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510(k) Data Aggregation
(85 days)
MICROAIRE SURGICAL INSTRUMENTS, INC.
The MicroAire® 1000E System is indicated for use in cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and other bone related tissue in a variety surgical procedures. The applications include ENT, maxilliofacial, neurological, oral, orthopedic, plastic, podiatric and spinal surgery.
The MicroAire® 1000E System consists of an electric power supply, powerconnecting cable(s), a foot and/or hand lever power activation control, modular and unitized handpieces, modular head assemblies and accessories.
The provided text from K014060 is a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study proving the device meets said criteria.
This document is a premarket notification for fundamental equivalence to an existing device, the Stryker® HERMES-Ready™ Total Performance System (TPS™). The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a predicate device already on the market, meaning it has the same intended use and similar technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.
Therefore, I cannot extract the requested information from the provided text because it is not present. The document focuses on:
- Identification of the device and manufacturer.
- Identification of a predicate device (Stryker® HERMES-Ready™ Total Performance System).
- Assertion of substantial equivalence based on intended use, design, energy, materials, performance, safety, effectiveness, labeling, biocompatibility, and applicable standards.
- Description of the technological characteristics of the new device and a comparison to the predicate device.
- The FDA's decision letter granting substantial equivalence.
- Indications for use.
None of these sections discuss specific acceptance criteria or details of a study that would quantify the device's clinical performance against such criteria.
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(192 days)
MICROAIRE SURGICAL INSTRUMENTS, INC.
The MicroAire® PAD™ System is indicated for the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
The MicroAire® PAD™ System consists of two primary components: a pneumatic or electric reciprocating handpiece and a disposable cannula with attached suction tubing. The disposable cannula with attached suction tubing connects to an external suction sources that is not part of the PAD™ System. A disposable cannula with attached tubing is also available with a syringe to facilitate manual suction.
The pneumatic reciprocating handpieces operate with an air or nitrogen power supply. The handpieces are capable of driving the cannula through a stroke distance of 2.4-6mm (0.093-0.240in.) at a rate of 3500-4500 strokes per minute. The electric reciprocating handpiece is capable of driving a cannula through a stroke distance of 2.4mm (0.093in.) at a rate of 3500-4500 strokes per minute. The electric handpiece is powered and controlled by the MicroAire® Smartdrive™ electric console.
The cannula is essentially a blunt tipped hollow tube comprised of stainless steel with an attached PVC suction tube and optional syringe. The cannula internal diameter is approximately 3mm and ranges from 26-33cm in overall length. Fluid and tissue is aspirated through windows located near the tip of the cannula when the tubing is connected to a suction source. The number of windows varies between 3-6 openings with window lengths from 7-10mm at 2mm in width.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroAire® PAD™ System, structured according to your request.
Please note: The provided document is a 510(k) summary and FDA clearance letter for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a comprehensive study report typical of a clinical trial for a novel AI/software as a medical device (SaMD) product. Therefore, much of the requested information (especially regarding AI-specific criteria, human readers, ground truth establishment for training, etc.) is not present in this historical regulatory submission for a physical surgical device. I will extract what is available and note what is not.
Description of Acceptance Criteria and Study for MicroAire® PAD™ System
The MicroAire® PAD™ System is a surgical aspiration device indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for aesthetic body contouring. Its regulatory clearance (K981922) was based on demonstrating substantial equivalence to a legally marketed predicate device, with its performance affirmed through nonclinical evaluations and compliance with voluntary standards.
