(269 days)
TracCell™ 2000 System is intended as a computer-aided optical microscope system used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. The mapping of the slide into "presented" and "excluded" areas 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.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the AccuMed International's TracCell™ 2000 Slide Mapping System, dated August 18, 1997. This type of letter generally grants market clearance based on substantial equivalence to a predicate device and does not typically include detailed studies or acceptance criteria for the device itself. Instead, it confirms that the device is substantially equivalent to a previously cleared device. Therefore, a significant portion of the requested information cannot be extracted from this document alone.
However, I can extract the available information and point out what is missing based on common practices during that era for 510(k) submissions.
Here's a breakdown of the available and unavailable information:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not provide specific performance metrics, acceptance criteria, or a table detailing them for the TracCell™ 2000. 510(k) clearance in 1997 focused on substantial equivalence, and detailed performance studies with acceptance criteria were often not a mandatory component of the public summary unless specifically requested by the FDA for certain device types.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Available: The document does not mention any sample sizes for test sets, data provenance, or study design (retrospective/prospective).
3. 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 Available: The document does not discuss the establishment of ground truth by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Available: The document does not describe any adjudication methods.
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
- Not Available: The document does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is described as a "computer-aided optical microscope system" for "mapping" and "segmenting," suggesting it assists cytotechnologists/cytopathologists, but no comparative effectiveness data is provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Available: The document does not provide standalone performance data for the algorithm. Its stated use is "for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation," implying a human-in-the-loop system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Available: The document does not specify the type of ground truth used.
8. The sample size for the training set
- Not Available: The document does not provide information about a training set or its sample size.
9. How the ground truth for the training set was established
- Not Available: The document does not provide information about how ground truth was established for a training set.
Summary of Available Information from the Document:
- Device Name: AccuMed International's TracCell™ 2000 Slide Mapping System
- Intended Use: "as a computer-aided optical microscope system used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. The mapping of the slide into 'presented' and 'excluded' areas 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."
- Regulatory Class: II
- Product Code: JOY
- Date of Clearance: August 18, 1997
Conclusion:
This 510(k) clearance letter primarily confirms the substantial equivalence of the TracCell™ 2000 Slide Mapping System to a predicate device. It does not contain the detailed study results, acceptance criteria, or methodologies typically found in more recent, comprehensive device evaluations or public summaries. To obtain such information, one would generally need to refer to the full 510(k) submission (which is not publicly available in detail, only the summary), internal company documents, or potentially a peer-reviewed publication if one exists for the device's validation.
§ 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).