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The BE-ST NAV PAK is indicated for navigated pedicle pilot hole preparation. The BE-ST NAV PAK should only be used with a compatible Medtronic StealthStation® System.

The BE-ST NAV NIM® PAK is indicated for navigated pedicle pilot hole preparation, locating, and identifying nerves during surgery, including spinal nerve roots. The BE-ST NAV NIM® PAK should only be used with compatible Medtronic StealthStation® and Medtronic NIM® Systems.

The BE-ST Navigated PAK Needles are single use surgical instruments composed of stainless steel and plastic. They are sterile packaged. The devices are comprised of three main components: the cannula, stylet assembly, and tracker subassembly.

There are two devices in the family: the BE-ST Navigated NIM® PAK Needle and the BE-ST Navigated PAK Needle. The BE-ST Navigated NIM® PAK Needle is an accessory to the Medtronic StealthStation® System and is intended for use as a stimulating accessory to the Medtronic NIM® System. The BE-ST Navigated PAK Needle is an accessory to the Medtronic StealthStation® System.

The only significant differences between the two subject devices are the electrical insulation on the cannula and the connection to the NIM® System. The BE-ST Navigated PAK device has the same basic function and navigational capabilities as the BE-ST Navigated NIM® PAK device but is not an accessory to the Medtronic NIM® system and therefore cannot be used for nerve monitoring.

The provided document is a 510(k) Summary for the BE-ST Navigated PAK Needles. It describes the device, its indications for use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner for most tests (e.g., minimum tensile strength), but rather by concluding that the devices "passed" or "successfully completed" the tests. However, one specific quantitative acceptance criterion is mentioned: the device navigational accuracy met "the confidence/reliability tolerance interval requirement." Another is the "SAL of 10-6" for ETO sterilization.

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

The document does not explicitly state the sample sizes used for most of the performance tests. For "functional use and reliability testing," it mentions "the subject devices and the predicate devices" without specifying the number of units. Similarly, for biocompatibility, packaging, and age testing, only "finished devices" or "devices" are mentioned.

The data provenance is retrospective as the tests were conducted as part of the 510(k) submission process, using manufactured devices. There is no mention of country of origin of the data; it's implied to be from the manufacturer's testing or contracted labs.

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

This information is not applicable in the context of this device. The BE-ST Navigated PAK Needles are medical instruments for navigated pedicle pilot hole preparation and nerve monitoring. The "ground truth" for the performance tests is established through objective engineering and biological measurements (e.g., impact forces, electrical continuity, cell viability, sterility levels, accuracy measurements against a known standard from the StealthStation® System), not through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to the type of testing described for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., radiology reads) where discrepancies between readers need to be resolved. The performance data here is based on objective bench and lab testing.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves multiple human readers evaluating medical cases, often to compare the effectiveness of a diagnostic tool or AI assistance. The BE-ST Navigated PAK Needles are surgical instruments, not diagnostic AI software, and their evaluation focuses on technical performance and safety, not human interpretation of cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study, in the sense of an algorithm operating independently, was not performed because the device is a physical surgical instrument. However, the "device navigational accuracy and compatibility with Medtronic StealthStation® System" testing can be considered an evaluation of the device's technical performance in conjunction with the StealthStation® System, without explicit human variability being the primary focus of the test itself. The device's accuracy was tested against the StealthStation® system's inherent accuracy criteria.

7. Type of Ground Truth Used

For most tests, the "ground truth" refers to established engineering standards, material specifications, and biological safety limits.

• Functional Use & Reliability: Engineering specifications, predicate device performance, basic principles of mechanical and electrical integrity.
• Biocompatibility: ISO 10993 standards (e.g., in vitro cytotoxicity, irritation, systemic toxicity, hemolysis, sensitization, pyrogenicity).
• Sterilization: ISO 11135 standard (SAL of 10⁻⁶).
• Packaging: ISTA 1C Test standard, ISO 11607 standards, and typical packaging integrity tests (dye injection, seal strength).
• Age Testing: Controlled accelerated aging, followed by re-evaluation against functional and packaging integrity benchmarks.
• Surface Area: Dimensional measurements and comparison to predicate.
• Navigational Accuracy: The accuracy criteria set forth by the Medtronic StealthStation® System served as the ground truth/reference for navigational accuracy.

