(207 days)
HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Ca10(PO4)6 (OH)2) implants designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.
HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Ca1o(P04)s (OH)2) implants with a minimal 95 % quaranteed purity. Their porosity is 75% (pore diameter: 200-500 um). The porosity of the hydroxyapatite facilitates its colonization by fibrovascular tissue, which offers the advantages of reduced risk of infection or implant extrusion. They are available in the following diameters: 16, 17, 18, 19, 20 and 22 mm.
The provided text describes a 510(k) submission for the "HA ORBITAL IMPLANT". This document outlines the device's characteristics and its substantial equivalence to a predicate device, rather than a study designed to establish new performance criteria or conduct a comparative effectiveness study with human readers.
Therefore, many of the requested sections regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) process focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, primarily through referencing existing standards and literature for the material.
Here's an analysis of what can be extracted based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., success rates, complication rates) for the HA ORBITAL IMPLANT itself. Instead, its acceptance is based on demonstrating that its material (hydroxyapatite) meets a recognized standard and that its performance is substantially equivalent to a predicate device, supported by existing literature on hydroxyapatite orbital implants.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Conformance | HA ORBITAL IMPLANTS are made of hydroxyapatite which conforms to ASTM F1185-88 (reapproved 1993): "Standard specification for composition of ceramic hydroxylapatite for surgical implants". |
| Biocompatibility | ASTM F1185-88, an FDA recognized consensus standard, covers material characterization and biocompatibility. |
| Safety and Effectiveness | Assessed via data reviewed from the literature. "Large and numerous studies of hydroxyapatite have been performed and have demonstrated the well tolerance, the improved motility and the low incidence of complications." (Most studies with predicate device). |
| Substantial Equivalence to Predicate Device (Bio-Eye® hydroxyapatite ocular implant) | - Same intended use (fill orbital cavity post-enucleation, evisceration, or secondary implantation). |
- Microporous, sphere-shaped implants with interconnected pores.
- Manufactured from hydroxyapatite with the same chemical formula (Ca10(PO4)6 (OH)2).
- Available in several diameters and supplied sterile. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This submission relies on a literature review and a comparison to a predicate device, not a new clinical trial with a specific test set.
- Data Provenance: The document states that "Large and numerous studies" of hydroxyapatite were reviewed from the "literature," and "Most of these studies were performed with the predicate device." This suggests the data is retrospective, gathered from various published clinical studies, likely from multiple countries given the global nature of medical research, but specific countries are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set with expert-established ground truth was created for this 510(k) submission. The safety and effectiveness are supported by existing medical literature and the established use of hydroxyapatite.
4. Adjudication method for the test set
Not applicable. As there was no new test set, there was no adjudication method.
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
Not applicable. This device is an orbital implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is based on:
- Material Standards: Conformance to ASTM F1185-88 for hydroxyapatite composition and biocompatibility.
- Established Clinical Evidence: The collective body of evidence from "large and numerous studies" in the medical literature demonstrating the "well tolerance, the improved motility and the low incidence of complications" of hydroxyapatite orbital implants, particularly the predicate device.
- Physiological/Pathological Outcomes: The literature review discusses "reduced risk of infection or implant extrusion" and comparison of complication profiles (e.g., "overlying tissue breakdown and exposure") between hydroxyapatite and other materials.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this 510(k) submission for a physical implant. The assessment relies on existing scientific knowledge and clinical experience with similar devices (the "literature" and "predicate device").
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
§ 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.