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The IntelliSense Drill is intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc. In Bicortical mode, the IntelliSense Drill is indicated to be used in bicortical long bone, such are the fibri, fiber, fibel, f.but, f.but, humerus, ulna, and radius.

The IntelliSense Drill device will contain a drill unit (with attached cable), Control Console, and Sterilization Tray. Proprietary Drill Bits and Drill Bit Bushing will be sold separately as accessories. The drill bits and companion bushings are sold as a pair and are disposable (single-procedure). The IntelliSense Drill's design combines the drilling and depth measurement processes into one procedure, which determines drill bit location. By monitoring the load placed upon the drilling mechanism, the precise location of the drill bit may be determined relative to the bone. Secondary depth monitoring will provide the measurement of the drill bit depth and appropriate screw size.

The provided document is a 510(k) premarket notification decision letter and summary for the McGinley Innovations IntelliSense Drill. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Stryker Total Performance (TPS) System, K943589).

However, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for clinical performance metrics such as accuracy, sensitivity, specificity, etc., typically associated with AI/ML device evaluations. This document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, which is a common pathway for Class I and some Class II medical devices.

Therefore, many of the requested details, particularly those related to clinical performance studies, ground truth establishment, sample sizes for test and training sets, and expert involvement, are not present in this type of regulatory submission.

Here's a breakdown of what can be extracted from the document in relation to your request, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics (e.g., accuracy, sensitivity, specificity). The acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device.
• Reported Device Performance: The document provides a comparison of technological characteristics with the predicate device, but not performance against clinical outcome metrics. The "performance" discussed is related to features and operational parameters.

Here's a table based on the provided "Table 5-1: Comparison of Proposed Device with Predicate Devices," focusing on features that might be considered performance-related, though not explicitly acceptance criteria in a clinical validation sense:

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable. This document summarizes a 510(k) submission based on substantial equivalence, primarily comparing design and technological characteristics, not clinical performance data from a specific test set. There is no mention of a test set, data provenance, or a study involving such. The unique feature of automated depth measurement is described, but it's not clinically validated with sample sizes in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not Applicable. As there is no clinical test set described, there is no mention of experts or ground truth establishment for such a set.

4. Adjudication Method:

• Not Applicable. No clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This document does not mention an MRMC study or any studies comparing human reader performance with or without AI assistance. The device ("IntelliSense Drill") is a physical surgical instrument, not an AI/ML diagnostic or assistive software in the typical sense that would require an MRMC study for assessing human reader improvement. Its "intelligence" is in automating depth measurement during drilling.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study:

• No. This is a hardware device with an automated feature. While the document describes the mechanism for depth measurement, it does not present a standalone performance study in the context of an "algorithm only" as typically applied to image analysis or diagnostic AI. The intelligence is embedded in the device's function.

7. Type of Ground Truth Used:

• Not Applicable. No clinical ground truth is discussed in this context. The "truth" for substantial equivalence lies in comparing design specifications and intended use with a legally marketed predicate device.

8. Sample Size for the Training Set:

• Not Applicable. The device is a physical instrument, not an AI/ML model that is "trained" on a dataset in the conventional sense. The "intelligence" for depth measurement would likely be based on engineering principles and calibrated during product development.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. (See #8) There is no training set for an AI/ML model described. The device's functionality would be based on engineering design and validation against physical principles and benchmarks, not "ground truth" derived from patient data.

In summary: The provided FDA 510(k) document is for a conventional surgical drilling device seeking market clearance based on substantial equivalence to an existing predicate. It highlights technological features rather than presenting clinical trial data typical of AI/ML software devices. Therefore, most of your specific questions related to AI/ML device evaluation criteria are not addressed by this document.

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Ortho Solutions sterile drill bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

All Ortho Solutions Sterile Single-Use Drills Bits are manufactured from common Stainless Steel materials that are either cold-worked or heat treated for hardness cutting durability and for corrosion resistance. Ortho Solutions sterile drill bits are available in various sizes and lengths, have a fluted design, and are either in a solid or cannulated form and may be calibrated. The Ortho Solutions drill bits have various end coupling mechanisms. Ortho Solutions drill bits will be provided to the user 'sterile'. Gamma Radiation will be used to sterilize the device.

The provided 510(k) summary for Ortho Solutions Sterile Drill Bits (K102743) states that the device is substantially equivalent to the Synthes K962913 Sterile Drill Bits. This means that the device's acceptance criteria and the study proving it meets these criteria are based on demonstrating equivalence, rather than a standalone clinical study with detailed performance metrics.

