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Cove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cove Strip resorbs and is replaced with bone during the healing process. Cove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.

OsteoCove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. OsteoCove Strip resorbs and is replaced with bone during the healing process. OsteoCove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.

Cove Strip is comprised of a ceramic granule consisting of a ratio of 70:30 Beta-Tricalcium Phosphate (β-TCP): Hydroxyapatite (HA) combined with highly purified Type-1 collagen. The collagen scaffold contains ceramic granules throughout, providing osteoconductive substrates that support new bone formation. Cove Strip 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 double blister tray configuration.

OsteoCove Strip is comprised of a ceramic granule consisting of a ratio of 70:30 Beta-Tricalcium Phosphate (β-TCP): Hydroxyapatite (HA) combined with highly purified Type-1 collagen. The collagen scaffold contains ceramic granules throughout, providing osteoconductive substrates that support new bone formation. OsteoCove Strip combined with autograft in a 1:1 ratio, is intended to be placed in the posterolateral spine. The implant is provided sterile and nonpyrogenic for single use in a double blister tray configuration.

The provided document is a 510(k) premarket notification from the FDA for a medical device (Cove Strip, OsteoCove Strip), which are bone void fillers. It states explicitly that no clinical testing was performed and that the determination of substantial equivalence is not based on an assessment of clinical performance data. Therefore, most of the information requested about acceptance criteria and a study proving the device meets them (especially those related to AI/human performance) is not available in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of materials, manufacturing processes, design verification, sterilization, and packaging.

Here's a breakdown of the requested information based on the provided text, highlighting what is not applicable due to the nature of this 510(k) submission:

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

The document does not provide a table of acceptance criteria for a clinical or performance study, as no such study was conducted. The "performance" assessment is based on the subject device being "similar" to the predicate device in terms of components, design, materials, manufacturing, sterility, and packaging.

The non-clinical "verification and validation activities" were evaluated to demonstrate substantial equivalence. These activities and their successful execution serve as the "reported performance" for non-clinical aspects:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set data is provided or referenced, as no clinical testing was performed. The data provenance would refer to the non-clinical test results for design verification, sterilization, etc., which are presumably internal company data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No clinical test set requiring expert ground truth establishment was conducted.

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

Not applicable. No clinical test set requiring adjudication was conducted.

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. The device is a bone void filler, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. The device is a physical implant, not an algorithm.

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

Not applicable. No clinical ground truth was established, as no clinical testing was performed. The "ground truth" for this 510(k) submission is the demonstration of substantial equivalence to the predicate device through non-clinical means and a claim that the subject device does not introduce a new worst case for biocompatibility and in vivo performance compared to the predicate.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. As above, no training set or its ground truth establishment is relevant to this device submission.

Summary based on the document:

The K232668 submission for the Cove Strip and OsteoCove Strip devices achieved 510(k) clearance by demonstrating substantial equivalence to an existing predicate device (K230486). This was primarily achieved through non-clinical testing focusing on physical properties, manufacturing processes, and quality control (e.g., sterilization, packaging, design verification). The document explicitly states that no clinical testing was performed, and the substantial equivalence determination was not based on an assessment of clinical performance data. Therefore, all questions pertaining to clinical studies, human readers, AI, or expert ground truth are not applicable to the information provided in this FDA letter.

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