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Cocoon is a portable X-ray System indicated for taking diagnostic dental x-rays for both pediatric and adult patients using intraoral film or digital sensors.

The Cocoon device is intended for use in dental radiographic examination and diagnosis of the teeth, jaw, and oral structure for both pediatric and adult patients.

Cocoon Portable X-ray System from Dexcowin Co., Ltd., of Seoul, Korea is a handheld x-ray device. The technology of this device was originally developed in Korea more than a decade ago and global production is still concentrated in that country.

The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors.

The provided document is a 510(k) premarket notification for the "Cocoon Portable Handheld X-ray System." It demonstrates the device's substantial equivalence to a predicate device, focusing on technical specifications and conformity to various international and FDA standards for safety and performance. However, this document does not contain information about clinical study results, expert consensus, ground truth establishment, sample sizes for training or testing, or AI/human reader performance data.

The document details the device's technological characteristics, adherence to electrical safety, EMC, software validation, biocompatibility, usability, and risk assessment standards. It states that "All tests were performed in accordance with ISO standards and recognized by FDA" and that "Clinical Comparison" was performed, but no specifics of this comparison, such as acceptance criteria, sample size, or outcomes, are provided.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be extracted from this document because it is a submission focused on demonstrating substantial equivalence based on technical and safety specifications rather than a comparative clinical performance study.

Based on the provided text, I can only address a limited number of your questions:

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

The document does not explicitly present a table of acceptance criteria with reported device performance in the context of clinical efficacy or diagnostic accuracy. Instead, it demonstrates acceptance primarily through conformity to established safety and performance standards for X-ray devices. The "performance" discussed relates to meeting specific technical specifications and safety requirements.

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

• Sample Size for Test Set: Not specified. The document primarily references conformity to standards and technical comparisons. No specific "test set" in the context of clinical performance data for diagnostic accuracy is mentioned.
• Data Provenance: Not explicitly stated for specific test data used to support substantial equivalence beyond the manufacturer's internal testing and third-party electrical testing (Met Laboratories, Inc.). The technology's original development is noted as "more than a decade ago" and "global production is still concentrated" in "Korea."

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

This information is not available in the provided document. The submission focuses on the technical and safety aspects of the device, not a diagnostic performance study requiring expert ground truth establishment.

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

This information is not available in the provided document.

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:

This information is not available in the provided document. The device is a "Portable Handheld X-ray System," not an AI-powered diagnostic tool, so such a study would not be applicable within the scope of this 510(k) submission.

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

This information is not available in the provided document. The device is a hardware X-ray system, not an algorithm.

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

This information is not available in the provided document.

8. The sample size for the training set:

This information is not applicable as the device itself is an X-ray imaging system, not an AI model that requires a training set.

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

This information is not applicable as the device itself is an X-ray imaging system, not an AI model that requires a training set and ground truth establishment in that context.

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The ADX6000 (also known as iRay A6) is a handheld and portable general purpose X-ray system. The device uses a variable tube current with voltage from 50-80 kVp and, therefore, is limited to taking diagnostic x-rays of extremities.

It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. This device is not intended for mammography.

The ADX6000 is a portable x-ray system intended to generate and control the emission of xray energy for diagnostic procedures by exposing an x-ray image receptor to ionizing radiation, typically in a hospital or clinic environment.

The x-ray source, a tube by Toshiba (tube voltage 50-80kV with 0.8 mm focal spot) is located inside the handheld device. A flat panel detector (FPD), not part of the system, connects to the device via LAN port to enable image capture, manipulation, storage, and transmission through the user interface and device software/firmware.

The operator controls three key x-ray variables to obtain the best image at minimal exposure:

• 1. Exposure intensity (kV)
• 2. Exposure dosage (mA)
• 3. Exposure time setting (Sec)

The ADX6000 does not have a wireless feature for transmission of data.

This document describes a 510(k) premarket notification for the ADX6000 Portable X-Ray System (also known as iRay A6). The provided text does not contain information about a study that assesses the device's diagnostic performance against specific acceptance criteria using a test set of patient data, nor does it detail any AI-related studies. Instead, it focuses on the device's technical specifications, safety, and equivalence to predicate devices.

Therefore, many of the requested sections about acceptance criteria and study details cannot be directly answered from the provided text. I will address the points based on the information available.

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

Based on the provided text, the "acceptance criteria" primarily relate to safety and technical performance standards, rather than diagnostic accuracy on patient cases.

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 primarily focuses on technical safety and performance tests. For the diagnostic image quality evaluation, it states: "Images from the ADX6000 were evaluated for diagnostic quality by a board certified radiologist and were approved for diagnostic quality."

• Sample size for test set: Not specified. The number of images evaluated is not provided.
• Data provenance: Not specified. It does not mention if the images were from clinical studies, phantoms, or simulated data, nor their country of origin or whether they were retrospective or prospective.

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)

• Number of experts: One, as indicated by "a board certified radiologist."
• Qualifications of those experts: "a board certified radiologist." No further details on experience or sub-specialty are provided.

