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The Morrison Medical Torso/Waist Restraint is intended to help secure a patient at the torso and waist in an ambulance or other emergency vehicle while in transport to a hospital or other critical care facility.

The Morrison Medical Torso/Waist Restraint is constructed by combining two adjustable. nylon, "over-the-shoulder" straps that secure the upper torso and two adjustable nylon straps that secure the waist. All four straps are joined at the waist and are secured with a metal push button buckle and metal connectors. The nylon webbing is available in multiple colors.

This document describes a 510(k) premarket notification for the Morrison Medical Products Torso/Waist Restraint. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission generally does not require clinical studies or detailed performance data against specific acceptance criteria in the same way a novel device or a Premarket Approval (PMA) application would.

Therefore, many of the requested elements for describing specific acceptance criteria and a detailed study proving the device meets them are not applicable or explicitly stated in this 510(k) summary.

Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable (N/A) for a 510(k) submission of this nature.

1. A table of acceptance criteria and the reported device performance

   • Not Applicable (N/A) in the context of this 510(k) summary. This submission relies on substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria and performance metrics from a new study. The "performance" is implicitly deemed equivalent to the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Not Applicable (N/A). No new test set or data provenance from a device performance study is described as this is a substantial equivalence submission.

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)

   • Not Applicable (N/A). There is no mention of a test set requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Not Applicable (N/A). No test set requiring expert adjudication is described.

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 (N/A). This device is a physical medical restraint, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

   • Not Applicable (N/A). This device is a physical medical restraint and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not Applicable (N/A). No ground truth for a novel performance study is mentioned. The "ground truth" for this submission is the accepted safety and effectiveness of the predicate device.

8. The sample size for the training set

   • Not Applicable (N/A). This device is a physical medical restraint and does not involve machine learning requiring a training set.

9. How the ground truth for the training set was established

   • Not Applicable (N/A). This device is a physical medical restraint and does not involve machine learning.

Summary of the 510(k) Submission:

The provided document is a 510(k) summary for the Morrison Medical Products Torso/Waist Restraint. The core of this submission is substantial equivalence to a previously legally marketed device, which is stated to be the same device (Morrison Medical Torso/Waist Restraint).

• Predicate Device: Morrison Medical Torso/Waist Restraint.
• Basis for Substantial Equivalence: The submitter declares the subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications, and issues of safety and effectiveness to the predicate devices. The only difference noted is a revision to product labeling to comply with agency requirements.
• No new performance data or acceptance criteria are presented because the device is identical to a predicate. The prior acceptance and approval of the predicate device serves as the basis for the current device's safety and effectiveness.
• Biocompatibility Assessment: A review indicated "little potential to evoke an adverse reaction" based on the components and materials being identical to the predicate device, for which there were no reported complaints of skin irritation.

In conclusion, this 510(k) summary does not describe a study proving the device meets specific acceptance criteria because it's asserting substantial equivalence to a predicate device, for which safety and effectiveness have already been established. The acceptance criteria effectively stem from the characteristics and performance of the predicate device itself.

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The Morrison Medical Products Cinch Strap with Buckle is intended to limit a 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. The device is also intended to be used as an assist in securing equipment.

The Morrison Medical Products Cinch Strap with Buckle is constructed of a nylon hook and loop material. Heat Sealed to one end is a nylon hook material that is used to secure the patient or equipment in the Cinch Strap with Buckle. The Cinch Strap with Buckle is available in the following sizes: Series 1142 - 1" x 42" Series 1150 - 11/2" x 18" Series 1160 - 11/2 x 30"

The provided document is a 510(k) summary for the "Morrison Medical Products Cinch Strap with Buckle." This document does not contain information about acceptance criteria, device performance studies, or any of the other specific details requested in the prompt related to evaluating the performance of a device using statistical methods, human readers, or AI.

The document states that "The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification." It also mentions "The only difference is that the product labeling has been revised to comply with the Agency's labeling requirements."

Therefore, I cannot extract the requested information from the provided text. The document's purpose is to demonstrate substantial equivalence to a predicate device, not to present a new performance study with acceptance criteria.

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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.

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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The Morrison Medical Best Strap Restraint is a restraint system intended to help to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard.

The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher frame and secured with the Hook and Loop to allow for quick and easy application and release.

The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies for the Morrison Medical Products Best Strap Restraint.

The document is a "Safety and Effectiveness Summary" for a 510(k) submission, primarily focusing on demonstrating substantial equivalence to a predicate device. It describes the device, its intended use, and technological characteristics, and states that there are no changes to the device itself but only to the labeling to comply with regulatory guidance. It also briefly mentions biocompatibility.

Therefore, I cannot fulfill the request to build a table of acceptance criteria and reported device performance or provide details on the studies as the information is not present in the given text.

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The Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a cot or stretcher. The Ankle Restraint System is intended to secure the patient's ankles by keeping them in a fixed position.

The Ankle Restraint System is designed for situations requiring patient control. The Ankle Restraint System is a restraint system that secures the patient's ankles in a fixed position. It consists of two individual ankle restraints that are permanently attached at a specific distance apart from each other to a long security strap. The security strap is constructed using a nylon woven webbing that is 2 inches wide and 17 inches long. Straps attached to both ends of the security strap secure the ankle restraint system to a cot or stretcher. The individual ankle restraints are also constructed using a nylon woven webbing. A nylon hook and loop closure is secured to the webbing and is used to securely close the ankle restraint.

