(103 days)
The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.
The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.
The SmartBlock™ device comprises of the following components:
- Compression unit including solution reservoir (up to 500 ml)
- SmartInfuser regulating set (several versions of flow rate ranges, with or without MultiBolus™)
- 50/60 cc disposable svringe
- Wound dressing
- Medication labes
- Pump lables
- Carry pouch
- FlowSpliter™ (optional)
The SmartBlock™ Pain Pump is designed for the following flow rate options:
| Reference # | Flow Rate Range | Bolus Feature | |
|---|---|---|---|
| 1 | P49520 | 1-6 ml/hr | Included |
| 2 | P49524 | 5-15 ml/hr | Included |
| 3 | P49530 | 1-6 ml/hr | Not included |
| 4 | P49534 | 5-15 ml/hr | Not included |
The provided document is a 510(k) summary for the SmartBlock™ Pain Pump, a medical device for pain management. It does not include detailed information regarding acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/CADe device.
This document focuses on demonstrating substantial equivalence to a predicate device (On-Q Pump), which is a regulatory pathway for medical devices. The "study" mentioned here is primarily about demonstrating that the new device has "equivalent performance characteristics" to the predicate device, not necessarily a performance study against predefined numerical acceptance criteria like one might find for an AI algorithm.
However, I can extract information relevant to the equivalence claim and structure it as an answer, while noting the absence of explicit AI/CADe study details.
Here's an analysis based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define numerical acceptance criteria for a "study" in the typical sense of evaluating an AI algorithm's performance (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device, the On-Q Pump. The reported "device performance" relies on this equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent intended use as the predicate device (On-Q Pump). | Meets: "The SmartInfuser PainPump™ has the same intended use as the On-Q Pump..." |
| Equivalent performance characteristics as the predicate device (On-Q Pump). | Meets: "...and has equivalent performance characteristics." |
| No additional concerns regarding safety and effectiveness compared to predicate. | Meets: "The evaluation... does not raise any additional concerns regarding safety and effectivity..." |
The table of flow rates (P49520, P49524, P49530, P49534) and their associated ranges (e.g., 1-6 ml/hr, 5-15 ml/hr) can be considered part of the device's functional specifications, which would have been tested to demonstrate they meet design requirements. However, these are specifications, not performance criteria against a clinical "ground truth" as you'd find for an AI study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) summary does not detail specific "test set" data or studies with sample sizes, as it relies on demonstrating equivalence rather than a de novo clinical trial with defined data sets. It doesn't mention data provenance (country, retrospective/prospective).
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 information is not provided. As there's no mention of a "test set" for performance evaluation in the context of an AI/CADe device, there isn't a discussion of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. (See point 3).
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human readers improving with AI assistance. This device is a pain pump, not an AI/CADe diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The SmartBlock™ Pain Pump is a mechanical/electronic medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of an AI/CADe device. For this pain pump, the "ground truth" would be related to engineering specifications and performance testing (e.g., verifying actual flow rates against specified ranges, material compatibility, sterility, mechanical integrity). This document does not detail those specific engineering studies or their "ground truth" methods.
8. The sample size for the training set
This is not applicable. There is no AI algorithm involved that would require a training set.
9. How the ground truth for the training set was established
This is not applicable. (See point 8).
Summary of what is present:
The document serves as a 510(k) summary, aiming to demonstrate substantial equivalence of the SmartBlock™ Pain Pump to a legally marketed predicate device (On-Q Pump, K063530). The "study" in this context refers to the comparative analysis and testing that allowed the manufacturer to conclude that their device has the "same intended use" and "equivalent performance characteristics" to the predicate, and does not raise "any additional concerns regarding safety and effectivity." It does not provide details of clinical studies or data analysis related to AI performance metrics.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).