8. Sample Size for the Training Set

This information is not applicable. The BE-ST Navigated PAK Needles are physical medical devices, not AI/machine learning algorithms that require training sets. The development and testing revolve around engineering principles, materials science, and biological safety, not data-driven model training.

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

This information is not applicable as there is no training set for a physical medical device.

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The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are indicated for pedicle pilot hole preparation, locating, and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots.

The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are single use devices composed of stainless steel and plastic and are sterile packaged. The devices are comprised of two main components: the cannula and stylet assembly. Also, in the package are two monopolar cables: a subdermal needle electrode and a connecting cable. The NIM® PAK devices are available in standard "NIM® PAK" or longer "NIM® XPAK" configurations with 3 different types of tips: bevel, trocar or blunt. The blunt tips are only offered for the NIM® XPAK. In addition, there are three (3) NIM Pedicle Probes in lumbar, straight, and thoracic configurations. The BE-ST NIM® product family has a total of four (4) pedicle access needle configurations, three (3) pedicle probe configurations, and one (1) blunt configuration. All configurations are packaged with two (2) accessory monopolar cables. One cable is used to ground the patient and the other cable is used to connect the device to a Medtronic Neural Integrity Monitor (NIM®). The connection to the NIM® allows the subject device to provide stimulation to nerves.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured as requested:

Acceptance Criteria and Device Performance Study

The provided document describes the BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe (the 'subject device') and its substantial equivalence to predicate devices. The studies conducted are primarily focused on demonstrating this equivalence through various performance and safety tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test. Instead, it indicates that each test was successfully passed, demonstrating substantial equivalence or meeting specified requirements.

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

The document does not explicitly state the specific numerical sample sizes used for each test. For many tests (e.g., functional testing, electrical safety, biocompatibility, sterility), a sufficient number of devices would have been tested to ensure statistical validity and meet the requirements of the respective standards.

• Origin: The study was conducted by Boston-Endo Surgical Technologies, located in Bridgeport, CT, USA. The data provenance is presumed to be internal testing at their facility or through contracted testing laboratories.
• Retrospective/Prospective: The testing described appears to be prospective as it involves the physical testing of newly manufactured subject devices and their packaging to demonstrate their performance and safety.

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

The document does not mention the use of external experts or establishing ground truth through expert consensus for the presented performance data. The tests are primarily objective engineering and biological evaluations against established standards and predicate device performance. For the cadaver lab test, the "user needs (design inputs)" served as the "ground truth" criteria, but no specific number or qualification of experts is provided for its assessment beyond the internal team conducting the test.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned or applicable as the tests performed are objective, quantitative, and standardized evaluations, rather than subjective assessments requiring expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The device (a surgical nerve stimulator/locator and pedicle probe) is a physical tool, not an AI or imaging diagnostic device that would typically involve human readers interpreting cases.

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. The concept of an "algorithm only" or "standalone" performance is not relevant to this type of medical device. Its operation is always "human-in-the-loop" as it is used by a surgeon.

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests is based on:

• Established Standards: Adherence to international and national standards (e.g., IEC 60601-1, ISO 10993, ASTM, USP, ISO 11137, ISTA 1C).
• Predicate Device Performance: Demonstrating substantial equivalence to the performance characteristics of the legally marketed predicate devices (Medtronic Stimulation/Dissection Instruments, Ball-tip probes, K031003; Medtronic NIM Spine, K031510).
• Design Inputs/User Needs: For the cadaver lab, the successful outcome was measured against predefined user needs and design inputs (e.g., successfully creating a pilot hole, tapping, and fitting a pedicle screw).

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument; therefore, there is no "training set" in the context of machine learning or AI models. The development and validation process involved engineering design, material selection, and rigorous physical testing.

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

Not applicable. As a physical device, no training set or its associated ground truth was established in the context of statistical modeling or AI.

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Tissue grasping and control of bleeding of small vessels by bipolar coagulation.

