(199 days)
The Unimicro Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
The Unimicro Veress Needle is a sterile and single-use product. It incorporates a spring-loaded blunt stylet mechanism. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Unimicro Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
The provided document is a 510(k) summary for the Unimicro Veress Needle. It outlines non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing specific performance metrics against acceptance criteria. Therefore, directly addressing all points of your request for a study proving device acceptance criteria is not fully possible from this document, as it focuses on non-clinical performance and comparison.
However, I can extract the relevant information regarding acceptance criteria and testing where available.
Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:
The Unimicro Veress Needle underwent non-clinical testing to demonstrate its safety and effectiveness, and to establish substantial equivalence to its predicate device (Unimax Veress Needle, K111441). The acceptance criteria for these tests were "pre-defined," and the device "met the requirements of the pre-defined acceptance criteria." The specific numerical or qualitative values of these pre-defined acceptance criteria are not explicitly stated in the provided text. The study involved a series of in vitro and in vivo preclinical physical, mechanical, and biocompatibility tests.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Tests | Adherence to ISO standards: ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-12:2012 | Met the requirements of the pre-defined acceptance criteria (implied compliance with ISO standards for biocompatibility) |
| Cytotoxicity Test | (Not explicitly stated, but implied to be non-cytotoxic) | Met the requirements of the pre-defined acceptance criteria |
| Skin Irritation Test | (Not explicitly stated, but implied to be non-irritating) | Met the requirements of the pre-defined acceptance criteria |
| Skin Sensitization Test (Guinea Pig maximization test) | (Not explicitly stated, but implied to be non-sensitizing) | Met the requirements of the pre-defined acceptance criteria |
| EO Sterilization Validation | (Not explicitly stated, but implied to achieve sterility assurance level) | Met the requirements of the pre-defined acceptance criteria |
| Ethylene Oxide Sterilization Residuals Test | (Not explicitly stated, but implied to be within safe limits) | Met the requirements of the pre-defined acceptance criteria |
| Physical/Mechanical Tests | Performance "as well as the predicate device" and meeting "pre-defined acceptance criteria" | Performed as well as the predicate device and met pre-defined acceptance criteria |
| Tip Pull Test | (Not explicitly stated, but implied to withstand a certain force) | Met the requirements of the pre-defined acceptance criteria |
| Switch Operation | (Not explicitly stated, but implied to operate smoothly and reliably) | Met the requirements of the pre-defined acceptance criteria |
| Spring Obturator Operation | (Not explicitly stated, but implied to operate effectively) | Met the requirements of the pre-defined acceptance criteria |
| Needle Puncture Force Test | (Not explicitly stated, but implied to be within acceptable force ranges for puncture) | Met the requirements of the pre-defined acceptance criteria |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the non-clinical tests. It also does not discuss data provenance in terms of country of origin or whether the study was retrospective or prospective, as these are typically considerations for clinical studies and not explicitly for non-clinical lab testing of a medical device's physical properties.
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 information is not applicable and not provided in the document. The tests described are non-clinical, mechanical, and biocompatibility tests conducted in a laboratory setting. Ground truth in this context would typically refer to established scientific standards (e.g., ISO standards) and objective measurements rather than expert consensus on interpretations of data (as would be the case for medical imaging or diagnostic devices).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment. The tests performed are objective laboratory tests.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices often involving human interpretation and AI assistance, neither of which are discussed for this device. The document explicitly states "non-clinical testing" and compares the device to a predicate based on physical, mechanical, and biocompatibility properties.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a physical Veress Needle, not an algorithm or software. Therefore, the concept of standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests described would be based on objective measurements against established engineering, material, and biological safety standards (e.g., force values, operational efficiency, compliance with ISO 10993 standards for biocompatibility). It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms, which are not involved with this physical medical device.
9. How the ground truth for the training set was established
This information is not applicable and not provided as there is no training set for a physical medical device.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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 § 884.9.