Search Results

The Selectra accessory kit is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.

The Selectra accessory kit includes a variety of commonly used catheter accessories which are combined in a single package. The Selectra accessory kit includes the following components: 1 Selectra Slitter Tool, 1 Seldinger Guide Wire, 4 Transvalvular Insertion (TVI) Tools, 1 Syringe, 1 Torquer, 2 Stopcocks, 2 Check valves, 2 Sealing caps, 1 Technical Manual. The Selectra accessory kit may be used with the Selectra CS lead introducer system, BIOTRONIK's family of guiding catheters specifically used for the placement of coronary sinus leads.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than clinical performance studies with specific acceptance criteria in the way a clinical trial would. Therefore, many of the requested elements pertaining to clinical performance, ground truth, expert opinions, and AI effect sizes are not applicable here.

Here's a breakdown of what can be extracted from the provided text:

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

Since this is a Special 510(k) for a device modification, the "acceptance criteria" are primarily based on ensuring the modified device maintains the same characteristics and performance as the predicate device. The document explicitly states:

• Acceptance Criteria: The usage, indications for use, contraindications, and function of the Selectra accessory kit must remain unchanged compared to the predicate device (ScoutPro ACS accessory kit, K101776). The changes are "minor component modifications."
• Reported Device Performance: The document implicitly states that the device meets these criteria by asserting, "The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as indications for use, contraindications, and function, are the ScoutPro ACS accessory kit cleared on July 23, 2010 (K101776). Therefore, this previously cleared accessory kit will serve as the predicate device for the modified accessory kit included in this Special 510(k)."

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 (Special 510(k)) and is based on maintaining substantial equivalence to a predicate device, not on specific clinical trial data with a test set in the traditional sense. The evidence provided typically involves engineering and bench testing to demonstrate that the minor component modifications do not alter the safety or effectiveness of the device. There's no mention of a clinical "test set" from patients.

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. As noted above, this is not a study requiring expert-established ground truth on patient data.

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

• Not Applicable. No test set or human adjudication process for clinical data is described.

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 component kit for a lead introducer system; it does not involve AI or human readers for diagnostic interpretation.

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

• Not Applicable. This device is a physical medical accessory kit, not an algorithm.

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

• Not Applicable. The "ground truth" for this type of submission is the documented performance and characteristics of the legally marketed predicate device. The new device is compared against the predicate's established performance through engineering and design verification.

8. The sample size for the training set

• Not Applicable. There is no training set in the context of device modification for substantial equivalence.

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

• Not Applicable. There is no training set.

Ask a specific question about this device

The Spectra Guidewire Introducer Needle is intended to be used by medical professionals as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.

The Spectra Guidewire Introducer Needle is indicated for percutaneous introduction and placement of guidewires in vascular procedures.

The Spectra Guidewire Introducer Needle consists of a stainless steel needle and a colored translucent standard female Luer lock hub locking connector for rapid (flashback) visualization. The Spectra Guidewire Introducer Needle is available in a single-wall style with or without a Seldinger shield. The stainless steel needles are available with and without an echogenic feature. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need.

Spectra Guidewire Introducer Needles will be marketed as sterile, non-pyrogenic, and single use devices. Additionally, the device will be marketed as a guidewire introducer needle for use as an accessory in procedure kits. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The Spectra Guidewwire Introducer Needle will be incorporated into the procedure kit, packaged and sterilized.

The provided text describes the submission of a 510(k) premarket notification for the Spectra Guidewire Introducer Needle, arguing its substantial equivalence to predicate devices rather than claiming novel effectiveness. Therefore, the document does not contain a study that proves the device meets specific performance acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it focuses on demonstrating that the device is safe and effective for its intended use by meeting established standards and exhibiting similar technological characteristics to legally marketed predicate devices.

