(61 days)
The Dunlee "FORMAT" collimator family restricts the dimensions of the diagnostic X-rav field by limiting the size of the primary X-ray beam.
The Dunlee manual "FORMAT M" collimators are intended for use in diagnostic X-ray systems during radiographic examinations.
The Dunlee automatic "FORMAT A" collimators are intended for use in diagnostic X-ray systems during radiographic and fluoroscopic examinations.
The Dunlee "FORMAT" collimator family is a family of Beam-Limiting Devices, which comprises both manual and automatic collimators. The manual collimators are to be used in diagnostic radiographic X-ray systems, and the automatic collimators are to be used in both diagnostic fluoroscopy X-ray systems and diagnostic radiographic X-ray systems.
This 510(k) summary describes a device called the "Dunlee 'FORMAT' collimator family," which comprises both manual and automatic collimators for diagnostic X-ray systems. The submission asserts that this device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The provided document does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a table format. Instead, it focuses on general compliance with safety and performance standards and substantial equivalence to predicate devices.
However, based on the Safety Information section, we can infer the acceptance criteria are compliance with:
| Acceptance Criterion (Inferred from Safety Information) | Reported Device Performance (as stated in the document) |
|---|---|
| Compliance with Performance Standards for Ionizing Radiation Emitting Products (21CFR1020.30, 21CFR1020.31, 21CFR1020.32) | The Dunlee "FORMAT" collimator family will comply with the applicable requirements. |
| Compliance with National Safety Standard UL 2601-1 | The Dunlee "FORMAT" collimator family will comply. |
| Compliance with National Safety Standard CAN/CSA-C22.2 no. 601-1 | The Dunlee "FORMAT" collimator family will comply. |
| Compliance with International Safety Standard IEC 60601-1 | The Dunlee "FORMAT" collimator family will comply. |
| Compliance with International Safety Standard IEC 60601-1-2 | The Dunlee "FORMAT" collimator family will comply. |
| Compliance with International Safety Standard IEC 60601-1-3 | The Dunlee "FORMAT" collimator family will comply. |
| Compliance with International Safety Standard IEC 60601-2-28 | The Dunlee "FORMAT" collimator family will comply. |
| Compliance with International Safety Standard IEC 60601-2-43 | The Dunlee "FORMAT" collimator family will comply. |
| No new indications for use introduced | The Dunlee "FORMAT" collimator family does not introduce any new indications for use. |
| No new potential hazards introduced | The Dunlee "FORMAT" collimator family does not result in any new potential hazard. |
| Substantial equivalence to predicate devices | Dunlee considers the FORMAT collimator family to be substantially equivalent with the predicate devices. |
2. Sample size used for the test set and the data provenance:
The document does not mention a traditional "test set" sample size or data provenance in the context of a clinical performance study. The evaluation presented is one of compliance with standards and substantial equivalence to predicate devices, not direct performance data from a specific patient cohort.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or provided in the document. The substantial equivalence determination for this type of device (X-ray collimator) typically relies on engineering specifications, safety standards, and comparison to existing devices, rather than a "ground truth" derived from expert image interpretation or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable or provided. There is no mention of a test set that would require an adjudication method.
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 document does not describe an MRMC comparative effectiveness study. The device is an X-ray beam-limiting device (collimator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, this section is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This document does not describe a standalone performance study in the context of an algorithm. The device is hardware (a collimator), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
As discussed, a traditional "ground truth" for clinical performance is not applicable to the submission for an X-ray collimator. The "truth" in this context is adherence to engineering specifications, regulatory standards, and the demonstrated functionality of the device in limiting X-ray beams as intended.
8. The sample size for the training set:
The document does not mention a "training set" sample size. This is not an AI/machine learning device that undergoes a training phase with data.
9. How the ground truth for the training set was established:
This information is not applicable as there is no "training set" for this type of device.
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). 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.