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

Not applicable/Not specified. Since only one radiologist evaluated the images, there was no multi-reader adjudication method employed for diagnostic image quality. The radiologist "approved" the images for diagnostic quality.

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

• MRMC study: No, an MRMC study was not described.
• Effect size with/without AI: Not applicable. The device described is a portable X-ray system, not an AI-powered diagnostic tool. The document makes no mention of AI.

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

Not applicable. This is not an AI algorithm. The diagnostic performance mentioned refers to the quality of images produced by the X-ray system for human interpretation.

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

For the diagnostic quality evaluation, the "ground truth" was the opinion of a single board-certified radiologist who "approved" the images. This is essentially a form of expert opinion or evaluation of image quality suitability for diagnosis, rather than a definitive medical ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable. The document describes an X-ray imaging device, not an AI model requiring a training set.

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

Not applicable. There is no mention of an AI model or a training set.

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The ADX400W Cordless Portable Dental X-Ray System is indicated for use only by trained and qualified dentists or dental technicians for both adult and pediatic subjects for taking diagnostic extraoral dental x-rays using digital sensors.

Not Found

This document does not contain the requested information regarding acceptance criteria, device performance, study details (sample sizes, provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set details.

The provided text is an FDA 510(k) clearance letter for the ADX4000W Portable X-ray System. It confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements. It specifies the "Indications for Use" but does not include data from performance studies or acceptance criteria tables.

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DX3000 is a portable x-ray system indicated for taking diagnostic dental x-rays for both pediatic and adult patients using intraoral film or digital sensors

DX-3000 Portable X-Ray System

There is no information in the provided document about acceptance criteria, device performance, test set sample size, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, training set sample size, or how ground truth for the training set was established.

The document is an FDA 510(k) clearance letter for a dental X-ray system, confirming its substantial equivalence to previously marketed devices. It does not contain efficacy study details.

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The ADX4000-L, DX3000-L Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using digital sensors.

The ADX4000-L, DX3000-L are Cordless Portable Dental X-ray System operated by battery-powered and hand-held dental x-ray machine, This is a prescription device that can be used on pediatric and adult patients.

Acceptance Criteria and Device Performance Study for ADX4000-L, DX3000-L

Based on the provided 510(k) summary (K083532), the device's acceptance criteria and performance study are primarily focused on demonstrating equivalence to a predicate device and adherence to consensus standards, rather than specific performance metrics against a predefined acceptance threshold.

The document indicates that the device's performance was evaluated through "Bench testing" and by meeting "consensus standards." It does not provide a table of quantitative acceptance criteria with corresponding device performance values, nor does it detail a study that directly measures performance against such criteria.

Here's an analysis of the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, a direct table of quantitative acceptance criteria and reported device performance is not present in the provided 510(k) summary.

The summary states that the device is "**equivalent to the predicate devices in its intended use and technological characteristics, including: *indications for use technological characteristics performance properties". This suggests that the "acceptance criteria" were met by demonstrating this equivalence and compliance with relevant standards.

The "reported device performance" is broadly stated as:

• "This device meets consensus standards IEC 601-1, 60601-1-2, 60601-1-2, 60601-2-7 etc."
• "Bench testing was also conducted to demonstrate performance specifications."

Without specific metrics from the bench testing, it's impossible to create a quantitative table.

2. Sample Size for Test Set and Data Provenance

The 510(k) summary does not specify any sample size for a "test set" in the context of clinical images or patient data. The testing mentioned (bench testing and meeting consensus standards) implies engineering/design verification rather than a clinical performance study using a test set of images or patient data.

Therefore, information regarding data provenance (country of origin, retrospective/prospective) is also not provided.

3. Number of Experts and Qualifications for Ground Truth

The 510(k) summary does not mention using experts to establish ground truth for a test set. The focus is on demonstrating technological equivalence and compliance with engineering standards.

4. Adjudication Method for the Test Set

Since no clinical "test set" with ground truth established by experts is mentioned, an adjudication method is not applicable and therefore not provided in the document.

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

The 510(k) summary does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The device is an X-ray system, not typically an AI-driven image analysis tool, so comparative effectiveness with human readers using or not using AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study

The 510(k) summary does not describe a standalone (algorithm only) performance study. The device is a hardware product (dental X-ray system), not an AI algorithm.

7. Type of Ground Truth Used

The term "ground truth" as typically used in AI/image analysis studies (e.g., pathology, outcomes data, expert consensus) is not applicable to the type of testing described in this 510(k) summary. The "ground truth" for the device's performance would be compliance with the functional and safety requirements defined by the IEC standards and internal performance specifications.

8. Sample Size for the Training Set

The 510(k) summary does not mention a training set. This device is a traditional medical imaging hardware product and does not involve machine learning or AI models that would require a training set.

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned (as explained in point 8), the method for establishing its ground truth is not applicable and therefore not provided.

In summary, the K083532 submission focuses on demonstrating substantial equivalence to a predicate device and compliance with recognized electrical and medical device safety standards through bench testing. It does not contain information about clinical performance studies, evaluation by expert readers, or the use of AI/machine learning, which would typically involve the detailed criteria requested in the prompt.

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