Here's a breakdown based on your request, highlighting what information is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The submission mentions that "The Spectra Guidewire Introducer Needle will meet all established acceptance criteria for performance testing" and that "Performance data gathered demonstrated that the Spectra Guidewire Introducer Needle is substantially equivalent to the noted predicate devices." However, the specific quantitative acceptance criteria (e.g., tensile strength, flow rates, sharp-ness specifications) and the precise reported performance values are not detailed in the provided text.

The acceptance criteria are generally framed around adherence to recognized standards for medical devices and comparison to predicate devices, rather than novel performance benchmarks.

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

The document states that "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols." However, the sample size used for the test set (i.e., how many devices were tested for performance, how many units of materials, etc.) is not specified.

Regarding data provenance, the testing would have been conducted by Spectra Medical Devices, Inc. or contractors they employed, likely in the US (given the company's address in Wilmington, Massachusetts). The data is retrospective in the sense that it was generated for the purpose of this 510(k) submission, not from a prospective clinical trial on human subjects. The type of data is primarily in vitro and bench testing data to demonstrate compliance with standards and equivalence.

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

This type of information is not applicable in this context. The "ground truth" for a medical device like an introducer needle in a 510(k) submission is established by engineering specifications, material standards, and comparisons to legally marketed predicate devices, not by expert consensus on clinical findings. Performance is measured against physical and chemical parameters, not against interpretations of medical images or patient outcomes by experts.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human expert assessment of data (e.g., radiology reads). In the context of a 510(k) for an introducer needle, "adjudication" is not a standard part of the device's technical performance testing. Device performance is determined by meeting pre-defined physical and material specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data, often with AI assistance. The Spectra Guidewire Introducer Needle is a physical surgical instrument, not a diagnostic imaging device or an AI algorithm intended to assist human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable. The Spectra Guidewire Introducer Needle is a physical medical device, not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

For this device, the "ground truth" for performance assessment is primarily based on:

• Established engineering specifications and material standards: These define what constitutes acceptable strength, biocompatibility, sterility, dimensions, etc. (e.g., ISO 11135, ISO 10993).
• Performance characteristics of predicate devices: The "ground truth" for equivalency is that the new device performs similarly to legally marketed devices that have already been deemed safe and effective. This is assessed via various physical and chemical bench tests (e.g., material compatibility, physical dimensions, functional tests implicitly covered by "design, materials, and method of use").

There is no "pathology" or "outcomes data" ground truth in the context of this 510(k) submission to demonstrate substantial equivalence of a guidewire introducer needle. Clinical outcomes would typically be part of a PMA (Premarket Approval) submission for a novel, high-risk device.

8. The Sample Size for the Training Set

This is not applicable. A "training set" refers to data used to train an algorithm or AI model. As established, this device is a physical medical instrument, not a software or AI product.

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

This is not applicable for the same reasons as point 8.

Ask a specific question about this device

Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.

Cardiac stabilization and positioning devices are specially designed devices used in minimally invasive cardiac surgery for coronary artery bypass grafting. The devices offer a retraction as well as a stabilizing function to control the movement of the beating heart. The cardiac stabilization and positioning devices consist of a combination of one or more of the following components: tissue stabilizer, heart positioner, and sternum retractor blades.

The provided text describes a 510(k) submission for "Reprocessed Cardiac Stabilization and Positioning Devices" (K070034). This submission focuses on demonstrating substantial equivalence to predicate devices for reprocessed medical instruments, rather than a novel AI or diagnostic device. As such, the typical acceptance criteria and study designs relating to AI performance (e.g., sensitivity, specificity, reader studies, ground truth establishment) are not applicable.

Instead, the submission details how the reprocessed device meets performance standards to be considered safe and effective, and equivalent to the original predicate devices.

Here's an analysis of the provided text based on your request, highlighting why some aspects are not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for each test (biocompatibility, reprocessing validation, etc.). It states that "Each individual Cardiac Stabilization and Positioning Device is tested for appropriate function of its components." This implies testing on multiple reprocessed units.

