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OsteoFlo® NanoPutty®- Quadphasic Synthetic Bone Graft is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or the result of traumatic injury to the bone. The device resorbs and is replaced with bonedus ing the healing process.

The OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft is an osteoconductive, non-hardening bone void filler. The device is comprised of macroporous calcium phosphate particulates in a bioresorbable polymer binder. The quadphasic particles are composed of HA, a-TCP, B-TCP and bioactive glass. The device also contains micro-sized HA particles. On implantation, the binder is resorbed and bone forms on and between the porous particles as they are gradually resorbed. OsteoFlo® NanoPutty can be easily packed into osseous defects and adheres to bone surfaces. The device is ready to use, requiring no mixing before application. The single-use device is supplied sterile in multiple package formats.

This document is a 510(k) premarket notification for a medical device called OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft. As such, it does not contain a study proving the device meets acceptance criteria in the typical sense of a clinical trial or performance study with defined statistically significant acceptance criteria for efficacy.

Instead, this document provides evidence for substantial equivalence to a legally marketed predicate device. This means the manufacturer is asserting their device is as safe and effective as a device already on the market, rather than proving a novel therapeutic effect against strict, predefined performance metrics.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, there aren't formal "acceptance criteria" for a specific performance metric like sensitivity or specificity. Instead, the acceptance is based on demonstrating that the new device is as safe and effective as the predicate.

Study Details for Substantial Equivalence

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

   • Test set sample size: Not explicitly stated as a numerical sample size for the in vivo rabbit study. The document mentions "a critical-size rabbit femoral defect model." This typically implies a small number of animals (e.g., 5-10 per group) used for preclinical evaluation in medical device submissions, but an exact 'n' is not provided.
   • Data provenance: Preclinical in vivo study. Country of origin not specified, but typically conducted in a controlled lab environment. This is a prospective study (the rabbit study was designed and executed to compare the device to the predicate).

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

   • Not applicable in this context. The in vivo study's evaluation of "local biological effects and bone formation" would be assessed by trained histopathologists or researchers specializing in bone biology, but their number and specific qualifications are not detailed in this regulatory summary. The "ground truth" here is objective biological/histological analysis, not expert interpretation of an image or signal.

3. Adjudication method for the test set:

   • Not applicable. This is not a study requiring adjudication of human-interpreted results. The assessment of in vivo bone formation and biological effects is typically performed by a single or limited number of expert pathologists/researchers on tissue samples.

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:

   • Not applicable. This document describes a material and its in vivo biological performance, not an AI or imaging-based diagnostic device that would involve human readers.

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

   • Not applicable. This document describes a material device, not an algorithm.

6. The type of ground truth used:

   • For the in vivo study, the ground truth was histological analysis and biological assessment of tissue regeneration and local effects in the rabbit femoral defect model.

7. The sample size for the training set:

   • Not applicable. This device is not an AI algorithm requiring a training set. The "training" for such a device would be the R&D and manufacturing processes to ensure the material consistently meets its specifications.

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

   • Not applicable, as there is no training set mentioned for this type of device.

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The SignalMark Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.

The SignalMark Lung Biopsy Site Marker is a medical device used by a physician to percutaneously place a small implantable hydrogel marker in lung tissue biopsy to "mark" the location of the biopsy site. It is intended to be used on adults undergoing percutaneous lung biopsies, in surgical settings, such as hospitals or medical clinics with operating suites. The SignalMark Lung Biopsy Site Marker consists of two components:

• Applicator: Component made of plastic and stainless steel that pushes the marker into the tissue.
• Marker: Component made of USP-grade porcine gelatin-based hydrogel with methylene blue-colored silicon dioxide microspheres. The marker aids in the visualization of tissue allowing surgeons to readily locate the biopsy site for subsequent tissue or tumor resection.

This document is a 510(k) summary for the SignalMark Lung Biopsy Site Marker. It details the process taken to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria based on clinical performance in an AI/imaging context. Therefore, most of the requested information regarding acceptance criteria, specific study design (e.g., MRMC, standalone), ground truth establishment, expert qualifications, and sample sizes for training/test sets are not applicable or extractable from this document.

This device is not an AI/imaging device. It is an implantable marker used to physically mark a biopsy site for later surgical resection. The acceptance criteria and study detailed in this document are primarily focused on non-clinical performance (bench and animal testing) to demonstrate its safety and biological compatibility, and technical equivalence to a previously cleared predicate device.

However, I can extract information related to the device's performance testing from the "Summary of Non-Clinical Testing" section and interpret it in the context of "acceptance criteria" for this type of device.

Here's the relevant information that can be extracted, and where the requested information is not applicable:

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

For this device, "acceptance criteria" are implied by the non-clinical testing performed to demonstrate equivalence and safety. The document states "No FDA performance standards have been established for SignalMark Lung Biopsy Site Marker," meaning there aren't quantitative metrics like accuracy, sensitivity, specificity that need to be met. Instead, "acceptance" is demonstrated through successful completion of the listed tests, ensuring the device functions as intended and is safe.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each of the bench or animal tests. It only lists the types of tests performed (e.g., "Biodistribution in rodents," "Safety and efficacy in porcine").
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission, these are typically pre-market studies conducted specifically for regulatory submission, implying they are prospective.

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

• Not applicable. This device is not an AI/imaging device, and thus there is no "ground truth" to be established by experts in the context of image interpretation or diagnostic accuracy. The "ground truth" for this device's performance testing would be the physical properties measured in bench testing and biological responses observed in animal studies.

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

• Not applicable. This applies to establishing ground truth for diagnostic accuracy in imaging studies, which is not relevant here.

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 type of study is relevant for AI-assisted diagnostic tools, not for an implantable biopsy site marker.

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

• Not applicable. This also applies to AI algorithms.

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

• The "ground truth" for this device's evaluation is based on engineering measurements and biological observations from bench and animal testing. This includes:
  • Physical dimensions and deployment success (bench testing).
  • Material biocompatibility (ISO 10993-1).
  • Biodistribution, safety, and efficacy in animal models.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable. See point 8.

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