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The LEUKO EZ VUE™ test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE™ test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. FOR IN VITRO DIAGNOSTIC USE.

The LEUKO EZ VUE™ test is a 10 minute immunochromatographic device for the detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test utilizes the same polyclonal antibodies against human lactoferrin as our previously cleared LEUKO-TEST assay. The polyclonal antibodies to human lactoferrin are immobilized on nitrocellulose and the conjugate consists of the same antibodies linked to colloidal gold particles. The membrane cassette contains two stripes of immobilized antibodies. One stripe contains anti-lactoferrin antibodies. The other, representing a control stripe, contains anti-IgG antibodies. The diluted sample and gold conjugate migrate by capillary action when the sample is added to the well. If elevated lactoferrin is present in the sample, gold conjugate-lactoferrin complexes form and are captured by the immobilized anti-lactoferrin antibodies in the stripe. The lactoferrin-conjugate-antibody complexes appear as a single red line in the test portion of the Results window. In the control stripe, conjugate binds to the immobilized anti-IgG antibodies, demonstrating correct migration of the sample and conjugate along the membrane. The conjugate-anti-IgG antibodies appear as a single red line in the control portion of the Results window.

Here's a summary of the acceptance criteria and study details for the LEUKO EZ VUE™ device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the LEUKO EZ VUE™ were based on its agreement with the predicate device, LEUKO-TEST.

Study Information

This study evaluated the performance of the LEUKO EZ VUE™ test against the predicate LEUKO-TEST in clinical studies.

1. Sample size used for the test set and the data provenance:

   • Sample Size: 375 specimens
   • Data Provenance: The document does not specify the country of origin. It indicates "clinical studies" without further detail on the nature (retrospective or prospective) of the data collection for these specific comparative studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The "ground truth" for this study was established using the results of the LEUKO-TEST (K931241/A1), which is a previously cleared latex agglutination test. The document does not mention the use of experts to establish a separate ground truth or to interpret the LEUKO-TEST results for the purpose of this comparative study.

3. Adjudication method for the test set:

   • Not applicable. The study compares the LEUKO EZ VUE™ to the LEUKO-TEST directly, rather than against an expert-adjudicated ground truth.

4. 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. This device is a rapid in-vitro diagnostic test, not an AI-assisted diagnostic tool requiring human interpretation. The output is a visual presence of a red line.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the LEUKO EZ VUE™ test's performance was evaluated as a standalone device by comparing its results directly to the LEUKO-TEST results. It is an immunochromatographic device that provides a visual reading ("red line in the test portion of the Results window").

6. The type of ground truth used:

   • The ground truth for comparison was the results obtained from the LEUKO-TEST (K931241/A1).

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" or its size. As this is a performance comparison of an in-vitro diagnostic device against a predicate, typical machine learning training set paradigms are not directly applicable in the same way. The study focuses on evaluating the device's performance on a set of clinical samples.

8. How the ground truth for the training set was established:

   • Not applicable, as a distinct "training set" with established ground truth, in the context of machine learning, is not described for this type of IVD performance study. The performance evaluation samples were compared against the results of the predicate LEUKO-TEST.

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Disposable cement spacer molds with stainless steel reinforcements are intended to be used to mold a hemi-hip femoral prosthesis, indicated for temporary use (maximum 180 days) in skeletally mature patients undergoing a two-stage procedure due to septic process.

The temporary prosthesis is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The temporary prosthesis is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The hemi-hip femoral prosthesis is not intended for use more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection, arthroplasty, fusion, etc.)

Because of inherent mechanical limitations of the material (polymethylmethacrylate/gentamicin), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

The device consists of a sterile, assembled cement spacer mold made of medical grade silicone with a stainless steel reinforcement stem located inside the silicone mold, designed to construct a temporary cement hemihip femoral spacer. The silicone component of the spacer mold is designed to shape the temporary spacer but is not implanted, and is to be discarded after a single use. The stainless steel reinforcement stem serves as the load-bearing endoskeleton of the hemi-hip prosthetic implant and is incorporated into the prosthesis by being coated over by bone cement.

Polymethylmethacrylate/gentamicin bone cement is filled into the silicone mold containing the stainless steel reinforcement stem. The temporary hip prosthesis is removed from the silicone mold after the cement hardens and is placed into the patient's hip joint space.

The femoral cement spacer molds are offered in four sizes (9 mm x 125 mm/ 43mm head, 9 mm x 125 mm/ 51mm head, 13 mm x 145 mm/ 57 mm head & 17 mm x 165 mm/ 64 mm head).

The provided document is a 510(k) summary for the StageOne™ Disposable Cement Spacer Mold. It details the device's description, intended use, and indications for use, as well as non-clinical testing performed. However, it does not contain any information about acceptance criteria or specific study results that delineate device performance against such criteria in a quantitative manner.