• Test Set Size: Not explicitly stated as a single "test set" in the context of an AI study.
• Data Provenance: N/A for this type of device. The "data" here refers to bench and laboratory testing results of the reprocessed devices themselves, not patient data.

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

This concept is not applicable here. Ground truth in the context of medical device reprocessing refers to validated standards for cleanliness, sterility, functional integrity, and biocompatibility, not expert interpretation of images or clinical data. No "experts" in the sense of clinical reviewers are mentioned for establishing ground truth on these performance tests.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are relevant for studies involving human interpretation or subjective assessments. The tests described are objective, laboratory-based performance tests with predefined pass/fail criteria based on engineering and regulatory standards.

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

No. This type of study is for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The device in question is a reprocessed surgical instrument.

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

N/A. This is an AI-specific concept. The "algorithm" here is the reprocessing procedure, and its performance is assessed via the various validations listed (biocompatibility, sterilization, function, etc.).

7. The Type of Ground Truth Used

The "ground truth" for the reprocessed device is established by:

• Validated Standards: For biocompatibility, sterility, and packaging.
• Original Device Specifications/Performance: For functional equivalence, ensuring the reprocessed device performs "as originally intended" and identically to the predicate device.
• Regulatory Requirements: For decontamination and overall safety/effectiveness.

8. The Sample Size for the Training Set

N/A. There is no "training set" in the context of reprocessed medical instruments. This term is specific to machine learning and AI algorithms.

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

N/A, as there is no training set.

Ask a specific question about this device

Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.

Cardiac stabilization and positioning devices are specially designed devices used in minimally invasive cardiac surgery for coronary artery bypass grafting. The devices offer a retraction as well as a stabilizing function to control the movement of the beating heart. The cardiac stabilization and positioning devices consist of a combination of one or more of the following components: tissue stabilizer, heart positioner, and sternum retractor blades.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Reprocessed Cardiac Stabilization and Positioning Devices, presented in the requested format:

Acceptance Criteria and Study Information (K070036)

This submission describes the reprocessing of existing cardiac stabilization and positioning devices. As such, the "device" being evaluated is the reprocessed version of already marketed devices. The performance evaluation focuses on demonstrating that the reprocessed devices are equivalent in safety and effectiveness to the original, brand-new devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test (Biocompatibility, Sterilization Validation, Function Test(s), Packaging Validation). The data provenance is described as "Bench and laboratory testing," implying internal testing conducted by Ascent Healthcare Solutions. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical data, as this submission pertains to reprocessing, not a new clinical device.

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

Not applicable. This submission is for reprocessed medical devices, and the "ground truth" is primarily based on meeting engineering and performance specifications of the original device, rather than expert interpretation of medical images or conditions. The testing would be conducted by qualified laboratory personnel and engineers, but the document does not specify their number or qualifications.

4. Adjudication method for the test set

Not applicable. The "tests" described are bench and laboratory tests (biocompatibility, sterility, function, packaging). These tests typically involve objective measurements against predefined specifications, rather than a subjective adjudication process by multiple experts.

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 submission is for reprocessed cardiac surgical instruments, not an AI-powered diagnostic device.

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

Not applicable. This submission is for reprocessed cardiac surgical instruments, not a software algorithm.

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

The "ground truth" for the reprocessed device's performance is essentially the established performance and safety profile of the original, predicate device. The studies (bench and lab tests) aim to demonstrate that the reprocessed device performs identically to this established baseline. Specific types of ground truth used include:

• Engineering Specifications: For function tests, comparing reprocessed device performance against original design specifications.
• Validated Protocols: For biocompatibility and sterilization, adherence to recognized standards and validated protocols.
• Material Properties: Ensuring reprocessed materials maintain their original properties.

