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510(k) Data Aggregation
(200 days)
ORBITAL TISSUE EXPANDER (OTE)
The OTE would be used in the case of congenital anophthalmia, congenital microphthalmia or acquired anophthalmia from, e.g., childhood ocular tumors or trauma.
The integrated orbital tissue expander (OTE), consisting of a flexible "balloon/expander" is held in place by means of a titanium fixation plate that is anchored to the lateral orbital wall by screws. A slotted arm attached to the fixation plate, extends through a slot that is formed within the OTE. The OTE can be manually moved along the shaft of the fixation plate to achieve optimal central position in an expanding socket. A 30 gauge disposable hypodermic needle connected to a 1 cc disposable syringe filled with sterile saline is inserted into the OTE through an injection port. Inflation of the OTE will effect pressure on the orbit of the patient.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance Study
The provided document describes the Innovia Orbital Tissue Expander (OTE) and its premarket notification to the FDA. While it discusses performance data, it does not present specific, quantitative acceptance criteria for the device's performance that are then directly compared to reported device performance in a tabular format. The document focuses on demonstrating substantial equivalence to a predicate device and showing safety and effectiveness through various tests.
Therefore, for the acceptance criteria table, I will infer the types of performance criteria based on the described tests and present the qualitative findings. It's important to note that the document does not provide numerical thresholds for "acceptance."
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Manufacturing Repeatability & Reliability | Bench testing showed OTEs can be fabricated in a repeatable and reliable manner. |
| Volume & Diameter Maintenance (In vitro) | In vitro testing showed the tissue expander maintains adequate volume and diameter over time. |
| Volume & Diameter Maintenance (In vivo) | In vivo testing showed the tissue expander maintains adequate volume and diameter over time. |
| Durability (Fatigue) | Fatigue testing showed durability. |
| Effectiveness (Orbital Expansion/Bone Growth) | Animal study clearly demonstrated a noticeable difference in sockets expanded with the OTE compared to control sockets. Experimental expanded orbits kept pace with bone growth development on the contralateral non-enucleated side. Qualitative observation on CT scans and gross photos. |
| Safety (Tissue Reaction) | Histology in all animals showed normal tissues, free of foreign body reaction. |
| User Control of Size | The OTE size is user-controlled via saline injection, allowing matching with the contralateral eye using CT scans. (This is a feature comparison to the predicate, implying it meets a functional requirement). |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Study: The document refers to "the animal study" and "all animals" but does not specify the exact number of animals (sample size).
- Data Provenance: The animal study was conducted, which implies prospective data collection, but the country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not specify the number of experts or their qualifications for evaluating the animal study results (e.g., interpreting CT scans or histology). It states that the qualitative difference "can be observed on CT scans as well as in gross photos" and histology was performed, suggesting expert review, but details are absent.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for evaluating the animal study results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The document describes bench, in vitro, and animal testing. There is no mention of human readers evaluating cases with or without AI assistance. The device itself is a physical implant, not an AI-driven diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. The OTE is a medical device, not an algorithm or software. The performance studies evaluate the physical properties and biological effects of the expander.
7. Type of Ground Truth Used
- For the animal study:
- Qualitative Observation: Orbital expansion and bone growth compared to the contralateral non-enucleated side (visual assessment on CT scans and gross photos).
- Pathology/Histology: Histological analysis of tissues for foreign body reaction and normalcy.
8. Sample Size for the Training Set
- The document describes manufacturing of the OTE and subsequent testing. There is no mention of a "training set" in the context of machine learning or algorithm development, as this is a physical medical device. The "training" for the device would be its design and manufacturing processes, which are not quantified in terms of a "sample size" in this context.
9. How the Ground Truth for the Training Set Was Established
- Since there is no "training set" in the machine learning sense, this question is not applicable. The "ground truth" for the device's design and manufacturing relies on engineering principles, materials science, and pre-clinical animal models to demonstrate safety and efficacy for human use.
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