Here's a breakdown of the available information based on your request, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not explicitly stated in quantitative terms within the provided text. The document focuses on demonstrating "substantial equivalence" to a predicate device.
   • Reported Device Performance: The non-clinical testing section reports qualitative findings:
     • "The temporary hip prostheses were found to be substantially equivalent in fatigue characteristics."
     • "The percentage of total gentamicin eluted from the spacer made from a Biomet mold and antibiotic-loaded G bone cement was substantially equivalent to the percentage of gentamicin eluted from the Tecres Spacer-G."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified for the non-clinical testing.
   • Data Provenance: Not specified.

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)

   • This question is not applicable as there was no clinical testing involving expert review of patient data to establish ground truth. The testing was non-clinical (mechanical and elution).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • This question is not applicable as there was no clinical testing involving human adjudication of results.

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 MRMC study was done, nor were there any clinical studies involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   • No standalone algorithm performance study was done, as this device is a physical medical device (cement spacer mold), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • For the non-clinical testing, the "ground truth" was established by comparative mechanical and antibiotic elution testing against a legally marketed predicate device. This involved standardized laboratory testing methods, not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

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The IBD-SCAN™ test is a quantitative ELISA for measuring concentrations of fecal lactoferrin, a marker of fecal leukocytes. An elevated level is an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to distinguish messinal inflammatory bowel disease (IBD) from those with noninflammatory irritable bowel syndrome (IBS). FOR IN VITRO DIAGNOSTIC USE.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the IBD-SCANTM device. It acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot provide the requested information based on the input text. The text only confirms the device's regulatory clearance and its intended use as an in vitro diagnostic aid for distinguishing inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS) by measuring fecal lactoferrin.

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The IBD-QUIK CHEK™ test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active noninflammatory irritable bowel syndrome (IBS). FOR IN VITRO DIAGNOSTIC USE.

The IBD-OUIK CHEKM test is a 10-minute immunochromatographic device for the detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test utilizes the same polyclonal antibodies against human lactoferrin as our previously cleared I.F.UKO-12ST® and IBD-CHEK™ test. The polyclonal antibodies to human lactoferrin are immobilized on nitrocellulose and the conjugate consists of the same antibodies linked to colloidal gold particles.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for IBD-QUIK CHEK™ test 1.12

1. Table of Acceptance Criteria and Reported Device Performance

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

• Correlation Study (vs. LEUKO-TEST® and Microscopy): Not explicitly stated. The text mentions "the same study" for both comparisons but does not give a sample size.
• Clinical Evaluation Study (vs. Clinical Assessments and IBD-CHEK™):
  • Total Patients: 58 (active IBD) + 35 (inactive IBD) + 17 (active IBS) + 27 (healthy) = 137 individuals.
  • Data Provenance: Not explicitly stated, but clinical evaluations typically use prospective patient cohorts. Given the context of a 510(k) submission, it's highly likely to be a prospective study conducted in a clinical setting, but the country of origin is not mentioned.

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

• This information is not provided in the summary. For the correlation study with microscopy, a "microscopy" gold standard implies expert review of slides, but the number and qualifications of experts are not described.
• For the clinical evaluation study, "clinical assessments" are used, which would typically involve physicians or specialists. However, the exact number and their qualifications (e.g., gastroenterologists, years of experience) are not detailed.

4. Adjudication Method for the Test Set

• Not explicitly stated. For the microscopy comparison, it is implied that microscopy served as a direct ground truth. For the clinical assessment study, it's likely that a treating physician's diagnosis and possibly additional diagnostic tests (e.g., endoscopy, histology) formed the "clinical assessment," but the adjudication process (e.g., if multiple clinicians reviewed cases, or if a consensus was required) is not described.

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 applicable. This device is an in vitro diagnostic test, not an AI or imaging device where human readers interact with AI assistance. The comparisons are between the device and existing tests/clinical assessments, not human interpretation aided by AI.

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

• Yes. This device is a standalone diagnostic test. Its performance metrics (correlations, sensitivity, specificity implied by positive/negative rates) are reported for the device itself, without human intervention in its result generation. The test produces a direct positive or negative result.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Correlation Study:
  • Microscopy: Likely expert visual assessment of fecal samples for leukocytes, potentially considered as a form of expert consensus or established laboratory methodology.
  • LEUKO-TEST®: Another existing diagnostic test, used as a comparative standard.
• Clinical Evaluation Study:
  • Clinical Assessments: This would encompass a combination of clinical diagnosis, patient history, symptoms, and potentially other diagnostic tests (e.g., endoscopy, biopsies, imaging) and follow-up, which can lead to a 'clinical ground truth' or 'outcomes data' in terms of confirmed IBD, IBS, or healthy status.
  • IBD-CHEK™ test results: Another existing diagnostic test, used as a comparative standard.

8. The Sample Size for the Training Set

• Not applicable / Not explicitly stated. For an immunochromatographic device like this, there isn't typically a "training set" in the machine learning sense. The device's performance is based on its inherent biochemical properties and manufacturing consistency, not an algorithm "trained" on data. The polyclonal antibodies and colloidal gold conjugates are pre-determined components.

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

• Not applicable. As explained in point 8, there isn't a training set in the context of this type of diagnostic device. The ground truth for validating the device's performance (i.e., the test set ground truth) is described in point 7.

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