8. The sample size for the training set

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

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

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

Ask a specific question about this device

Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery. Tissue Stabilizers are designed to stabilize and minimize the movement of localized areas of a beating heart during offpump cardiac surgery. Tissue Positioners are designed to lift and hold the heart in position during cardiac surgery.

Heart Stabilizers are retractor-based devices that consist of two tissue stabilizers attached to an articulating arm. The ends of the tissue stabilizers are spaced about 8 to 15 mm apart, nominally. The articulating arm fastens to a retractor by use of a mounting clamp. The arm is tightened and loosened by a large knob on the proximal end. As the arm tightens, the tissue stabilizers spread a minimum of 3 mm in an arc fashion. Each slightly curved tissue stabilizer is composed of four suction pods. With the pods placed on either side of the anastamosis site, suction is applied to stabilize the tissue.. A stopcock provides control of suction.

Heart Positioners are designed to be used in conjunction with the Tissue Stabilizer to facilitate access to and enhance exposure of the coronary arteries for coronary artery bypass procedures. The device is retractor-based and incorporates a silicone suction apparatus, an articulating arm and a mounting clamp. The silicone apparatus is attached to the surface of the heart by the application of regulated vacuum. The mounting clamp has been designed to be compatible with most adult median sternotomy retractors.

This submission is for reprocessed heart stabilizers and positioners, and the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full study with acceptance criteria and detailed performance data like a clinical trial for a novel device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted from this type of regulatory document. The focus here is on functional and safety testing to show the reprocessed device performs as intended and is equivalent to the original.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document mentions "representative samples" for functional testing and "all products produced" for manufacturing process testing, but no specific number of devices or tests.
• Data Provenance: Not specified, but generally, such testing would be conducted internally by SterilMed, Inc. It is retrospective in the sense that it's testing on devices that have undergone reprocessing.

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

• This is not applicable to a 510(k) for a reprocessed medical device. The "ground truth" here is the original device's performance characteristics, and the reprocessing is validated against maintaining those characteristics, not against expert interpretation of data.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study involving human readers or expert adjudication of ambiguous cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for AI-assisted diagnostic devices, which is not the nature of this reprocessed instrument.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Not applicable. This device is a reprocessed physical instrument, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used for this submission is the performance specifications and characteristics of the original, new Medtronic Octopus Tissue Stabilizer (and Positioner) (K964445). The reprocessing process and the reprocessed devices are validated to ensure they meet these established specifications, effectively performing identically to the new device.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

• Not applicable, as there is no training set.

Ask a specific question about this device

The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.

This SPECIAL 510(k) is being submitted for a design modification to the Intuitive Surgical EndoWrist Instruments to incorporate the functionality (vacuum stabilization, irrigation) of the Medtronic Octopus TE Tissue Stabilizer (class I, cardiovascular surgical instrument, Product Codes DWS and MWS, under CFR Section 870.4500) on an EndoWrist Instrument known as the EndoWrist Stabilizer. This modification affects the instrument only, and there are no changes to the da Vinci Surgical System associated with this pre-market notification.

The Intuitive Surgical EndoWrist Stabilizer is a multiple use instrument similar to existing EndoWrist instruments and has the following key features:

• The EndoWrist Stabilizer incorporates collapsible "pods" as grips that provide suction based tissue stabilization. The collapsible feature allows the instrument to be used through a 12mm thoracic port.
• A disposable, pre-packaged sterilized tubing assembly known as "ClearField" tubing is used to connect the instrument to pressurized irrigation fluid to irrigate the surgical site reducing the amount of blood on the stabilized tissue.
• A disposable, pre-packaged sterilized tubing assembly known as "CardioVac" tubing provides vacuum suction to the stabilizer pods from the Vacuum Source tubing described below.
• A disposable, pre-packaged sterilized tubing assembly known as "Vacuum Source" tubing that connects the CardioVac tubing to a canister with a four-meter vacuum hose, and also includes a two-meter vacuum hose (with filter) to connect to a regulated vacuum source.

