(447 days)
The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape.
In this software application the ACIS device is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffinembedded tissue specimens immunohistochemically stained for Estrogen Receptors or Progesterone Receptors (ER/PR).
It is indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer.
Automated Cellular Imaging System (ACIS) for detection of ER/PR
This is an FDA Premarket Notification (510(k)) letter for the Automated Cellular Imaging System (ACIS) for detection of ER/PR receptors. The information provided is a determination of substantial equivalence, and as such, it does not include detailed study data, acceptance criteria, or performance metrics. Therefore, I cannot provide a comprehensive answer to your request based solely on this document.
The document indicates that the device is intended to "detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape," and specifically "to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for Estrogen Receptors or Progesterone Receptors (ER/PR)." It is indicated as an aid in the "management, prognosis and prediction of therapy outcomes of breast cancer."
To answer your specific questions, information from the actual 510(k) submission, not just the FDA's decision letter, would be required. The letter confirms that the device was found substantially equivalent to a predicate device, meaning the FDA found it performed as safely and effectively as a legally marketed device and had similar technological characteristics. However, the details of how that equivalence was demonstrated (e.g., specific acceptance criteria, study design, sample sizes, ground truth establishment, etc.) are not contained within this letter.
Without the full 510(k) submission, I can only state what is NOT available in this document regarding your questions:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not present. This type of study is typically associated with AI-assisted diagnostic devices where human interpretation is part of the workflow. The ACIS is described as an "Automated Cellular Imaging System" intended to "measure, count, and quantitate," which suggests a more standalone analytical role rather than an assist to human readers in interpretation. However, without the full submission details, this is an assumption.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The description of the device as an "Automated Cellular Imaging System" strongly suggests standalone performance was evaluated, but the details of such a study are not in this letter.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
§ 864.1860 Immunohistochemistry reagents and kits.
(a)
Identification. Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.(b)
Classification of immunohistochemistry devices. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. This exemption applies to IHC's that provide the pathologist with adjunctive diagnostic information that may be incorporated into the pathologist's report, but that is not ordinarily reported to the clinician as an independent finding. These IHC's are used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.
(3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
(c)
Date of PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See § 864.3.