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The Kensey Nash Bone Void Filler XC is intended to be gently packed into the bony voids or gaps of the extremities and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of the autogenous products does not alter the performance of the device.

The Kensey Nash Bone Void Filler XC is a mixture of beta tricalcium phosphate and polylactic acid. The product will be provided gamma sterilized for one time use in a healthcare facility. The products are supplied in a variety of shapes ranging from pre-formed cylinders, granules, cubes, blocks, and wedges ranging up to 25mm in diameter and up to 30cc in volume.

The provided FDA 510(k) summary for the Kensey Nash Bone Void Filler XC (K120141) indicates that this device is claiming substantial equivalence to a predicate device, K060917 (Kensey Nash Bone Void Filler). Therefore, the study described is primarily focused on demonstrating this equivalence rather than establishing new performance criteria.

Here's an analysis based on the provided text:

Acceptance Criteria and Study for Kensey Nash Bone Void Filler XC (K120141)

The submission for K120141 does not detail new acceptance criteria or a new standalone study directly for the Kensey Nash Bone Void Filler XC. Instead, it relies on the performance data and established equivalence to its predicate device (K060917). The performance data cited are from the predicate device and are considered applicable to the new device because the technological characteristics are stated to be identical.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim based on the predicate device's existing data, specific quantitative acceptance criteria for this submission are not explicitly stated in the provided text. The performance is indirectly "accepted" by virtue of being identical to a previously cleared device.

2. Sample Size Used for the Test Set and Data Provenance

• The provided document does not specify the sample size for the test sets used in the biocompatibility, physical properties, compressive strength, or animal studies from the predicate device (K060917).
• The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). This information would typically be found in the actual predicate device's 510(k) submission (K060917).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The provided text does not mention the involvement of experts for establishing ground truth specifically for the performance data of the predicate device (K060917). This type of information is usually not relevant for a materials-based device in the context of biocompatibility, physical testing, and animal studies, where objective measurements and observations are typically used.

4. Adjudication Method for the Test Set

• The provided text does not describe any adjudication method. This is generally not applicable to the types of non-clinical tests (biocompatibility, physical properties, animal studies) typically employed for bone void fillers where objective laboratory measurements and animal observations are made.

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

• No MRMC comparative effectiveness study was done. This device is a bone void filler (a physical implant), not a diagnostic or AI-driven medical imaging device. Therefore, a study involving human readers or AI assistance is not relevant to its evaluation.

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

• No standalone algorithm performance study was done. This device is a physical implant and does not involve any algorithms or AI components.

7. The Type of Ground Truth Used

For the non-clinical testing referenced from the predicate device (K060917):

• Biocompatibility: Likely relies on established biological safety standards (e.g., ISO 10993 series) as ground truth, demonstrated through specific in vitro and in vivo tests.
• Physical Properties & Compressive Strength: Ground truth is based on engineering and material science standards, measured objectively (e.g., ASTM standards).
• Animal Study: Ground truth is established through histological analysis, radiography, and other objective observations of bone ingrowth and material resorption in an animal model, often reviewed by veterinary pathologists or other trained personnel.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve training sets as it is a physical implant, not a machine learning model.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set, there is no ground truth established for one.

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