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The Universal Drive System functions as a powered instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: Orthopedic, Oral/Maxillofacial, Otolaryngological, Arthroscopic, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.

The Linvatec Universal Drive System is a modification of the Universal Drive System with the addition of three new handpieces used in large bone orthopedic procedures. The Universal Drive System was cleared under 510 (k) #K971059 on 6/18/97 for the following intended uses: Cutting of soft tissue and bone in Orthopedic, Oral/Maxillofacial, Otolaryngological, Arthroscopic, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.

The Universal Drive System consists of an AC powered drive console, a sterilizable handpiece cord, various motorized handpieces, various shavers, blades, burrs, drills, routers, and a foot switch.

The modification will take place within the Universal drive console power unit. A software computer chip will be upgrade to allow the use of additional motorized handpieces for large in order to have more available current to drive the large bone handpieces.

Three handpieces used in large bone orthopedic procedures will be added to the system. The new handpieces include single trigger modular, dual trigger modular handpiece and an oscillating saw. These handpieces are similar in design to the Hall® Versipower® Plus handpieces. The handpieces will be sold with a detachable handpiece cord. The detachable handpiece cord will allow the handpieces run on the same console. The new handpieces will to perform as the Versipower® Plus handpieces described in the predicate information.

The accessories used with the system include shavers, blades, burrs, drills, and routers as described in 510(k)# K971059.

The Linvatec Universal Drive System's 510(k) submission (K981269) does not provide a table of acceptance criteria, device performance, or details about a specific study designed to prove the device meets acceptance criteria in the manner typically expected for AI/ML medical devices. This document is a premarket notification for a traditional medical device (a surgical drive system) submitted in 1998, long before AI/ML-driven device evaluation frameworks were established.

Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary regulatory pathway for devices of this type at that time.

Here's an analysis based on the provided text, addressing the points where information is available or applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission. The document states: "Testing has been done to prove safety and effectiveness of the devices," but it does not present a table of specific acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) or quantifiable performance metrics for the Universal Drive System. The "performance" in this context refers to its ability to perform its intended function similarly to predicate devices.

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

Not applicable. This is a mechanical surgical device, not a diagnostic or prognostic AI/ML device that would typically involve test sets of patient data. The "testing" mentioned would likely refer to engineering verification and validation tests (e.g., torque, speed, durability) in a lab setting, not a "test set" of patient data.

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

Not applicable. As above, this type of ground truth establishment is not relevant for a surgical drive system.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. This type of study is relevant for AI-assisted diagnostic or prognostic tools where human readers interpret medical images or data. The Universal Drive System is a surgical instrument.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical instrument, not an algorithm.

7. Type of Ground Truth Used

Not applicable in the AI/ML sense. The "ground truth" for a device like this would be established through engineering specifications, performance standards, and comparison to the functional capabilities of the predicate devices. For example, if the device is spec'd to provide a certain RPM or torque, the ground truth is that it should meet or exceed that.

8. Sample Size for the Training Set

Not applicable. A "training set" is a concept for AI/ML model development, not for a traditional mechanical surgical tool.

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

Not applicable.

Summary of Device-Specific Information from the Text:

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices (Linvatec Universal Drive System K971059, Hall® Versipower® Plus Large Bone Instrument System K895198, and 3M™ Maxi-Driver™ Electric Powered Instrument System K951118).

• Device Description: The Universal Drive System is a modification of an existing Linvatec system (cleared under K971059) with the addition of three new handpieces (single trigger modular, dual trigger modular, oscillating saw) and a software upgrade to the console to provide more current for large bone handpieces.
• Intended Use: Cutting of soft tissue and bone in Orthopedic, Oral/Maxillofacial, Otolaryngological, Arthroscopic, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures. The new handpieces specifically target "Large Bone Orthopedic Procedures."
• Substantial Equivalence Justification: The new handpieces are described as similar in design and performance to the Hall® Versipower® Plus handpieces. The document implicitly asserts the safety and effectiveness through this substantial equivalence claim and states that "Testing has been done to prove safety and effectiveness of the devices," without providing further details on the nature or results of these tests within the provided text.

