Search Results

Serim Blood Leak Test Strips – 2 provide a rapid and convenient means for testing dialysate for occult blood leaks that may occur during the conventional hemodialysis procedure or continuous renal replacement therapy procedures such as continuous arteriovenous hemodialysis or continuous venovenous hemodialysis.

The SERIM Blood Leak Test Strips-2 consist of a 0.2 x 0.2 inch reagent pad attached to one end of a white 0.2 x 3.25 inch polystyrene handle. The reagent pad is immersed into a sample, removed immediately and allowed to react for 60 seconds. Then the reagent pad color is compared to two color blocks on the bottle label. One color block marked Negative is yellow with a few green speckles. If a reagent pad has a similar yellow color the dialysate does not contain significant blood. The second color block is green with small yellow speckles and is marked Positive. A reagent pad with green color equal to or darker than this color block indicates the presence of a significant blood leak.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the SERIM™ Blood Leak Test Strips-2:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 60 negative samples and 60 positive samples (totaling 120 samples).
• Data Provenance: The document does not specify the country of origin. The data appears to be from a controlled laboratory study, not directly referenced as prospective or retrospective patient data. It describes "blind studies" using "blood standards" in "dialysis buffer."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that positive ground truth was defined as "1.5 mg/dL hemoglobin, determined by the cyanmethemoglobin method." This implies reliance on a laboratory assay rather than human expert interpretation for the quantitative ground truth. The color block comparison is manual, but the underlying "true" hemoglobin levels were determined by a standard analytical method.

4. Adjudication Method for the Test Set

• The document does not mention an adjudication method. The test strips are designed for visual comparison to distinct positive and negative color blocks. The 100% sensitivity and specificity reported suggest no ambiguity in interpretation for the tested samples, implying direct comparison to the color blocks was sufficient, without needing further adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance of the device and its comparison to a predicate device's chemical properties. The document does not discuss human reader performance, either with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone performance study was conducted. The "SERIM Blood Leak Test Strips-2" themselves are a standalone diagnostic device. The reported sensitivity and specificity demonstrate the performance of the device independent of human interpretation ambiguity, beyond simply visual classification after the test is run. The device is the "algorithm" in this context (chemical reaction leading to a visual output).

7. Type of Ground Truth Used

• The ground truth for positive samples was established using a quantitative laboratory method: "1.5 mg/dL hemoglobin, determined by the cyanmethemoglobin method."
• The ground truth for negative samples was "dialysis buffer without blood."

8. Sample Size for the Training Set

• The document does not describe a training set or a machine learning algorithm. This device is a chemical test strip, not an AI-based system. Therefore, the concept of a "training set" is not applicable in this context.

9. How the Ground Truth for the Training Set Was Established

• As the device is a chemical test strip and not an AI-based system, there is no "training set," and therefore, no process for establishing its ground truth.

Ask a specific question about this device

SERIM Blood Leak Test Strips provide a rapid and convenient means for testing spent dialysate for blood in hemodialysis clinics. The presence of blood in dialysate indicates a leak in the dialysis membrane.

The SERIM Blood Leak Test Strip consists of a 0.2 x 0.2 inch reagent pad attached to one end of a white 0.2 x 3.25 inch polystyrene handle. The reagent pad is immersed into a sample, removed immediately and allowed to react for 60 seconds. Then the reagent pad color is compared to two color blocks on the bottle label. One color block marked Negative is yellow with a few green speckles. If a reagent pad has a similar yellow color the dialysate does not contain significant blood. The second color block is green with small yellow speckles and is marked Positive. A reagent pad with green color equal to or darker than this color block indicates the presence of a significant blood leak.

Here's a breakdown of the acceptance criteria and study detailed in the provided document for the SERIM™ Blood Leak Test Strips:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • 100 negative samples (dialysis buffer without blood).
  • 100 positive samples (dialysis buffer with 1.5 mg/dL hemoglobin).
  • 101 dialysate samples collected at a dialysis clinic.
  • 33 of the 101 dialysate samples were spiked with blood.
• Data Provenance: The document does not explicitly state the country of origin, but given the FDA submission, it is likely US-based. The study appears to be a prospective evaluation of the strips against defined standards and collected dialysate samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document mentions that "12 participants" used the SERIM Blood Leak Test Strips to test blood standards in "blind studies." It does not specify their qualifications or if they are considered "experts" in the sense of establishing ground truth.

For the ground truth of the blood concentrations (1.5 mg/dL hemoglobin), it was "determined by the cyanmethemoglobin method," which is a laboratory assay. This implies chemical validation rather than expert consensus on visual interpretation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for disagreements. The results are presented as direct counts of positive and negative readings. Since it's a diagnostic strip interpreted against a color chart, the "adjudication" (if any) would likely be an intrinsic part of the 12 participants' individual interpretations, though this isn't explicitly detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done. This study evaluates a diagnostic test strip, which is a standalone device interpreted by a user, not an AI system assisting human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, the study evaluates the SERIM Blood Leak Test Strips as a standalone diagnostic device. The "algorithm" here is the chemical reaction on the strip leading to a color change, which is then visually compared to a reference color chart on the bottle label by the user. The performance reported (specificity and sensitivity) is for this standalone function (device + user interpretation). The "12 participants" are the human-in-the-loop for interpretation, but the focus is on the device's ability to produce the correct color change.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

• Laboratory Assay/Known Concentration: For the 100 positive samples, the hemoglobin concentration of 1.5 mg/dL was "determined by the cyanmethemoglobin method." For the negative samples, it was dialysis buffer without blood, representing a known absence.
• Comparator Device Performance (for clinical samples): For the 101 dialysate samples and the 33 spiked samples, the performance of the SERIM strips was compared to "Chemstrip occult blood strips" (the predicate device). While not a standalone "ground truth" in terms of direct pathology or outcomes data, the agreement with an established, legally marketed equivalent device serves as a strong comparator for substantial equivalence.

8. The Sample Size for the Training Set

The document does not mention a training set for the device. This is a diagnostic test strip that relies on chemical reactions and visual interpretation, not a machine learning or AI-based device that typically requires a training set.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or applicable for this type of device, this question is not relevant to the provided documentation.

Ask a specific question about this device