The Intuitive Surgical Endowrist Stabilizer is used with the da Vinci Surgical System Model IS2000, which is also known as the da Vincis S™ Surgical System. The surgeon sits at a Surgeon Console and controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The EndoWrist Stabilizer is operated in the same way as other Intuitive Surgical EndoWrist Instruments, and the surgeon "locks" the stabilizer in position by switching MTM control away from the arm holding the tabilizer instrument by tapping a foot pedal on the Surgeon Console.

The provided text describes a 510(k) Special submission for a design modification to the Intuitive Surgical EndoWrist Instruments, incorporating vacuum stabilization and irrigation functionality. This is a medical device submission, and as such, the concept of "acceptance criteria" is typically met through demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit numerical performance targets like those found in AI/ML performance studies.

Therefore, the "acceptance criteria" here refer to proving that the modified device is as safe and effective as the predicate devices, and that the design output meets the design input requirements without raising new safety or effectiveness concerns.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

• Safety and effectiveness are comparable to legally marketed predicate devices.
• No new issues of safety or effectiveness are introduced. | - "Design Analysis and comparison, as well as bench testing, has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited..."
• "...results of the design control process confirm that the design input meets the design output requirements, and that there are no new issues of safety or effectiveness." |
  | Functional Equivalence (Vacuum Stabilization and Irrigation):
• The incorporated vacuum stabilization and irrigation features perform comparably to the predicate Class I tissue stabilizer. | - "The vacuum stabilization and irrigation features are identical to the Medtronic Octopus TE Tissue Stabilizer and accessories cleared by FDA under K041338."
• "...the stabilizer end effector and irrigation is the same as the Octopus TE Stabilizer (Medtronic)." |
  | Compatibility with da Vinci Surgical System:
• No changes in design, technology, materials, manufacturing, performance, specifications, or method of use for the da Vinci Surgical System. | - "This modification affects the instrument only, and there are no changes to the da Vinci Surgical System associated with this pre-market notification."
• "The Intuitive Surgical Endowrist Stabilizer is used with the da Vinci Surgical System Model IS2000, which is also known as the da Vincis S™ Surgical System." |
  | Controlled Delivery and Use:
• Instrument operation is consistent with other EndoWrist Instruments, allowing the surgeon to "lock" the stabilizer in position. | - "The EndoWrist Stabilizer is operated in the same way as other Intuitive Surgical EndoWrist Instruments, and the surgeon 'locks' the stabilizer in position by switching MTM control away from the arm holding the tabilizer instrument by tapping a foot pedal on the Surgeon Console." |
  | Material and Technological Characteristics:
• Materials and technological characteristics are consistent with predicate devices for the robotic operation and architecture. | - "The technological characteristics of the subject device are the same as for the predicate device(s). The robotic operation and architecture are the same as existing Intuitive Surgical EndoWrist Instruments..." |

Study Details

The provided document describes a 510(k) Special submission, which generally focuses on demonstrating substantial equivalence for a modification to a previously cleared device. It is not a clinical trial or performance study akin to those for AI/ML devices with specific numerical performance metrics.

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

   • The document mentions "bench testing" but does not specify a sample size for any test set (e.g., number of instruments tested or specific conditions).
   • Data provenance is not explicitly stated but would typically be internal testing conducted by the manufacturer, Intuitive Surgical, Inc. This is not a clinical study with patient data.

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

   • This concept is not applicable to this type of submission. "Ground truth" established by experts is relevant for diagnostic or AI/ML-driven devices where accuracy against a known standard is measured. Here, the focus is on functional verification against design requirements and comparison to predicate devices. The "ground truth" is primarily engineering specifications and functional performance.

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

   • This is not applicable. Adjudication methods are typically used in clinical studies or expert review processes for diagnostic accuracy, which is not the nature of this submission. The "adjudication" is essentially the manufacturer's internal quality and design review process, and ultimately the FDA's regulatory review.