The document does not specify explicit "acceptance criteria" in a quantitative, pre-defined manner for device performance, as would be common for new AI/SaMD devices. Instead, it relies on demonstrating that the device functions as intended and safely, primarily through engineering specifications and in-vitro testing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (a mechanical surgical tool) and the document (510(k) summary), the "acceptance criteria" are implied by the performance specifications provided and tested.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Mechanical Reciprocating Action: | |
| Pneumatic Handpieces: Stroke Distance & Rate | Capable of driving cannula through a stroke distance of 2.4-6mm (0.093-0.240in.) at a rate of 3500-4500 strokes per minute. |
| Electric Handpiece: Stroke Distance & Rate | Capable of driving cannula through a stroke distance of 2.4mm (0.093in.) at a rate of 3500-4500 strokes per minute. |
| Tissue Penetration Force Reduction: | Reciprocating cannula reduced the magnitude of penetration force by approximately 70% compared to non-reciprocating cannulae in successive trials of in vitro animal experiments. |
| Aspiration Performance: | Demonstrated ability to aspirate physiological saline and a viscous wound cleansing solution (consistency similar to synovial fluid or mucus) with a vacuum pressure of 20 cm Hg for ten seconds. The reciprocating cannula did not affect the rate of aspiration. Specific volume measurements were taken (details in Appendix F, which is not provided). |
| Sterilization Efficacy (Multiple-Use Instruments): | Gravity Discharge: 35 minutes @ 270°F (132°C) with an 8-minute drying cycle. |
| Prevaccum System: 4 minutes @ 270°F (132°C) with an 8-minute drying cycle. (This demonstrates the ability to achieve sterility per AAMI's Good Hospital Practice). | |
| Sterilization Efficacy (Disposable Components): | Pre-sterilized at 25-40 kiloGray according to ANSI/AAMI/ISO 11137-1994 (Radiation Sterilization). |
| Electrical Safety (Electric Console): | Designed to meet the electrical safety requirements of UL-544 and IEC-601-1. |
| Biocompatibility/Material Safety: | Components comprised of materials with a long history of safety when incorporated in medical devices. |
| Compliance with Special Controls for Suction Lipoplasty: | The device "complies with appropriate voluntary standards designated as special controls to assure safety and effectiveness of the device in accordance with the requirements of 21 CFR §878.5040." (While stated, specific details of these "voluntary standards" beyond the mentioned sterility and electrical safety ones are not fully enumerated here, but are implied to be met to ensure substantial equivalence for a suction lipoplasty system). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" sample size in the context of a clinical study or a large dataset for algorithmic evaluation. The performance metrics reported (e.g., 70% force reduction, aspiration rates) are derived from "successive trials of in vitro animal experiments" and "laboratory tests" measuring aspirated fluid volume. The exact number of trials or animal subjects is not detailed in the summary.
- Data Provenance: The testing appears to be prospective, in-vitro laboratory testing and animal experiments conducted by MicroAire® Surgical Instruments. Country of origin for data is implicitly the USA, where MicroAire® is located. This is not a study involving human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a summary for a mechanical device, not an AI/SaMD requiring ground truth established by medical experts on diagnostic images or patient data. The "ground truth" for the performance tests would be the measured physical properties (e.g., force, volume, stroke rate) as determined by engineering and laboratory testing protocols.
4. Adjudication Method for the Test Set
- Not Applicable. There was no "test set" in the sense of a dataset requiring expert adjudication for ground truth. Performance was measured objectively in a laboratory setting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI/SaMD product. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is an electro-mechanical surgical device, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply. The device's performance characteristics (e.g., stroke rate, force reduction) are inherent to its mechanical design.
7. The Type of Ground Truth Used
- The ground truth for the performance evaluation was based on objective physical measurements from laboratory and in-vitro animal experiments (e.g., force transducers for penetration force, volume measurements for aspiration, RPM/stroke counters for mechanical rates).
- For safety, ground truth was established by adherence to recognized voluntary standards (e.g., AAMI for sterility, UL/IEC for electrical safety) and material biocompatibility.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/ML system and does not involve a "training set" in that context. The device design and engineering are based on principles of mechanics and fluid dynamics, not data-driven learning.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, there is no ground truth for it. The "truth" informing the device's design would be engineering principles, material science, and the clinical understanding of surgical aspiration.
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(89 days)
MICROAIRE SURGICAL INSTRUMENTS, INC.
The MicroAire PAD System is indicated for the removal of tissue or fluid from the body during general surgical procedures.
