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510(k) Data Aggregation
(261 days)
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
The intended use of a compression sleeve is to aid in blood circulation in bed confined patients, to prevent deep vein thrombosis and pulmonary embolism.
The intended use of a compression sleeve is to increase venous blood flow in bed-confined patients, to prevent deep vein thrombosis and pulmonary embolism.
Compression sleeves come in 3 adjustable sizes for the leg, one size for the knee and various sizes for the foot. They are composed of either a plastic or cloth cover, over one or more plastic or rubber bladders. There are one or more plastic tubes leading from the bladder to a connector that attaches to a compressor. All work on the same principal, a compressor inflates the bladder(s) with air to squeeze the blood out of the foot or leg and deflates to allow the blood to flow back into the foot or leg. On many of the machines, air pressure can be adjusted to allow for the length and thickness of the leg.
Acceptance Criteria and Device Performance Study for Reprocessed Compression Sleeves
The provided document describes the 510(k) premarket notification for Medical Instruments Technology, Inc.'s reprocessed compression sleeves, seeking substantial equivalence to the Kendall Sequential Compression Device. The study focuses on demonstrating that the reprocessed devices maintain the same functional and technological characteristics as new devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Characteristics: | |
| - Color | Reprocessed devices were substantially equivalent to new devices. |
| - Dimensions | Reprocessed devices were substantially equivalent to new devices. |
| - Damage | Reprocessed devices were substantially equivalent to new devices. |
| Performance Characteristics: | |
| - Ability to hold pressure | Reprocessed devices were substantially equivalent to the predicate device. |
| - Ability to release pressure | Reprocessed devices were substantially equivalent to the predicate device. |
| Biocompatibility: | No biocompatibility concerns exist with sequential compression devices reprocessed using MIT's procedures. |
| Technological Characteristics: | Same technological characteristics as the Kendall SCDs. Materials used in manufacture are not changed. No part affecting function is changed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the "test set" or the number of reprocessed devices subjected to detailed evaluation. It mentions "Testing by MIT has shown that the reprocessed devices are substantially equivalent..." and "MIT compared the reprocessed compression devices to the predicate device...".
The data provenance is retrospective, as the devices are reprocessed versions of existing products. The country of origin of the data is United States, as Medical Instruments Technology, Inc. is based in Saint George, UT, and the submission is to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The evaluation seems to have been conducted by MIT's internal team.
4. Adjudication Method for the Test Set
The document does not describe any explicit adjudication method (e.g., 2+1, 3+1). The comparisons were made by MIT directly, implying an internal assessment rather than a formal expert panel adjudication process for discrepancies.
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, an MRMC comparative effectiveness study was not performed. This submission is for reprocessed medical devices, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance study was not done. The "device" in question is a physical reprocessed medical sleeve, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for performance comparison was primarily comparison to the new, predicate device. This involved:
- Direct observation and measurement for physical characteristics (color, dimensions, damage).
- Functional testing to assess pressure holding and release capabilities, likely against manufacturer specifications or observed performance of new devices.
Essentially, the "ground truth" was defined by the characteristics and performance of the original, new devices.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here, as this is not a machine learning or AI-based device. The reprocessed devices are compared against the predicate device to demonstrate functional equivalence, not to train an algorithm.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable, the establishment of ground truth for a training set is also not relevant to this submission.
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(199 days)
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
The intended use of the cutting and coagulation accessory is to ablate tissue and/or cauterize. The devices are indicated for use in joints such as, ankles, knees, hips, wrist, elbow, and shoulders.
The cutting and coagulation system consists of a system controller that is connected to a power source. Two cables extend from the system controller, one to a foot-pedal to allow the operator to control the device; the other cable leads to the wand portion, which functions in the surgical site. The wand is the accessory for which MIT has developed the reprocessing technology.
This submission (K012640) describes the reprocessing of electrosurgical wands. The document provided does not contain the detailed acceptance criteria or a study demonstrating that the reprocessed device meets such criteria in a format applicable to AI/ML device studies. This 510(k) is for a reprocessed electrosurgical wand, not an AI/ML device. Therefore, the questions regarding AI/ML device performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this submission.
However, based on the provided text, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices and adherence to general controls. The primary "study" or justification for acceptance is the assertion that the reprocessed device maintains the same technological characteristics and intended use as the original, legally marketed predicate devices.
