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The Test is a qualitative immunoassay intended for non professional / Over The Counter Use for qualitative detection of the human chorionic gonadotropin (hCG) in urine. The test is for use as an aid in the diagnosis of early pregnancy.

A single step, visually read, qualitative immuno-chromatographic single use stick test.

Here's an analysis of the provided information, focusing on acceptance criteria and the study detailing device performance:

Acceptance Criteria and Device Performance for Mid Stream Pregnancy Test (K023037)

The document focuses on demonstrating the substantial equivalence of the Mid Stream Pregnancy Test to a predicate device, rather than establishing de novo acceptance criteria. The primary "acceptance criteria" presented are the device's ability to correlate 100% with the predicate device and the high repeatability and precision observed in various studies.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set (Correlation Study):

  • Sample Size: Not explicitly stated for the "comparison studies" against the predicate device. However, the subsequent "consumer study" used 115 consumers.
  • Data Provenance: The document does not specify the country of origin. The studies appear to be prospective evaluations for the purpose of this 510(k) submission.

• POL Study (Point-of-Care/Laboratory Study):

  • Sample Size: Not explicitly stated.
  • Data Provenance: Not explicitly stated. The study involved "different personnel with diverse educational background and work experience," suggesting it was conducted within a controlled (lab or clinical) environment. It's likely prospective.

3. Number of Experts and Qualifications for Ground Truth

• Correlation Study & POL Study:

  • The document implies that the predicate device's results served as a form of ground truth for the correlation study. The "different personnel with diverse educational background and work experience" involved in the POL study would have been trained professionals, but their exact number or specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. They are referred to as "professionals" in contrast to "consumers."

• Consumer Study:

  • The results obtained from "professionals" served as the ground truth against which consumer results were compared. The number and specific qualifications of these professionals are not stated.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1 or 3+1). For the core comparison/correlation studies, the method appears to be a direct comparison of the new device's results to the predicate device's results. For the consumer study, the "professionals" likely provided the definitive interpretation, against which consumer interpretations were measured.

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

No Multi Reader Multi Case (MRMC) comparative effectiveness study is mentioned. The comparison is between the new device and a predicate device, and between consumers and professionals, rather than evaluating human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

This device is an immuno-chromatographic stick test, not an algorithm or software. Therefore, the concept of a "standalone" algorithm-only performance study does not apply. The performance described is the standalone performance of the physical test device.

7. Type of Ground Truth Used

• Correlation Study: The results from the predicate device (Acon Midstream Pregnancy Test, K983090) served as the primary ground truth.
• POL Study & Consumer Study: The results obtained by trained professionals using the device (or the predicate device) were used as the ground truth against which other interpretations (e.g., consumer interpretations) were compared. This is a form of expert consensus/professional standard.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or machine learning. For this type of diagnostic test, the "training" typically refers to the development and optimization of the assay itself, which is not detailed in terms of sample sizes here.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of an algorithm, this question is not applicable. The development process would have involved establishing the assay's sensitivity and specificity against known positive and negative samples, but the specifics of how this 'ground truth' was established during development are not provided.

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Diagnostic ultrasound imaging of human soft tissues.

The DEI System acoustical holography imaging system is intended for the following uses: Small Parts, Pediatrics, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

Small organ imaging is intended for the breast.

Breast biopsy.

The DEI System is a general purpose, software-controlled, diagnostic ultrasound system that complies with pre-amendment application-specific acoustic output levels (track 1). Its function is to acquire ultrasound data in accustical holography mode and display it on an LCD monitor.

The DEI System is similar to the predicate device (OS-2000, K001510) in that both use an oblect transducer that is coupled to the patient by use of a water-path (immersion in water bath or use of water bladders) to transmit pulsed ultrasound through the targeted tissues. These transmitted pulses are then acoustically focused ultrasound beam is then combined with a second plane wave (reference wave) of the same frequency as the transmit wave. The interaction of the transmit wave and the reference wave creates an interference pattern on a target detector device within the enclosed system, forming an acoustic hologram of the object. The detector is illuminated with a coherent light source (laser) resulting in a visual image. The visual image is recorded with a CCD video camera and the images are displayed on a video monitor. Images may be stored to hard disk. This modification to the predicate involves the addition of biopsy capability. The Avera is substantially equivalent to a predicate device, the Sonopsy LA System (K 980423) in that both allow real time image-guided biopsy within image guidance in 1 plane and an assist device to locate the plane of focus (depth plane).

The provided text describes the Avera Model DEI System, an acoustical holography imaging system that includes a real-time image-guided biopsy capability. However, the text does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics.

The document is primarily a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to predicate devices and outlining the intended uses and technical comparisons. It does not include details on the following:

1. A table of acceptance criteria and the reported device performance: This information is missing.
2. Sample size used for the test set and the data provenance: This information is missing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is missing.
4. Adjudication method for the test set: This information is missing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: The document describes an "Acoustical Holography Imaging System" and a "biopsy feature," but it does not mention any AI component or human-in-the-loop performance studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As there's no mention of an algorithm or AI, standalone performance is not discussed.
7. The type of ground truth used: This information is missing.
8. The sample size for the training set: This information is missing.
9. How the ground truth for the training set was established: This information is missing.

In summary, the provided text explains the regulatory clearance of the device and its technical description but does not offer any details regarding specific performance studies, acceptance criteria, or the methodology used to establish ground truth or assess performance.

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The DEI System ultrasound imaging system is intended for the following uses: Small Parts, Pediatrics, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The DEI System is a general purpose, software-controlled, diagnostic ultrasound system that complies with pre-amendment application-specific output levels (track 1). Its function is to acquire ultrasound data in acoustical holography mode and display it on an LCD monitor.

The provided text is a 510(k) summary for the Altair Model DEI System, an acoustical holography imaging system. It describes the device, its intended use, and its technological comparison to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as typically found in performance testing sections of a 510(k) submission.

The document primarily focuses on regulatory compliance (safety standards, substantial equivalence to a predicate device) and a general description of the device's technology and intended uses.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on the provided text. The requested information (points 1-9) is not present in this document.

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