Here's the information extracted from the provided text, recognizing the nature of a 510(k) SE submission:

1. A table of acceptance criteria and the reported device performance:

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

• Sample size: Not explicitly stated as a separate test set. The claim of "identical" in material, geometry, and indications implies that the design and manufacturing specifications of the Ortho Solutions drill bits conform to the established characteristics of the predicate device (Synthes K962913). Demonstrating this identity typically involves detailed engineering comparisons and possibly verification testing on a sample of the manufactured devices, rather than a clinical "test set" in the traditional sense of a clinical trial.
• Data provenance: Not applicable in the context of a comparative effectiveness study or clinical trial. The data provenance would relate to the manufacturing specifications and design verification documentation of the Ortho Solutions device, showing its equivalence to the predicate. The predicate device's country of origin is not specified, but the manufacturing firm for the new device is based in the United Kingdom.

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

• Not applicable. Ground truth as established by experts for a test set (e.g., in an AI or diagnostic device context) is not part of this type of 510(k) submission. The "truth" here is the equivalence to the predicate device, which is a regulatory and technical assessment.

4. Adjudication method for the test set:

• Not applicable. There was no clinical "test set" requiring adjudication in the context of a clinical trial. The adjudication is regulatory, based on the FDA's assessment of the provided documentation for substantial equivalence.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging) involving human interpretation with or without AI assistance, which is not applicable to a surgical drill bit.

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. This is also relevant for AI/software-as-a-medical-device (SaMD) products, which does not apply to a physical surgical instrument.

7. The type of ground truth used:

• The "ground truth" in this context is the identity and performance characteristics of the predicate device (Synthes Sterile Drill Bits, K962913). The Ortho Solutions device's performance is demonstrated to be equivalent to this established standard. This is based on a technical and regulatory comparison, rather than pathology, expert consensus on clinical cases, or outcomes data from the new device itself.

8. The sample size for the training set:

• Not applicable. There is no concept of a "training set" for physical surgical instruments in this type of 510(k) submission. Training sets are relevant for machine learning algorithms.

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

• Not applicable, as there is no training set.

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Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.

The Anspach Irrigation Pump System is a stand-alone pump and pump control system, designed to deliver a constant flow of irrigation fluid by means of a peristaltic pump.
The Irrigation Tube, (the subject of this submission), is a fluid delivery device that functions as a component of the irrigation system, to draw fluid from a standard IV bag to a 1/16" OD accessory for delivery to the operating site. Tubing size determines the available flow range for the system, while the pump RPM determines the specific flow rate within that range.

The provided document, K063688, describes a 510(k) premarket notification for a device modification to a Surgical Irrigation System. This submission is for a device modification, specifically to the Irrigation Tube, and primarily relies on substantial equivalence to a predicate device (K030576). It does not contain an independent study with "acceptance criteria" and "reported device performance" in the typical sense of a clinical or performance study that would generate sensitivity, specificity, or similar metrics for a diagnostic device.

The document focuses on demonstrating that the modified irrigation tube maintains the same technological characteristics and intended use as the predicate device, with the only change being in its inner diameter, outer diameter, and length. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not applicable to this type of submission.

Here's the information extracted from the document, addressing the prompt's request where applicable:

1. A table of acceptance criteria and the reported device performance

Since this is a device modification for an irrigation tube, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device and adherence to relevant standards for materials and safety. There isn't a performance table with specific numerical metrics like accuracy or sensitivity for this type of device.

• Bio-safety - Cytotoxicity ISO10993-5 (EN 30993-5) - Pre-sterilized devices only.
• ANSI/AAMI/ISO 11737-1:1995 Bio burden - Pre-sterilized devices only.
• ANSI/AAMI/ISO 11137:1994 - Pre-sterilized devices only.
• AAMI TIR 27: 2001 Alternative (11137) - Pre-sterilized devices only. |
  | Electrical Safety (for the overall system): The system's electrical components must meet recognized safety standards. | - IEC 60601 and other similar recognized electrical safety standards. |
  | Quality System Compliance: Manufacturing must adhere to established quality management systems. | - Quality System(s) in addition to US Federal requirements: ISO9001, ISO13485. |
  | Functional Equivalence: The irrigation tube must function as a component of the irrigation system to deliver fluid as intended. | The Irrigation Tube functions as a component of the irrigation system, to draw fluid from a standard IV bag to a 1/16" OD accessory for delivery to the operating site. Tubing size determines the available flow range for the system, while the pump RPM determines the specific flow rate within that range. (This is a description of its function, implied to be equivalent to the predicate). |

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. This submission is for a device modification based on substantial equivalence, not a clinical study or performance evaluation requiring a test set of data samples. The modifications are physical dimensions of the tube.

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)

Not applicable. No test set requiring expert ground truth was mentioned.

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

Not applicable. No test set requiring adjudication was mentioned.

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

Not applicable. This device is a surgical irrigation tube, not an AI-assisted diagnostic tool or an imaging device to be read by human readers.