This document is a 510(k) premarket notification for an Ankle Restraint System by Morrison Medical Products. It does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert qualifications, etc.) that would typically be found in a study demonstrating device performance for a modern AI/ML medical device.

The document states that the subject device is identical to the predicate device in terms of intended use, design, materials, manufacturing process, physical and mechanical specifications, and issues of safety and effectiveness. The only difference mentioned is a revision to product labeling to comply with agency requirements.

Therefore, the "study" that proves the device meets the acceptance criteria is essentially a claim of substantial equivalence to a predicate device, which implies that the predicate device already met such criteria. This document does not describe a new performance study for the Ankle Restraint System itself.

Given this, I cannot answer the requested points with specific details about acceptance criteria, sample sizes, experts, or AI performance, as they are not present in the provided text.

Here is a breakdown of what can be inferred or directly stated from the document regarding the closest analogous concepts:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The implicit acceptance criteria are that the device is "safe and effective for its intended use" and "substantially equivalent to the predicate device."
• Reported Device Performance:
  • Safety: "Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in these devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction."
  • Effectiveness: "The Ankle Restraint System is designed for situations requiring patient control... intended to secure the patient's ankles by keeping them in a fixed position." The claim of substantial equivalence implies it performs this function comparably to the predicate.

For points 2 through 9, the information is not applicable or not provided in the context of a new performance study.

• 2. Sample size used for the test set and the data provenance: Not applicable. No new test set for performance was described. The claim is based on equivalence to a predicate device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No formal ground truth establishment for a new test set was described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process was described.
• 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 physical restraint system, not an AI/ML diagnostic or assistive tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical restraint system, not an AI/ML algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a new performance study. The "ground truth" here is the prior acceptance of the predicate device.
• 8. The sample size for the training set: Not applicable. No training set for an AI/ML algorithm was described.
• 9. How the ground truth for the training set was established: Not applicable. No training set for an AI/ML algorithm was described.

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The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard.

The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard. The straps are constructed of an acrylic coated polyester woven material with an adhesive band on each end of the strap. The patient is secured to the backboard by lying the strap across the patient's body and peeling the release paper from the strap. The strap is woven through the hand hold in the backboard and stuck back onto the polyester strap. After use the strap is cut off with scissors.

This document is a 510(k) premarket notification for a disposable restraint strap, not a study evaluating a device's performance against acceptance criteria using statistical methods. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or expert involvement.

The document states that the "subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification." The only difference is revised product labeling.

This implies that the device's safety and effectiveness are established by its substantial equivalence to a predicate device, not through a new study with specific performance acceptance criteria.

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Morrison Medical Stretcher/Cot and Backboard Restraints are intended to help secure a patient's body to a stretcher, cot or backboard.

The Morrison Medical Stretcher/Cot and Backboard Restraints are intended to be used by qualified and properly trained personnel to help secure a patient's body to a stretcher, cot or backboard.

The Morrison Medical Stretcher/Cot and Backboard restraints connect to or wrap around a stretcher, cot or backboard. The restraints are constructed by combining various webbing, buckles/closures and end styles. The webbing is available in nylon. polypropylene and vinyl coated polyester materials. The webbing that is used is dependent on user preference. The Morrison Medical Stretcher/Cot and Backboard Restraints are available as a reusable or disposable (series 139x) restraint. The restraint is available in either a one-piece length or two-piece lengths depending on user preference. The one-piece restraint wraps around a patient and the stretcher, cot or backboard and is secured with a buckle. The two-piece restraint is connected to the frame on both sides of the stretcher, cot or backboard with an end-style (end-style description below) and is secured together with a buckle/closure.

The provided text is a Safety and Effectiveness Summary for Morrison Medical Stretcher/Cot and Backboard Restraints and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document states: "The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency's labeling requirements set forth in the draft 'Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints' dated December 1995."

This indicates that the submission is for a labeling change on an existing device, and not for a new device requiring performance testing against acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established is not present in the provided text.

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The Morrison Medical Wrist Restraint 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 positions.

The Morrison Medical Wrist Restraint is constructed of a nylon woven webbing and metal D-Ring. There is nylon hook and loop material sewn onto the nylon webbing. This nylon hook and loop combination is intended to secure the wrist restraint to the patient. The Wrist Restraint is intended to restrain the patient to a chair, cot or stretcher.

This document is a 510(k) premarket notification for a medical device (Morrison Medical Wrist Restraint). It states that the device is identical in intended use, design, materials, manufacturing process, physical and mechanical specifications, and issues of safety and effectiveness to a predicate device, with the only difference being revised labeling.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for the following reasons:

• No new studies were performed or are described. The submission relies on substantial equivalence to a predicate device, meaning it asserts that the new device performs as safely and effectively as a device already on the market without needing new performance studies.
• No specific acceptance criteria are defined for device performance. Since no new performance studies were conducted, there are no new acceptance criteria or reported device performance metrics.
• The document focuses on substantial equivalence, not de novo performance testing.

In situations like this 510(k) submission, the "study" proving the device meets acceptance criteria is often the demonstration of its substantial equivalence to a legally marketed predicate device, which inherently means it meets the safety and effectiveness standards previously established for the predicate. However, this submission does not detail those predicate device studies or criteria.

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