In essence, the "study" proving the device meets acceptance criteria in this context is the company's internal engineering verification and validation testing, which supports the claim of substantial equivalence to already cleared devices. The FDA's acceptance of the 510(k) (K981269 letter) confirms that the device is substantially equivalent and can be marketed subject to general controls.

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The Universal Drive System functions as a powered instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: Orthopedic, Otolaryngological, Oral/Maxillofacial, Arthroscopic, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.

The Universal Drive System is a combination of the entire MicroChoice® System and component Linvatec handpieces/blades/burrs of the Apex® Universal Drive System. Both systems and their intended uses are cleared by MicroChoice 510(k) #K942660 and Apex Universal Drive System 510(k)'s #K944476 & #K964548.

The Universal Drive System consists of a AC powered drive console, a sterilizable handpiece cord, various motorized handpieces, various shavers, blades, burrs, drills, routers, and a foot switch.

The modification will take place within the MicroChoice drive console power unit software. A computer chip will be upgraded to allow additional motorized handpieces from the Apex Universal Drive system for orthopedic and arthroscopic type procedures.

Three handpieces from the Apex Universal Drive System will be modified with a detachable handpiece cord. The detachable handpiece cord will allow the "Apex style" handpieces to run on the same console as the MicroChoice original handpieces. All new handpieces will perform as described in the previous 510(k) submissions.

The accessories including shavers, blades, burrs, drills, and routers from the Apex Universal Drive System will be used in addition to the MicroChoice System accessories. The shavers will have diameters of 2.0-6.0mm and lengths of 75-200mm.

The provided document is a 510(k) summary for the Linvatec Universal Drive System, submitted in 1997. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics described in your request.

Therefore, the document does not contain the specific information required to fill out the table and answer all the questions about acceptance criteria and a detailed study proving the device meets them. This filing process relies on bench testing and comparisons to existing devices, not typically extensive human clinical trials with endpoints like effect size or expert adjudication.

However, I can extract what is implied or directly stated regarding safety and effectiveness and the testing performed for substantial equivalence.

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

Based on the document's content, specific quantitative "acceptance criteria" are not explicitly stated in a table format, nor are detailed "reported device performance" metrics outside of general qualitative statements. The document focuses on demonstrating substantial equivalence to predicate devices. The implied acceptance criterion is that the new Universal Drive System would perform functionally similarly to the predicate devices for its intended surgical uses.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set sample size" in terms of patient data or clinical study subjects. The testing mentioned refers to bench testing for engineering and functional verification, not clinical trials. There is no information about data provenance (country of origin, retrospective/prospective clinical data) because the submission is for device modification and substantial equivalence, not a clinical study.

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. This type of submission relies on engineering and functional testing rather than expert-established ground truth from clinical cases.

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

Not applicable. No expert adjudication method is mentioned or implied 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

Not applicable. The device is a surgical drive system (drills, saws, handpieces), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. The device is a physical surgical instrument system, not an algorithm.

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

For this type of device, the "ground truth" for safety and effectiveness is largely based on:

• Engineering specifications and performance metrics: Verifying that motor speeds, torque, vibration, material strength, sterility, and electrical safety meet predefined standards and are comparable to predicate devices.
• Functional equivalence benchmarking: Testing that the modified system and new components perform surgical actions (cutting, drilling) in a manner consistent with, and as effectively as, the predicate devices.
• Compliance with recognized standards: Meeting relevant industry standards for medical devices.

No clinical "ground truth" from human patients (e.g., pathology, outcomes data) is described in this 510(k) summary.

8. The sample size for the training set

Not applicable. This refers to a physical device, not a machine learning algorithm that requires a training set.

