(146 days)
MK300L is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.
MK300L is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.
The provided text is a 510(k) summary for the Compressible Limb Therapy System MK300L, which is a medical device and not an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies or acceptance criteria in the context of AI/ML evaluation.
However, based on the provided text, I can extract information relevant to the device's regulatory review and intended use:
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it meets the safety and effectiveness standards comparable to the predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly quantitative) | Reported Device Performance (Implicitly met through substantial equivalence) |
|---|---|---|
| Intended Use Equivalence | Intended use is substantially equivalent to predicate devices. | MK300L has substantial equivalent intended use as the-market-cleared LX-7. |
| Technological Characteristics Equivalence | Technological characteristics are substantially equivalent to predicate devices. | MK300L has substantial equivalent technological characteristics with Lympha press plus and WIC-2008. |
| Performance Characteristics Equivalence | Performance characteristics are substantially equivalent to predicate devices, without new safety/effectiveness concerns. | Confirmed through bench and laboratory testing to applicable standards. Concluded that MK300L is as safe and effective as predicate devices. |
| Safety Standards Compliance | Compliance with relevant medical device safety, quality, and electromagnetic compatibility standards. | Conducted and applied by standards including Council Directive 93/42/EEC, IEC 980:2003, IEC 1041:1998, ISO 13485:2003, ISO 14155-1.2003, ISO 14971:2007, IEC 60601-1, IEC 60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "bench as well as laboratory testing to applicable standards" but does not specify sample sizes for any test sets in terms of patient data or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically not included in a 510(k) summary focused on substantial equivalence for a non-AI/ML device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This question pertains to AI/ML device evaluation where expert consensus is often used for ground truth. For a physical medical device like a massager, ground truth would typically relate to physical measurements, engineering standards, or clinical outcomes, not expert interpretation of data.
4. Adjudication Method for the Test Set:
Not applicable. This question is relevant to AI/ML evaluations where disagreements between experts need to be resolved. For a non-AI device, adjudication methods in this context are not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. MRMC studies are specific to evaluating how human readers' performance changes with or without AI assistance, which is not applicable to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical massager and does not involve an algorithm or AI component in the sense of a software-as-a-medical-device (SaMD) evaluated for standalone performance.
7. The Type of Ground Truth Used:
The "ground truth" for this device's evaluation is based on compliance with established medical device standards (e.g., electrical safety, quality management, risk management, clinical investigation general requirements) and demonstrating that its performance is comparable to legally marketed predicate devices through "bench as well as laboratory testing." Clinical outcomes data might be inferred from the predicate devices' long-standing safety and effectiveness, but it's not explicitly stated as the ground truth for this specific device's evaluation.
8. The Sample Size for the Training Set:
Not applicable. This device does not use a training set as it is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device does not have a training set.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).