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510(k) Data Aggregation
(132 days)
HAGER WORLDWIDE, INC.
The MIRAMATIC Box Sharps Container is intended for use in dental offices for collection and disposal of contaminated wastes and sharps. Indicated for use as an aid in minimizing needle stick injuries during needle disposal. For use with 25, 27 and 30 gauge long and short dental needles.
The Cap Trap Needle Re-capper is intended for use in dental offices during uncapping/recapping procedures. Indicated for use as an aid in minimizing needle stick injuries during re-capping and needle disposal.
The MIRAMATIC Box Sharps Container is designed for use with the MIRAMATIC cartridge syringe to enable single-handed disengagement, ejection and disposal of needles during dental procedures.
The Cap Trap Needle Re-capper is a mechanical re-capper designed to allow single-handed re-sheathing so that the needle is re-sheathed without directing it toward any part of the body. It consists of a base, carrier plate and activation plate.
This document, K061933, describes two separate devices: the Hager MIRAMATIC Box Sharps Container and the Cap Trap Needle Re-capper. The provided text discusses the general characteristics, intended use, and preliminary testing activities for these devices, but it does not contain the specific details required to answer the questions about acceptance criteria and a study that proves the device meets those criteria.
The document states that "Testing activities were conducted to establish the performance and reliability characteristics of the accessories. Testing included mechanical testing, cleaning and sterilization efficacy and simulated use evaluation." However, it does not provide:
- Specific acceptance criteria: No numerical targets (e.g., "must reduce needle sticks by X%") or qualitative benchmarks are listed.
- Reported device performance: No results from the mentioned testing activities are presented.
- Details of the study: Information on sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods is absent.
Therefore, for each of your specific questions, the answer based on the provided text is that the information is not available in this document.
Summary of Missing Information:
- A table of acceptance criteria and the reported device performance: Not provided. The document mentions "testing activities were conducted to establish the performance and reliability characteristics," but it does not list the criteria or the results.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided. The document generally refers to "testing activities" and "simulated use evaluation" without detailing the study design or sample size.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. The document does not mention the involvement of experts in establishing ground truth for any testing.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
- 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: Not applicable. These devices are mechanical, not AI-driven diagnostic tools.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. These are mechanical devices, not algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. The document vaguely mentions "simulated use evaluation" but doesn't specify what constituted the "ground truth" for evaluating performance (e.g., actual needle stick reduction, measured force, etc.).
- The sample size for the training set: Not applicable (not an AI/algorithm). If interpreted as a sample size for an initial testing or development phase, it is not provided.
- How the ground truth for the training set was established: Not applicable.
In conclusion, this 510(k) summary provides an overview of the medical devices and their intended use, but it does not contain the detailed study results or acceptance criteria that you are requesting.
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(231 days)
HAGER WORLDWIDE, INC.
Indicated for use with pre-filled anesthetic cartridges and press fit dental needles for the manual injection of local dental anesthetics into the oral tissues.
The cartridge syringe may aid in the reduction of needle stick injuries.
The Hagar MIRAMATIC System consists of a cartridge syringe (the MIRAMATIC) and dental needles (MIRAJECT).
The MIRAMATIC System is a manual system designed exclusively for use with MIRAJECT needles. The hub of the syringe is designed to receive the needle using a compression fit mechanism rather than a threaded screw-on motion or slip-fit. The needles have a corresponding specially designed cone to allow seating by push fit on to the hub. The syringe hub has locked and unlocked positions.
The Hager MIRAMATIC Safe Syringe System is a dental cartridge syringe system with an antistick feature, needle re-capper, and sharps container, indicated for use with pre-filled anesthetic cartridges and press-fit dental needles for the manual injection of local dental anesthetics into the oral tissues. The device is also stated to aid in the reduction of needle stick injuries.
1. Acceptance Criteria and Reported Device Performance
The provided submission does not explicitly state quantitative acceptance criteria for the Hager MIRAMATIC Safe Syringe System. However, it indicates that the device's performance and reliability characteristics were established through various tests.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Testing) |
|---|---|
| Mechanical integrity and functionality. | Mechanical testing was conducted. |
| Cleaning and sterilization efficacy. | Cleaning and sterilization efficacy was tested. |
| Performance in a simulated clinical environment, particularly regarding safety features. | Simulated clinical evaluation was performed. |
| Substantial equivalence to predicate device (SafeStep™ Safety Dental Cartridge Injector K022959, "1-Shot™ Safety Syringe"). | The device was found substantially equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the mechanical testing, cleaning, sterilization efficacy, or simulated clinical evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The submission does not specify the number of experts used or their qualifications for establishing ground truth, particularly for the simulated clinical evaluation.
4. Adjudication Method for the Test Set
The submission does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided document. The device is a physical medical device (syringe system) rather than an AI-powered diagnostic tool, so such a study would not typically be applicable in this context.
6. Standalone Performance Study
The submission describes "Testing activities" conducted to establish the performance and reliability characteristics of the new device. This refers to the standalone performance of the device itself and its components (syringe, needles, and their interaction), rather than an algorithm. This includes mechanical testing, cleaning and sterilization efficacy, and simulated clinical evaluation.
7. Type of Ground Truth Used
The "ground truth" for this medical device would be established based on:
- Mechanical Engineering Principles and Standards: For mechanical testing (e.g., ensuring secure fit, proper ejection, durability).
- Microbiology/Sterilization Standards: For cleaning and sterilization efficacy (e.g., absence of viable microorganisms after specified processes).
- Clinical Safety and Efficacy Observations in a Simulated Environment: For the simulated clinical evaluation, focusing on the device's function as intended, particularly the "antistick feature" and ease of use. This would likely involve observing the device's operation under controlled conditions and confirming that it performs its intended functions effectively and safely.
The document does not detail specific "ground truth" methodologies beyond these general categories.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI/software product, the concept of a "training set" in the context of machine learning does not apply. The development and testing process would involve iterative design, prototyping, and testing of physical components and assemblies to meet specified design requirements.
9. How the Ground Truth for the Training Set Was Established
Since the concept of a "training set" is not applicable, there is no corresponding method for establishing a ground truth for it. The device's design and functionality would be validated against engineering specifications, user needs, and regulatory requirements through the testing activities mentioned.
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(74 days)
HAGER WORLDWIDE, INC.
For use as a periodontal wound dressing to protect injured periodontal tissue by forming a barrier to avoid further irritation.
The product is a periodontal wound dressing. It is intended for use only by dental practitioners; and will not be offered for OTC use. It contains materials that pose no health hazard when used according to directions.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a device called "Reso-Pac," a periodontal wound dressing.
It primarily discusses:
- The manufacturer and submitter details.
- The product's intended use and substantial equivalence to predicate devices.
- FDA's clearance of the device for marketing.
- Regulatory requirements and contacts.
- Indications for use.
There is no mention of:
- Specific performance metrics or acceptance criteria (e.g., sensitivity, specificity, accuracy).
- Any study design, test sets, training sets, ground truth establishment, expert qualifications, or adjudication methods for evaluating the device's performance against such criteria.
- A multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
Therefore, I cannot provide the requested information based on the input text.
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