(90 days)
The TriplePlay-VT, model TPVT-01 (supplied with a pair of model TP-3333 "cuffs") is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:
- Aid in the prevention of DVT; .
- Enhance blood circulation; .
- Diminish post-operative pain and swelling; .
- . Reduce wound healing time;
- Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and . diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
The TriplePlay-VT Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescriptive device that is intended to be used by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).
The system utilizes pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid valves. All pump, battery and control components are protectively housed in a plastic case. A mylar control panel overlays 4 tactile touch control switches, an LED display for monitoring pressure, LED "selected function", "low battery" and "charging" indicators. There is also a port for connecting the battery charger/AC adapter plug.
The leg wrap (cuff), model TP-3333, consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric made from common kitchen sponge material, which is adhered to the PVC air bladder. The cuffs are supplied clean, non-sterile, packaged in pairs. One set of cuffs are supplied with the TPVT-01 system, and are also available as accessory items.
In operation, the user selects either 1 of 5 different output modes (leg 1, leg 2, auxiliary, or a combination of leg 1 + auxiliary or leg 1 + leg 2 + auxiliary). An LED corresponding to each output indicates the selected modes. Appropriate single user "cuffs" containing air bladders are connected to the unit via externally accessible plastic quick-disconnect air ports. The control unit then fills the cuffs to a pre-determined pressure (50 mmHg for the leg cuffs, with the auxiliary cuff setting being adjustable between 20 and 50 mmHg - default setting of 35 mmHg is preset for the auxiliary function). The LED that corresponds to the activated cuff flashes slowly while that cuff is being filled with air. Cuff pressure is monitored by an integrated pressure transducer and system software. Once the pressure reaches the proper level, the pump is turned OFF for a predetermined "rest" period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the "rest" period, the next cuff is sequenced, and so on. This cycle repeats until the unit is turned off.
The "rest" period is internally preset to allow each cuff approximately 60 seconds between inflations in order to insure adequate relaxation time between compressions. When multiple cuff modes are selected, only one cuff is inflated at a time.
The provided document is a 510(k) summary for the Wildcat Medical, Inc. TriplePlay-VT Vascular Therapy System. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but does not contain acceptance criteria or a study proving the device meets said criteria in the format requested.
The document details non-clinical testing (electrical safety, EMC, mechanical integrity, environmental, and life cycle testing) which showed the device's performance characteristics were "substantially equivalent to or surpassing those of the listed predicate devices." It also states that "in-house bench testing has verified equivalent pressure delivery, cuff (bladder) fill time, cycle time and overall system operation as the predicate devices listed."
Crucially, no clinical testing was performed on the TriplePlay-VT Vascular Therapy System itself. Instead, the submission references two published clinical studies on predicate devices, concluding substantial equivalence based on similar operational parameters.
Therefore, I cannot provide the requested table or answer most of the questions directly. However, I can extract the available information regarding the assessment that was done:
Summary of Assessment from the Provided Document:
1. A table of acceptance criteria and the reported device performance:
No specific "acceptance criteria" for clinical performance are defined for the TriplePlay-VT device in this document, nor are there direct "reported device performance" metrics from a clinical study of the TriplePlay-VT. The document relies on substantial equivalence to predicate devices and their reported performance in clinical studies.
| Acceptance Criteria (Not explicitly stated for TriplePlay-VT) | Reported Device Performance (TriplePlay-VT via equivalence to predicate) |
|---|---|
| (Implied: Effectiveness in decreasing risk of postoperative DVT as demonstrated by predicate devices) | Similar operational parameters to predicate devices (e.g., mean blood flow velocity of 76.2 +/- 23.77, average inflation pressure of 43 mmHg, fill time of 11.6 seconds, total cycle time of 60 seconds of predicate device). |
| (Implied: Substantial equivalence in pressure delivery, cuff fill time, cycle time, and overall system operation) | "In-house bench testing has verified equivalent pressure delivery, cuff (bladder) fill time, cycle time and overall system operation as the predicate devices listed." (Bench testing performed for TriplePlay-VT) |
2. Sample size used for the test set and the data provenance:
- Sample Size (Clinical for Predicate Devices): Not explicitly stated within this document for the referenced predicate device studies.
- Data Provenance (Clinical for Predicate Devices): The referenced studies are published clinical studies, implying prospective data collection in a clinical setting. Country of origin not specified, but peer-reviewed publications generally represent global research.
- Sample Size (Non-Clinical for TriplePlay-VT): Not specified (e.g., number of devices tested).
- Data Provenance (Non-Clinical for TriplePlay-VT): In-house bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical testing was performed specifically on the TriplePlay-VT for which ground truth would need to be established by experts for performance evaluation.
4. Adjudication method for the test set:
- Not applicable as no clinical testing was performed specifically on the TriplePlay-VT.
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:
- Not applicable. This device is a pneumatic compression system, not an AI-driven diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an electromechanical system, not an algorithm. Bench testing of the device's physical parameters (pressure, cycle time) was performed without human intervention as part of the "non-clinical testing."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical effect (DVT prevention) of predicate devices: The referenced studies likely used clinical outcomes data (e.g., incidence of DVT diagnosed by ultrasound or venography).
- For the TriplePlay-VT: No clinical ground truth was established. The "ground truth" for non-clinical testing was based on engineering specifications and comparison to the operational parameters of predicate devices (e.g., target pressure of 50 mmHg, cycle time of 60 seconds).
8. The sample size for the training set:
- Not applicable as no machine learning algorithm was developed for this device.
9. How the ground truth for the training set was established:
- Not applicable as no machine learning algorithm was developed for this device.
Conclusion from the document:
The Wildcat Medical, Inc. TriplePlay-VT Vascular Therapy System applied for 510(k) clearance based on substantial equivalence to existing predicate devices. This equivalence was argued through:
- Comparison of Indications for Use (stated to be the same).
- Comparison of Technological Characteristics (function, operating principles, pressure delivery, cycle times, cuff design, power source).
- Non-clinical bench testing of the TriplePlay-VT confirming its pressure delivery, cuff fill time, cycle time, and overall system operation were equivalent to predicate devices.
- Referencing published clinical studies of predicate devices that demonstrated the effectiveness of intermittent pneumatic compression devices in decreasing the risk of postoperative DVT, and noting that the TriplePlay-VT's operational parameters are "nearly identical" to those of a predicate device evaluated in one of the studies.
Therefore, the "proof" the device meets acceptance criteria is primarily an argument of its substantial equivalence to other legally marketed devices, rather than a direct clinical study of the TriplePlay-VT itself against predefined clinical acceptance criteria.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).