(49 days)
The device intended to be used in conjunction with the FMS/Depuy/Mitek arthroscopic pump systems and delivers irrigation fluid both to and from the pump and to and from the operative site during arthroscopic procedures.
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) are tube sets that deliver irrigation fluid both to and from the pump and to and from the operative site during arthroscopic procedures.
The provided document describes the HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) and asserts their substantial equivalence to predicate devices. The document does not describe a study involving an AI/Machine Learning device, human readers, or the establishment of ground truth in the way anticipated by the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance.
Instead, this document pertains to a 510(k) submission for a medical device that is a pump tube set for arthroscopic procedures, not an AI or diagnostic imaging device. Therefore, many of the requested fields are not applicable.
Here's the information derived from the provided text, with an explanation of why certain fields are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance (HEMODIA ARTHROSCOPY PUMP TUBE SETS) |
|---|---|
| Technological Characteristics: Similar in material (including packaging material), design, function, and application to single-use predicate devices. Not self-powered, uses the same energy source (pumps) as predicate devices. | The TUBE SETS are similar in material (including packaging material), design, function, and application to the single use predicate devices. The device is not self-powered but uses the same energy source (pumps) as the predicate devices. The technological characteristics are the same as the predicate device. |
| Performance Data (Bench Testing): Functional equivalence, tube set leak testing under pressure, bond strength. Support that design, packaging, sterilization, and labeling are substantially equivalent to currently marketed single-use predicate devices. | Performance testing was performed to demonstrate equivalence to the tube sets (not the hardware) referenced in the predicate devices. Hemodia's testing included bench testing for functional equivalence, tube set leak testing under pressure, bond strength. These tests support that the design, packaging, sterilization & labeling of the TUBE SETS are substantially equivalent to currently marketed single use predicate devices. |
| Clinical Performance Data: Not explicitly stated as a general acceptance criterion, but the report justifies why clinical testing was not necessary. | A clinical evaluation report was undertaken, supporting that clinical testing was not necessary to support substantial equivalence to predicate devices. |
| Intended Use: Same as predicate devices. | The proposed devices have the same intended use (delivers irrigation fluid to and from the pump and operative site during arthroscopic procedures when used with specific FMS/Depuy/Mitek arthroscopic pump systems). |
| Overall Equivalence: Differences between the HATS tube sets and the predicates single-use sets are minor and do not raise questions concerning safety and effectiveness. | Based on the comparison of the intended use, the technological characteristics and performance data, Hemodia S.A.S has determined that the proposed HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) are substantially equivalent to the currently marketed single-use predicate devices. Any differences between the HATS tube sets and the predicates single-use sets are considered minor and do not raise questions concerning safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This device is a physical medical device (pump tube set), not an AI or diagnostic device that uses a "test set" of data in the common understanding of AI/ML performance evaluation. The "testing" referred to is bench testing (e.g., leak testing, bond strength), not a dataset of patient cases. Thus, this question is not applicable in the context of the provided document.
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)
This question is not applicable as the device is not an AI or diagnostic imaging device that requires radiologist or medical expert interpretation of a "test set" for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the reasons stated above.
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 question is not applicable as the device is not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to AI performance (e.g., disease presence) is not relevant here. The "truth" or acceptance of the device's performance is based on meeting engineering and functional specifications during bench testing (e.g., no leaks under pressure, sufficient bond strength, functional equivalence to predicate devices).
8. The sample size for the training set
This question is not applicable as the device is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.