(43 days)
the storage of FCR image with patient identification data. The subject devices add the additional capability to store image and patient identification data from sources other than computed radiography image readers.
These devices store FCR (Fuji Computed Radiography) and other (for example CT and MRI) image and patient ID data on glass 12-inch (OD-F614 Series) or 5-inch OD-F624 Series optical disks using a single optical disk drive (OD-F614 or OD-F624) or optical disk library (OD-F614L or OD-F624L).
These devices are connected to FCR image reader through HI-C654 CRT image consoles, and connected to other image sources through Fuji multiformatters MF-300L. FCR images are compressed at the transmitter HI-C654 by reversible compression rate: 1:2), transmitted to OD-F614 via the network, and recorded on optical disks. Images data from other modalities are compressed at the multiformatter (compression rate: 1:2), and similarly transmitted to OD-F614 via the network, and recorded on optical disks.
Patient ID data stored on the optical disks is simultaneously recorded on a magnetic disk for database retrieval. Using the database, image data can be retrieved by various criteria according to remote search requests from the image consoles (HI-C654), and transmitted to the image console where it is displayed on the CRT as may be printed on film. The subject optical disk filing units do not monitor, control, or affect any equipment that is directly involved with the patical disk filing units do not come in contact with the patient. The optical disk filing units perform no data manipulation, but store data received from host imaging modalities.
Images stored and retrieved from the subject device are expected to be used for primary radiographic interpretation when displayed on a soft- or hard-copy device (not part of this submission). Interpretation provides adequate opportunity for competent human intervention. The level of concern associated with the function of the device is minor; failures or latent design flaws are not expected to result in injuries to patients.
This 510(k) submission describes an optical disk image filing unit, not a device that directly performs medical diagnoses or analyses. Therefore, traditional "acceptance criteria" related to diagnostic performance (like sensitivity, specificity, or accuracy) and a "study that proves the device meets acceptance criteria" as applied to AI/diagnostic efficacy do not apply in the same way.
Instead, the performance data presented focuses on the technical reliability of data storage, which is appropriate for this type of device.
Here's an analysis based on the provided text, using the requested categories, but adapted to the nature of the device:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Data Error Rate (after correction) | 10^-12 bit (equivalent to one bit in the data stored in 148 of the new, larger, 12-inch, 7 GB optical disks) |
2. Sample Size Used for the Test Set and the Data Provenance:
- The document does not specify a "test set" sample size in the traditional sense of patient data.
- The performance metric (data error rate) is described as an intrinsic characteristic of the device's data storage technology. It refers to the error rate in bits, not in terms of images or patient cases.
- Data Provenance: Not applicable in the diagnostic sense. The performance relates to the hardware's reliability in transferring and storing bits.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. The ground truth for a data error rate is defined by the technical specifications of the optical disk storage and retrieval process, not by human expert interpretation of medical images.
4. Adjudication Method for the Test Set:
- Not applicable. Data error rates are determined through technical testing and measurement of the disk drive's and media's ability to store and retrieve data without corruption, not through adjudication of medical interpretations.
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:
- No. This is not an AI-enabled diagnostic device. It's a data storage system. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the diagnostic sense. The "standalone performance" of this device is its reliable storage and retrieval of digital data, as described by its data error rate.
7. The type of ground truth used:
- The "ground truth" here is the integrity of the digital data as it is written to and read from the optical disk. This is a technical ground truth related to electrical engineering and data storage, not medical "ground truth" like pathology or expert consensus.
8. The sample size for the training set:
- Not applicable. This device is not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device Function and Performance Focus:
This device is a data archiving and retrieval system for medical images (FCR, CT, MRI). Its primary function is to reliably store this data. The acceptance criteria and performance data provided correctly focus on the technical integrity of the stored data, specifically the "data error rate." The comparison point for performance is with a predicate device, which reportedly has the "same data error rates," indicating substantial equivalence in this critical technical aspect for a storage device. The submission emphasizes that the device does not manipulate data, come into contact with patients, or affect equipment involved with patients, and that human intervention (interpretation of the displayed images) provides an adequate safety buffer.
§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.