(114 days)
The MacroPore Barrier Film is indicated for use as an orbital implant wrap to cover orbital implants used in enucleation surgery and to protect the surrounding orbital tissue from the surface of the implant.
MacroPore Surgical Barrier Film is a resorbable implant in sheet form manufactured from polylactides (PLA). MacroPore Surgical Barrier Film can be cut with scissors to the desired shape and size. MacroPore Surgical Barrier Film is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Surgical Barrier Film is provided in various shapes such as squares, rectangles, ovals, and circles. The MacroPore Surgical Barrier Film will be provided in sheets of 30mm x 30mm to 200mm x 200mm so that the surgeon may cut specific shapes and sizes. The thickness of the MacroPore Surgical Barrier Film will range from 0.05 mm to 1.0 mm. The MacroPore Surgical Barrier Film will be provided in solid sheets and in porous sheets that have pores that range in pore size from 0.5mm to 3.0mm with pores distributed randomly or uniformly throughout the film in an offset or aligned pattern. The pores are spaced at a distance of 1.5mm or greater. The MacroPore Surgical Barrier Film is fabricated from polylactide (PLA).
This document is a 510(k) premarket notification for the MacroPore Surgical Barrier Film. It's a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove acceptance criteria in the typical sense of a clinical trial. Therefore, many of the requested categories (like MRMC study, sample size for training set, number of experts for ground truth) are not applicable or directly derivable from this type of document.
However, I can extract the "acceptance criteria" through the lens of proving substantial equivalence, which revolves around demonstrating similar performance to predicate devices, and the "study" is the in vitro testing and comparison described.
Here's the information formatted to the best extent possible given the document type:
Acceptance Criteria and Device Performance for MacroPore Surgical Barrier Film
Note: This document is a 510(k) for substantial equivalence, not a clinical trial report. "Acceptance criteria" are inferred from the requirements for substantial equivalence, and "reported device performance" refers to the results of the described in vitro tests and comparisons to predicate devices. A "study" in this context refers to the non-clinical testing performed to support the 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred from 510(k) Requirements) | Specific Criterion (Inferred) | Reported Device Performance/Findings |
|---|---|---|
| Material Stability | Maintain appropriate viscosity after heating at 60°C for ~120 minutes (to simulate surgical preparation). | Viscosity stayed within an appropriate range over 120 minutes of heating in saline at 60°C. Brief exposure during surgical preparation is not expected to significantly affect mechanical properties. |
| Mechanical Strength (Aging) | Retain sufficient strength for the indicated use after aging. | Testing demonstrated that the MacroPore Surgical Barrier Film is strong enough for the indications for use. |
| Mechanical Strength (Comparison to Predicate) | Be substantially equivalent in mechanical strengths (e.g., tensile, suture pull-out) to predicate devices under indication for use conditions. | Mechanical testing determined the MacroPore Surgical Barrier Film to be substantially equivalent to the mechanical strengths of the predicate devices (Bio-Vascular Ocu-Guard and Bio-Eye II Orbital Implant) under indication for use conditions (as measured by tensile and suture pull-out testing). |
| Indications for Use (Comparison) | Share identical indications for use principles with predicate devices. | MacroPore Surgical Barrier Film shares identical indications for use principles with the predicate devices; both are indicated for the same surgical procedures (orbital implant wrap for enucleation surgery and protecting surrounding orbital tissue). |
| Design and Materials (Comparison) | Be substantially equivalent in physical design (thin semirigid sheets, contourability, dimensions, malleability) and material (PLA vs. bovine pericardium). | Physical designs are substantially equivalent (thin semirigid sheets). Both allow for contouring (MacroPore when heated to 55°C). Dimensions (rectangular sheets, several cm) are comparable. Material is PLA, which is different from predicate bovine pericardium, but the overall design and function are deemed equivalent. |
| User Adaptability (Comparison) | Allow end-user cutting to specific shapes and sizes. | Both the MacroPore Surgical Barrier Film and the predicate devices can be cut to specific shapes and sizes by the end user. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this is non-clinical testing. The "test set" would refer to the samples of the MacroPore Surgical Barrier Film subjected to in vitro heating, aging, and mechanical tests. The number of samples tested for each specific test (e.g., viscosity, tensile strength) is not quantified in this summary.
- Data Provenance: The data is from in vitro laboratory testing performed by MacroPore Biosurgery, Inc. It is considered prospective in the sense that the tests were specifically conducted for this 510(k) submission. Country of origin for data generation is likely the USA, implicitly where the manufacturer is located (San Diego, CA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable / not provided. This is an in vitro device and a 510(k) submission. It does not involve human subjects or expert assessment for establishing "ground truth" in a clinical sense. The "ground truth" for the material properties would be established by standard engineering and materials science principles and testing protocols.
4. Adjudication Method for the Test Set
- Not applicable / none. Since the "test set" refers to in vitro measurements against established material science parameters and comparisons to predicate device specifications, there is no need for expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is a type of clinical comparative effectiveness study involving multiple human readers evaluating diagnostic cases. This document describes an in vitro device and a 510(k) submission for substantial equivalence based on material properties and design, not diagnostic accuracy requiring human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Partially applicable, but in a non-AI context. The "standalone" performance here refers to the intrinsic material and mechanical properties of the device itself (e.g., its viscosity retention, strength, malleability, dimensions) as measured in laboratory tests, without human interaction beyond the initial setup and measurement. There is no AI algorithm involved in this device.
7. The Type of Ground Truth Used
- Engineering and Material Science Standards / Predicate Device Specifications. The "ground truth" for the in vitro tests is derived from:
- Established scientific principles for material behavior (e.g., viscosity, mechanical strength).
- Comparison to the known performance and specifications of legally marketed predicate devices (Bio-Vascular Ocu-Guard and Bio-Eye II Orbital Implant).
- The assumption that the predicate devices are safe and effective for their intended use.
8. The Sample Size for the Training Set
- Not applicable / No training set in the AI sense. This is not an AI/machine learning device. The "training" for the device itself would refer to its manufacturing and design process, informed by polymer science and surgical needs, not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI training set, this question is not relevant. The device's design and material selection are based on established engineering principles, material properties of polylactides, and the functional requirements for an orbital implant wrap, with reference to predicate devices.
§ 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.