Search Results
Found 1 results
510(k) Data Aggregation
(248 days)
The Novamed, Ltd. DipStreak Urine Culture Device is used for the isolation and enumeration of bacteria in urine. A set of plastic prongs on the end of the device are dipped into the urine sample. The drops of urine which adhere to the prongs are then streaked across two different agar surfaces (CLED agar on one side, MacConkey agar on the other). A dilution effect takes place which allows the isolation of single colonies.
DipStreak comprises a plastic paddle with two types of agar attached back-to-back, housed in a closed transparent plastic tube. A ring with elongated prongs is attached to the end of the paddle so that there are prongs on each side of the slide. The ends of the prongs are dipped into the urine sample. Upon re-insertion into the plastic tube, the prongs are prevented from moving and the agar surfaces are inoculated with bacteria from the urine sample as the agar-coated paddle passes over the prongs. The result is a series of streaks of decreasing bacterial concentration which permits isolation of single colonies even when the original bacterial population of the sample was as high as 10' organisms per milliliter.
The provided text describes the DipStreak Urine Culture Device and studies supporting its performance. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Detection Range | Pathogenic bacteria found in urine samples at levels from 10^3 to 10^7 CFU/ml are detected accurately and consistently. | Precision Study: Experimental evidence to support this claim is given in the application's "Precision Study." (Specific numerical results for this range are not explicitly provided in the excerpt, but the claim is made that it's detected accurately and consistently.) |
| Agreement with Predicate Device | Not explicitly stated as a numerical acceptance criterion, but implied to be high due to substantial equivalence. | Study 1 & 2 (vs. Predicate Device): Overall agreement of 96.4% at the cutoff level of 10^5 CFU/ml and 96.9% at the cutoff level of 10^4 CFU/ml when compared to the Savyon Diaslide Urine Culturing Device (K921045) in two studies comprising 522 clinical samples. |
| Sensitivity and Specificity (Standalone) | Not explicitly stated as numerical acceptance criteria, but implied to be high for standalone performance. | Study 3 (vs. Traditional Petri Dish Culture): Sensitivity and specificity values for cutoff levels of 10^5 and 10^4 CFU/ml were all above 98.6% when compared to traditional petri dish culture in a study of 1000 clinical samples. |
| Quality Control Tests | Device must support the expected growth of organisms. Failure indicates deterioration. | User Quality Control: Specific "Typical Culture Response" table provided for E. coli, S. aureus, and P. vulgaris with expected growth rates and colony appearances after 24 hours at 37°C. (This serves as an in-use acceptance criterion, not a study outcome, but demonstrates a defined performance expectation for functionality). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Predicate Device Comparison: 522 clinical samples (across two studies).
- Sample Size for Traditional Petri Dish Comparison: 1000 clinical samples (one study).
- Data Provenance: The text does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It refers to "clinical samples," implying human-derived samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
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, an MRMC comparative effectiveness study was not done. The device being described is a urine culture device (a diagnostic tool for bacterial enumeration and isolation), not an AI-powered diagnostic imaging or interpretation tool. Therefore, "human readers improving with AI vs without AI assistance" is not applicable to this device type.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The comparison of the DipStreak device to "traditional petri dish culture" in a study of 1000 clinical samples, yielding sensitivity and specificity values, represents a standalone performance evaluation of the device itself. The device is designed to be used independently to grow and identify bacteria, without an "algorithm only" component in the modern AI sense. Its "standalone" performance is its direct ability to detect and enumerate bacteria.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the comparison studies was traditional petri dish culture and the predicate device (Savyon Diaslide Urine Culturing Device). These methods are considered standard clinical practices for urine culture and bacterial enumeration, and thus serve as the reference standard or "ground truth" against which the DipStreak device's performance was measured.
8. The Sample Size for the Training Set
- This information is not provided in the given text. The description focuses on performance studies (test sets) rather than development or training data. Being a physical diagnostic device, it likely did not have a "training set" in the machine learning sense. The "Precision Study" likely refers to internal development and validation work rather than a data training phase.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided and is likely not applicable in the context of a physical diagnostic device like the DipStreak. The "ground truth" for its design and manufacturing would be based on established microbiology principles and standard culturing techniques.
Ask a specific question about this device
Page 1 of 1