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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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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 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 process. Cove 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 (B-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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Cove Strip device.

It's important to note that the provided text is an FDA 510(k) clearance letter and its summary. These documents focus on establishing substantial equivalence to a legally marketed predicate device rather than presenting a detailed new performance study with acceptance criteria in the way one might find for a novel AI/software device. The "acceptance criteria" here are implicitly tied to the performance of the predicate devices.

Re-interpretation for a medical device (not AI/software):

Since the device is a medical implant (bone void filler) and not an AI/software device, the questions about "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," MRMC studies, and ground truth for training sets are not applicable in their original context. The FDA 510(k) process for this type of device relies on demonstrating equivalence to predicate devices through design, material, non-clinical (e.g., biocompatibility, sterilization, animal study), and sometimes clinical data.

Here's the information extracted and re-contextualized for the Cove Strip bone void filler:

1. Table of Acceptance Criteria and Reported Device Performance

For this particular medical device (Cove Strip, a bone void filler), "acceptance criteria" are not explicitly defined in terms of specific performance metrics with numerical thresholds in the same way they would be for a diagnostic test or an AI algorithm. Instead, acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices in terms of:

• Intended Use/Indications for Use: The subject device must be similar to the predicate.
• Technological Characteristics: Design, materials, manufacturing, labeling, sterility, etc.
• Non-Clinical Performance: Including biocompatibility, sterilization, and in vivo performance.

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

The primary "test set" described for performance is an animal study (in vivo).

• Sample Size: Not explicitly stated (e.g., number of animals). The document only mentions "An in vivo (animal) study."
• Data Provenance: An animal study, likely conducted in a preclinical lab setting. No country of origin is specified. It is a prospective study as it was conducted to evaluate the subject device.

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

This concept is not directly applicable in the context of this 510(k) submission for a bone void filler, which relies on physical and biological testing:

• For the in vivo animal study, "ground truth" would be established by standard histological, radiographic, and surgical evaluation techniques. The "experts" would be veterinary surgeons, pathologists, histologists, and radiologists involved in the animal study, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable in the AI/software sense (e.g., 2+1, 3+1 for image interpretation). Adjudication for in vivo studies typically involves consensus among experienced histopathologists, radiologists, and surgeons regarding outcomes like fusion, resorption, and local effects. The specific adjudication method is not mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done...

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging devices or AI-assisted interpretation, which is not the nature of the Cove Strip device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done (for AI/software devices)

Not applicable. The Cove Strip is a physical implant, not an AI algorithm.

7. The Type of Ground Truth Used

For the in vivo animal study, the ground truth would be based on:

• Histopathology: Microscopic examination of tissue samples to assess bone formation, resorption, and inflammation.
• Radiography/Imaging: To assess bone healing and fusion.
• Gross observation/Surgical evaluation: Direct assessment during necropsy or follow-up surgeries.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model, so there is no "training set" in that sense. The foundational data for its design and manufacturing would come from material science research, biological studies, and engineering principles, but not a "training set" for an algorithm.

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

Not applicable. (See point 8).

Summary of the 510(k) Approach for Cove Strip:

The K230486 submission for Cove Strip demonstrates substantial equivalence to predicate devices (MASTERGRAFT Putty and IsoTis Mozaik Strip) through:

• Direct Comparison: Similar indications for use, device description, and technological characteristics (materials: B-TCP:HA ceramic granules with Type-1 collagen; design, manufacturing, sterilization).
• Non-Clinical Bench Testing: Biocompatibility (ISO 10993-1), bacterial endotoxin, and sterilization (ISO 11135) to ensure safety.
• In Vivo Animal Study: Demonstrating comparable performance (resorption, remodeling, fusion rates) to a legally marketed predicate, and local effects as per ISO 10993-6. This animal study serves as the primary "performance study" for this type of device, showing that it functions as intended in a biological environment similar to how the predicate performs.

The FDA explicitly states: "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data." This further emphasizes that the clearance relies on non-clinical data and direct comparison to the predicates rather than new human clinical efficacy trials with explicit, quantitative acceptance criteria for superiority.

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