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510(k) Data Aggregation
(54 days)
The BONE MARROW MSC ASPIRATION KIT is intended for use for aspiration / explant of bone marrow through a piston syringe.
The BONE MARROW MSC ASPIRATION KIT is a single use disposable needle intended for the aspiration / explant of bone marrow. The structure of BONE MARROW MSC ASPIRATION KIT device includes a cannula with a stylet inside, with a threaded insert and a rotating spacer that allow the precise retraction of the cannula to a determined length. Once the cannula has been inserted and positioned, the stylet can be removed and a syringe is connected to execute the aspiration. By manually rotating the rotating spacer, the cannula retracts, raising inside the bone marrow, in order to be able to perform aspiration / explant from fresh sites at different heights.
The provided document is a 510(k) Premarket Notification for the "BONE MARROW MSC ASPIRATION KIT". This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, meaning they generally do not require extensive de novo clinical studies to prove effectiveness in the same way a new drug or novel medical device might. The document focuses on demonstrating substantial equivalence rather than presenting a detailed study proving device meets specific clinical acceptance criteria in a comparative effectiveness study with human readers or standalone performance.
Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC study effect size, type of ground truth for test and training sets) are not typically included in a 510(k) for a device like a bone marrow aspiration kit, as the primary evidence provided is performance data from design verification and validation testing, and comparison to predicate devices, rather than clinical efficacy data.
Here's a breakdown of the information that can be extracted and what is not available in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in a single, clear format for clinical outcomes. Instead, it lists performance/functionality/safety tests and states that the "Results of the evaluations demonstrate that the subject device met the safety and performance requirements as per its indication for use."
However, we can infer some criteria from the tests performed:
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Material mediated pyrogenicity, Acute systemic toxicity) | Compliant to ISO 10993-1. (Results demonstrate meeting safety and performance requirements) |
| Efficacy of Needle retraction | Met requirements |
| Excursion of the Needle threaded insert | Met requirements |
| Maximum useful length of the needle cannula | Met requirements |
| Adequacy of the Needle aspiration surface | Met requirements |
| Needle handle Grip during bone insertion procedures | Met requirements |
| Needle perforation capacity in the bone | Met requirements |
| Adequacy of the Needle Luer-Lock Connection | Met requirements |
| Quantity of bone marrow sample collected by the needle | Met requirements |
| Integrity of the aspiration syringe | Met requirements |
| EO Sterilization Validation | Met requirements |
| Washing Process Verification | Met requirements |
| Packaging shelf life accelerated aging tests | Met requirements |
2. Sample size used for the test set and the data provenance
The document does not provide details on sample sizes for each test listed under "Performance Data." These are typically engineering and laboratory verification and validation tests, not clinical trials with human subjects. Thus, information on "country of origin of the data" or "retrospective or prospective" is not applicable in the context of these engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance data presented are from technical/engineering tests, not clinical evaluations requiring expert interpretation of results to establish ground truth.
4. Adjudication method for the test set
Not applicable. This typically refers to resolving discrepancies in expert interpretations in clinical studies, which are not detailed here.
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
No. This device is a bone marrow aspiration kit, not an AI-powered diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document indicates "Performance Data" obtained through various engineering and functional tests (e.g., biocompatibility testing, mechanical performance testing, sterilization validation). The "ground truth" for these types of tests would be adherence to established engineering standards, material specifications, and regulatory requirements (e.g., ISO 10993 for biocompatibility). There is no "expert consensus, pathology, or outcomes data" mentioned in the context of establishing ground truth for these device performance tests.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is a physical device and not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable.
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