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Device 300397 Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Device 300397 Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, ilium and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device 300397 Putty must be used with blood or autogenous bone marrow aspirate and autograff in posterolateral spine.

Device 300397 Putty is an osteoconductive, porous, resorbable bone graft substitute which consists of calcium phosphate granules (a-TCP and hydroxyapatite) and Type I and III porcine collagen. The single-patient, single-use product is supplied in three (3) sizes as a sterile, dry block. When mixed with autogenous bone marrow aspirate, blood or sterile non-pyrogenic saline, the product forms a moldable non-setting putty (net volume: 2.5 cc, 5 cc or 10 cc).

The provided text is a 510(k) Summary for a medical device (Device 300397 Putty), which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing a new device to an existing one, rather than presenting a detailed clinical study with acceptance criteria, sample sizes, and ground truth establishment in the way typically seen for a novel diagnostic or AI device.

Therefore, the requested information components related to acceptance criteria, specific study design for proving acceptance criteria for an AI/diagnostic device, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance metrics are not applicable to this document.

This document describes a device approval process based on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety and performance through various tests, primarily non-clinical, not a study designed to meet specific performance metrics against a defined ground truth for a diagnostic outcome.

However, I can extract information regarding the safety and performance studies that were conducted to support the substantial equivalence claim.

Here's a summary based on the provided document, addressing the closest relevant points:

1. Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria in the manner of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implicitly met by successful execution and favorable results of the numerous safety and performance tests to demonstrate substantial equivalence to the predicate device. The "reported device performance" is described qualitatively through these tests.

• Progression in healing vs. time when implanted on decorticated transverse processes in the posterolateral space.
• Further healing at host decorticated transverse process interfaces with new bone formation and active osteoblasts.
• New bone formation directly on the graft material surfaces.
• Confirmed progression and maturation of fusions via histology.
• Bone remodeling and new marrow spaces at the decorticated host transverse process interface, with an association with a reduction in local inflammatory cells. Performance evaluated per FDA guidance for calcium salt bone void fillers. |

2. Sample Size and Data Provenance (for test set for AI/diagnostic devices):

• Not applicable for this 510(k) submission as it's not an AI/diagnostic device.
• For the in vivo animal study, the model used was the NZ White Rabbit Single Level Spinal Fusion Model. The specific number of animals is not provided in this summary. This is a prospective animal model study.

3. Number of Experts and Qualifications (for ground truth for AI/diagnostic devices):

• Not applicable as there is no mention of establishing ground truth by human experts for a diagnostic task.
• The evaluation of the in vivo study results (e.g., histology interpretation, assessment of bone formation) would typically be performed by veterinary pathologists or experts in orthopedics/bone regeneration, but their specific number and qualifications are not detailed in this summary.

4. Adjudication Method (for test set for AI/diagnostic devices):

• Not applicable for this type of device and submission.

5. MRMC Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study for human readers with and without AI assistance was not done, as this is not an AI/diagnostic device.

6. Standalone Performance Study:

• No, a standalone algorithm-only performance study was not done, as this is not an AI/diagnostic device.
• The "standalone" performance for this device is represented by the in vivo animal study where the device's ability to promote bone healing was directly assessed.

7. Type of Ground Truth Used:

• For the in vivo animal study, the "ground truth" for assessing bone healing and tissue reaction was based on histology (microscopic examination of tissue samples) and observation of fusion progression in the animal model. This could be considered similar to "pathology" for human studies, reflecting direct biological evidence of effect.

8. Sample Size for Training Set:

• Not applicable as this is not an AI/machine learning device that requires a training set.

9. How Ground Truth for Training Set Was Established:

• Not applicable as this is not an AI/machine learning device.

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OsteoFlo® HydroPutty™ is indicated for 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 defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device provides a bone void filler that is resorbed with host bone during the healing process.

The OsteoFlo® HydroPutty™ is a resorbable bone void filler comprised of porous carbonated apatite granules and bioglass, in a synthetic polymer binder. The OsteoFlo® HydroPutty™ is intended to be easily packed into osseous defects. The single-use device is supplied sterile via gamma radiation and dry. The device requires mixing with aqueous sterile saline solution in a 1:1 ratio prior to use. The OsteoFlo® HydroPutty™ is supplied as either a pre-filled syringe or vial, in 1, 2.5, 5 and 10mL configurations.

The provided document is a 510(k) summary for the OsteoFlo® HydroPutty™ bone void filler device. It does not include acceptance criteria or a study that specifically proves the device meets such criteria in the traditional sense of a performance study with metrics like sensitivity, specificity, or accuracy, as would be typical for an AI/software device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. The "acceptance criteria" here are effectively the successful completion of these non-clinical tests, showing that the device meets established standards for biocompatibility, sterility, packaging, shelf-life, and material characteristics, and performs comparably to the predicate in an in vivo animal study.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Equivalence)

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

The document describes an "in vivo evaluation in a critical-size rabbit femoral defect model."

• Sample Size: The exact number of rabbits used in this animal model is not specified in the provided text.
• Data Provenance: The study was an animal model (in vivo rabbit study), which is typically prospective.

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

This type of information (experts establishing ground truth for a test set) is typically relevant for studies evaluating the diagnostic accuracy or interpretive performance of a device (e.g., AI algorithms for image analysis). For a bone void filler device evaluated in an in vivo animal model, the "ground truth" for bone formation and absorption would likely be established through histological analysis, micro-CT imaging, and other quantitative measures performed by veterinary pathologists or researchers. The document does not provide details on the number or qualifications of such experts, as it is a summary focused on substantial equivalence.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies where human readers are interpreting data and consensus is needed for ground truth. Since this study involved an in vivo animal model and non-clinical tests, such a method would generally not be applicable or described in this context.

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, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI assistance on human reader performance, which is not relevant for a bone void filler device.

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

No, a standalone algorithm performance study was not done. This concept is applicable to AI/software devices, not physical medical devices like a bone void filler.

7. The Type of Ground Truth Used

For the in vivo evaluation, the ground truth would be based on direct biological observation and quantitative assessment of bone formation and device absorption in the rabbit model (e.g., histological analysis, radiographic imaging, micro-CT evaluations). The document states "Effectiveness, in terms of device absorption and bone formation, has been shown in the animal study."

8. The Sample Size for the Training Set

This concept is specific to machine learning/AI models. As this document describes a physical medical device (bone void filler) and not an AI algorithm, there is no "training set" as understood in AI development.

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

Not applicable, as there is no AI training set.

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