(84 days)
MacroPore IB Resorbable Plug is indicated for use as a cement restrictor in the femur, tibia and humerus.
MacroPore IB Resorbable Plug is a resorbable implant manufactured from poly lactic acid (PLA). The MacroPore IB Resorbable Plug is designed to wedge into the inter medullary region of long bones to restrict the flow of cement. The MacroPore IB Resorbable Plug is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. Resorbable Plug is provided in various shapes such as rectangles, ovals, and MacroPore IB cylinders and will be provided in other similar shapes and sizes as needed for particular surgical procedures. The wall thickness of the MacroPore IB Resorbable Plug ranges from 0.5 mm to 4.0 mm according to the region to be treated. The major outer diameter of the MacroPore IB Resorbable Plug ranges from 4mm to 30mm according to the region to be treated. A minimum of two sides of the MacroPore IB Resorbable Plug contain fenestrated edges to assure fit within the inter medullary region and to prevent dislodging. These fenestrated edges also allow for a secure fit between segmental defects.
Here's an analysis of the provided text regarding the MacroPore IB Resorbable Plug, focusing on acceptance criteria and supporting studies:
It's important to note that the provided documents are a 510(k) Summary and the FDA's Substantially Equivalent Letter. This type of submission generally doesn't contain the detailed, formal acceptance criteria and comprehensive study results one would find in a Pre-Market Approval (PMA) application or a peer-reviewed publication. Instead, 510(k)s rely on demonstrating substantial equivalence to a predicate device. This means the studies conducted often aim to show similar performance characteristics rather than proving specific, pre-defined quantitative acceptance criteria against a clinical gold standard.
Based on the provided information, I will infer the "acceptance criteria" as the performance characteristics the manufacturer tested to demonstrate equivalence, and "device performance" as their reported findings.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Mechanical Properties after Heating (Prolonged exposure to 60°C saline) | Viscosity remained within an appropriate range over 120 minutes. The brief anticipated surgical exposure is not expected to significantly affect mechanical properties. |
| Material Crystallinity (Amorphous nature) | Tests on sterile and non-sterile samples revealed no endothermic spikes, confirming the amorphous (non-crystalline) nature of the implants. |
| Indications for Use (Substantial Equivalence) | Shares substantially equivalent indications for use as a cement restrictor in the femur, tibia, and humerus with predicate devices. |
| Design Features, Principles of Operation, and Materials (Substantial Equivalence) | Shares substantially equivalent design features, principles of operation, and materials with predicate devices. |
No formal, quantitive acceptance criteria with specific thresholds (e.g., "sensitivity must be >X%") are stated in this 510(k) summary. The focus is on demonstrating that the new device is as safe and effective as the predicate devices, primarily through in vitro testing of material properties and a comparison of design and indications.
Study Details
Given the nature of a 510(k) for a Class II device like this, clinical trials demonstrating clinical performance against a human or pathology-based ground truth are typically not required if substantial equivalence can be shown through other means (e.g., material testing, biomechanical testing, comparison to predicates). The document focuses on in vitro testing.
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Sample size used for the test set and the data provenance:
- Test Set (Material Testing): The document doesn't explicitly state the sample size (number of plugs) used for the in vitro tests (heating/viscosity and crystallinity). It refers to "the testing" and "tests ran on the sterile and non-sterile samples," implying some number of samples were used, but no specific count is given.
- Data Provenance: The nature of the tests (material composition, in vitro studies) indicates the data was generated in a lab setting, likely by the manufacturer, MacroPore, Inc., based in San Diego, California, USA. This would be considered prospective in vitro testing undertaken specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. The "ground truth" for the in vitro material tests is based on established scientific principles and analytical methods (e.g., measuring viscosity, DSC for crystallinity). These are objective measurements, not subject to expert interpretation for ground truth establishment. Equivalence to the predicate is established through comparison of design, materials, and intended use, which is reviewed by FDA experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to determine a clinical outcome or diagnosis for a test set. The tests described are objective material science evaluations.
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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:
- Not applicable. This device is a resorbable medical plug, not an AI-powered diagnostic or assistive tool. MRMC studies are used to evaluate diagnostic accuracy and reader performance, usually for imaging or AI-based systems.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the in vitro testing is based on objective physical and chemical properties measured against scientific standards. For example, viscosity measurement using established methods, and crystallinity detection via DSC.
- For the overall substantial equivalence determination, the "ground truth" is the established safety and effectiveness of the existing predicate devices already cleared by the FDA. The new device is compared to these predicates in terms of indications, design, materials, and performance characteristics (as demonstrated by in vitro tests).
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The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The material properties are inherent to the PLA material and manufacturing process, not learned from data.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.