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Porous Biologic Scaffold is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Porous Biologic Scaffold is indicated to be packed gently into bony voids or gaps of the pelvis and posterolateral spine and is used combined with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process.

Porous Biologic Scaffold is a resorbable bone void filler that is available in two versions:

Version 1 is comprised of a porous collagen mesh that is either prefilled or separately packaged with human demineralized allograft bone matrix. In the prefilled format, the demineralized bone matrix is completely enclosed inside the collagen mesh. In the separately packaged format, an open-ended collagen mesh bag is supplied with separately packaged demineralized bone matrix and is filled and sewn closed with absorbable suture by the clinician. Version 1 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and are combined with autograft bone prior to implantation.

Version 2 is comprised of a porous resorbable collagen mesh bag either prefilled or separately packaged with activated biphasic ceramic granules. In the prefilled format, the biphasic granules are completely enclosed inside the collagen mesh. In the separately packaged format, an open-ended collagen mesh bag is supplied with separately packaged biphasic granules and is filled and sewn closed with absorbable suture by the clinician. Version 2 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and are combined with autograft bone prior to implantation.

Both formats of the Porous Biologic Scaffold are supplied terminally sterile and are available in sizes of 18 x 50 mm, 18 x 100 mm, 24 x 50 mm, and 24 x 100 mm.

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OsteoSelect® PLUS DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect® PLUS DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® PLUS DBM Putty can be used as follows:

• Extremities ●
• . Pelvis
• Posterolateral spine ●

OsteoSelect® PLUS DBM Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose (a wax-like material) and phosphate buffered saline (a dispersing agent). OsteoSelect® PLUS DBM Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.

This document is a 510(k) premarket notification for the OsteoSelect® PLUS Demineralized Bone Matrix Putty. It does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and studies for an AI/ML medical device. This is a traditional medical device (bone void filler) and not an AI/ML device, therefore, many of your questions related to AI/ML specific evaluations (e.g., human-in-the-loop performance, effect size of AI assistance, training set details) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria (based on the documented performance testing) and the studies that support it.

Here's the breakdown of what can be inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for any of the performance tests. The text indicates "each lot of OsteoSelect® PLUS DBM Putty is also tested for osteoinductive potential in a rodent model." This implies ongoing lot-release testing, but the specific number of samples or animals per test is not detailed.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This device is not an AI/ML device and does not involve human interpretation of outputs that would require establishing a "ground truth" by human experts in the context of diagnostic accuracy.
• The "ground truth" for the osteoinductive potential is established through the rodent model, which is a biological assay. The interpretation of these assays is typically done by qualified laboratory personnel, but the number or specific qualifications are not detailed in this submission.

4. Adjudication method for the test set

• Not applicable as this is not an AI/ML diagnostic or prognostic device requiring expert adjudication of outputs.

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

• Not applicable. This is not an AI-assisted diagnostic or prognostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device (bone void filler), not an algorithm.

7. The type of ground truth used

• Osteoinductive Potential: The ground truth is established through a rodent model (animal study/biological assay).
• Biocompatibility: Established through compliance with ISO 10993 standards, which may involve various in vitro and in vivo tests.
• Viral Inactivation: Established through validation studies using model viruses.
• Mechanical/Handling: Established through in-house testing against predefined specifications (though the specific specifications are not detailed, only the categories of assessment).

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML model that undergoes "training."

9. How the ground truth for the training set was established

• Not applicable.

Summary of Studies that Prove the Device Meets Acceptance Criteria:

The document mentions that the device's performance against the acceptance criteria is demonstrated through:

• Prior Comprehensive Biocompatibility Testing: Conducted on the predicate device in accordance with ISO 10993. This testing supports the biocompatibility of OsteoSelect® PLUS DBM Putty.
• Viral Inactivation/Clearance Validation: Studies that validated the process used to make Demineralized Bone Matrix for its ability to inactivate and/or clear a panel of model human viruses. This included specific validation for the modified particle size formulation of the PLUS version.
• Performance Testing (for DBM particle size change): Due to a change in DBM particle size distribution, specific tests were conducted on OsteoSelect® PLUS DBM Putty to evaluate:
  • Extrusion from a syringe.
  • Maintenance of consistent handling characteristics over shelf life.
  • Performance under irrigation.
  • Cohesiveness when packing into void spaces.
  • Handling without sticking to surgical gloves.
• Lot Release Osteoinductive Potential Testing: Each lot of OsteoSelect® PLUS DBM Putty is tested in a rodent model after gamma sterilization to confirm osteoinductive potential.
• Referenced Non-Clinical Testing (Chemical, Physical, Animal): The submission references and relies upon a "comprehensive battery" of such tests previously conducted for the OsteoSelect® DBM Putty (predicate device).

In essence, the acceptance criteria are met through a combination of biocompatibility and viral inactivation studies inherited from the predicate device, specific performance testing for the new formulation (especially handling characteristics), and ongoing lot-release testing for osteoinductivity.

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