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510(k) Data Aggregation
(59 days)
PEDI-SPIDER STRAP
The Pedi-Spider strap is designed for securing a pediatric patient to a long spine board, by the use of a checker board series of straps that are placed over the patient and secure to the back board with Velcro hook and loop closures on each side of the back board. The device should be used on children from 10 to 100 pounds and 12 to 55 inches in height.
The Pedi-Spider utilizes 1 ½" nylon or polypropylene material in a cargo net fashion with Velcro on the ends for securing the strap to the backboard.
The provided text describes a 510(k) submission for a medical device called the "Pedi-Spider Strap." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through a study with acceptance criteria in the same way a novel, high-risk device might.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, including MRMC studies or standalone algorithm performance, is not applicable to this type of regulatory submission.
The "study" here is essentially the comparison to a predicate device, arguing for substantial equivalence.
Here's a breakdown based on the provided text, addressing the points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the traditional sense for a 510(k) submission demonstrating substantial equivalence of a low-risk device like a patient restraint. The "acceptance criteria" for a 510(k) is that the device is substantially equivalent to a legally marketed predicate device.
| Acceptance Criterion | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Intended Use | To secure an injured child to a backboard at the scene of an emergency and during transport to prevent movement. |
| Equivalent to the Pedo Cush because the main use is to immobilize pediatric patients and minimize trauma. | |
| Physical Characteristics | Utilizes 1 ½" nylon or polypropylene material in a cargo net fashion with Velcro on the ends for securing to the backboard. |
| Similar to Pedo Cush which uses material and Velcro. | |
| Mechanism of Action | Applied and tightened enough to secure the patient from movement, but not restrict breathing or circulation (two fingers should fit under straps). |
| Similar to Pedo Cush which uses Velcro to hold the patient in place and keep them from further injury. | |
| Patient Population | Children from 10 to 100 pounds and 12 to 55 inches in height. |
| Safety | Minimize trauma for the situation and prevent further injury. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. There was no specific "test set" of patients or data used in a clinical study to evaluate the device's performance against predefined metrics. The assessment is based on the device's design, materials, and intended use compared to a predicate.
- Data Provenance: Not applicable. No clinical data or patient-specific data was mentioned as being used for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No "ground truth" for a test set was established by experts in the context of a performance study. The regulatory assessment is made by the FDA based on the provided submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no test set requiring adjudication.
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
- MRMC Study: Not applicable. This device is a physical restraint, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the context of a traditional performance study. For a 510(k), the "ground truth" is effectively the established safety and effectiveness profile of the predicate device (Pedo Cush), to which the new device (Pedi-Spider Strap) claims substantial equivalence based on similar design, materials, and intended use.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI with a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As above, this device does not involve AI or algorithms with a training set.
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