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Cove Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Cove Putty is hydrated with saline at the point-of-use. When used in intervertebral body fusion procedures, Cove Putty must be used as a bone graft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Cove Putty is formulated into a putty which consists of a collagen scaffold containing ceramic granules and a resorbable polymer carrier throughout. The combined collagen and ceramic provide osteoconductive substrates that support new bone formation. Cove Putty combined with autograft in a 1:1 ratio is intended to be placed in the posterolateral spine. The implant is provided sterile and non-pyrogenic for single use in a standard syringe.

This document, K242273, is a 510(k) clearance letter from the FDA for a medical device called "Cove Putty, OsteoCove Putty," a resorbable calcium salt bone void filler. It describes the device's indications for use, its substantial equivalence to predicate devices, and a summary of non-clinical testing.

However, this document does NOT contain information about any AI/ML model, nor any study proving that a device meets an acceptance criterion related to AI/ML performance.

Therefore, I cannot provide the requested information, as there is no mention of acceptance criteria or a study related to AI/ML device performance in the provided text.

Specifically, the document refers to:

• Non-clinical testing: Biocompatibility, bacterial endotoxin safety, sterilization, and an in vivo animal study for safety and performance (resorption, remodeling, and rates of fusion).
• Clinical rationale: To support the expansion of indications for use.

None of these studies or tests relate to the performance of an AI/ML device in the manner described in your prompt (e.g., diagnostic accuracy, human reader improvement with AI assistance, ground truth establishment by experts, etc.).

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Cove Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Cove Putty is hydrated with saline at the point-of-use.

OsteoCove Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. OsteoCove Putty is hydrated with saline at the point-of-use.

Cove Putty is formulated into a putty which consists of a collagen scaffold containing ceramic granules and a resorbable polymer carrier throughout. The combined collagen and ceramic provide osteoconductive substrates that support new bone formation. Cove Putty combined with autograft in a 1:1 ratio is intended to be placed in the posterolateral spine. The implant is provided sterile and non-pyrogenic for single use in a standard syringe.

This document is an FDA 510(k) clearance letter for two bone void fillers, Cove Putty and OsteoCove Putty. As such, it does not contain the information requested about acceptance criteria and study data for an AI/ML powered device.

The document states:

• "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." on page 6.

Therefore, I cannot provide the requested information, which pertains to the validation of AI/ML devices. The 510(k) summary focuses on non-clinical testing (biocompatibility, bacterial endotoxin, sterilization, and an in vivo animal study) to demonstrate substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for an AI/ML algorithm.

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