(289 days)
The Crit-Line Anemia Management software is a database application used to record, track and trend patient data as pertains to the management of anemia, and provide a dosage recommendation.
The CLAM software is a database application that records, tracks, trends, and analyzes patient data (Hematocrit, Oxygen Saturation, and Hemoglobin) along with current ESA dose in order to effectively manage anemia. During dialysis treatment, the CLAM downloads initial, real-time Hematocrit (HCT), Oxygen Saturation (SaO2), and Hemoglobin (Hb) data from the Crit Line blood monitor. The CLAM software trends this patient data along with current Erythropoiesis Stimulating Agent (ESA) dosage to determine the patient's Hb levels, the need (if any) for ESA dosing, and to track patient's response to treatment. The CLAM software uses a proprietary algorithm to calculate a recommendation for ESA dosage based on patient data trends and current ESA dose in order to establish and maintain predetermined patient Hb levels. The CLAM proprietary algorithm used to determine ESA dosing for anemia treatment is based on the current manual algorithm. In addition, the CLAM software generates and prints patient reports for review and record keeping. The CLAM software resides on a host computer separate from the Crit Line units and acquires real-time data from the clinic's Crit Line monitors via wireless radio signal or by a serial cable.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Crit Line Anemia Management (CLAM) software:
The provided 510(k) summary focuses primarily on establishing substantial equivalence to predicate devices and describes a performance comparison of its ESA dosage recommendation algorithm to manual calculations. It does not provide explicit "acceptance criteria" in the typical quantitative sense (e.g., target specificity, sensitivity, or accuracy thresholds) for the device's performance, nor does it conduct a comprehensive clinical study to prove these against a definitive ground truth. Instead, the study aims to show agreement with current manual practice.
However, based on the information provided, we can infer the implicit "acceptance criteria" as the calculated ESA dosage recommendation being "exactly the same" as manually calculated doses.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| CLAM software calculated recommended ESA dose = Manually calculated ESA dose | The CLAM software calculated recommended dose and the manually calculated dose were exactly the same. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 62 dialysis patients
- Data Provenance:
- Country of Origin: New England (United States, as per typical use of "New England" in this context)
- Retrospective or Prospective: Retrospective data using "the last two weeks of a patient's Hb values" being recorded for analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth was established by "manually calculated ESA dosage calculations," implying that medical personnel (e.g., clinicians, nurses, physicians as described in Intended User Population) performed these calculations.
- The document does not specify the number of experts, their specific roles (e.g., physician, nurse), or their qualifications (e.g., years of experience).
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method. The comparison was directly between the CLAM software's calculation and the "manually calculated dose," which presumably represents the established practice. There's no mention of a consensus process among multiple manual calculators or a tie-breaking mechanism.
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
- No, an MRMC comparative effectiveness study was not explicitly done. The study's focus was on the agreement between the CLAM software's recommendation and manual calculations, not on comparing human reader performance with and without AI assistance or quantifying an "effect size" of improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance evaluation was done. The "performance test" directly compared the CLAM software's calculated ESA dosage recommendations (algorithm only) to manually calculated recommendations. The CLAM software generated its recommendation based on inputted patient data (Hb values and current ESA dose), independently of human input for that specific calculation step.
7. The Type of Ground Truth Used
- Expert Consensus / Expert Determination (via manual calculation): The ground truth for this specific performance test was the "manually calculated ESA dosage calculations." This represents a determination made by medical professionals based on established protocols. It is not pathology, imaging, or direct outcomes data, but rather a calculation based on clinical parameters and existing practice.
8. The Sample Size for the Training Set
- The document does not explicitly state the sample size used for training the CLAM software's proprietary algorithm. It mentions the algorithm is "based on the current manual algorithm" but provides no details on how it was developed or trained on specific datasets.
9. How the Ground Truth for the Training Set Was Established
- The document does not specify how ground truth for any potential training set was established. It states the CLAM algorithm "is based on the current manual algorithm," which implies that the logic and principles of existing manual ESA dosing protocols formed the basis of the algorithm's design. It does not detail if or how a separate, labeled dataset with established ground truth was used to train or refine the algorithm.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).