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

Not applicable. This device is a physical component (irrigation tube), not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. Ground truth, in the context of diagnostic or AI performance, is not relevant to this submission. The "ground truth" here is adherence to engineering specifications, material standards, and functional equivalence to the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

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The Explant® Osteonecrosis Intervention Implant Removal Kit is intended for removal of a Trabecular Metal™ Osteonecrosis Intervention Implant.

The instruments are supplied sterile in a preassembled kit. Two size kits are available; a 10mm ID kit and a 14mm ID kit. The 10mm kit cannot be used alone and must be used in combination with the 14mm kit. The instrument come preassembled to Zimmer Hudson Fitting Adaptors, allowing the Tubes to be driven via a Zimmer T-Handle or a Zimmer Power Driver. The Hudson fittings can be removed to expose a through-hole at the end of the tube to allow for removal of a specimen that remains in the coring tube. All components of these kits are single use only.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Explant™ Osteonecrosis Intervention Implant Removal Kit, focusing on its substantial equivalence to predicate devices, indications for use, and regulatory classification. It does not contain details about performance studies, acceptance criteria, or specific metrics like sample sizes, expert qualifications, or ground truth establishment.

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The Synthes Electric Pen Drive (EPD) System is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, reaming, decorticating, shaping and smoothing of bones and teeth in a wide variety of surgical procedures, including but not limited to general orthopedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive and spine surgery.

The Synthes Electric Pen Drive System consists of a console, handpieces, attachments, footswitch, and cutting tools. The console is connected to the mains by an electric cord, and includes connectors for the handpieces and the footswitch, as well as speed controls, torque limiting feature, and irrigation pump. The handpieces are pen-shaped, and will be available in two versions: 60,000 rpm and 90,000 rpm. The handpieces are connected to the console via a sterilizeable cord. The rotation speed of the motor can be controlled via the footswitch or a removable handswitch. Multiple attachments are available that have a quick-connect into the handpieces; these attachments accept various cutting tools, including drill bits, burrs and saw blades.

I apologize, but the provided text from the 510(k) summary for the "Synthes Electric Pen Drive (EPD) System" (K043310) does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a standard 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device. It includes:

• Sponsor and Device Name
• Classification and Predicate Device
• Device Description
• Intended Use Statement
• A general statement about comparative information supporting substantial equivalence.

Without specific performance data, statistical metrics, or details of a study, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. How training set ground truth was established.

This type of information is typically found in detailed validation reports or clinical study summaries, which are not part of the publicly available 510(k) summary document provided.

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Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.

Reprocessed Used Disposable Arthroscopic Blades and Burs are single use surgical devices used for resection of tissue within joint spaces under arthroscopic control. MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades Burs are composed of the same materials as currently marketed hand-manipulated Stryker and Dyonics Disposable Arthroscopic Blades/Burs sold new.

The provided text is a 510(k) summary for the reprocessing of used, disposable arthroscopic blades and burs. It focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, performance studies, or data related to AI or ground truth establishment.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, or information about MRMC, standalone, or AI studies based on the provided document. The document is about a reprocessed medical device, not an AI/ML-driven device, and does not describe any such studies.

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Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.

Arthroscopic blades and burs are single use instruments consisting of several tubes and designs. The inner blade rotation is driven by a motor. AMI intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready. Only dispossible, non angled arthroscopy blades and burs manufactured by Dyonics and Stryker, that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.

This is a 510(k) summary for Adven Medical, Inc.'s reprocessed used disposable arthroscopic blades and burs (K012694). This document pertains to the regulatory clearance of a reprocessed medical device, not a new AI-powered diagnostic or treatment device. Therefore, much of the information typically requested for AI/ML device studies (such as diagnostic accuracy metrics, MRMC studies, or training/test set details) is not applicable here.

The core of this 510(k) submission is to demonstrate substantial equivalence to a previously cleared predicate device, asserting that the reprocessed devices remain safe and effective for their intended use after reprocessing.

Here's an attempt to address the requested information based on the provided text, noting where specific AI/ML-related questions are not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this submission are primarily focused on demonstrating that the reprocessed devices:

• Can withstand the necessary cleaning and sterilization process.
• Do not have their physical characteristics or quality adversely affected.
• Remain safe and effective for their intended use.
• Are substantially equivalent to the new, legally marketed predicate device.

The document does not provide a table with quantitative performance metrics typical for new device clearances. Instead, it relies on the assertion that the reprocessed product is substantially equivalent to a cleared predicate.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of performance data, as would be expected for a diagnostic or AI device. The submission focuses on the reprocessing protocol (Protocol Number 40006) for commercially available devices. The data provenance would relate to the validation of this reprocessing protocol, but specific numbers or details are not provided in this summary.

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

Not applicable. This is not a study assessing the diagnostic accuracy or performance of an AI model with ground truth established by experts.

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

Not applicable.

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

Not applicable. This device is not an AI-powered tool for human readers.

