground Truth Used

For non-clinical testing, the "ground truth" would be established by reference to engineering specifications, phantom measurements, and compliance with recognized standards (e.g., image quality metrics like spatial resolution (5lp/mm) measured with phantoms, radiation dose measurements, electrical safety checks).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The device is a traditional medical imaging system.

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

Not applicable, as no training set was used.

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Dental Cone-beam Computed Tomography (Model:iDT901X1) is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

( Product Name: Dental Cone-beam Computed Tomography, The product Model:iDT901X1) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dental, oral and maxillofacial areas to provides diagnostic details for the medical facilities. This product consists of Frame, X-ray generator (including Integrated X-ray source tube head, X-ray tube,Collimator), Image receptor and Image processing system (including Computer, Monitor, Software workstation).

The provided document is a 510(k) Summary for a Dental Cone-beam Computed Tomography device (Model: iDT901X1). It includes a comparison with a predicate device and a summary of testing conducted. Based on the document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific quantitative acceptance criteria for image quality and a direct comparison with reported device performance in a tabular format. However, it broadly states that "The overall image quality was acceptable for all cases and image types in various scanning mode for both adult and pediatric" based on a clinical evaluation.

Instead of clear acceptance criteria for image quality, the document lists various standards and guidance documents that the device complies with, which implicitly define performance expectations in relation to safety, electromagnetic compatibility, radiation protection, usability, software lifecycle, and acceptance tests for imaging performance. These standards serve as the basis for the "acceptance criteria" and the device's adherence to them is the "reported device performance."

Here's an interpretation based on the provided text, focusing on performance aspects mentioned in the comparison table and the summary of non-clinical tests:

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

• Test Set Sample Size: The document refers to "a number of sample scans and diagnostic images" for the clinical evaluation. It does not specify the exact number of cases or images used in this "test set."
• Data Provenance: Not specified. The document states that the manufacturer is "Yian Medical Technology (Haining) Co., Ltd." in CHINA, but does not explicitly mention the country of origin for the clinical evaluation data. It also does not specify if the data was retrospective or prospective.

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

• Number of Experts: "One US radiation-board certified experienced radiologists."
• Qualifications: "US radiation-board certified experienced radiologists." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified. The clinical evaluation was performed by a single radiologist who "studied independently a number of sample scans and diagnostic images to score different essential image quality related items." There is no mention of an adjudication process for consensus or conflict resolution, as only one expert was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The clinical evaluation involved a single radiologist.
• Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as no AI component for image interpretation by human readers is described in the provided sections, nor was an MRMC study conducted. The device is a Dental Cone-beam Computed Tomography system for image acquisition, not an AI software for interpretation assistance.

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

• Standalone Performance: The document describes the device as a "Dental Cone-beam Computed Tomography" system, which is a hardware device that produces X-ray images. There is no mention of an independent algorithm or AI component that would have standalone performance separate from human-in-the-loop operation. The "image processing system" is part of the overall device. However, the summary of testing includes "overall operation by taking and reviewing test images" and "image quality was acceptable," which implies an evaluation of the device's intrinsic imaging capabilities.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical evaluation of image quality was based on expert consensus (or in this case, expert opinion from a single radiologist). The radiologist "scored different essential image quality related items." There is no mention of pathology or outcomes data being used as ground truth.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not specify a training set sample size. The device is a hardware imaging system with an image processing system, not a machine learning algorithm or AI model that typically requires a distinct training set in the context of diagnostic performance evaluation for regulatory submission. The term "training set" is not used in relation to device performance testing in this document.

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

• Ground Truth for Training Set: Not applicable, as no training set for a machine learning model is mentioned or implied by the document.

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The Heart5R-110. Heart3R-110 are Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).

The system is subject to the following limitations of use when stand-mounted:

• The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities. -The device may be used for imaging of the chest when used without a grid.

This device is not intended for mammography.

The Portable X-ray machine directly provides rays for diagnostic operation, which is composed of the following parts: power supply circuit, inverter, high-voltage tank ball tube, filament circuit, control circuit, high-voltage cabinet body, user interface and collimator.

This document is a 510(k) summary for a portable X-ray machine. It demonstrates substantial equivalence to a predicate device rather than providing acceptance criteria and a study proving the device meets those criteria. Therefore, most of the requested information cannot be extracted directly from the provided text.

However, I can provide the following based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device to meet. Instead, it compares the specifications of the subject device to a predicate device to establish substantial equivalence.

Comparison of Subject Device (Heart5R-110, Heart3R-110) vs. Predicate Device (SR-8230/SR-8230S):

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