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

Not applicable. This refers to a physical device, not a machine learning algorithm.

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The Apex Universal Drive System is utilized for shaving of soft tissue and bone during otolaryngological and reconstructive surgery. The drive system is reusable.

The Apex Universal Drive system contains a drive console, micro handpiece, blades/burrs/routers and foot switches.

The forward/reverse speed is being increased to reduce the incidence of bur chatter. The oscillation speed is being modified to increase the rate of resection.

The modification will take place within the drive console power unit software. A computer chip will be upgraded to allow the handpiece to run at a higher maximum rpm in forward/reverse and oscillate mode.

The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device called the "Apex™ Universal Drive System." This document is a regulatory submission to the FDA, and it describes modifications made to an existing device and compares it to predicate devices.

It does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be described.

Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary requirement for a 510(k) submission. The "testing" mentioned is to prove the safety and effectiveness of the modified device in comparison to the predicates, ensuring it doesn't raise new questions of safety or effectiveness.

Therefore, I cannot fulfill your request for specific acceptance criteria or the details of a study structured around proving those criteria, as the document does not provide this information.

However, I can extract information regarding device performance from the provided text and explain what type of "acceptance" is implied by this regulatory submission.

Implied "Acceptance Criteria" and Reported Device Performance (from the perspective of a 510(k) submission for substantial equivalence):

The implied "acceptance criteria" for a 510(k) submission like this are that the modified device is substantially equivalent to predicate devices and that the modifications do not introduce new questions of safety or effectiveness. The "device performance" in this context primarily refers to the operating specifications that are being modified and compared to predicates.

Rationale for change: "The forward/reverse speed is being increased to reduce the incidence of bur chatter. The oscillation speed is being modified to increase the rate of resection." (This implies the new performance is "better" or addresses a specific functional improvement while maintaining safety). |
| Substantial Equivalence in Design, Function, and Intended Use: The modified device should be substantially equivalent to predicate devices in its design, function, and intended use. This is demonstrated through a comparative analysis. | Design: Drive console, micro handpiece, blades/burrs/routers, foot switches. Modification is a software upgrade (computer chip) to allow for higher maximum RPMs.
Function: Utilized for shaving soft tissue and bone.
Intended Use: Otolaryngological and reconstructive surgery. |

Now, addressing the specific points of your request based on the absence of this information in the provided document:

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

   • See table above. Specific, quantifiable acceptance criteria with pass/fail thresholds for clinical performance (e.g., sensibility, specificity, accuracy against a gold standard) are not present in this document. The "performance" described is hardware specification, not clinical outcome.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • N/A. The document does not describe a clinical "test set" in the sense of patient data. It refers to "Testing has been done to prove safety and effectiveness of the devices" but provides no details on what was tested, sample size (e.g., how many devices or units), or data provenance. This likely refers to in-vitro or bench testing of the device's mechanical and electrical properties.

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. As there is no described clinical "test set" with patient data requiring expert consensus for ground truth, this information is not applicable.

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

   • N/A. Not applicable, as there is no described clinical test set requiring adjudication.

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 document predates the widespread use of AI in medical devices and describes a surgical drive system. An MRMC AI study is completely irrelevant to this device and document.

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

   • N/A. This is a hardware device (surgical drive system), not an algorithm or AI.

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

   • N/A. For this type of device and submission, the "ground truth" for safety and effectiveness is largely based on engineering principles, component specifications, and comparison to the known safety and effectiveness of predicate devices. There's no mention of pathology or outcomes data in the context of a new study for this specific 510(k). The "ground truth" for the new device's performance would be its measured RPMs, stability, etc., compared against design specifications and predicate performance.

8. The sample size for the training set

   • N/A. This is a hardware device submission, not an AI/ML algorithm that requires a training set.

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

   • N/A. Not applicable.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence for a hardware modification, not a clinical study on diagnostic accuracy or AI performance. Therefore, most of your requested information is not present or applicable.

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