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The Safety Push Button Blood Collection Set is intended to be used for insertion into a patient's vascular system for blood specimens. When used without the male adapter, the device allows the clinician to obtain blood sampling from the female hub with a syringe, if necessary, or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician. It aids in the prevention of accidental needle stick through the use of an active safety feature. The device is a sterile, multiple sample, single-use.

The proposed device consists of these components: (1) Needle, (3) Spring, (4) Butterfly wings, (5) Hub, (6) Safety sheath, (7) Flexible tube, (8) Female luer, (9) Male luer hub, (10) Puncture needle, (11) Rubber sleeve, (12) Puncture needle protect cover or holder, (13) Safety push button protect cover. The proposed device have three configurations: With holder, With holder, Without male adapter. For without male adapter, there is a a protective cap to cover female luer. The proposed device is available various needle size and tube length. The range of needle size is from 25G(0.5mm). The range of tube length is from 10cm(4") to 30cm(12"). The proposed device have sharps injury protection features. It aids in the prevention of accidental needle stick through the use of an active safety feature. The proposed device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years. No DEHP, BPA and Natural Rubber Latex are added in the proposed device.

The provided document, a 510(k) Summary for the Safety Push Button Blood Collection Set, is a premarket notification to the FDA. It aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving that it meets specific, independently defined acceptance criteria through a clinical study.

Therefore, many of the requested details, such as a table of acceptance criteria with reported performance, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies, are not applicable or found in this type of submission. This document focuses on demonstrating equivalence through non-clinical testing and comparison of technical characteristics.

Here's an analysis of the provided information in relation to your request:

1. A table of acceptance criteria and the reported device performance

• Not Applicable in this format. This document is a 510(k) submission for substantial equivalence, not a clinical trial report with defined acceptance criteria for a new performance claim. The "acceptance criteria" are implied by the performance standards the device was tested against and found to comply with, as detailed in Section 8 "Non-Clinical Test Conclusion."
• Implied Performance: The document states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies applicable parts of the following standards." This implies the device performed within the specifications of these standards.
• Specific Compliance Examples (from Section 8):
  • Biological Safety: Complied with ISO 10993-7 (Ethylene Oxide Sterilization Residuals), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and delayed-type hypersensitivity), ISO 10993-11 (systemic toxicity), USP (Pyrogen Test), ASTM F756-17 (Hemolytic Properties), USP (Bacterial Endotoxins Test).
  • Packaging and Sterility: Complied with ASTM F1929-15 (detecting seal leaks), ASTM F88/F88M-21 (seal strength), ASTM F1886/F1886M-16 (integrity of seals by visual inspection), ISO 11607 and ISTA 3A (shelf-life validation for sterility maintenance over 3 years).
  • Device Performance: Complied with ISO 80369-7 (small-bore connectors), ISO 8536-4 (infusion sets), ISO 9626 (stainless steel needle tubing), ISO 7864 (sterile hypodermic needles).
  • Safety Feature: "Simulated Clinical Study for safety feature" and "Sharps injury protection testing in accordance with ISO 23908" were performed. The document states it aids in the prevention of accidental needle sticks.

A table summarizing this would look like:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for each test. The document refers to "non-clinical tests" and "verification or testing." For a 510(k) submission of a physical device like this, sample sizes would typically be determined by the specific ISO/ASTM standards being followed for each test (e.g., a certain number of units for sterility, strength, or material compatibility tests). These are typically in-house lab tests, not human subject studies.
• Data Provenance: The tests were conducted by the manufacturer, Jiangsu Caina Medical Co., Ltd., based in China. The tests are non-clinical, likely in-house laboratory testing following international standards. No human data is involved. It's prospective testing of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. As a non-clinical device where substantial equivalence is demonstrated through engineering and material testing, there is no "ground truth" established by human experts in the way that would apply to an AI/imaging device (e.g., radiology reads). The "ground truth" is defined by the physical, chemical, and biological properties measured against established industry standards (ISO, ASTM, USP).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or expert review processes for AI. This is a non-clinical testing submission.

