(142 days)
The GORE BIO-A™ Fistula Plug device is intended for use in the reinforcement of soft tissue for repair of anorectal fistulas.
The GORE BIO-A™ Fistula Plug is a surgical mesh supplied in a preformed three-dimensional shape (disk with attached tubes) and comprised of a porous structure of synthetic bioabsorbable PGA/TMC copolymer fiber, degraded via a combination of hydrolytic and enzymatic pathways. The PGA:TMC material is bioabsorbable and has been demonstrated to be both biocompatible and non-antigenic. It is not derived from animal or human tissues. The GORE BIO-A™ Fistula Plug is a tailorable, bioabsorbable material intended to reinforce soft tissue during the phases of wound healing by initially occupying the fistula defect and at the same time eliciting a physiological tissue response which fills the fistula defect with native tissue as the fistula plug gradually absorbs. The GORE BIO-A™ Fistula Plug is provided sterile for single use only.
The provided text is a 510(k) summary for the GORE BIO-A™ Fistula Plug. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics in the way a new, novel device might.
Therefore, the specific information requested about acceptance criteria, performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this type of regulatory submission.
Here's an analysis based on the provided text, explaining why those details are missing:
Analysis of the GORE BIO-A™ Fistula Plug 510(k) Summary (K083266):
The 510(k) process is primarily a premarket notification where a manufacturer demonstrates that their device is "substantially equivalent" in terms of safety and effectiveness to a legally marketed predicate device. This typically involves comparing technological characteristics and intended use, rather than conducting new clinical trials to establish de novo performance criteria.
Therefore, a table of acceptance criteria with reported device performance, information on sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance studies are not typically included or required in a 510(k) submission unless the device is truly novel or has significantly different technological characteristics from its predicates.
Here's a breakdown of what can be extracted or inferred:
- Device Name: GORE BIO-A™ Fistula Plug
- Intended Use: Reinforcement of soft tissue for repair of anorectal fistulas.
- Predicate Devices:
Regarding the requested information:
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A table of acceptance criteria and the reported device performance:
- Not present. The document states: "A variety of in vitro and in vivo tests and comparisons demonstrate that the GORE BIO-A™ Fistula Plug device is substantially equivalent in intended/indications for use, performance, materials and technology to the predicate devices." It does not report specific acceptance criteria or performance metrics for the GORE BIO-A™ Fistula Plug, but rather asserts its equivalence to the performance of the predicate. To understand the "performance" considered, one would need to refer to the 510(k) summaries or other regulatory documents for the predicate devices (K050337 specifically for "performance").
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present. Detailed study designs, including sample sizes for specific in vitro or in vivo tests, are not provided in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not present. This type of information is relevant for studies involving subjective assessment (e.g., image interpretation for AI algorithms). For a physical medical device like a fistula plug, "ground truth" would relate to objective measurements of biocompatibility, degradation, mechanical properties, and potentially clinical outcomes if clinical trials were performed (which are not detailed here as part of the substantial equivalence argument). The 510(k) summary does not mention expert review in this context.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not present. See point 3.
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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/Not present. This device is a physical implant, not an AI or imaging-based diagnostic tool. Therefore, MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not present. This device is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred based on "in vitro and in vivo tests": For a physical device, ground truth would typically refer to objective measurements of material properties (e.g., tensile strength, pore size, degradation rate), biocompatibility assessments (e.g., histological analysis of tissue response), and potentially animal model outcomes related to fistula healing or tissue integration. The summary mentions biocompatibility and bioabsorbability as key characteristics. Specific details are not provided.
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The sample size for the training set:
- Not applicable/Not present. This concept is for AI/machine learning models.
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How the ground truth for the training set was established:
- Not applicable/Not present. This concept is for AI/machine learning models.
In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It relies on comparisons to predicate devices and general statements about in vitro/in vivo testing rather than detailing specific studies with acceptance criteria and performance metrics relevant to an AI/diagnostic device.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.