(120 days)
The ORI II is intended for augmentation or restoration in the craniofacial region.
The Orbital Reconstructive Implant II is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos.
The Orbital Reconstructive Implant II (ORI II) is a non-absorbable, inert, sterile, porous, implant composed of porous silicone elastomer and expanded polytetrafluoroethylene (ePTFE). This polymeric implant is available in a range of lengths and widths to accommodate the surgical application and the needs of the individual surgeon practicing medicine.
The Orbital Reconstructive Implant II (ORI II) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through
non-clinical performance testing and biocompatibility evaluation.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test) | Reported Device Performance (ORI II) | Basis for Equivalence |
|---|---|---|
| Tensile load at break | Approximately 50% greater than the ORI predicate. | Demonstrates improved mechanical strength compared to a predicate device, supporting safety and effectiveness. |
| Tensile elongation at break | Approximately 25% of that of the ORI predicate. | Demonstrates different mechanical properties compared to a predicate, assessed as not affecting safety/effectiveness for intended use. |
| Elastic (Young's) modulus | Performed. Results support substantial equivalence. | Compared to predicate devices. |
| Compression deflection | Performed. Results support substantial equivalence. | Compared to predicate devices. |
| Uniaxial compressive modulus | Performed. Results support substantial equivalence. | Compared to predicate devices. |
| Compressive set | Performed. Results support substantial equivalence. | Compared to predicate devices. |
| Suture pullout | Performed. Results support substantial equivalence. | Compared to predicate devices. |
| Shear modulus | Performed. Results support substantial equivalence. | Compared to predicate devices. |
| Ultimate shear strength | Performed. Results support substantial equivalence. | Compared to predicate devices. |
| Shear load at break | Performed. Results support substantial equivalence. | Compared to predicate devices. |
| Biocompatibility | Evaluated based on the long-term implant section of the ISO-10993 standard and shown to be biocompatible. | Direct compliance with recognized standards for implantable medical devices, ensuring biological safety. |
| Material Composition | Polydimethylsiloxane elastomer ("silicone elastomer") and expanded polytetrafluoroethylene (ePTFE). These are the same materials as the ORI predicate (K070130). | Use of established, biocompatible materials found in predicate devices. |
| Processing (core layer) | Silicone elastomer processed to form a porous core layer. (Differs from ORI predicate which had a film core). | Design difference from predicate, but overall performance shown to maintain safety and effectiveness. |
| Intended Use & Indications for Use | Same as predicate devices: augmentation, reconstruction, or restoration in and around the orbit of the eye (e.g., following orbital trauma, tumor excision, to treat orbital volume deficiencies, or correction of enophthalmos). | Maintenance of the same clinical applications and patient population as currently marketed, cleared predicate devices, minimizing new clinical risks. The slight differences in design and performance from the predicate devices do not affect the safety and/or effectiveness for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified. The study involved bench testing of the Orbital Reconstructive Implant II (ORI II). This refers to a series of laboratory tests conducted on the device itself, rather than testing on biological samples or human patients.
- Data Provenance: The data is from non-clinical performance testing (bench testing) and biocompatibility evaluation. There is no information regarding the country of origin of the data as it's not clinically collected patient data. It is inherently prospective in the sense that the device was manufactured and then tested according to established protocols.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable as the study is based on laboratory bench testing and biocompatibility assessment, not interpretation of clinical data or images by experts to establish a "ground truth" for diagnostic accuracy. The "ground truth" for mechanical properties is typically derived directly from the physical measurements themselves. Biocompatibility ground truth is established by standardized toxicity tests.
4. Adjudication Method for the Test Set:
- This information is not applicable as the study does not involve human readers interpreting data or making subjective judgments that would require adjudication. The testing methods are objective measurements of physical and chemical properties.
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:
- This information is not applicable as the device is an implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable as the device is an implant, not an algorithm or AI system.
7. The type of ground truth used:
- The "ground truth" in this context is based on objective measurements of physical properties (e.g., tensile strength, elongation, modulus) obtained through standardized engineering test methods (e.g., ASTM-D624, ASTM-D1777, ASTM-F88, ASTM-D412, ASTM-D3787).
- For biocompatibility, the ground truth is established by adherence to the ISO-10993 standard, specifically the long-term implant section, which involves standardized biological assessments to determine the device's compatibility with living tissues.
8. The sample size for the training set:
- This information is not applicable as the device is an implant and does not involve machine learning or an algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as above; there is no training set for this type of device submission.
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.