(54 days)
Position and secure a patient in the prone or supine positions.
The Strap Wedge is an assembly of covered foam blocks to which five (5) restraining straps have been sewn.
The provided text describes a 510(k) summary for a medical device called "Strap Wedge." It outlines the device's description, intended use, and states that there have been no reports of death or serious injury. However, the document does not contain any information about acceptance criteria, a study proving the device meets those criteria, or any of the specific details requested in your prompt regarding performance metrics, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information from the given text.
The information you are asking for typically relates to the performance evaluation of diagnostic or AI-powered devices, which require specific metrics, a test dataset, and a rigorous evaluation process that includes ground truth and potentially expert involvement. The "Strap Wedge" appears to be a physical positioning and restraint device, and its 510(k) summary focuses on demonstrating substantial equivalence to pre-amendment devices and lack of reported adverse events, rather than quantitative performance metrics like sensitivity, specificity, or reader improvement.
{0}------------------------------------------------
Image /page/0/Picture/4 description: The image shows the logo for AliMed Inc. The logo consists of a black square with a white diamond inside, followed by the text "AliMed inc." in a bold, sans-serif font. Below the logo is the address "297 High Street, Dedham, MA 02026".
OCT 28 1996
510(k) SUMMARY
Strap Wedge
Applicant:
AliMed®, inc. 297 High Street Dedham, MA 02026
Contact: Jonathan C. Bretz
Telephone: 617-329-2900 FAX: 617-329-8392
Submitted by:
...
Curtin & Associates International 1200 East Street Dedham, MA 02026
Contact: Donald A. Lincoln
Telephone: 617-329-1955 FAX: 617-329-2529
Date this Summary was prepared: 30 August 1996
Trade Name: Strap Wedge
Common Name: Strap Wedge
Classification Name: Patient Restraint
Legally Marketed Devices to Which Substantial Equivalence is claimed:
Various Preamendments strap and support assemblies.
(617) 329-2900 · fax: (617) 329-8392
{1}------------------------------------------------
510(k) SUMMARY-continued
Description of Device: The Strap Wedge is an assembly of covered foam blocks to which five (5) restraining straps have been sewn.
Intended Use of the Device: Position and secure a patient in the prone or supine positions.
User Experience: There have been no reports of death or serious injury received by the firm during the time these devices have been manufactured. Device was first manufactured in September of 1995.
Biocompatibility: Based on the topological use of this device and the materials used, it is unlikely that biocompatibility difficulties would arise. In addition, the firm has received no information from users indicating that a biocompatibility question has developed.
Comparative Information: The firm has been unable to obtain pre-1976 information related to specific devices of this type. However, the use of covered foam padding and straps such as are incorporated in this device appear to have been in use before the Medical Device Amendment as well as after the date of the amendment.
§ 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.