(28 days)
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.
| Acceptance Criteria (Implied from Standards & Comparision) | Reported Device Performance (from document) |
|---|---|
| Electrical Safety (IEC 60601-1:2005 / AMD1:2012) | Conforms |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2007) | Conforms |
| Radiation Protection (IEC 60601-1-3:2008 & 21 CFR 1020.30, 1020.31) | Conforms |
| Usability (IEC 60601-1-6:2010 / AMD1:2013, IEC 62366-1:2015) | Conforms |
| Software Validation (IEC62304:2015) | Conforms |
| Biocompatibility (ISO 10993-1:2009) | Conforms |
| Risk Management (EN ISO 14971:2012) | Conforms |
| Quality Management System (EN ISO 13485:2012) | Conforms |
| Technical Specifications (Comparison to Predicate) | |
| - Tube Voltage | 70kVp fixed (for DX-7017 and DX-7020) |
| - Tube Current | 1.7mA (DX-7017) / 2.0mA (DX-7020) |
| - Exposure Time | 0.05~1.00 seconds in 0.001 increments |
| - Timer Accuracy | ±(10% + 1ms) |
| - Source to Skin Distance | 180mm |
| - Cone Diameter | 58mm |
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.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.