4. 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 done. This type of study is specifically designed for evaluating the impact of an AI assistance tool on human performance (e.g., radiologists reading images with and without AI). The Intuitive Surgical EndoWrist Stabilizer is a surgical instrument, not an AI diagnostic or assistance tool.

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

   • No, this is a physical surgical instrument modification, not an algorithm. Therefore, a standalone algorithm-only performance study is not relevant.

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

   • The "ground truth" for this regulatory submission is primarily based on engineering specifications, functional requirements, and direct comparison to the physical and functional characteristics of legally marketed predicate devices. This includes:
     • Demonstrating that the vacuum stabilization and irrigation capabilities are "identical" to the Medtronic Octopus TE Tissue Stabilizer.
     • Ensuring the instrument's mechanical and operational characteristics are "the same as" existing Intuitive Surgical EndoWrist Instruments.
     • Confirmation through "Design Analysis and comparison, as well as bench testing" that functional characteristics are met.

7. The sample size for the training set:

   • This concept is not applicable. "Training set" refers to data used to train an AI/ML algorithm. This submission is for a physical surgical instrument.

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

   • This concept is not applicable. There is no training set for a physical surgical instrument.

Ask a specific question about this device

The Medtronic Octopus TE Stabilizer is used to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used by trained medical professionals in operating room environments.
The Stabilizer is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.

The non-sterile, reusable Medtronic Octopus TE Heart Stabilizing System is a suction-based tissue stabilizer with a collapsible pod assembly, a rigid shaft and 5 articulating links designed to enable transfer into the thoracic cavity via a 12 mm thoracic port or traditional sternotomy access. It is comprised of four distinct elements: (1) the Medtronic Octopus TE Tissue Stabilizer, (2) the Medtronic Octopus TE Suction Lines, (3) the Medtronic Octopus TE Vacuum Lines, and (4) the Medtronic Octopus TE Irrigator (optional).
The Medtronic Octopus TE Heart Stabilizer is secured to a flexible arm and universal mounting rail, which attached to the operating table rail. Vacuum is delivered to the pod assembly by a disposable suction line inserted through the shaft of the stabilizer and a disposable vacuum line that connects the stabilizer to the vacuum source. The accessories are sold separately.

The provided text is a 510(k) summary for the Medtronic Octopus® TE Stabilizer & Accessories, which is a cardiovascular surgical instrument. It outlines the device's description, intended use, and substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as it would apply to a diagnostic or AI-driven medical device.

This 510(k) pertains to a physical surgical instrument, not a device that generates data or requires performance metrics like sensitivity, specificity, or accuracy. The assessment of such a device focuses on "substantial equivalence" to legally marketed predicate devices in terms of design, materials, manufacturing processes, and intended use, rather than a clinical performance study with statistical endpoints.

Therefore, most of the requested information (acceptance criteria, device performance table, sample sizes, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types and establishment) is not applicable to this type of regulatory submission and is not present in the provided text.

Here's a breakdown of why the information is not present based on the nature of the device:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. Performance for a surgical instrument is assessed through comparisons of its technological characteristics (e.g., design, materials, principle of operation) to predicate devices, and potentially through bench testing for safety and functional specifications, not a performance table against clinical acceptance criteria as would be seen for a diagnostic or AI device.
• 2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of clinical performance data for this type of surgical instrument in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review process of clinical data is described in this 510(k) summary for the device's performance.
• 4. Adjudication method 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 is not an AI-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. This is not a machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Cardiovascular Surgical Instrument/Heart Stabilizer.
• Regulatory Pathway: 510(k) Premarket Notification, indicating substantial equivalence to predicate devices.
• Predicate Devices: Medtronic Octopus Tissue Stabilizer (K964445) and the CTS (Guidant) Vacuum Assist Stabilizer (K992833).
• Basis of Equivalence: Patient population, intended use, function, basic system components, device design, and principal of operation were found to be substantially equivalent to the predicate devices.
• Study Described: The document refers to "Comparisons between the new and predicate devices shows that technological characteristics (i.e. device design and principal of operation) are substantially equivalent." This implies an engineering and design comparison rather than a clinical study with performance metrics in the typical sense.