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 is a physical medical device (blood collection set), not an AI-powered diagnostic or imaging device. MRMC studies are not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Defined by International Standards/Lab Results. For this device, "ground truth" is implicitly established by the quantitative and qualitative results of highly standardized laboratory tests against predefined limits set by ISO, ASTM, and USP standards. For example:
  • Sterility: Absence of microbial growth, reaching a SAL of 10^-6.
  • Biocompatibility: No cytotoxicity, sensitization, irritation, pyrogenicity, or hemolysis as per standard tests.
  • Physical Integrity: Meeting specified tensile strength, leak detection, and dimensional requirements.
  • Sharps Injury Protection: Successful activation of the safety feature and prevention of needle sticks as per ISO 23908.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device. There is no "training set" in this context. The company manufactures these devices, and testing is done on production samples.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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The Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. It can be used for direction, intermittent infusion, continuous infusion or aspiration.

The proposed device, Needleless Connector, is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. It can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

The proposed device is a needleless connector which can be activated by a male luer, and the flush volume for the device is 5ml. The device can be used for less than 7 days and 100 activations.

The Needleless Connector also suitable for power injection of contrast media into the central venous system only through IV line that is also indicated for power injection at a maximum pressure of 325psi and a flow rate of 10ml/s.

The provided text is related to an FDA 510(k) premarket notification for a "Needleless Connector." This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of technical characteristics, rather than a study of an AI-powered device. Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document.

The document details the device's technical specifications, materials, and non-clinical performance tests (e.g., biocompatibility, sterility, integrity, fluid dynamics) to show it is as safe and effective as a previously cleared device. It explicitly states: "No clinical study is included in this submission."

To address your request, I would need a document describing an AI device and its associated clinical or performance study.

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The Retractable Safety Insulin Syringe is a sterile, single use, disposable and non-reusable, automatically retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

The Retractable Safety Insulin Syringe has the same technological characteristics as the Retractable Safety Syringe(manufacture by Jiangsu Caina Medical Co., Ltd.) as cleared in K191490 at date 2019/10/03. The difference between the Retractable Safety Insulin Syringe and the 1ml Retractable Safety Syringe is only the scale.

The Retractable Safety Insulin Syringe works like a conventional insulin syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe plunge, the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

The Retractable Safety Insulin Syringe is available in various specifications. The proposed device consists of eleven components: (1) plunger. (2) piston. (3) barrel. (4) needle cap. (5) sealing plug. (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub.

The proposed device is provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

The provided text is a 510(k) Summary for a Retractable Safety Insulin Syringe (proposed device) and focuses on demonstrating its substantial equivalence to a predicate device (U&U Insulin Syringe with/without Safety Retractable Device). The acceptance criteria and supporting study details provided are primarily non-clinical, comparing the proposed device against established standards and to the predicate.

Here's the information extracted and organized as requested, with "N/A" where the document does not provide the specific detail, indicating it was likely not part of this specific submission or the type of device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated for each test, but standard test methods (e.g., ISO, ASTM) typically specify lot sizes or sample numbers for compliance testing. The provided values for force measurements (e.g., 10.48-20.91 N) are ranges, suggesting multiple units were tested.
   • Data Provenance: The tests were non-clinical, conducted by the manufacturer (Jiangsu Caina Medical Co., Ltd., China) as part of their substantial equivalence submission. The studies are by nature prospective tests performed on the manufactured device.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Number of Experts: N/A. This was a non-clinical device performance and materials testing study, not a study involving expert human interpretation or ground truth establishment in a clinical sense (e.g., image-based diagnosis). The "ground truth" here is compliance with established international and national standards for medical devices and their components.
   • Qualifications of Experts: N/A. The compliance is assessed by technical testing, not expert consensus on interpretations.

3. Adjudication Method for the Test Set:

   • Adjudication Method: N/A. As a non-clinical, standards-based compliance study, there was no "adjudication" in the sense of reconciling differing expert opinions. Test results are objective measurements against predefined criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • MRMC Study: No. The document explicitly states: "Simulated clinical study was not conducted on proposed device," and "No clinical study is included in this submission." This type of study is common for diagnostic AI, not for a mechanical medical device like a syringe.
   • Effect Size of Human Readers Improvement: N/A, as no MRMC study was performed.

5. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:

   • Standalone Performance: N/A. This device is a mechanical syringe, not an algorithm. The "performance" discussed is the mechanical, biological, and material compliance of the device itself.

6. The Type of Ground Truth Used:

   • Ground Truth: The ground truth for this device's acceptance is adherence to established international and national standards (e.g., ISO, ASTM, USP) for the performance, safety, and biocompatibility of syringes and their components, as well as comparison to a legally marketed predicate device. For example, the "ground truth" for "Force to activation" is that it must be

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