(157 days)
PICO 14 is indicated for patients who would benefit from a suction device (NPWT) as it may promote would healing via removal of low to moderate levels of exudate and infectious materials.
Appropriate wound types include:
- Chronic
- Acute
- Traumatic
- Subacute and dehisced wounds
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed Surgical incisions
PICO 14 Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.
PICO 14 Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a flexible tube to a super-absorbent, gentle adhesive dressing. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressing and fixation strips are supplied sterile and for single use.
The provided text describes the PICO 14 Single Use Negative Pressure Wound Therapy System and its substantial equivalence to the predicate device, PICO 7. However, the information presented primarily focuses on demonstrating equivalence through bench testing and a clinical study on patient outcomes rather than a traditional setup of acceptance criteria and a study dedicated to proving the device meets those specific criteria in a formal, AI-centric evaluation.
The device itself is a powered suction pump for wound therapy, not an AI/ML-driven diagnostic or treatment device, which explains the absence of some of the requested AI-specific information.
Here's an attempt to extract and present the information as requested, aligning it as closely as possible to the nature of the provided text:
Acceptance Criteria and Device Performance Study for PICO 14 Single Use Negative Pressure Wound Therapy System
The PICO 14 device is an electro-mechanical pump system and does not appear to involve AI/ML. Therefore, typical AI-specific acceptance criteria (like sensitivity, specificity, AUC) and an AI-specific study structure are not applicable to the information provided. Instead, "acceptance criteria" here refers to the demonstrated performance aspects that allow the device to be considered substantially equivalent and safe/effective for its intended use. The "study" refers to the non-clinical bench tests and the clinical evidence presented for the device.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a medical device clearance and not an AI/ML product, the "acceptance criteria" are derived from the demonstrated functionalities and safety profiles required for its intended use and comparison to the predicate device.
| Acceptance Criteria Category | Specific Criterion (Implicit/Explicit) | Reported Device Performance/Evidence |
|---|---|---|
| Functional Performance | Ability to function effectively for 14 days without failure. | Bench tests successfully completed, representing worst-case scenarios. Wound model tests demonstrated the system can manage wound exudate and deliver Negative Pressure over 14 days. |
| Ability to manage wounds up to 4.5 cm deep. | Bench tests successfully completed, representing worst-case scenarios. Wound model tests demonstrated the system can manage wounds up to 4.5 cm deep. | |
| Maintain nominal negative pressure of -80mmHg and same pressure profile as predicate. | The PICO 14 system delivers the same nominal negative pressure of -80mmHg and the same pressure profile as the PICO 7 System. This was confirmed as the NPWT delivery profile is unchanged. | |
| Software changes do not impact the function of NPWT delivery. | Only minor convenience updates to software for maximum pump down times and 14-day use. No changes to the function of NPWT delivery. | |
| Safety and Biocompatibility | Biocompatibility of materials. | PICO 14 uses the same dressings and materials as the predicate PICO Single Use NPWT System; materials are identical, thus no new biocompatibility data required. Evaluated according to BS EN ISO 10993 and FDA guidance. |
| Electrical safety and Electromagnetic Compatibility (EMC). | PICO 14 has the same electrical characteristics as the predicate system (K180698). Software updates do not impact electrical safety. | |
| Acceptable adverse event rate. | In a clinical study, the adverse event rate in PICO groups (depth 2cm: 2.5%) was lower than the non-PICO group (6.6%). No PICO device-related adverse events in the > 2cm group. | |
| Human Factors/Usability | No new user tasks or impact on critical tasks. | The minor changes are not considered to change the safety profile, raise new safety/efficacy questions, reflect new user tasks, or impact critical tasks. User interface remains similar with minor changes to appearance/packaging. |
| Duration of Use | Extended use time from 7 days to 14 days. | Bench tests demonstrated 14-day functionality. Clinical study data encompassed a longer observation period, and the device was able to manage exudate and pressure over 14 days. An additional set of batteries is provided to support the extended use. |
2. Sample Size and Data Provenance for the Test Set (Clinical Evidence)
- Sample Size for Clinical Evidence:
- Total patients followed: 3,159
- Patients using PICO device: 917
- PICO patients with wound depths > 2 cm: 409 (comprising 233 DFUs, 18 PUs, 147 dehisced surgical wounds, and 11 VLUs).
- Patients discontinuing PICO: 32 out of 917 (2.8%).
- Data Provenance: Retrospective, from two community care access centers.
- Country of Origin: Not explicitly stated but "community care access centers" suggests a real-world setting. Assuming within the country where the company operates or where the study was managed, which might be the UK (Smith & Nephew Medical Limited is in Hull, UK) or another location.
3. Number of Experts and Qualifications for Ground Truth for the Test Set
The clinical evidence provided appears to be an observational study of patient outcomes rather than a ground truth establishment by experts for a specific test set in the context of an AI device.
- Number of Experts: Not specified. The study involved patient care in community care access centers, suggesting healthcare professionals (e.g., nurses, doctors) were involved in patient admission, care, and data recording including wound depth and healing.
- Qualifications of Experts: Not specified, but implied to be healthcare professionals involved in wound care. Clinicians decided if exudate rate increased beyond indicated levels.
4. Adjudication Method for the Test Set
Not applicable. The clinical study was an observational study of patient outcomes, not an evaluation where expert adjudication of individual cases was performed to establish a definitive ground truth for device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is a physical therapy system, not an imaging or diagnostic AI tool that would typically involve human readers interpreting cases with and without AI assistance. The clinical evidence compared patient outcomes with PICO vs. non-PICO treatment.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Yes, in a sense, the functionality of the device itself (the PICO 14 system delivering negative pressure) was evaluated in "standalone" bench tests, demonstrating its mechanical and software performance over 14 days and for deep wounds. This is not "algorithm only" in the AI sense, but rather the device's inherent function.
7. The Type of Ground Truth Used (Clinical Evidence)
The "ground truth" for the clinical evidence was based on patient outcomes data (time to healing, number and duration of dressing changes, and adverse events) and clinically observed wound parameters (wound depth, exudate levels, and clinicians' decisions).
8. Sample Size for the Training Set
Not applicable. The PICO 14 is an electro-mechanical device. There is no mention of an AI/ML algorithm that requires a "training set" in the context of machine learning. The "training" for the device's development would be engineering and design iterations.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI/ML component or "training set" described for this medical device in the provided text.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.