(51 days)
The Great Smokies lactulose/mannitol test for intestinal permeability is intended to measure the ratio of lactulose to mannitol in urine; the measurement is used in the diagnosis of gastrointestinal malabsorption syndrome.
The device is a kit consisting of exempt components and accessories (urine specimen transport tubes (one white-capped "before drink" specimen tube and one purple-capped "after drink" specimen tube), a pipette, a small urine collection cup, a large urine collection container, a biohazard bag with absorbent pad, and a drink accessory (5g lactulose, 1g mannitol, 10g glycerine, and 3.84 ml water)). The drink is ingested after an overnight fast, and voided urine is then collected over a period of 6 hours to measure the level of lactulose and level of mannitol in urine and to obtain a ratio; the result is expressed as the percent recovery of an ingested dose of lactulose divided by the percent recovery of an ingested dose of mannitol. The measurement is used in the diagnosis of gastrointestinal malabsorption syndrome (a group of disorders in which there is abnormal absorption of dietary constituents, e.g., excessive absorption of substances or excessive loss from the body of nonabsorbed substances).
The provided text is a 510(k) summary for a medical device: "Great Smokies Diagnostic Laboratory Intestinal Permeability Test System." It contains information primarily related to the device's equivalence to a predicate device and its intended use. However, it does not include a study describing acceptance criteria, reported device performance metrics, or details about a study design (sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone performance).
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or information about a study proving the device meets those criteria, as this information is not present in the provided text.
The document indicates that the device has the "same intended use and similar technology and performance characteristics" as the predicate device (Xylose Test System). This implies that its performance is considered comparable to the predicate, but specific performance metrics for the Great Smokies device are not provided.
Based on the provided text, I can only state the following:
- Acceptance Criteria/Performance: Not explicitly stated or evaluated in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device based on intended use and similar technological/performance characteristics.
- Study Details: No study is described that proves the device meets specific acceptance criteria.
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
- Number of Experts/Qualifications for Ground Truth: Not specified.
- Adjudication Method: Not specified.
- MRMC Comparative Effectiveness Study: Not mentioned or conducted based on the provided text.
- Standalone Performance Study: Not mentioned or conducted based on the provided text.
- Type of Ground Truth: Not specified.
- Sample Size for Training Set: Not applicable as this is an in vitro diagnostic test kit, not typically a machine learning device with a training set.
- How Ground Truth for Training Set was Established: Not applicable.
§ 862.1820 Xylose test system.
(a)
Identification. A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in which there is subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances).(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 § 862.9.