(67 days)
The new TracCell™ 2000 Slide Mapping System is intended as a computeraided Slide Mapping System integrated to an automated optical microscope workstation (AccuMed International's AcCell™ Workstation). The TracCell™ 2000 Slide Mapping System is used to map adequately stained. well-preserved. cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. In addition to the present intended use as cleared by FDA, the new TracCell™ 2000 Slide Mapping System can be used for the purposes of mapping Cytyc ThinPrep® specimens. The mapping of the slide into ìpresentedî and iexcludedî fields of view is performed by segmenting the light-absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation.
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- All cellular material within the expanded cell deposition area, comprising the standard cellular deposition area, and a narrow bleed zone immediately surrounding it, will be presented for human screening, using the minimum number of fields-of-view.
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- All adequately stained, well preserved cells located in the annular ring, the area lying between the expanded cellular deposition area, and the imprinted boundary area and the imprinted boundaries of the slide, will be included in additional fields-of-view presented for human screening.
The mapping of a Cytyc Thin Prep™ specimen is carried out in precisely the same manner as the predicate TracCell 2000 Slide Mapping System. The mapping of the slide in presented and excluded fields-of view, is performed by segmenting the light absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation. These techniques are identical to the predicate TracCell 2000™.
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The provided text describes a 510(k) submission for the TracCell™ 2000 Slide Mapping System. However, it does not contain the detailed information necessary to answer all sections of your request. Specifically, it lacks data regarding acceptance criteria, reported device performance, sample sizes used, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established.
Therefore, based only on the provided text, I can only address what is explicitly stated or can be reasonably inferred about the device's function.
Here's an analysis of the provided text in relation to your request, highlighting what is missing:
Acceptance Criteria and Study for TracCell™ 2000 Slide Mapping System
The provided 510(k) letter and "Indications For Use" document do not contain a table of explicit acceptance criteria or reported device performance data from a study conducted for this specific submission. The focus of the 510(k) is on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data against pre-defined acceptance criteria.
The "Indications For Use" outlines how the device performs its mapping function, which can be interpreted as the functional requirements it aims to fulfill.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Indications For Use) | Reported Device Performance (Not stated in document) |
|---|---|
| 1. Present all cellular material within the expanded cell deposition area (standard area + narrow bleed zone) for human screening using the minimum number of fields-of-view. | Not reported in this document. The document states this is the intended function of the device. |
| 2. Include all adequately stained, well-preserved cells in the annular ring (between expanded cellular deposition area and imprinted boundary) in additional fields-of-view for human screening. | Not reported in this document. The document states this is the intended function of the device. |
| 3. Map Cytyc ThinPrep® specimens in the same manner as the predicate TracCell 2000™. | Not reported in this document. The document states this is the intended function of the device and that the techniques are identical to the predicate. |
| 4. Segment light-absorbing objects from background material using standard image processing techniques for efficient presentation. | Not reported in this document. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided documents.
- Data Provenance: Not specified in the provided documents. The document refers to the device mapping "adequately stained, well-preserved, cervical cytology preparations." It does not mention country of origin or whether data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified in the provided documents.
- Qualifications of Experts: Not specified in the provided documents. The system aims to present fields-of-view to a "cytotechnologist or cytopathologist for diagnostic interpretation," implying these are the end-users whose diagnostic interpretations would ultimately be the clinical ground truth.
4. Adjudication method for the test set
- Adjudication Method: Not specified in the provided documents.
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
- MRMC Study: Not specified or indicated in the provided documents. The 510(k) process often relies on substantial equivalence to a predicate device, and the provided text does not describe a comparative effectiveness study with human readers. The device serves to "map" and provide "efficient presentation" for human screening, rather than replacing or directly augmenting diagnostic performance in a quantifiable way described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not explicitly stated as being evaluated. The device is described as a "computer-aided Slide Mapping System" for "efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation." This strongly implies a human-in-the-loop system, where the algorithm 'pre-processes' the slide for human review, rather than making a standalone diagnostic call.
7. The type of ground truth used
- Type of Ground Truth: The document implies that the human interpretation by a "cytotechnologist or cytopathologist" is the ultimate diagnostic ground truth for cervical cytology. The device's role is to ensure all relevant areas are presented for this human interpretation. The ground truth for the mapping function itself would likely be related to whether all cellular material (as defined) is indeed presented.
8. The sample size for the training set
- Sample Size (Training Set): Not specified in the provided documents.
9. How the ground truth for the training set was established
- Ground Truth (Training Set): Not specified in the provided documents. The device uses "standard image processing techniques" for segmentation, which would typically rely on established principles for identifying cellular material.
§ 864.5260 Automated cell-locating device.
(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).