(277 days)
Lyoplant is indicated as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.
The Lyoplant® device is a lyophilized dura substitute of pure collagen derived from bovine pericardium. The product is supplied sterile, non-pyrogenic and packaged as single or double pieces of varying sizes.
Here's a summary of the acceptance criteria and the study that proves the device (Lyoplant Dura Substitute) meets those criteria, based on the provided text:
Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data in the format of a typical clinical trial report. As such, explicit quantitative acceptance criteria for device performance (e.g., a specific percentage of success for a given outcome) are not defined in the text. Instead, the document focuses on demonstrating that the device meets the general requirements for a dura substitute and is comparable to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) summary, specific numerical acceptance criteria for clinical efficacy are not detailed. The criteria are qualitative, focusing on biocompatibility, handling, and functional equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| * Non-sensitizing | Found not to be a sensitizing agent under standard test procedures. |
| * Non-toxic | Found to be non-toxic. |
| * Weak/non-reactive immunogenic potential | Possesses a weak or virtually non-reactive immunogenic potential. |
| * Well-tolerated by tissues (no adverse cellular/allergic rxns) | Animal studies have shown Lyoplant to be extremely well tolerated by tissues. No adverse cellular or allergic reactions were observed. |
| * No foreign body reaction (absence of giant cells) | The absence of giant cells demonstrates that Lyoplant is not recognized as a foreign body by the host. |
| * Integration into connective tissue | The implant is integrated completely into connective tissue. (Animal Studies) The implants showed development of connective tissue with no immunological or adverse response. (Human Clinical Investigation) |
| Functional Characteristics (as a dura substitute): | |
| * Sterile | Product is supplied sterile, non-pyrogenic. (Device Description) Confirmed by Final product microbiological testing. (Manufacturing) Performance data... relative to... sterility... have been performed. (Performance Data) |
| * Non-pyrogenic | Product is supplied sterile, non-pyrogenic. (Device Description) Performance data... relative to... pyrogenicity... have been performed. (Performance Data) |
| * Adequate tear resistance | Available as sterile, thin flexible sheets with adequate tear resistance and handling properties... (Technological Characteristics - comparison to predicates). |
| * Satisfactory handling properties | Available as sterile, thin flexible sheets with adequate tear resistance and handling properties... (Technological Characteristics - comparison to predicates). A clinical investigation also confirmed the excellent biocompatibility and handling properties of Lyoplant for human use. (Clinical Studies) |
| * Impermeability to CSF | Available as sterile, thin flexible sheets with adequate tear resistance and handling properties, impermeability to CSF... (Technological Characteristics - comparison to predicates). |
| * Equivalence to predicate devices | The study establishes that Lyoplant is equivalent to predicate devices in its biocompatibility and its safety and effectiveness as a dura substitute. (Conclusion) The technological differences between Lyoplant and the predicate devices do not raise new types of safety or effectiveness issues. The technological differences have been assessed by valid scientific and clinical methods. (Technological Characteristics) |
2. Sample Size Used for the Test Set and Data Provenance
- Preclinical Studies (Animal Studies): The text states "Animal studies have shown the Lyoplant to be extremely well tolerated by tissues." It does not specify the number of animals or the type of animal used.
- Clinical Studies (Human): The text states "A clinical investigation also confirmed the excellent biocompatibility and handling properties of Lyoplant for human use." No sample size for this human clinical investigation is provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the "clinical investigation" implies prospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies described are preclinical (animal) and a human clinical investigation, focusing on direct observation of tissue response and handling rather than interpretation by experts.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the studies (biocompatibility, tissue integration), formal adjudication methods like 2+1 or 3+1 are typically not applicable. Outcomes would likely be based on direct observation, histological analysis, and clinical assessment by the researchers/clinicians involved.
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 is not applicable. The device is a physical dura substitute, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As a physical medical device (dura substitute), the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
- Preclinical (Animal Studies):
- Direct observation: Absence of adverse cellular or allergic reactions.
- Histology: Absence of giant cells, complete integration into connective tissue.
- Clinical Studies (Human):
- Clinical observation: Excellent biocompatibility and handling properties.
- Histology/Pathology (implied): Development of connective tissue with no immunological or adverse response.
- Bench Testing: Analytical, physical, and microbiological testing (for manufacturing and final product quality).
8. The Sample Size for the Training Set
This is not applicable. The Lyoplant device is a physical product, not an algorithm that requires a "training set" in the context of machine learning. The term "training set" is not relevant to its development or evaluation as described in this 510(k) summary.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as point 8.
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).