(364 days)
AccuSert Needle Inserter is intended for use at home or hospital environment to assist inserting EMED subcutaneous administration needle sets into the subcutaneous tissue at 90 degrees. Single patient use only.
The EMED AccuSert Needle Inserter is a manually operated, reusable, spring-loaded injection device. This device is used to insert EMED subcutaneous infusion administration sets. The device is contraindicated for use with other sets. The AccuSert Needle Inserter consists of a plastic body containing a stainless-steel spring and a needle carrier component.
The provided text is related to a 510(k) premarket notification for the AccuSert Needle Inserter. However, it does not contain the detailed acceptance criteria and study results typically found in the clinical study section of a 510(k) submission for a device that involved an AI/ML component or complex efficacy claims.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, the Sil-Serter Inserter (K010377). This typically involves comparing technological characteristics, intended use, and performance without necessarily requiring extensive human-in-the-loop or standalone AI performance studies.
Here's a breakdown based on the information provided and what is missing:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria Mentioned (Implicitly or Explicitly):
- Cocking Force: 9-7 lbf (AccuSert) vs. Less than 7 lbf (Predicate). Note: The range for AccuSert (9-7) seems unusual, usually it's a min-max or a single value/range. This could be a typo in the document.
- Trigger/Release Force: Less than 7 lbf (AccuSert) vs. Less than 7 lbf (Predicate).
- Insertion Force: 1.0-2.5 lbf (AccuSert) vs. 1.67 lbf (Predicate).
- Life Cycle: Designed to withstand 550 cycles (AccuSert) vs. 600 cycles (Predicate).
- Biocompatibility: Meet ISO 10993 standards (Chemical Characterization, Cytotoxicity, Sensitization, Skin Irritation).
- Usability: Intended users could use the device safely and effectively without user errors or difficulties that could cause harm.
- Mechanical Integrity/Functionality: Retains mechanical properties and functions, passes visual/functional tests, chemical resistance, and drop test.
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Reported Device Performance:
- Cocking Force: "9-7 lbf" (AccuSert). The document states "validated as appropriate though Usability Validation that demonstrated that the intended users could use the device safely and effectively without user errors or difficulties that could cause harm."
- Trigger/Release Force: "Less than 7 lbf" (AccuSert).
- Insertion Force: "1.0 -2.5 lbf" (AccuSert). The document states "AccuSert was designed with adequate force to insert the intended needle sets with the minimum force and impact to the patient skin as confirmed by conducted performance testing."
- Life Cycle: "Designed to withstand 550 cycles" (AccuSert). The text states: "The number of simulated uses for the AccuSert Needle Inserter includes data derived from testing of multiple Inserters as well as performance testing to validate expected usable life duration."
- Biocompatibility: "AccuSert Needle Inserter has been evaluated for biocompatibility and is acceptable for its intended use by Biological Evaluation." (Passed all listed tests).
- Usability: "The conducted Human Factors Validation Testing serve as objective evidence that the instructions for use provide the user with sufficient information to understand how the device is used." It also states for Cocking Force and Trigger/Release Force that "validated as appropriate though Usability Validation that demonstrated that the intended users could use the device safely and effectively without user errors or difficulties that could cause harm."
- Mechanical Integrity/Functionality: "Results from performance testing indicate that the product meets the established performance requirements." (Implies passing visual/functional, chemical resistance, and drop tests).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated for performance tests (e.g., how many devices were subjected to life cycle testing, drop tests, etc.). For usability/human factors, the sample size is also not specified.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory/engineering tests ("Design Verification," "Biocompatibility," "Usability Evaluation").
- Retrospective or Prospective: These appear to be prospective design verification and validation tests, not historical data analyses.
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 / Not Provided: This question is highly relevant for AI/ML devices where expert interpretations form ground truth. For a mechanical device like a needle inserter, ground truth is established through physical measurements, engineering standards, and usability testing with representative users, rather than expert interpretation of medical images or conditions. The document mentions "Human Factors Validation Testing" and "Usability Validation" with "intended users" but does not specify the number or qualifications of experts establishing ground truth in the way this question implies. Ground truth here relates to meeting pre-defined physical and usability specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: Adjudication is typically used in clinical studies or expert review processes to resolve discrepancies in diagnoses or interpretations for AI/ML ground truth generation. For direct performance testing of a mechanical device, results are typically objective measurements against specified criteria. Usability studies have methods for assessing user errors and difficulties, but "adjudication" in the sense of reconciling conflicting expert opinions is not described.
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: The document explicitly states: "No clinical study is included in this submission." An MRMC study is a type of clinical study, specifically for diagnostic devices (often AI-assisted). This device is a mechanical inserter, not a diagnostic tool, and its 510(k) submission relied on non-clinical performance and substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a mechanical device, not an algorithm. Therefore, "standalone" performance for an algorithm is not relevant. The device's "standalone" performance is its mechanical performance (cocking force, insertion force, life cycle, etc.), which was tested as described under "Design Verification."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Engineering Specifications and Usability Objectives: For this device, ground truth is defined by:
- Pre-defined engineering specifications (e.g., target force ranges, number of cycles).
- Biocompatibility standards (ISO 10993).
- Human Factors/Usability standards (ANSI/AAMI HE75, IEC 62366-1) which define what constitutes safe and effective user interaction and freedom from critical errors.
- Physical performance standards (ISO 28620 for drop test).
- The "truth" is whether the device performs within these acceptable parameters during testing.
8. The sample size for the training set
- Not Applicable: This is a mechanical device, not an AI/ML model that requires training data.
9. How the ground truth for the training set was established
- Not Applicable: See point 8.
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).