(54 days)
This device is intended to be used to obtain bone from the iliac crest or other skeletal sites. It is indicated in conditions requiring the examination of bone, e.g., metabolic bone disease, metastatic disease to the bone, osteoporosis, and osteomalacia, or in conditions requiring the use of bone graft, e.g., nonunion or delayed union of fractures, bone defects, and fusions.
Bone Graft Harvester
This document is a 510(k) clearance letter from the FDA for a Bone Graft Harvester device, not a study evaluating a device's performance against acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.
The document indicates that the device is "substantially equivalent" to predicate devices, which is the basis for its market clearance. This substantial equivalence is a regulatory finding, not a clinical study demonstrating performance against specific numerical acceptance criteria.
Here's a breakdown of what can be inferred or what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as numerical performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criterion for 510(k) clearance is "substantial equivalence" to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics and performance (safety and effectiveness) without raising new questions of safety or effectiveness.
- Reported Device Performance: Not reported in terms terms of clinical outcomes or performance metrics. The letter confirms that based on the provided information, the device is considered substantially equivalent.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document does not describe a performance study with a test set.
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 test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process is described.
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. This is a clearance for a physical medical device (Bone Graft Harvester), not an AI diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth is described.
8. The sample size for the training set
- Not applicable. This document is not describing a machine learning or AI device with a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided document is a regulatory clearance letter based on substantial equivalence, not a scientific publication detailing a study about a device's performance against specific, quantifiable acceptance criteria.
§ 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.