(163 days)
The P-POD Plagiocephaly Orthosis Device is intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.
The Lorica Scientific LLC P-POD Plagiocephaly Helmet is a Class II cranial orthosis intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads. The P-POD helmet is similar to the predicate devices in such that it is an orthosis designed for each patient from a cast of the infant's head. Each orthosis is composed on an outer shell with a layer of foam and a side strap for securing the orthosis. Additionally, the helmet has a top vent and side opening as typically seen with the predicates. Optimum fit and alignment is insured and monitored by the clinical practitioner.
The Lorica Scientific LLC P-POD Plagiocephaly Helmet differs from the predicate devices in that the device is made in the physician's office via a simplified casting process that can be performed in approximately 30 minutes. The predicate devices rely on a 2 to 4 week process of sending the child for a 3-D scan and then using casting and molding processes to create a customized helmet.
The P-POD standardized (2 sizes) helmet consists of a hard outer shell with an inflatable bladder lining the inside. Modeling putty is used to fill in the flattened portion of the infants head to form the desired symmetrical shape and the helmet is placed on the infant. The physician then mixes a pre-measured solution in an easy-to-use, pre-measured pouch and pours the mixed solution into the bladder of the helmet through a specially designed filling port located at the top of the helmet. As the chemical solution cures, there is an exothermic foaming process from a liquid to solid foam which expands to fill the empty space in the bladder thus customizing the helmet to the shape making a negative copy of the infant's skull. Since the putty is used to fill in the undesired negative regions of the skull deformity, once the foam is completely cured and putty removed, the resulting helmet provides an ideal cast to help promote proper skull re-contouring. As with all other similar cranial orthosis devices, as the infant wears the helmet, the head grows into the shape formed by the foam, thereby correcting the deformity.
Here's an analysis of the provided text regarding the P-POD Plagiocephaly Orthosis Device, focusing on acceptance criteria and the supporting study:
The provided document, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval. It does not contain a detailed study proving device meets specific acceptance criteria in terms of efficacy metrics (e.g., specific improvement in cranial symmetry measurements). Instead, it relies on demonstrating that its technological characteristics are equivalent to legally marketed devices and that its unique manufacturing process does not introduce new risks, as validated by human factors studies and biocompatibility testing.
Therefore, many of the requested fields regarding performance metrics and clinical study design cannot be filled from the given text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria Mentioned in Document | Reported Device Performance / Evaluation Outcome |
|---|---|---|
| Biocompatibility | No cytotoxicity (ISO 10993-5) | Cell culture treated with test sample exhibited no reactivity (Grade O). Conclusion: Non-toxic. |
| No sensitization reaction (ISO 10993-10) | Albino guinea pigs treated with test sample did not elicit a sensitization response (Grade O). Conclusion: No sensitization reaction. | |
| No irritation (ISO 10993-10) | Rabbits treated with test samples exhibited no irritation (Grade 0). Conclusion: Non-irritating. | |
| Functional / Material | Foam Stiffness (Durometer A) | $45 \pm 4.61$ (Min: 39, Max: 54) |
| Foam Thickness | 0.1875 inches minimum | |
| Human Factors | Naive users can be trained via video and IFU to produce a helmet. | Human factors studies performed to ensure naive users can be trained via a video and reading the IFU to produce a helmet and appropriately accept or reject a helmet based on defined criteria. |
| Naive users can appropriately accept or reject a helmet based on defined criteria. | Human factors studies performed to ensure naive users can be trained via a video and reading the IFU to produce a helmet and appropriately accept or reject a helmet based on defined criteria. | |
| Infants (4-18 months) can tolerate the treatment. | Human factors studies performed to ensure the infants in the intended treatment range of 4 to 18 months can tolerate the treatment. The human factors studies also stated that it showed "physicians can make the helmet and determine adequacy of helmet for child." | |
| Manufacturing Process | Molding process accuracy (implicitly, that it produces a functional and safe helmet) | Evaluation of molding process accuracy was performed. The non-clinical evaluation confirmed device equivalency. The human factors study showed the production process can be successfully produced by clinicians. |
| Equivalence to Predicates | Equivalence in indication for use, device classification, product code, environment of use, principles of operation. | The entire 510(k) submission and comparative table are dedicated to demonstrating this, concluding that the device is "substantially equivalent." Differences in manufacturing are evaluated to ensure "No New Risk." |
| No new risks from differences in manufacturing process. | "No New Risk. Differences in manufacturing helmets will not affect quality of final product. Human factors studies for P-POD helmet show physicians can make the helmet and determine adequacy of helmet for child." |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided document. The human factors studies involved "naive users" and "infants in the intended treatment range," but no specific numbers are given.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified.
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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 document mentions "clinical practitioner" monitors optimum fit and alignment, and "physicians can make the helmet and determine adequacy of helmet for child" based on human factors studies, but details on expert qualifications for ground truth are absent.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. The document describes human factors studies and biocompatibility testing, not an assessment requiring adjudication of diagnostic outcomes.
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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. This type of study (MRMC, AI assistance) was not conducted or mentioned for this device. The device is a physical cranial orthosis, not an imaging or diagnostic AI tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a physical orthosis, not an algorithm. The "human factors studies" refer to human interaction with the physical device and its assembly process, not a human-in-the-loop AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility, the ground truth was established by adherence to ISO standards for cytotoxicity, sensitization, and irritation.
- For human factors, the ground truth likely involved direct observation of the training process, the ability of users to produce helmets correctly, and infant tolerance, as evaluated by study personnel (implicitly, clinical experts, but not explicitly defined as "ground truth experts" in a diagnostic sense).
- For foam stiffness and thickness, the ground truth was quantitative measurement against specifications.
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The sample size for the training set:
- Not applicable/Not specified. There is no mention of a "training set" in the context of an AI/machine learning model. The "training" mentioned refers to training human users on the device's manufacturing process.
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How the ground truth for the training set was established:
- Not applicable. Assuming "training set" refers to an AI/machine learning context, this is not relevant. If it refers to the training of human users, the "ground truth" for their performance was likely established by predetermined criteria for correct helmet production and acceptance/rejection, as stated.
§ 882.5970 Cranial orthosis.
(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).