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PANA SPRAY Plus is a lubricant to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization and is intended for use to clean and lubricate the dental and medical surgical handpieces.

PANA SPRAY Plus (PSP) is an alcohol-based general handpiece and air-motor lubricant. The lubricant is introduced into the handpiece through the air-drive pipe or the back end. PANA SPRAY Plus can be used for the maintenance of high speed handpieces, low speed handpieces, and air motors and should be used after each patient and prior to sterilization of handpiece and air motors. Additional testing has been conducted to support the claim for cleaning.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "PANA SPRAY Plus" device.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results typical of a device seeking de novo authorization or a PMA. As such, the information about "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of a 510(k) submission, meaning it refers to non-clinical performance testing against established standards and comparisons to predicate devices to demonstrate equivalent performance and safety. There is no mention of a traditional "study" with a test set of patients or human readers.

Acceptance Criteria and Reported Device Performance

The "PANA SPRAY Plus" device is a lubricant for dental and medical surgical handpieces, with an added claim for cleaning. The acceptance criteria are benchmarked against performance of predicate devices and relevant ISO standards.

• Bur extraction force
• Eccentricity
• Noise level
• Stopping torque
  All results were reported as "in compliance with ISO 14557." (This implies that the measured values for these parameters for PANA SPRAY Plus were within the acceptable ranges defined by ISO 14557 and comparable to the predicate.) |
  | Safety and Efficacy (General) | "The test results indicate that PANA SPRAY Plus is substantially equivalent to the predicate devices and does not raise new questions of safety or efficacy." |

Detailed Study Information (Based on provided text)

Given that this is a 510(k) summary for a Class I device (lubricant/cleaner), the "study" described is primarily non-clinical, involving laboratory testing and comparison to predicate devices, rather than clinical trials with human subjects.

1. Sample size used for the test set and the data provenance:

   • Cleaning Efficacy: The document states that "reprocessing/cleaning validation" was done "in accordance with FDA guidance." This typically involves testing a defined number of soiled devices, but the specific sample size for the cleaning test is not mentioned in this summary.
   • Biocompatibility: "Biocompatibility testing was conducted in accordance with ANSI/AAMI/ISO 10993-1." Specific sample sizes for cytotoxicity, sensitization, and irritation tests are not mentioned. These are typically in-vitro or animal studies.
   • Reliability & Durability: "Continues to meet all NAKANISHI, INC. internal requirements." The sample sizes for package vibration, unit drop, temperature testing, repeated usage, actual usage, and contra/turbine testing are not mentioned.
   • Functional Equivalence (ISO 14557): "Comparison testing was conducted using predicate K113674 to demonstrate performance equivalence for bur extraction force, eccentricity, noise level, and stopping torque." The sample size (number of handpieces tested, number of repetitions) for these comparisons is not mentioned.
   • Data Provenance: The testing was conducted by NAKANISHI, INC. (the manufacturer) or their contracted labs. The country of origin for the testing would likely be Japan or a region where Nakanishi Inc. operates, but it's not explicitly stated. The data is implicitly prospective as it was generated to support the 510(k) submission.

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

   • As this is non-clinical testing focused on physical performance, cleaning efficacy, and biocompatibility, the concept of "experts establishing ground truth for a test set" in the human diagnostic context isn't directly applicable. The "ground truth" for these tests is defined by the methods and acceptance criteria of the respective standards (e.g., FDA guidance for reprocessing, ISO 10993-1 for biocompatibility, ISO 14557 for handpiece performance).
   • Therefore, the "experts" involved would be those qualified to conduct and interpret these specific types of laboratory and engineering tests (e.g., microbiologists for cleaning validation, toxicologists for biocompatibility, mechanical engineers for functional performance). Their specific number and qualifications are not detailed in the summary.

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

   • None. This type of adjudication method is used in studies involving human interpretation or subjective assessments, typically for clinical endpoints or diagnostic accuracy. It is not relevant for the non-clinical performance and safety tests described here, where outcomes are quantitative measurements against defined standards.

4. 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. An MRMC study is not applicable to this device. This device is a lubricant/cleaner, not an AI-powered diagnostic tool or a device that assists human readers.

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

   • The concept of "standalone performance" typically applies to AI algorithms. This device is a physical product (lubricant/aerosol) and does not involve an algorithm. Therefore, this question is not applicable.

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

   • The "ground truth" is defined by the established scientific and engineering standards and methods utilized for testing:
     • Cleaning Efficacy: Ground truth is linked to the reduction of simulated soil as measured by validated laboratory methods, as per FDA guidance.
     • Biocompatibility: Ground truth is determined by the presence/absence of toxicological responses as per ISO 10993 methods.
     • Functional Performance (ISO 14557): Ground truth is established by the quantitative measurements (e.g., force, RPM, noise level) compared against the specified limits and ranges within the ISO 14557 standard.

7. The sample size for the training set:

   • This question is not applicable. This device is not an AI/machine learning device that requires a "training set."

8. How the ground truth for the training set was established:

   • This question is not applicable as there is no training set for this type of device.

Ask a specific question about this device

PANA SPRAY Plus is a lubricant intended to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization.

PANA SPRAY Plus is an alcohol-based general handpiece and air-motor lubricant. The lubricant is introduced into the handpiece through the air-drive pipe or the back end. PANA SPRAY Plus can be used for the maintenance of high speed handpieces, low speed handpieces, and air motors and should be used after each patient and prior to sterilization of handpiece and air motors.

This document, K131014, is a 510(k) Premarket Notification for a dental handpiece lubricant, PANA SPRAY Plus. It is not a document about an AI/ML medical device, and therefore, most of the requested information regarding AI/ML device testing criteria (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth) is not applicable to this submission.

The acceptance criteria and study proving device performance for the PANA SPRAY Plus are based on demonstrating substantial equivalence to a predicate device through non-clinical testing for reliability and durability.

Here's the information that can be extracted from the provided text, adapted to the context of this non-AI/ML device:

Acceptance Criteria and Device Performance:

• Acceptance Criteria: The device was evaluated to confirm it met "NSK America internal requirements for reliability (package vibration, unit drop, and temperature testing) and durability (repeated usage, actual usage, and contra/turbine testing)."
• Reported Device Performance: "The test results indicate that PANA SPRAY Plus met all NSK America internal requirements and is therefore substantially equivalent to the predicate device."

Table of Acceptance Criteria and Reported Device Performance:

Information Not Applicable or Not Provided for This Device (Common to AI/ML Device Submissions):

• Sample size used for the test set and the data provenance: Not specified for this type of non-clinical testing (e.g., for mechanical/chemical lubricant).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for lubricants is physical/chemical performance, not expert interpretation.
• Adjudication method for the test set: Not applicable.
• 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 (this is not an AI/ML device).
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this is not an AI/ML device).
• The type of ground truth used: For this device, the "ground truth" would be the fulfillment of pre-defined engineering and performance specifications for a lubricant (e.g., lubricating properties maintained after various stress tests, no adverse effects on handpiece function, package integrity). The document refers to "NSK America internal requirements."
• The sample size for the training set: Not applicable (this is not an AI/ML device; there is no training set).
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

This new device is a lubricant and is intended for use to lubricate the dental and medical surgical handpieces.

This new device is a lubricant and is intended for use to lubricate the dental and medical surgical handpieces.

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a dental handpiece lubricant called "Pana-Spray", indicating it is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, intended use, and general controls, but not specific performance criteria or a study proving those criteria are met.

Ask a specific question about this device