The Bipolar Forceps device is a single use hand held insulated medical device approximately 295mm in overall length featuring a 190mm distance from the user's grasp to the tip. The bayonet offset is 1.5cm. The tips are Titanium Nitride coated and have polished contact surfaces 1.5mm wide by 1cm long. The device is offered in straight and 20 degree angled tips. The Bipolar Forceps are sold as a single use sterile packaged device used in general surgical procedures. The Bipolar Forceps are limited to maximum 70 watts and shall be used only by personnel with training in electrosurgical procedures and with compatible generators compliant with IEC 60601 requirements. The Bipolar Forceps are rated at 1000V peak and can be used with a compatible reusable pin plug cable (1.8mm pin, 5.8mm spacing). The Bipolar Forceps are single use disposable devices packaged in double blisters with Tyvek lid.

The provided text describes the 510(k) submission for the Boston Endo Surgical Technologies (division of Lacey Manufacturing) Bipolar Forceps. However, it does not contain a study explicitly designed to prove device performance against specific acceptance criteria in the manner typically seen for complex diagnostic or AI-driven medical devices.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (K032327 Modern Medical Bipolar Forceps) through a comparison of technological characteristics and performance testing to ensure safety and basic functionality.

Here's an breakdown of the information that is present, and what is absent from the provided text, in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicitly stated numerical "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy) or device performance beyond general functional and safety standards. The performance section focuses on safety and biocompatibility.

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

• Test Set Sample Size: The text mentions "animal tissue of various diameters" for the electrosurgical function testing. No specific sample size (number of animals, number of tissue samples) or details about the tissue types or conditions (e.g., healthy vs. diseased) are provided.
• Data Provenance: Not specified. It's internal company testing, likely conducted in a lab setting rather than clinical data from a specific country.
• Retrospective/Prospective: Not applicable in the context of this device's performance testing. The biocompatibility and safety tests are laboratory-based, and the functional testing on animal tissue is a controlled experimental setup.

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

• Number of Experts: Not applicable. The "ground truth" for these types of tests (biocompatibility, electrical safety, functional cutting/coagulation) is typically determined objectively by laboratory measurements and observation against established standards, not by expert consensus on clinical findings.
• Qualifications of Experts: Not applicable beyond the implicit assumption that the testers were qualified laboratory personnel.

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

• Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1 for clinical image interpretation) is not relevant for the type of testing described for this device.

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

• MRMC Study: No. This is a basic surgical instrument, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant to this submission.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

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

• Ground Truth: For biocompatibility tests, the ground truth is defined by the results of the specific ISO 10993 tests (e.g., presence/absence of cytotoxic effects, irritation, sensitization). For electrical safety, it's compliance with electrical standards. For functional testing, "properly cut and coagulated" acts as the objective ground truth against the expected performance of an electrosurgical device on tissue.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no training set in the typical sense.

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

• Ground Truth for Training Set: Not applicable.

Summary of the Study Demonstrated in the K131058 Submission:

The submission for the Bipolar Forceps primarily relies on design and material equivalence to a predicate device (K032327 Modern Medical Bipolar Forceps), coupled with benchtop and laboratory testing to ensure safety, biocompatibility, and basic functional performance.

The "study" that proves the device meets (implied) acceptance criteria consists of:

• Biocompatibility Testing: Performed according to ISO 10993 guidelines, FDA General Program Memorandum No. G95-1, and ODE Bluebook Memorandum G95-1. These tests (Cytotoxicity, Irritation, Sensitization) concluded the device was non-cytotoxic, non-irritating, and non-sensitizing.
• Performance Testing: Conducted after sterilization, using "animal tissue of various diameters" to simulate vessels at different power settings. The conclusion was that "The device properly cut and coagulated the tissue."
• Safety and Efficacy Testing: This included Electrical safety, Biocompatibility (reiterated), Packaging validation, Shipping & transportation, Aging Shelf Life, and Hi-Pot tests. All testing "found no issues of safety or effectiveness."

The core argument for substantial equivalence is that the new device is almost identical to the predicate, with the only significant difference being that the subject device is sterile and single-use, while the predicate is reusable. This difference does not alter the fundamental mechanism of action or intended use.

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