(50 days)
MP 719 is indicated for use as an implant material and for use in the control of bleeding from bone surfaces. The material may be used during surgical procedures and in treating traumatic injuries. MP719 is intended for use under the direction of a healthcare professional.
MP 719 is a sterile, resorbable, non-woven membrane material comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae, intended for use in the management of bleeding. MP 719 is available in a range of sizes from 4cm x 4cm to 10cm x 10cm.
The provided document describes the MP 719, a sterile, resorbable, non-woven membrane material for bone hemostasis. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to predicate devices, rather than prove effectiveness through specific acceptance criteria and clinical studies in the same way a PMA (Premarket Approval) would. Therefore, the information provided focuses on comparative testing and biocompatibility rather than defined clinical acceptance metrics and their achievement in randomized controlled trials.
Here's an analysis based on the provided text, addressing the requested points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the sense of predefined thresholds for clinical efficacy that the device must meet (e.g., sensitivity, specificity for a diagnostic device). Instead, it presents results of various tests demonstrating that the device performs similarly to or better than predicate devices and is safe for its intended use. The "Conclusion" column largely serves as the reported "device performance" relative to internal specifications or predicate devices.
| TEST Category | Test Name | Acceptance/Performance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|---|
| BENCH TOP | Chemical Analysis | Pass according to specifications (e.g., IR identification, elemental analysis, ash, absence of protein, % moisture). | Pass according to specifications. |
| Safety | Pass according to specifications (e.g., bioburden, endotoxin). | Pass according to specifications. | |
| Shelf Life | 3-year real-time stability study without degradation or loss of function. | Pass according to specifications. | |
| Device Hardness | Similar mechanical properties to Bone Wax (predicate). | MP719 and Bone Wax exhibit similar mechanical properties. | |
| Handling Properties | Similar handling properties to Bone Wax (predicate) in benchtop experiments. | MP719 and Bone Wax handle similarly in benchtop experiments. | |
| ANIMAL STUDIES | Hemostasis (in vivo) | Similar hemostatic performance to Bone Wax (predicate) in cortical defects in the rabbit femur. | MP719 and Bone Wax handle similarly in in vivo experiments. (Note: "handle similarly" is stated, which implies similar performance in hemostasis in this context). |
| Biocompatibility | Cytotoxicity (L929 MEM Elution) | No biological reactivity (Grade 0). | No biological reactivity (Grade 0). |
| Sensitization (Kligman Maximization) | 0% sensitization. | 0% sensitization. | |
| Irritation (Intracutaneous Injection) | Negligible irritant. | Negligible irritant. | |
| USP Class VI (Intracutaneous Injection) | No signs of erythema or edema. | No signs of erythema or edema. | |
| Genotoxicity (Samonella typhimurium REVERSE MUTATION ASSAY) | Non-mutagenic. | Non-mutagenic. | |
| Mammalian Genotoxicity (Publication) | Non-mutagenic. | Non-mutagenic. | |
| Implantation (USP Class VI - Intramuscular) | No inflammation, encapsulation, hemorrhage, necrosis, or discoloration. | No inflammation, encapsulation, hemorrhage, necrosis, or discoloration. | |
| Implantation (ISO Intramuscular, 2, 4, 12 wk) | Non-reactive. | Non-reactive at 2, 4, and 12 weeks. | |
| Hemocompatibility (ASTM Hemolysis) | Non-hemolytic. | Both test article and test article extract are non-hemolytic. | |
| Systemic Toxicity (USP Class VI - Systemic) | No significantly greater biological reactivity than control. | No significantly greater biological reactivity than control. | |
| Comparison (MP 719 vs. Bone Wax) | Implantation (Bone Implant - Rabbit Femur) | Lacked any macroscopically detectable adverse reactions (similar to predicate). | Both MP719 and Bone Wax lacked any macroscopically detectable adverse reactions. |
| Hemostasis (Comparative - Rabbit Femur) | Equivalent hemostatic performance to legally marketed bone wax (predicate). | MP719 and Bone Wax were considered equivalent in their hemostatic performance. |
2. Sample Sizes and Data Provenance (for test set/studies)
- Animal Studies:
- Hemostasis produced by MP719 Implanted in Cortical Defects in the Rabbit Femur: The study was conducted in rabbits. The specific number of rabbits or defect sites used is not provided.
- Implantation Study of MP719 in Femur Cortical Bone of Rabbit: Again, conducted in rabbits. Specific sample size is not stated.
- Biocompatibility tests (e.g., Cytotoxicity, Sensitization, Irritation, USP Class VI, ISO Implantation, Hemocompatibility, Systemic Toxicity, Genotoxicity): These refer to standard biological evaluation tests. While the species are mentioned (e.g., L929 cells for cytotoxicity, rabbits/mice for various in vivo tests, Salmonella for genotoxicity), specific sample sizes for each test are not detailed in this summary.
- Data Provenance: The animal studies were in vivo experiments. The country of origin for the data is not specified, but typically such studies would be conducted in the country of the submitting company or by contract research organizations (CROs) adhering to international standards. The studies appear to be prospective in their design (i.e., designed specifically to test MP719).
3. Number of Experts and Qualifications (for ground truth)
This type of information is generally not applicable to a 510(k) submission for a device like MP 719. The "assessments" here are primarily objective laboratory and in vivo animal study results, not subjective interpretations requiring expert consensus for a "ground truth" as would be the case for a diagnostic imaging AI, for example. The "conclusion" for animal studies, such as "MP719 and Bone Wax were considered equivalent in their hemostatic performance," would involve assessment by veterinarians or researchers involved in the animal model. Their specific qualifications (e.g., DVM, PhD in toxicology, etc.) are implied by the nature of the studies but not explicitly stated or quantified in terms of "number of experts."
4. Adjudication Method (for test set)
Not applicable. There is no "test set" in the sense of human-interpreted cases requiring adjudication. The studies are empirical laboratory and animal experiments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically used for evaluating diagnostic devices (e.g., imaging AI) where human readers interpret cases. This device is a bone hemostasis implant.
6. Standalone Performance
The vast majority of the studies (benchtop, biocompatibility, and the hemostasis/implantation animal studies) assess the MP 719 device itself without human intervention in the "performance" component beyond its application. For example, the biocompatibility tests evaluate the device's material properties and interaction with biological systems in a standalone manner. The animal hemostasis study compares MP719 directly against bone wax, demonstrating its standalone effectiveness in controlling bleeding in that model.
7. Type of Ground Truth Used
- Benchtop Tests: Based on predefined analytical specifications (e.g., IR spectrum matching, quantitative limits for elements or moisture, thresholds for bioburden/endotoxin).
- Biocompatibility Tests: Based on standardized biological assay results (e.g., cell viability, observed skin reactions, mutation rates, systemic toxicity scores, histological findings) according to established international standards (ISO, USP, ASTM).
- Animal Studies (Hemostasis, Implantation): Based on direct observation and measurement of biological effects in animal models (e.g., cessation of bleeding, macroscopic and microscopic assessment of tissue reactions, comparison to control/predicate devices). This is akin to outcomes data within the experimental animal model.
8. Sample Size for the Training Set
Not applicable. MP 719 is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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