(75 days)
The Odontit Autogenous Bone Collection Device is indicated for use as an aspirator for the removal and collection of blood, autogenous bone chips, or other extraneous fluids from a surgical site. Using a vacuum source, the Odontit aspirator will remove materials (including blood, bone chips and other fluids) from the surgical site and pass them through a stainless steel screen which is designed to capture and collect autogenous bone. At the option of the surgeon, this bone may be removed from the aspirator, washed and cleansed as necessary, and returned to the same patient as an autogenous bone graft.
The capacity for bone collection in the screen is approximately 16 cc.
The Odontit Autogenous Bone Collection Device is a portable suction device intended for use as an aspirator for the removal and collection of blood, autogenous bone, or other extraneous fluids from a surgical site. The device consists of the following components: Body Assembly, Aspirator Tip, Screen Filter, Flex tubing, Rigid tubing and a Plunger.
The provided text describes a 510(k) Premarket Notification for the "Odontit Autogenous Bone Collection Device." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specified acceptance criteria. Therefore, the information requested in your prompt related to clinical studies, acceptance criteria, sample sizes, expert ground truth, MRMC studies, and standalone performance is generally not applicable to a 510(k) submission of this nature.
Here's an explanation based on the document:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The 510(k) process for a device like this focuses on demonstrating "substantial equivalence" to a predicate device, not on meeting specific, pre-defined acceptance criteria from a performance study. Clinical performance metrics (like sensitivity, specificity, accuracy) or detailed engineering performance criteria (beyond basic functional specifications) are not presented in this document.
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. No test set or associated data provenance is discussed in this 510(k) summary. The submission is a regulatory filing, not a report of a clinical study.
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 ground truth establishment by experts is described, as no specific test set or clinical study requiring such a method is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or corresponding adjudication method is discussed.
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 non-powered, single-patient, portable suction apparatus for collecting bone chips. It is not an AI-assisted diagnostic or interpretative device, so an MRMC study and AI-related effectiveness are entirely irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm, so standalone performance in the context of an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. As no clinical study results are presented, there is no discussion of ground truth.
8. The sample size for the training set:
- Not Applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As it's not an AI/ML algorithm, there's no training set or ground truth establishment for it.
Summary of the 510(k) Submission:
The provided document is a 510(k) Premarket Notification for the "Odontit Autogenous Bone Collection Device". The core of this submission is demonstrating substantial equivalence to a predicate device, the "KAM Super Sucker™" (K822065).
The claim for substantial equivalence is based on:
- Product design
- Material of construction
- Function as an aspirator
The device's intended use is "as an aspirator for the removal and collection of blood, autogenous bone chips, or other extraneous fluids from a surgical site." It uses a vacuum source to pass materials through a stainless steel screen to capture autogenous bone, which can then be returned to the patient as an autogenous bone graft. The capacity for bone collection in the screen is approximately 16 cc.
The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed devices, allowing it to proceed to market. This type of submission does not typically involve the extensive clinical studies or performance data that would necessitate the reporting of acceptance criteria, sample sizes for test/training sets, or expert-established ground truths.
§ 878.4680 Nonpowered, single patient, portable suction apparatus.
(a)
Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.(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.