The MicroAire® PAD™ System differs from the predicate devices in that it possesses a powered reciprocating cannula. The small (2-6 mm), rapid stroke of the PAD" cannula simulates the manual hand motion that the surgeon would use during aspiration with the predicate devices. Thus, use of the PAD" System does not raise safety and effectiveness issues that are significantly different from those of the predicate devices. At the same time, the powered cannula minimizes surgeon effort by reducing the amount of necessary arm motion. Furthermore, the slight reciprocating action of the PAD" System facilitates the passage of the cannula through tissue. When the reciprocating action is not activated by the surgeon, the PAD" device functions in an identical manner to the predicate devices.
This submission pertains to the MicroAire® “Power Aspiration Device” PAD™ System, which is a surgical aspiration system. The main difference from predicate devices is its powered reciprocating cannula.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Claim | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Aspiration Rate | Comparable aspiration rate to predicate devices for both physiological saline and viscous solutions (like synovial fluid/mucus). | "There were no significant differences between the aspiration rates of the PAD™ System and the regular suction cannula. The reciprocating cannula did not affect the rate of aspiration." |
| Penetration Force | Reduced force required to enter soft tissue compared to non-reciprocating cannulae. | "The reciprocating cannula reduced the magnitude of penetration force by approximately 70%." |
| Sterility (Multiple-use components) | Compliance with AAMI's "Good Hospital Practice-Steam Sterilization and Sterility Assurance." | "Sterility of the multiple-use PAD™ instruments and power supply hoses can be achieved through the procedures detailed in AAMI's Good Hospital Practice-Steam Sterilization and Sterility Assurance." |
| Sterility (Disposable components) | Pre-sterilization according to ANSI/AAMI/ISO 11137-1994, "Sterilization of Health Care Products-Requirements for Validation and Routine Control-Radiation Sterilization." | "The disposable suction cannulae and tubing are pre-sterilized according to ANSI/AAMI/ISO 11137-1994, Sterilization of Health Care Products-Requirements for Validation and Routine Control-Radiation Sterilization." |
| Electrical Safety | Compliance with UL-544 and IEC-601-1 electrical safety requirements. | "The MicroAire® 6025 electric console is designed to meet the electrical safety requirements of UL-544 and IEC-601-1." |
| Biocompatibility / Material Safety | Components comprised of materials with a long history of safety when incorporated in medical devices. | "components of the MicroAire® PAD™ System are all comprised of materials with a long history of safety when incorporated in medical devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Aspiration Rate Study: The text indicates "The volume of aspirated fluid was measured several times for both tools." The exact sample size (number of repetitions or devices tested) is not specified.
- Penetration Force Study: No specific sample size is provided for the "in vitro animal experiments."
- Data Provenance: The studies are described as "Laboratory tests" and "Nonclinical evaluations... using in vitro animal experiments." This suggests the data is prospective and generated within a laboratory setting, likely in the US where MicroAire is based. Specific country of origin for the "animal experiments" is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a surgical instrument, and its performance evaluation focused on physical properties (aspiration rate, penetration force) and compliance with safety standards, not on diagnostic accuracy requiring expert interpretation of results.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements of physical properties, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is assessed. This submission is for a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies conducted (aspiration rate, penetration force, safety compliance) are standalone evaluations of the device's physical and functional properties without human interpretation of results being a primary endpoint. The device's function is evaluated intrinsically.
7. The Type of Ground Truth Used
- Aspiration Rate: The ground truth for comparative aspiration rate was the direct measurement of fluid volume aspirated under controlled conditions.
- Penetration Force: The ground truth for comparative penetration force was the direct measurement of force required for tissue entry.
- Sterility, Electrical Safety, Biocompatibility: The ground truth was established by adherence to recognized industry standards (AAMI, ANSI/AAMI/ISO 11137-1994, UL-544, IEC-601-1) and historical safety data for materials.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical surgical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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(42 days)
MICROAIRE SURGICAL INSTRUMENTS, INC.
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