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510(k) Data Aggregation
Neptune Pad (calcium alginate pad alone): Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy.
Neptune Comfort-Band (Pressure Band with calcium alginate pad): Neptune Comfort-Band is used to provide pressure and promote the rapid control of bleeding and promote hemostasis following needle puncture, arterial/venous catheterization and access sites, including patients on anticoagulation therapy, and following hemodialysis.
Comfort-Band (Pressure Band alone): Comfort-Band is used to provide pressure and promote the rapid control of bleeding and hemostasis following needle puncture, arterial/venous catheterization and access sites, including patients on anticoagulation therapy, and following hemodialysis. It may be used alone, with Neptune Pad, with sterile gauze or other sterile wound dressings.
Neptune Pad - Varying size, packaged sterile pads may be used alone as a wound dressing. The Pad may also be used with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasisat the skin surface.
Neptune Comfort-Band - The Comfort-Band is packaged with a Neptune Pad, and sterilized. It is strapped around the arm (hemodialysis graft, or radial/brachial arteries) to provide pressure for rapid control of bleeding and hemostasis.
Comfort-Band - The Comfort-Band is provided sterile or non-sterile, single use only. Non-sterile Comfort-Bands are provided with cleaning and high level disinfectant instructions) The Sterile Comfort-Band is packaged alone and EtO sterilized. The Comfort-Bands may be used with or without a dressing. The device is strapped around the arm (hemodialysis graft, or radial/brachial arteries) to provide rapid pressure control of bleeding and hemostasis.
The provided text describes the regulatory aspects of TZ Medical's Neptune products (Neptune Pad, Neptune Comfort-Band, and Comfort-Band), including their indications for use and a summary of substantial equivalence testing. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a specific study proving the device meets those criteria.
Based on the available information, here's what can be inferred and what is missing:
Missing Information:
The document does not provide:
- A specific table of acceptance criteria with reported device performance metrics (e.g., specific thresholds for hemostasis time, bleeding reduction).
- Details about sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established. This is likely because the document is a 510(k) summary, which focuses on substantial equivalence rather than detailed clinical trial results.
Here's an attempt to answer based on the provided text, highlighting the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Neptune products. Instead, it makes a general statement about the products being "considered safe and effective" and that "Data demonstrates there are no new risks associated with the product."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide any information regarding the sample size, data provenance, or study design (retrospective/prospective) for any test sets.
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)
The document does not mention the use of experts to establish a ground truth or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method.
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
The document does not mention any MRMC studies, nor does it describe an AI component for these devices. The Neptune products are physical hemostatic devices, not AI-driven diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the Neptune products are not algorithms but physical medical devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used. The statement "Data demonstrates there are no new risks associated with the product" implies some form of testing was conducted to support safety and effectiveness, likely comparing their performance (e.g., hemostasis time) to predicate devices or established benchmarks, but the details are not provided.
8. The sample size for the training set
The document does not specify a training set or its sample size. This is consistent with the nature of the device as a physical product, not an AI model.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI model is mentioned.
Summary of the Study Mentioned:
The document briefly mentions a "Substantial Equivalence Testing Summary."
- Device Tested: Neptune Pad, Neptune Comfort-Band, and Comfort-Band.
- Methodology (Implied): The devices were tested to demonstrate substantial equivalence to previously cleared predicate devices:
- Key Findings: "The TZ Medical Neptune products have been tested and are considered safe and effective." The submission states that with the "exception of the Comfort-Band material and an adhesive interface between the Comfort-Band and calcium alginate pad, all other products and processes are identical to products with current 510(k)s K920614, and K941176)." It concludes that "Data demonstrates there are no new risks associated with the product."
- Limitations: The summary does not provide specific performance data, test protocols, sample sizes, or details on how "safety and effectiveness" were quantified or compared. This summary confirms that some testing was performed to satisfy the regulatory requirement for substantial equivalence, rather than detailing a clinical study with specific acceptance criteria and results.
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