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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

• Handling Characteristics: Maintained consistent characteristics for the duration of shelf life.
• Performance Under Irrigation: Tested.
• Cohesiveness: Showed cohesiveness while packing into void spaces.
• Adhesion: Handled without sticking to surgical gloves. |
  | Osteoinductive Potential | Each lot tested in a rodent model after gamma sterilization as part of release criteria. The document implies it meets the criteria for osteoinductivity. |
  | Shelf Life | Tested to maintain consistent handling characteristics. |
  | Chemical/Physical Testing | Comprehensive battery of non-clinical chemical and physical testing referenced and relied upon. |

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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