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510(k) Data Aggregation
(72 days)
The Morrison Medical Products Limb Restraint with Double D-Ring and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting position.
Morrison Medical Products has developed two limb restraints that are intended to be a protective restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The following is a description of the two limb restraints.
Limb Restraint with Double D-Ring and Strap:
The Double D-Ring and Strap limb restraint uses it its construction a foam/fabric laminated material that is reinforced with a polyester webbing strap. The device is secured to the patient's limb using a double D-ring closure mechanism.
The Limb Restraint with Double D-Ring and Strap is available in the following size:
Stock No. 1114 Adult Size:
Cuff size: 11½" long x 2½" wide Strap: 1" wide x 60" long
Limb Restraint with Strap:
The Limb Restraint with Strap is constructed of a foam laminated material that is reinforced with a polyester webbing strap. The device is secured to the patient using a hook and loop closure.
The Limb Restraint with Strap is available in the following sizes:
Stock No. 1103 Adult size: Cuff size: 11½" long x 2½" wide Strap: 1" wide x 60" long
Stock No. 1124 Youth size: Cuff size: 9" long x 2" wide Strap: 1" wide x 36" long
Stock No. 1119 Infant size: Cuff size: 6" long x 1¼ wide Strap: 1" wide x 24" long
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Study for Morrison Medical Products Limb Restraint
This document describes a safety and effectiveness summary for a medical device (limb restraint), but it does not present a study with specific acceptance criteria and performance metrics for the device itself.
Instead, the document asserts that the device is substantially equivalent to a predicate device. The "study" mentioned is a comparison to a predicate device, focusing on material, design, and manufacturing rather than new performance data.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria or reported device performance metrics are provided in the document. The primary "acceptance criterion" appears to be "substantially equivalent" to predicate devices in terms of intended use, design, materials, manufacturing, and safety/effectiveness.
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Substantially equivalent to predicate device in intended use | Stated to be identical | Based on comparison to predicate device |
| Substantially equivalent to predicate device in design | Stated to be identical | Based on comparison to predicate device |
| Substantially equivalent to predicate device in materials | Stated to be identical | Based on comparison to predicate device |
| Substantially equivalent to predicate device in manufacturing process | Stated to be identical | Based on comparison to predicate device |
| Substantially equivalent to predicate device in physical and mechanical specifications | Stated to be identical | Based on comparison to predicate device |
| Substantially equivalent to predicate device in safety and effectiveness | Stated to be identical | Based on comparison to predicate device |
| Compliance with labeling requirements | Product labeling revised to comply with draft "Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints" dated December 1995. | This is related to regulatory compliance, not device performance. |
| Biocompatibility | Biocompatibility review indicated little potential to evoke an adverse reaction. No reports or complaints of skin irritation. | Based on material composition and lack of adverse events for predicate devices. |
2. Sample Size for Test Set and Data Provenance
Not Applicable. The document does not describe a "test set" in the context of performance testing with a specific sample size. The claim is based on the inherent properties of the device and its similarity to existing predicate devices.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
Not Applicable. This document does not detail a study involving expert consensus for ground truth establishment. The evaluation is a regulatory comparison to predicate devices, not an independent assessment of new performance data by experts.
4. Adjudication Method for the Test Set
Not Applicable. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe an MRMC comparative effectiveness study, nor does it address human reader improvement with or without AI assistance. This device is a limb restraint, not an AI-powered diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
No. The document does not describe a standalone performance study. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this submission is effectively substantial equivalence to existing predicate devices. This means the established safety and effectiveness of the predicate devices serve as the benchmark. There is no new "ground truth" being established by this submission directly related to performance metrics.
8. Sample Size for the Training Set
Not Applicable. There is no "training set" in the context of this regulatory submission for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, this question is not applicable.
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