Here's an attempt to structure the information based on the prompt, acknowledging that much of it is not relevant to a traditional AI/ML device evaluation:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: The reprocessed device materials must be substantially equivalent to the original. | The only material change is the sheathing, which is replaced. The replacement sheathing is stated to be substantially equivalent and "actually acts as a better electrical insulator as shown in the dielectric test." |
| Technological Equivalence: The reprocessed device must have the same technological characteristics as the predicate devices. | "MIT's reprocessed electrosurgical devices have the same technological characteristics as the predicate devices. MIT does not change any of the design characteristics or materials during reprocessing." |
| Intended Use Equivalence: The reprocessed device must maintain the same intended use. | "MIT's unique reprocessing of the wands does not change their intended use. The intended use... is to ablate tissue and/or cauterize. The devices are indicated for use in joints such as, ankles, knees, hips, wrist, elbow, and shoulders." |
| Safety and Effectiveness: Implied by substantial equivalence to a legally marketed predicate device, and compliance with general controls. | Not explicitly detailed as a separate study with quantitative metrics in this summary, but the FDA's clearance implies this criterion was met. The dielectric test for the sheathing implicitly supports safety. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A). This K012640 submission is for a reprocessed medical device (an electrosurgical wand), not an AI/ML diagnostic or prognostic device requiring a test set of data for performance evaluation in the usual sense. The testing mentioned (e.g., dielectric test for sheathing) would have been performed on the reprocessed physical devices.
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)
- N/A. Ground truth in the context of expert consensus for AI/ML performance is not applicable to a submission for a reprocessed physical device. Device functionality and material equivalence are evaluated through engineering tests and comparison to specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable, as there isn't a "test set" requiring expert adjudication for this type of device submission.
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
- N/A. This is not an AI/ML device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A in the context of AI/ML ground truth. For this device, the "ground truth" for demonstrating equivalence would be based on:
- Predicate Device Specifications: The known design, material, and performance specifications of the original Mitek (K974022) or Arthrocare Wands (K962321).
- Engineering Tests: Such as the dielectric test mentioned for the sheathing, demonstrating specific physical properties.
- Functional Testing: Ensuring the reprocessed device performs its intended functions (ablation, cauterization) as expected.
8. The sample size for the training set
- N/A. Not an AI/ML device.
9. How the ground truth for the training set was established
- N/A. Not an AI/ML device.
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(87 days)
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
Disposable Arthroscopy Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Simus Surgery (FESS). The FESS application is limited to those small blades, which are appropriate for the procedure.
The arthroscopic blade is composed of stainless steel tubing with plastic connectors. A small tube is fitted within a larger tube. The distal ends of the tubes are serrated and/or sharpened. The proximal end of each stainless steel tube is insertion molded into plastic connectors. The inner tube is fitted into the outer tube. The inner tube rotates within the outer tube and creates a scissor action that cuts soft tissue in the arthroscopy procedure. The assembled arthroscopic blade is connected to a power device that is adjusted by the clinician to rotate the inner tubing during use at the selected RPMs. Depending on the size and configuration of the device, the inner tube may be fitted with a plastic sheathing, or copper bearings, may be plated with an alloy such as nickel/tin and may be lubricated to facilitate rotation within the outer shaft. In addition the inner and outer tubes must be straight with no bends or kinks to ensure adequate rotation of the shafts during use. Burs must be absent from the cutting edges to prevent inadequate rotation and freezing up of the inner shaft during use.
Reprocessed Arthroscopic Blade
Note: The provided text describes the regulatory submission for a reprocessed medical device, not an AI/ML powered device. Therefore, many standard AI/ML study components (like expert ground truth, MRMC studies, training set details) are not applicable and will be marked as "Not Applicable". The study focuses on demonstrating substantial equivalence through performance and biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" are implied by showing the reprocessed device performs "equal to, or better than" the predicate device in specific tests.
| Test | Acceptance Criteria (Implied: Equal to or better than predicate) | Reported Device Performance (Reprocessed device vs. Predicate) |
|---|---|---|
| Free-spin test | Must perform equal to or better than predicate | Performed equal to or better than predicate (specifically, replacement sheathing acts as a better friction barrier) |
| Cut-test | Must perform equal to or better than predicate | Performed equal to or better than predicate |
| Shed test | Must perform equal to or better than predicate | Performed equal to or better than predicate |
| TOC test | Must demonstrate substantial biocompatibility | Passed, demonstrating substantial biocompatibility |
| ETO residual test | Must demonstrate substantial biocompatibility | Passed, demonstrating substantial biocompatibility |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each test (free-spin, cut, shed, TOC, ETO residual). It refers to "the reprocessed devices" and "predicate devices" generically.
- Sample Size: Not explicitly stated for each test.
