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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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