(53 days)
The Spine-Tech Bone Harvester is indicated for the cutting and collection of morselized autogenous bone graft from the anterior or posterior iliac crest, tibia or femur.
This device is intended to cut and collect finely morselized autogenous bone graft for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include; spinal fusion, joint arthrodesis, total joint replacement, fracture repair, maxillofacial reconstruction and tumor removal.
All components of the Spine-Tech Bone Harvested are intended for single use only.
The Spine-Tech Bone Harvester consists of two cutting head/collection tube sizes, Hudson or Hall fitting adapter for power use, trocar and plunger. The cutting heads and trocar are constructed from stainless steel. The collection tube and adapter are constructed from medical grade polycarbonate. The plunger is constructed from acetal copolymer.
After cutting and collection of morselized bone graft, the cutting head is removed from the collection tube with the trocar and bone is pushed out of the collection tube with the plunger.
Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and study details.
Based only on the provided text, it's immediately clear that the device is a physical medical instrument (bone harvester), not a software or AI-driven diagnostic device. Therefore, many of the requested points, such as those related to AI assistance, ground truth establishment for AI models, and sample sizes for training sets, are not applicable to this type of submission.
The 510(k) summary for a Class I device like the Spine-Tech Bone Harvester focuses on demonstrating substantial equivalence to predicate devices and verifying basic safety and performance, rather than complex clinical efficacy studies typically seen for higher-risk devices or novel technologies.
Acceptance Criteria and Study Details for Spine-Tech Bone Harvester
Given the nature of the device (a Class I surgical instrument), the "acceptance criteria" discussed in the 510(k) are related to materials, design, and basic functional performance, rather than diagnostic accuracy metrics like sensitivity or specificity. Similarly, the "study" referred to is primarily bench testing and internal quality assurance, not clinical trials with patient populations or expert reviews.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Materials used in construction are biocompatible. | "Biocompatibility testing has been performed on the materials used in the construction of this device and is documented in the ASTM Standard." (Implies meeting ASTM standards for biocompatibility). |
| Performance (Functional): Device adequately cuts and collects morselized autogenous bone graft. | "Performance and quality testing of the product included bench testing... All testing of the device yielded acceptable results." (Indicates successful functional performance). |
| Quality (Dimensional & Workmanship): Device meets specified dimensions and workmanship standards. | "Performance and quality testing of the product included... dimensional and workmanship inspection. All testing of the device yielded acceptable results." (Indicates compliance with design specifications). |
| Material/Design/Function Equivalence: Device is substantially equivalent to predicate devices. | "The Spine-Tech Bone Harvester is substantially equivalent in material, design, and function to Acumed Bone Graft System and other general and orthopedic surgical instruments used for the harvesting of autogenous bone." (This is a summary conclusion based on internal comparison and testing). |
| Single Use Only: Components are designed for single use as intended. | Implied by the statement "All components of the Spine-Tech Bone Harvested are intended for single use only." and the lack of mention of reprocessing or reuse protocols. |
2. Sample Sizes used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The "test set" here refers to the actual devices or components tested during bench and quality assurance. This would typically involve a sample from manufacturing lots. The specific number of units tested is not provided in this summary.
- Data Provenance: The "testing" described is internal bench testing and quality inspection. Therefore, the data would be internally generated by Spine-Tech, Inc. There is no mention of specific country of origin for this testing data, nor whether it was retrospective or prospective (as these terms usually apply to clinical data, not manufacturing verification).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is Not Applicable to this type of device and submission. "Ground truth" and "experts to establish ground truth" are concepts relevant to diagnostic devices, particularly those involving image interpretation or clinical judgment. For a bone harvester, "ground truth" would relate to its ability to physically cut and collect bone, which is verified through engineering tests, not expert consensus on diagnoses.
4. Adjudication method for the test set:
This information is Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among multiple experts interpreting data, typically in diagnostic studies. For mechanical device testing, the results are objectively measured (e.g., dimensions, cutting efficiency, material strength) against pre-defined specifications, not subject to subjective expert interpretation requiring adjudication.
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:
This information is Not Applicable. An MRMC study and discussions of AI assistance are relevant for AI/ML-driven diagnostic devices, not for a manual surgical instrument like a bone harvester.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
This information is Not Applicable. This concept applies to AI/ML software. The Spine-Tech Bone Harvester is a physical instrument requiring user operation.
7. The type of ground truth used:
The "ground truth" for this device's performance would be:
- Engineering Specifications: Successful completion of bench tests (e.g., material strength, cutting efficiency, dimensional accuracy) against pre-defined engineering and design specifications.
- Adherence to Standards: Compliance with relevant material and biocompatibility standards (e.g., ASTM standards mentioned).
- Substantial Equivalence: Demonstrated equivalence in material, design, and function to legally marketed predicate devices, implying that if the predicate is safe and effective, the new device, being equivalent, also is.
8. The sample size for the training set:
This information is Not Applicable. "Training set" refers to data used to train AI/ML models. This device is a manual surgical instrument; there is no AI model involved.
9. How the ground truth for the training set was established:
This information is Not Applicable, for the same reason as point 8.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.