(81 days)
MDA® Simplastin® HTF is a tissue thromboplastin reagent derived from cultured human cells for use in determination of the prothrombin time (PT) in human plasma.
Tissue Thromboplastin reagent for use in determination of the prothrombin (PT) in human plasma.
This document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML medical devices. This is a 510(k) summary from 1998 for a laboratory reagent (MDA® Simplastin® HTF), which is a device type significantly different from modern AI/ML devices. Therefore, many of the requested categories are not applicable.
However, I can extract the information provided regarding the device's performance and the studies conducted to demonstrate substantial equivalence to a predicate device, as required for a traditional 510(k).
Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a laboratory reagent and not an AI/ML device, explicit numerically defined "acceptance criteria" and "reported device performance" in the typical sense of metrics like sensitivity, specificity, or AUC are not presented in this summary. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through various performance characteristics.
The table below summarizes the key performance characteristics and comparisons mentioned:
| Performance Characteristic | MDA® Simplastin® HTF (New Device) | Ortho RecombiPlasTin® (Predicate Device) | Study to Demonstrate Equivalence |
|---|---|---|---|
| Normal Patient Mean | 12.1 seconds | 11.7 seconds | Prothrombin Time method comparison with clinical specimens |
| Precision | Demonstrated | N/A (implied acceptable for predicate) | Precision studies on three levels of plasma controls; normal, borderline abnormal, and coumadin plasma pools |
| INR Values | Demonstrated equivalence to predicate | N/A (implied acceptable for predicate) | INR method comparisons with clinical specimens |
| Factor II, V, VII, X | Demonstrated equivalence to predicate | N/A (implied acceptable for predicate) | Factor II,V,VII and X method comparison with clinical specimens |
| Interference | Demonstrated acceptable performance | N/A (implied acceptable for predicate) | Interference studies on lipemic, icteric and hemolyzed samples |
| Reference Ranges | Established for normal plasma pool | N/A (implied acceptable for predicate) | Reference ranges on normal plasma pool |
| Heparin Tolerance | Evaluated | N/A (implied acceptable for predicate) | Heparin tolerance evaluation utilizing heparin spiked plasma samples |
| Open Vial Stability | Demonstrated | N/A (implied acceptable for predicate) | Open vial stability studies |
| Safety and Efficacy | Supported by precision, interference, normal donor, and stability data | N/A (implied acceptable for predicate) | Nonclinical and clinical tests |
| Substantial Equivalence | Demonstrated to predicate device | N/A | All comparison studies (PT, INR, Factor comparisons) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the "test set" (clinical specimens). It mentions "clinical specimens" were used for method comparisons (PT, INR, Factor comparisons), precision studies (on plasma pools), and interference studies (on lipemic, icteric, hemolyzed samples). Without specific numbers, it's impossible to quantify.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies involved "clinical specimens," suggesting real-world human plasma samples. Given the submitter's address in North Carolina, USA, it's highly probable the data originated from the USA.
- Retrospective or Prospective: Not explicitly stated. The nature of the "method comparison" and "precision studies" could allow for either retrospective analysis of banked samples or prospective collection. However, for a device of this type and era, prospective studies involving fresh samples would be common for some elements like reference range determination.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: N/A. For a laboratory reagent determining prothrombin time (PT), the "ground truth" is typically established by measurements from an established, reference method or the predicate device itself, not by expert interpretation of images or clinical data. There is no mention of experts establishing a ground truth in this context.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: N/A. This concept is not applicable to a laboratory reagent that provides a quantitative measurement. The "ground truth" (or reference standard) would be the result from another lab method.
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
- MRMC Study: No. This type of study is specific to AI/ML devices that assist human interpretation (e.g., radiologists reading images). This device is a laboratory reagent.
- Effect Size of Human Readers with/without AI: N/A.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable in the context of an AI/ML algorithm. The "performance" of this device is its standalone ability to accurately measure prothrombin time, which was demonstrated through precision, accuracy (vs predicate), and interference studies.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device would be the results obtained from a legally marketed predicate device (Ortho RecombiPlasTin® Reagent) or other established, reference prothrombin time methods, against which the new device's measurements were compared (e.g., "Prothrombin Time method comparison," "INR method comparisons," "Factor II,V,VII and X method comparison").
8. The Sample Size for the Training Set
- Training Set Sample Size: N/A. This device is not an AI/ML algorithm that requires a "training set" in the computational sense. Its performance is based on the chemical and enzymatic reactions of the reagent itself.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: N/A, as there is no training set for this type of device.
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).