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SIGNAFUSE Bioactive Strip (SBS) is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Strip (SBS) is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis, posterolateral spine, and intervertebral disc space. When used in the posterolateral spine, SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender. When used in intervertebral disc space. SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device resorbs and is replaced by host bone during the healing process.

SIGNAFUSE Putty is a bone void filler device intended for use in bony voids or gaps 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. SIGNAFUSE Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, posterolateral spine, and intervertebral disc space fusion procedures). SIGNAFUSE Putty can also be used with autograft as a bone graft extender in the posterolateral spine. When used in intervertebral body fusion procedures, SIGNAFUSE Putty can used on its own or as a bone graff extender, and with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

SIGNAFUSE Bioactive Strip (SBS) is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix, and it identical to the device cleared in K193513. SIGNAFUSE Putty is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in an alkylene oxide polymer (AOP) resorbable carrier and is identical to the device cleared in K132071. The SIGNAFUSE Family of devices are single use implants in contact with bone that are sterilized by irradiation with a sterility assurance level (SAL) of 106. This submission expands the SIGNAFUSE Family indication to include use in the intervertebral space.

The provided text is a 510(k) summary for medical devices (SIGNAFUSE Bioactive Strip (SBS) and SIGNAFUSE Putty), focusing on their substantial equivalence to predicate devices and an expanded indication for use in the intervertebral disc space.

Based on the information provided, it states that:

• No new acceptance criteria or clinical studies (beyond leveraging previous clearances and providing clinical rationale) were conducted for this specific 510(k) submission regarding device performance metrics in the way one might expect for a novel AI device or a new clinical endpoint.
• The performance assessment for this submission relies heavily on previous clearances (K193513 and K132071), which established the device's sterility, shelf-life, endotoxin, biocompatibility, and characterizations/bench performance.
• The expanded indication for use in the intervertebral body space was supported by a "clinical rationale of bone grafting materials in the intervertebral space," rather than a new clinical study with defined acceptance criteria and performance data for this specific submission.

Therefore, the requested information regarding detailed acceptance criteria, a specific study proving the device meets these criteria, sample size, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for this specific submission is not present in the provided document.

The document is a regulatory submission demonstrating substantial equivalence, not a detailed report of a new clinical performance study for an AI/software as a medical device (SaMD) or a new physical device requiring novel clinical endpoint demonstration. The 'performance' section refers to leveraging previously established data and providing a clinical rationale, not new trials to meet defined (and quantified) acceptance criteria for efficacy or diagnostic performance.

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Mineral Collagen Composite Bioactive Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

For spine applications, Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.

Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.

The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine Achilles tendon.

The product is available in various sizes and is provided sterile, non-pvrogenic, and for single use only.

The provided text is a 510(k) summary for the Mineral Collagen Composite Bioactive Moldable device. This document describes a medical device seeking regulatory clearance, not an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical testing (biocompatibility, sterilization, pyrogen, packaging, shelf life, and animal studies). Clinical studies were explicitly not required for this determination.

Here's an attempt to answer the questions based on the provided document, highlighting where the requested information is not applicable:

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

The document does not specify quantitative acceptance criteria in a table format for performance. Instead, it relies on demonstrating that the device performs substantially equivalently to its predicate and reference devices, particularly for the expanded indications for use.

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

• Animal Study: The document mentions "a rabbit femoral condyle critical-sized defect model." It does not specify the number of rabbits or exact sample size used for this study.
• Data Provenance: The studies mentioned (biocompatibility, sterilization, pyrogen, packaging, shelf life) were completed under the original submission (K182074). The animal study appears to be part of the current submission, likely conducted for the expanded indications. The country of origin and whether the data was retrospective or prospective is not specified, but animal studies are typically prospective.

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

This information is not applicable as this is not an AI/ML device requiring human expert annotation for ground truth. Ground truth for a bone void filler would typically be established through histological analysis of tissue regeneration in the animal model. The document does not specify who conducted such analyses or their qualifications.

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

Not applicable for this type of device and study.

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/ML device that assists human readers.

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

Not applicable. This is not an AI/ML algorithm.

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

For the animal study, the "ground truth" for assessing device performance would primarily be based on pathology/histology of bone regeneration and integration within the rabbit femoral condyle defects, comparing the test device to the reference device. The document states "The results demonstrate performance substantially equivalent to the reference device with regards to the expansion of the indications for use," implying such an assessment was made.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

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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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