(87 days)
The MAMMOGRAPHY PRO and Diagnostic PRO-M film digitizers are intended for coveting analog Medical x-ray films to digital images.
The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.
The x-ray film digitizer, an electronic device used to convert analog x-ray film to digital images.
This 510(k) summary (K993598) focuses on demonstrating substantial equivalence of the MAMMOGRAPHY PRO and Diagnostic PRO-M film digitizers to a predicate device (MedScan 12, K933632). It does not contain specific acceptance criteria, a study proving device performance against those criteria, or most of the requested detailed information about clinical studies.
The document states: "Technical differences between the devices and the predicate raise no new issues of safety and effectiveness." This implies that the performance is considered equivalent to the predicate without needing new, extensive performance studies with acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated:
-
A table of acceptance criteria and the reported device performance
- Not provided in the document. The document claims "Technical differences... raise no new issues of safety and effectiveness," implying performance similar to the predicate. No specific performance metrics or acceptance criteria are listed.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. There is no mention of a test set or data provenance for a performance study.
-
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 applicable/Not provided. No test set or ground truth establishment process is described.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No test set or adjudication method is described.
-
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 an x-ray film digitizer, not an AI-assisted diagnostic tool. A MRMC comparative effectiveness study for human readers with and without AI assistance is not relevant to this type of device and is not mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device digitizes images; it's not an algorithm performing a diagnostic task.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No ground truth is mentioned as relevant for a substantial equivalence claim for a digitizer based on technical differences.
-
The sample size for the training set
- Not applicable/Not provided. This is not an AI/machine learning device that would require a training set.
-
How the ground truth for the training set was established
- Not applicable/Not provided. This is not an AI/machine learning device that would require a training set and ground truth.
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.