- Data Provenance: Not explicitly stated, but the tests were performed by "MIT" (Medical Instruments Technology, Inc.), suggesting internal testing. The submission does not specify country of origin for test data, nor if it was retrospective or prospective, though it would logically be prospective testing conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is not an AI/ML study involving human expert interpretation for ground truth. Performance was assessed through objective physical and chemical tests.
4. Adjudication Method for the Test Set
- Not Applicable. This is not an AI/ML study involving human interpretation or adjudication. Test results would be quantitative measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not done. This is a submission for a physical medical device, not an AI/ML diagnostic or assistive tool.
6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in the context of device performance. The tests (free-spin, cut, shed, TOC, ETO residual) were performed on the devices themselves to assess their inherent physical and chemical properties and performance, without human "in-the-loop" interpretation as would be relevant for an AI algorithm.
7. The Type of Ground Truth Used
- Benchmark Performance: The ground truth for performance tests (free-spin, cut, shed) was based on the performance of the legally marketed predicate device (Dyonics Shavers K833587).
- Established Standards: For biocompatibility tests (TOC, ETO residual), the ground truth would be established safety and biocompatibility standards and acceptable limits for residual ethylene oxide and total organic carbon.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML study; there is no "training set" in the conventional sense. The "training" for their reprocessing procedure would involve process development and validation, not a data-driven model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for the reprocessing method itself would have been established through process validation studies to ensure consistent and effective reprocessing.
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(74 days)
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
The intended use of a tourniquet cuff is to restrict blood flow to a patient's limb during surgery.
Tourniquet cuffs are composed of either a plastic or cloth cover, over one or more plastic or rubber bladders. There are one or more plastic tubes leading from the bladder to a connector that attaches to a compressor. All work on the same principal, a compressor inflates the bladder(s) with air to restrict the blood flow in the limb during surgery.
Here's an analysis of the provided text regarding the acceptance criteria and study for Medical Instruments Technology, Inc.'s reprocessed tourniquet cuffs:
Acceptance Criteria and Device Performance Study for Reprocessed Tourniquet Cuffs
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Characteristics: | Reprocessed devices were "substantially equivalent" to new devices. |
| - Color | (Implicitly met, as "substantially equivalent") |
| - Dimensions | (Implicitly met, as "substantially equivalent") |
| - Damage | (Implicitly met, as "substantially equivalent") |
| Performance Characteristics: | Reprocessed devices were "substantially equivalent" to new devices. |
| - Ability to hold pressure | (Implicitly met, as "substantially equivalent") |
| Bio-compatibility & Cleanliness: | Met. |
| - Freedom from residual bioburden | Achieved through washing procedure utilizing chosen cleaning agents. |
| - Freedom from residual cleansers | Achieved through rinsing after washing. |
| - Continued cleanliness | Achieved by packaging in an environmentally controlled room. |
| Sterilization & ETO Residuals: | Met. |
| - Sterilization system validation | ETO sterilization system validated. |
| - Acceptable residual ETO levels | Residual ETO testing performed and reduced to an acceptable level. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It broadly refers to "reprocessed tourniquet cuffs" and "the predicate device" during comparisons.
The data provenance is internal to Medical Instruments Technology, Inc. and is retrospective, as the testing was performed on their reprocessed devices and compared against an existing predicate device (Instrumed, Color Cuff K890014).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set in the traditional sense of clinical or diagnostic evaluation. The assessments seem to be engineering and performance-based comparisons conducted by MIT.
4. Adjudication Method
The document does not describe an adjudication method for the test set, as there is no indication of multiple reviewers or differing interpretations of results requiring resolution. The evaluation appears to be a direct comparison against pre-defined parameters by MIT staff.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic imaging or interpretation tasks where human readers make assessments. The device in question is a reprocessed medical instrument, and the evaluation focuses on its physical and performance characteristics, not human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The entire evaluation described is a standalone assessment of the reprocessed device's physical and performance characteristics, comparing it directly to the predicate device without human-in-the-loop performance being a factor. The "algorithm" here is the reprocessing procedure and subsequent quality checks, which are evaluated on their own merits.
7. Type of Ground Truth Used
The "ground truth" for the test set was essentially the characteristics and performance of the new predicate device (Instrumed Color Cuff K890014). The reprocessed cuffs were evaluated for "substantial equivalence" against this established benchmark.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of device evaluation. This concept is typically associated with machine learning or AI models. The evaluation here is for a physical medical device, not a software algorithm that would require training data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned or implied, the method for establishing its ground truth is not applicable.
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