Search Results

Reduce patient movement in recover, in bed, or other uses as determined by the health care professiona user.

The devices are fabricated using nylon or nylon and polyethol foam of various lengths and widths as described in advertising. The closure is Velcro® or Velcro®-like hook and loop.

This document is a 510(k) summary for "Various General Purpose Straps" manufactured by AliMed®, inc. It focuses on establishing substantial equivalence to pre-amendment devices rather than proving a device meets specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not applicable or cannot be extracted from the provided text.

Here is an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

Not applicable. The document does not describe specific acceptance criteria or quantitative performance metrics for the device. The goal is to demonstrate substantial equivalence to pre-amendment devices, not to meet a defined performance standard through testing.

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. No formal test set or study is described to evaluate performance against acceptance criteria. The document relies on historical use and the lack of adverse events.

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. No ground truth establishment by experts for a test set is mentioned.

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

Not applicable. No test set or adjudication method 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. This document is for general purpose straps, not an AI-assisted diagnostic device.

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

Not applicable. This document is for general purpose straps, not an algorithm.

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

Not applicable. No ground truth determination for performance evaluation against acceptance criteria is described. The "ground truth" in this context is the historical, safe use of similar general purpose straps.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable.

Summary of available information related to safety/effectiveness from the document:

• Intended Use: Reduce patient movement in recovery, in bed, or other uses as determined by the healthcare professional user.
• Materials: Nylon or nylon and polyethol foam with Velcro® or Velcro®-like hook and loop closures.
• Substantial Equivalence Claim: To "Various Preamendments General Purpose Straps." The applicant states they were "unable to locate pre-Amendment catalogs, or similar materials," but it is "generally known that they were in use prior to May of 1976 and that they have continued to be supplied by other firms since that time."
• Biocompatibility: "Based on the materials used in construction of these straps, and the topological application with the normal use arrangement having some other material between the patient's skin and the strap, there is little likelyhood of a biocompatibility concern arising."
• User Experience (Safety): "The firm has received no information related to a death, serious injury or allegent reaction to the materials during the time these devices have been manufactured." This statement covers devices manufactured from 1989 and 1990 (Econo-straps) and 1994 (Universal 1 piece).

In conclusion, this 510(k) summary for general purpose straps relies on demonstrating substantial equivalence to devices that were legally marketed prior to the Medical Device Amendments of 1976, and on the absence of reported adverse events during the device's manufacturing history. It does not present a study with acceptance criteria and measured performance in the way that would be expected for a novel medical device requiring such proof of performance.

Ask a specific question about this device

Reduction of patient movement, or restrain of patient, during medical procedure, during transportation of the patient, or in other situation s deemed appropriate by the health car facility.

The devices are fabricated various lengths and widths as described in advertising. The closure is "hook and loop".

This document is a 510(k) summary for "Various Procedural Restraints" manufactured by AliMed®, inc. It does not present information about a novel device requiring performance acceptance criteria or a study to prove it meets them in the way medical software or AI devices do.

Instead, this document is focused on establishing substantial equivalence for existing devices (various types of straps and restraints) by comparing them to pre-amendment devices and describing their current use and safety history.

Therefore, I cannot directly extract the requested information (acceptance criteria table, sample size for test/training sets, ground truth details, MRMC study results, etc.) because these concepts are not applicable to the content provided.

Here's what can be inferred or stated based on the document's purpose:

• Acceptance Criteria & Device Performance: Not applicable in the context of this 510(k). The "acceptance criteria" here would be meeting the definition of a patient restraint and demonstrating safe use, which is addressed through comparative information and user experience data.
• Study That Proves the Device Meets Acceptance Criteria: No formal study is presented to meet quantifiable performance metrics as would be required for a novel device. The "proof" is based on historical use and the lack of adverse events.
• Sample Size for Test Set and Data Provenance: Not applicable. There's no "test set" in the sense of a new system being evaluated.
• Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
• Standalone Performance Study: Not applicable.
• Type of Ground Truth Used: Not applicable. The closest concept is "user experience" and "lack of adverse events."
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set Was Established: Not applicable.

Summary of relevant information from the document as it pertains to safety/effectiveness:

• Comparative Information: The devices are compared to "Various Preamendments straps and restraints." The document states that similar devices were in use prior to the Medical Device Amendment (1976) and others were introduced afterward. Pre-1976 catalogs showing these exact devices were not found, but "it is understood that these types of devices were in use prior to the Medical Device Amendment."
• Biocompatibility: "Based on the materials, and the method of use (topological), it is unlikely that any concern of this nature would develop."
• User Experience: "The firm has received no information related to a death, serious injury or allergenic reaction to the materials used during the time these devices have been marketed." This serves as the primary "evidence" for the safety and effectiveness of the existing devices.

Ask a specific question about this device

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.

Ask a specific question about this device