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OSTEOSET® DBM Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. OSTEOSET® DBM Pellets are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

OSTEOSET® DBM Pellets are made of surgical grade calcium sulfate incorporating Human Demineralized Bone Matrix (DBM) and stearic acid as a tableting aid. OSTEOSET® DBM Pellets are provided as preformed 3.0 mm or 4.8 mm pellets. The biodegradable, radiopaque pellets are used to fill bone voids and are resorbed in approximately 30-60 days when used according to labeling. This product is supplied sterile for single patient use.

The provided text describes a 510(k) premarket notification for a medical device called OSTEOSET® DBM Pellets. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy trial with specific acceptance criteria as might be seen for novel drug or high-risk device approvals.

Therefore, the concept of "acceptance criteria" in the context of this 510(k) is primarily tied to demonstrating that the new device performs similarly to the predicate device, not necessarily against pre-defined numerical thresholds for a specific clinical outcome. The study described focuses on establishing this equivalence.

Here's an analysis based on the information provided, addressing your points where possible:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate device. The study's "performance" is the lack of difference when compared to the predicate in relevant metrics.

Study Information

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The primary performance testing was conducted in a canine model. The specific number of animals is not provided in the summary.
   • Data Provenance: Animal model (canine), prospective study design (comparing the new device to a predicate). The in-vitro DBM osteoinductivity bioassay and athymic rat model data are also mentioned, along with human clinical correlation data from prior studies (presumably retrospective, as they are used to validate the bioassay's predictive power for DBM generally, not directly for this specific device).

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

   • The document does not specify the use of human experts or ground truth establishment in the traditional sense for the animal model study. Performance was evaluated via "radiographic, mechanical, histological and quantification of new bone formation." These are objective measurements typically conducted by trained laboratory personnel or pathology specialists, rather than clinical experts providing a subjective "ground truth."

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable / None specified. The animal study relied on objective measurements rather than subjective assessments requiring adjudication.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or decision-support tools where human reader performance is a key outcome. The OSTEOSET® DBM Pellets are a bone void filler, not an imaging or AI diagnostic device.

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

   • No, this is not applicable. The device is a physical implant, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the canine model, the "ground truth" for performance was based on objective measures: radiographic imaging, mechanical testing, histological analysis, and quantitative assessment of new bone formation. These are direct biological and physical measurements, rather than human expert interpretation or consensus.
   • For the DBM osteoinductivity, the in-vitro bioassay was correlated with in-vivo bone formation in an athymic rat muscle model (pathology) and prior human clinical healing rates (outcomes data) from different studies to demonstrate its predictive power for the DBM component generally.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set. The DBM bioassay mentions having been correlated with past studies, which could be considered historical data sets, but there's no "training set" in the context of the device itself.

8. How the ground truth for the training set was established:

   • Not applicable. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment for a training set. The bioassay's predictive power was established by correlating its results with in vivo new bone formation in rats and human clinical healing rates from previously published work.

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