(179 days)
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.
| Acceptance Criterion (Implicitly based on Predicate Device Performance) | Reported Device Performance (Cove Strip) |
|---|---|
| Biocompatibility: Safe for biological contact. | Compliant with ISO 10993-1. |
| Bacterial Endotoxin Limit: Meeting safety standards. | Testing complies with AAMI ST72, USP, and USP. Validated to ensure a BET limit of ≤20 EU/Device. |
| Sterility: Achieving a required sterility assurance level (SAL). | Sterilization complies with ISO 11135 (Ethylene Oxide) to ensure a SAL of 10^-6^. (Equivalency was established with a predicate device of identical product sizing and packaging, allowing adoption of its sterilization validation). |
| In Vivo Performance (Resorption, Remodeling, Fusion Rates): Comparable biological response to predicate. | An in vivo (animal) study demonstrated comparable resorption, remodeling, and rates of fusion when compared to a legally marketed predicate. Assessed per ISO 10993-6:2016 for local effects after implantation. (Specificity on what constitutes "comparable" and the exact metrics/thresholds found comparable are not detailed in this summary, but are part of the full submission). |
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.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.