Heelbo Quilted Limb Holder 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 positions.

Device Description

Heelbo Quilted Limb Holder with Double D-Ring and Strap is a quilted limb holder with a Velcro® fastener, Double D-Ring and Straps that secure to a bed, gurney, chair, gerichair or wheelchair. The Heelbo Quilted Limb Holder 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 adjustable Double D-Ring allows for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable.

The Heelbo Quilted Limb Holder with Double D-Ring and Strap is available in the following sizes: Stock No. 9320 Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long Stock No. 9330 Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long

AI/ML Overview

The provided document describes a medical device, the "Heelbo Quilted Limb Holder with Double D-Ring and Strap," and its safety and effectiveness summary for a 510(k) submission. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic or AI-powered device would.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is a common pathway for medical device clearance in the US, rather than demonstrating performance against a predefined set of acceptance criteria through a specific study.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to performance studies and evaluations typically conducted for devices with measurable outputs or diagnostic capabilities.

Here's an explanation based on the available information:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.). The "acceptance criterion" for this submission is implicitly related to demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: Not reported in quantitative terms like those expected for a diagnostic or AI device. The document states that the device is "safe and effective for its intended use and is substantially equivalent to the predicate device."
Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/not provided. No test set involving patient data or device performance evaluation on a "test set" as typically understood for AI or diagnostic devices was described.
- Data Provenance: Not applicable/not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not provided. No ground truth establishment Process is described.
Adjudication method for the test set:
- Not applicable/not provided.
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:
- No MRMC study was described. This device is a physical restraint, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used:
- Not applicable. There is no mention of ground truth as typically understood for diagnostic device validation. The basis for "safety and effectiveness" appears to be the design, materials, manufacturing process, physical and mechanical specifications, and intended use being identical to a predicate device, coupled with a history of safe use of materials in the clothing industry and absence of skin irritation reports.
The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable.

In summary, this document is a 510(k) premarket notification for a physical medical device, the Heelbo Quilted Limb Holder. Its purpose is to demonstrate substantial equivalence to an already legally marketed predicate device rather than to present performance data from a clinical trial or algorithmic validation study against specific acceptance criteria. Therefore, the detailed information requested about performance studies is not present in this type of submission.

Summary

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1134 N. Homan Ave. Chicago, IL 60651 312/489-7711

Telex RCA 297-248 800/323-5444 Fax 312/489-7744

K962832

OCT 18 1996

Heelbo, Inc. Heelbo Quilted Limb Holder with Double D-Ring and Strap

Safety and Effectiveness Summary

1. Submitter's name, Address and Contact Person

Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651

Contact Person Joseph S. Tokarz; Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847)680-2849. Fax: (847)918-3860 Ph:

Date Summary Prepared - July 17, 1996

2. Name of Device:

Heelbo Quilted Limb Holder with Double D-Ring and Strap

3. Name of Predicate Device(s)

Heelbo Quilted Limb Holder with Double D-Ring and Strap

4. Description of Device

The Heelbo Quilted Limb Holder with Double D-Ring and Strap is available in the following sizes: Stock No. 9320 Stock No. 9330

Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long

Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long

5. Statement of Intended Use

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Image /page/1/Picture/0 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is black and appears to be the name of a company. The word "Heelbo" is followed by a comma, and then "Inc." is written after the comma.

1134 N. Homan Ave. Chicago, IL 60651 312/489-7711

Telex RCA 297-248 800/323-5444 Fax 312/489-7744

Heelbo, Inc. Heelbo Quilted Limb Holder with Double D-Ring and Strap

6. Statement of Technological Characteristics of the Device

Heelbo Quilted Limb Holder with Double D-Ring and Strap is a quilted limb holder with a Velcro® fastener, Double D-Ring and Straps that secure to a bed, gurney, chair gerichair or wheelchair. The Heelbo Quilted Limb Holder 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 adjustable Double D-Ring allows for supine and sitting positions.

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 [501(kk)] Submissions for Protective Restraints" dated December 1995.

7. Biocompatibility Assessment

The subject devices are identical in component materials to the predicate devices. The suppliers of the materials use in the fabrication of these devices have stated that there is a history of safe use of their materials in the clothing and garment industry. In addition, Heelbo, Inc., is not aware of any reports or complaints of skin irritation associated with these materials.

Conclusion

Based upon the information presented above it is concluded that the Heelbo Quilted Limb Holder with Double D-Ring and Strap is safe and effective for its intended use and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.6760 Protective restraint.

(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.