(136 days)
Pedo Cush Pedo Cuddle is to be used under the direction and/or the supervision of a dentist only, as a tool to help manage an uncontrollable child for the purpose of protection of the child from injury while receiving dental treatment. It is not to be used as a punishment tool. The Health Professional must be in control of his/hers emotions while using the Pedo Cush if at any time he/she feels the overwhelming of the exnotions he/she must take a break, deliver the child back to the parent's arms. After the emotions are under control then helshe may continue to work. Remember that the option of referring out to another dentist is a possibility.
A combination restraint and cushion for securing a pediatric patient in a dental chair, said combination comprising; a restraint comprising a main body portion which has a plurality of flaps attached thereto, each of said flaps having hook and loop fasteners affixed thereto, such that said flaps can be positioned and fastened around said patient to hold said patients torso in position a plurality of strings (straps) for tying said restraint around said dental chair and a headpiece which fits around the top of said dental chair, said restraint having adhesive material affixed to the back thereof to hold said restraint in position on said dental chair, and a cushion having an arcuste indentation at its top end to hold said petient's buttooks in position, said cushion being enclosed in a pillowcase having an adhesive material affixed to the underside thereof in order to maintain said cushion in position on said dental chair, said pillowcase having a plurality of flaps attached thereto, said flaps each having hook and loop fasteners affixed thereto such that said flaps can be positioned and fastened around said patient's legs to hold them in position. Pedo Cush Pedo Cuddle is covered by U.S. Patent N. 5,425, 381 and is described in more detail therein.
The provided text describes a 510(k) premarket notification for a medical device called "Pedo Cush Pedo Cuddle." This document is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study designed to prove the device meets specific acceptance criteria in the way a clinical trial or performance study would. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth, and expert involvement is not present in this type of regulatory document.
However, based on the information provided, we can infer some aspects and extract others.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantifiable manner as would typically be seen in a performance study. Instead, the device's performance is described qualitatively in comparison to the predicate device. The primary "acceptance" is the FDA's determination of substantial equivalence, which is based on similar technological characteristics and performance for the stated intended use.
| Acceptance Criterion (Inferred from Performance Section) | Pedo Cush Pedo Cuddle Reported Performance |
|---|---|
| Control of Patient Motion | Controls side-to-side and up-and-down motion of patient in dental chair. Tested on over 1,000 child patients with behavior ranging from uncooperative and fearful to hysterically out-of-control; successfully managed the patients to allow dental procedures to be performed. |
| Sterility/Cleanability | Jacket can be laundered and bleached. |
| Safety | Secures patient firmly and comfortably in dental chair. |
| Anatomical Coverage | Secures patient's torso and legs. |
| Human Factors (Comfort) | Comfortable and relaxing for patient. |
| Compatibility | Can be used with any standard dental chair. |
| Intended Use Fulfillment | To protect both patient and clinician from sudden and unsafe patient movement. (Stated in intended use, performance section implicitly supports this by successful management of patients). Tool to help manage an uncontrollable child for the purpose of protection of the child from injury while receiving dental treatment. (Stated in Indications for Use). |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: "over 1,000 child patients" were reportedly tested.
- Data Provenance: Not specified, but given the submitter's address (St. Paul, MN), it can be inferred the testing was likely conducted in the USA, at the submitter's facility or associated clinics. The data appears to be retrospective observation of clinical use rather than a controlled prospective study, as it describes a range of patient behaviors encountered in practice.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The "testing" appears to be based on the experience of "Cavity Free Kids," likely dentists or dental professionals at their practice, observing the device's effectiveness. No independent experts or specific qualifications beyond being the users are mentioned for establishing a formal "ground truth."
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Adjudication method for the test set:
- No formal adjudication method is described. The performance claim is based on the general observation of "successfully managed the patients to allow dental procedures to be performed."
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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, an MRMC study was not done. The device is a physical pediatric restraint, not an AI or imaging device that would involve "readers" or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is a physical device, not an algorithm. Its performance is inherently tied to human (clinician) interaction and application.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is implicitly the successful completion of dental procedures on uncooperative children, as observed by the clinicians using the device. This is a form of outcomes data based on clinical observation, though not formally structured as a study with predefined endpoints and expert consensus. The "management" of the patients to allow procedures is the key outcome.
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The sample size for the training set:
- Not applicable/Not provided. This is not a machine learning model, so there is no training set in that sense. The "testing" on "over 1,000 child patients" appears to be the only data mentioned for performance evaluation.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned in the context of an AI/machine learning model.
§ 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.