(77 days)
Rapid identification of non-fastidious aerobic and facultatively anacrobic gram-negative bacilli from human clinical specimens
Not Found
Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroScan® Rapid Gram-Negative Identification Type 3 Panel:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, it implicitly defines successful performance based on comparison with the predicate device (API 20E System) and supplemental conventional methods.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High agreement with predicate device (API 20E System) and | 97.1% combined final agreement (species level, high and low probabilities) |
| supplemental tube methodologies for identification of gram-negative | with API 20E System identifications + supplemental tube methodologies. |
| isolates. | |
| High reproducibility of results. | >95% agreement with expected results. |
| Acceptable Quality Control (QC) performance. | QC performance was acceptable for both systems during the clinical trial. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 405 fresh and stock gram-negative isolates.
- Data Provenance: The text states, "Efficacy testing was conducted with a total of 405 fresh and stock gram-negative isolates at two (2) external sites." This indicates the data was collected prospectively (fresh isolates) and retrospectively (stock isolates) from clinical settings, likely within the country where the external sites were located (which isn't specified but generally implied to be the US for FDA submissions).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing the ground truth. It states that "Isolates meeting a pre-defined criteria were either repeated and/or were arbitrated using conventional tube methodologies."
4. Adjudication Method for the Test Set
The adjudication method used was a form of arbitration. When the initial MicroScan Rapid Gram-Negative Identifications were compared with API 20E System identifications, isolates that did not meet a "pre-defined criteria" were "either repeated and/or were arbitrated using conventional tube methodologies." This suggests a process where discrepancies or uncertain results were resolved by referring to conventional laboratory methods, which often involves expert interpretation.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an automated microbiological identification system, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The entire efficacy testing described (comparison of MicroScan RNID Type 3 panel results to API 20E System and supplemental tube methodologies) evaluates the performance of the device itself ("algorithm only") without an explicit "human-in-the-loop" component for interpretation during the initial identification phase. The "arbitration" step using conventional methods would involve human expert judgment, but this is a secondary step for discrepancy resolution, not primary interpretation of the device's output.
7. The Type of Ground Truth Used
The ground truth was established by:
- Comparison to a predicate device: API 20E System identifications.
- Arbitration with conventional tube methodologies: These are generally considered the gold standard or reference methods in microbiology for definitive identification when discrepancies arise. This implies a form of expert-driven reference standard based on established laboratory practices, rather than pathology or outcomes data.
8. The Sample Size for the Training Set
The document does not provide information about a separate "training set" or its sample size. The description focuses on "efficacy testing" against historical methods. This suggests a validation study rather than a machine learning model that would require a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
Since no separate training set is mentioned in the provided text, information on how its ground truth was established is not available. The efficacy study serves as the primary validation of the device's performance against established microbiological identification methods.
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Page 1 of 2 510(k) Summary - Attachment 1
DADE INTERNATIONAL
<961042
MicroScan Inc 1584 Enterprise Boulevard West Sacramento, CA 95691 916.372.1900
510(k) Submission Information:
| Device Manufacturer: | Dado MicroScan Inc. |
|---|---|
| Contact name: | Sharolyn Lontsch, Sr. Regulatory Affairs Administrator |
| Fax: | 916-374-3144 |
| Date prepared: | May 28, 1996 |
| Product Name: | Microbiological Identification System |
| Trade Name: | MicroScan® Rapid Gram-Negative Identification Type 3 Panel |
| Intended Use: | Rapid identification of non-fastidious aerobic and facultatively anacrobic gram-negativebacilli from human clinical specimens |
| 510(k) Notification: | Modified Device Request |
| Predicate devices: | MicroScan® Rapid Gram-Negative Identification Type 2 PanelAPI 20E System |
MAY 3 0 1996
510(k) Summary:
The proposed MicroScan Rapid Gram-Negative Identification Panel (referred to as the MicroScan RNID Type 3 panel) is substantially equivalent in intended use, technology, and methodology to the current MicroScan® Rapid Gram-Negative Identification Type 2 Panel and is subscantially equivalent to the API 20E System with regard to performance.
The Premarket Notification (510/k)) presents data in support of a fornulation modification for the current MicroScan" Rapid Gram-Negative Identification Type 2 Panci and requests a release to market for the modified device (i.e., the MicroScan® Rapid Gram-Negative Identification Type 3 Panel).
Efficacy testing was conducted with a total of 405 fresh and stock gram-negative isolates at two (2) external sites. MicroScan Rapid Gram-Negative Identifications were compared with API 207. System identifications. Isolates meeting a pro-defined criteria wore cither repeated and/or were arbitrated using conventional tube methodologies. Overall the MicroScan RNID Type 3 panel demonstrated a combined final agreement (percent at the species level, high and low probabilities) of 97.1% (393/405) when compared with API 20E System identifications supplementional lube methodologics. There was only one (1) Very Rare Biolype (VRB) result.
Reproducibility testing with the MicroScan" Rapid Gram-Negative Identification Type 3 Panel (RND) was comprised of 15 stock isolates tested at two (2) external sites and at MicroScan. Reproducibility was evaluated using individual biochemical test results, biotype frequencies, and overall identification performance. Overill inc MicroScan RNID Type 3 pancl gave results which were > 95% in agreement with expected results.
510K-SUM.DOC
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Dade MicroScan Inc. May 28, 1996 MicroScan® Rapid Gram-Negative Identification Type 3 Pancl
Quality control (QC) testing with the MicroScan Rapid Gram-Negative Idcritification Type 3 Panel (RNID) was conducted with cight (8) strains and a sallne blank. Quality control (QC) testing was performed on the API 20E System at the clinical trial sites according to the API 20E procedure manual. The QC performance was acceptable for both systems during the clinical trial. The four (4) struins recommended for routine user (customer) OC for the MicroScan RNID Type 3 pancl provide adequate coverage to vorily that the panel is performing as expected during routine use (c.g. > 95% aercement). User OC recommendations for user QC as described by NCCLS Document M7-A3 (Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerohically, Ed.3; Approved Standard. Pennsylvania, NCCLS, December 1993).
We therefore believe that the MicroScan® Rapid Gram-Negative Identification Type 3 Panci (RNID) gives appropriate rapid identifications with non-fastidious aerobic and facultatively anacrobic gram-negative bacilli from human clinical spocimens.
510K-SUM.DOC
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.