(25 days)
BioMend Extend™ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
BioMend Extend™ Absorbable Collagen Membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon. Bovine tendon is known to be one of the purest sources of Type I Collagen that can be readily obtained and processed in commercial amounts. BioMend Extend is completely absorbable, eliminating the need for the second surgical procedure often required to remove a non-resorbable membrane. The collagen is currently used for general and dental surgery as absorbable hemostatic agents and absorbable wound dressings.
Under scanning electron microscopy, BioMend Extend™ has a morphology of condensed laminated sheets in cross-section and a textured surface. BioMend Extend" appears paperwhite in the dry state and translucent and non-slippery when wet. BioMend Extend" can be cut to any size or shape in the wet or dry state, without tearing or fragmenting.
BioMend Extend™ has an effective pore size of 0.004 microns, which will effectively retard epithelial downgrowth during early phases of healing. Being semi-occlusive, it allows essential nutrients to pass through the membrane. BioMend Extend™ incorporates into the surrounding tissue and is completely absorbed within 18 weeks.
BioMend Extend™ is sterilized by ethylene oxide gas.
The provided text describes a medical device, BioMend Extend™ Absorbable Collagen Membrane, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, or adjudication methods in the context of a study demonstrating the device meets performance criteria. The document is a 510(k) submission for device clearance, focusing on safety and equivalence rather than a performance study with specific metrics.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "BioMend Extend™ Absorbable Collagen Membrane is substantially equivalent to the unmodified device, BioMend® Absorbable Collagen Membrane. The modifications do not affect the intended use or fundamental scientific technology of the device." Substantial equivalence is the primary acceptance criterion for a 510(k) submission, meaning the modified device is as safe and effective as a legally marketed predicate device. Specific performance metrics for a new study are not detailed as the claim is based on equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. No specific test set or clinical study data is described to assess performance against acceptance criteria. The submission relies on demonstrating substantial equivalence to a predicate device and biocompatibility testing.
3. 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)
- Cannot be provided. No experts were involved in establishing a ground truth for a test set for performance evaluation as no such study is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method is mentioned as there is no test set or performance study described.
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
- Cannot be provided. This is not an AI device, and no MRMC study or comparative effectiveness study is described. The device is an absorbable collagen membrane for guided tissue regeneration.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No specific ground truth for performance evaluation is mentioned. The ground for the submission is the substantial equivalence to the predicate device, BioMend® Absorbable Collagen Membrane, which was previously cleared.
8. The sample size for the training set
- Cannot be provided. No training set is applicable or mentioned for this device submission.
9. How the ground truth for the training set was established
- Cannot be provided. No training set is applicable or mentioned.
Information that can be extracted relevant to acceptance criteria and safety:
The document focuses on demonstrating the BioMend Extend™ Absorbable Collagen Membrane is substantially equivalent to the predicate device, BioMend® Absorbable Collagen Membrane (K924408).
The acceptance criteria for this 510(k) submission are implied by the demonstration of:
- Identical Intended Use: "Used for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus."
- Similar Technological Characteristics:
- Same basic design
- Same operating principle (Cell occlusive, implantable, resorbable, hemostatic, effective pore size 0.004 microns)
- Same materials (Type I Collagen from bovine deep flexor tendon)
- Same sterilization process (ETO)
- Biocompatible
- Non-pyrogenic
- Same shelf life (24 months)
- Same product sizes (15 mm x 20 mm, 20 mm x 30 mm, 30 mm x 40 mm)
- Safety (Biocompatibility): The device must be non-cytotoxic, non-pyrogenic, non-irritating, and non-sensitizing.
Reported Device Performance / Evidence for Acceptance Criteria:
The "study" that proves the device meets the acceptance criteria is the 510(k) submission itself, which presents a comparison to a predicate device and biocompatibility testing. No clinical performance study with specific outcome measures, patient cohorts, or statistical analyses are presented in this document for the modified device.
The document indicates:
- Comparison of technological characteristics in Table 1 shows direct correspondence for all listed features between BioMend Extend™ and BioMend® Absorbable Collagen Membrane.
- Safety studies (biocompatibility) were conducted, demonstrating the new device is:
- Noncytotoxic
- Nonpyrogenic
- Nonirritating
- Nonsensitizing
- The manufacturing process complies with FDA and European Standards for animal tissue sourcing and viral inactivation.
The conclusion is that "BioMend Extend™ Absorbable Collagen Membrane is substantially equivalent to the unmodified device, BioMend® Absorbable Collagen Membrane. The modifications do not affect the intended use or fundamental scientific technology of the device." This implies that the performance is expected to be equivalent to the predicate device.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.