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

Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this type of submission is the demonstrated safety and effectiveness of the original, new single-use device (the predicate device, Smith & Nephew Dyonics K953695) and the evidence that the reprocessing protocol maintains these characteristics. This is achieved through validation of the cleaning, sterilization, and functional integrity after reprocessing, rather than a diagnostic "ground truth."

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

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Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery.

AMI intends to reprocess all brands of used disposable surgical saw blades, burs, bits and taps. Reprocessing includes all the steps performed to make a contaminated single use device patient ready.

Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.

AMI intends to market used disposable surgical blades, burs, bits and taps that have been reprocessed. Reprocessing blades, burs, bits and taps is performed by AMI to AMI protocol Number 40014. "Reprocessed," means all operations performed to render a contaminated singleuse device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals).

AMI is a "third party reprocessor" and reprocesses used single-used medical devices.

Used blades, burs, bits and taps that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the item is not reprocessed at all) or anytime during subsequent reprocessings.

AMI believes that used single-use blades, burs, bits and taps can be considered "reusable" as defined in the Food and Drug Administration Compliance Policy Guide #7124: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.

Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery.

AMI reprocessed blades, burs, bits and taps are composed of the same materials as currently marketed blades, burs, bits and taps sold new.

Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) are reprocessed by Adven Medical, Inc.

The information provided does not contain details about specific acceptance criteria or a study that evaluates device performance against such criteria. The document is a 510(k) summary for reprocessed surgical blades, burs, bits, and taps, outlining the manufacturer's intent to market these reprocessed devices and asserting their substantial equivalence to new, disposable devices already on the market.

Instead of performance metrics, the key aspects discussed are:

• Substantial Equivalence: The primary claim is that the reprocessed devices are substantially equivalent to new disposable devices. This is based on their ability to withstand cleaning and sterilization, their material composition (same as new devices), and their intended use.
• Reprocessing Protocol: Adven Medical, Inc. (AMI) has a specific protocol (Number 40014) for reprocessing these devices, and devices that do not meet this protocol are rejected. This protocol itself acts as a form of internal acceptance criteria for reprocessing.
• Regulatory Compliance: The FDA review confirms that the device is substantially equivalent for the stated indications of use and can be marketed under general controls provisions of the Act.

Therefore, I cannot populate the requested tables and information based on the provided text, as it does not describe a performance study with acceptance criteria in the typical sense for a medical device. It focuses on the process of reprocessing and the assertion of equivalence to existing devices, rather than a standalone performance evaluation with specific numerical targets.

If there were a study, one might expect to see:

• Mechanical testing (e.g., sharpness, torque, tensile strength) before and after reprocessing.
• Biocompatibility testing to ensure no harmful residues.
• Sterility assurance level (SAL) validation.

None of these are present in the provided text.

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The AV Core System is a system of cannulated trephines and drills used to obtain and insert a contoured bone graft into a matched hole in the femoral head. The use of the system is indicated for patients suffering from Avascular necrosis, in which the head does not suffer from collapse or degenerative changes.

The AvCore System comprises of a series of trephines and purchased canulated drill bits of matched size, used to obtain a appropriate sized and contoured bone graft in the treatment of avascular necrosis of the femoral head. The device is classified under the nomenclature of drills, burs, Trephines & accessories ( compound, powered). The product code is 84HBF and regulation number 882:4305 and is a Class II device.

I'm sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.

The document is a 510(k) summary for the AvCore System, which is a set of trephines and drills used to obtain and insert bone grafts for avascular necrosis of the femoral head. The focus of the document is on establishing substantial equivalence to pre-amendment devices and other currently marketed trephines, rather than on reporting on specific performance studies or acceptance criteria for the AvCore System itself.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions about studies, sample sizes, ground truth, experts, or MRMC studies.

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Aesculap's HilLan Motor System is a high-speed pneumatic motor system intended for use in surgical procedures to drive handpieces which cut and shape bone. It is indicated for use in orthopedics, spine, and plastic/reconstructive (i.e. maxillofacial and craniofacial) procedures.

The Hillan Pneumatic Motor System consists of a small hand held motor, an air hose, a foot control, a pneumatic motor hose, and various handpieces. The system components connect to each other via a proprietary coupling system.

The provided document is a 510(k) summary for the Aesculap HiLan Motor System, a pneumatic motor system for surgical procedures. It details the device description, intended use, technological characteristics, and a substantial equivalence review by the FDA.

Based on the provided text, the document states there are no applicable performance standards for this device under Section 514 of the Food, Drug and Cosmetic Act. Instead, the motor system is manufactured in accordance with ISO and German DIN Standards, and Aesculap AG has received ISO 9001 certification.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or the specific type of ground truth used for training or testing. The approval is based on "substantial equivalence" to predicate devices already on the market, rather than a detailed performance study against specific acceptance criteria.

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