Ask a specific question about this device

The Medtronic Model 10626 Myocardial Implant Tool is used to facilitate myocardial pacing lead placement. It is designed to assist in the placement and manipulation of the Model 5071 myocardial pacing lead.

The implant tool consists of a handle, malleable shaft and lead hub fixation assembly (tongs) which grab and release a Model 5071 lead when the springloaded button actuator is depressed and released. The handle assembly includes a rotable, thumbwheel. Rotation of this thumbwheel in a clockwise direction results in equivalent rotation of a lead hub fixation assembly located at the distal end of the tool. Depression of the actuator allows fixation to the Model 5071 lead and also activates the fixation release upon completion of implant. Release of the actuator activates the fixation of the tool to the Model 5071 lead.

The provided text describes the Medtronic Model 10626 Myocardial Implant Tool, a Class I accessory device intended to facilitate myocardial pacing lead placement. It is a mechanical tool, not an AI/ML powered device, and therefore the majority of the requested information (related to AI/ML specific studies, ground truth, expert consensus, etc.) is not applicable.

However, I can extract the acceptance criteria and the study performed for this device based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text mentions "Testing was performed on tools built according to a documented process and subjected to environmental conditioning." This suggests some number of physical devices were manufactured and tested, but the exact number is not provided.
• Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin of patient data). The testing was an in vitro (benchtop/laboratory) evaluation of the physical device's mechanical and functional properties. The tests were performed by Medtronic.

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

• Not Applicable. This is a mechanical implant tool, not a diagnostic or AI/ML device that requires expert-established ground truth for its performance evaluation. The "ground truth" for this device's performance is its ability to meet documented engineering and functional specifications.

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

• Not Applicable. As a mechanical device, performance testing involves objective measurements against engineering specifications, not subjective interpretation requiring adjudication among experts.

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. This is not an AI/ML device and therefore no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• Not Applicable. This is a mechanical tool operated by a human, not an algorithm. Its performance is always tied to human use, though the in vitro tests assess its standalone functional integrity.

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

• The "ground truth" for this device's performance is adherence to predefined product specifications and engineering requirements for its mechanical and functional attributes (e.g., grabber insertion, rotation, lead fixation, shaft flexibility).

8. The sample size for the training set:

• Not Applicable. This device is not an AI/ML model, so there is no "training set."

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

• Not Applicable. There is no training set for this mechanical device.

Ask a specific question about this device

The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima™ OPCAB™ System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.

The CTS Vacuum Assist Stabilizer consists of a curved shaft with an articulating foot at the distal end and a mount that connects to the CTS AccessRail™ Platform. The stabilizer provides local immobilization of an anastomotic site.

The provided text is a 510(k) Summary for the CardioThoracic Systems, Inc. Vacuum Assist Stabilizer. It outlines the device's description, intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, specific study designs, or performance metrics that would allow for the completion of the requested table and answers.

The summary states: "Functional bench, animal and histology testing has been conducted and the results of the testing verified that the Vacuum Assist Stabilizer performs as designed and is suitable for its intended use." This is a general statement and does not provide the detailed information needed to address your specific questions about acceptance criteria, study sizes, ground truth establishment, or clinical performance.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory submission summary rather than a detailed study report.

Ask a specific question about this device

The Applied Medical Modular Clip Applier System is indicated for ligation of tubular structures or vessels where a non-absorbable ligating device is indicated.

The Applied Medical Modular Clip Applier System (MCAS) is a modular reposable device intended for ligation of tubular structures or vessels where a nonabsorbable ligating device is indicated. The reusable clip applier is made of stainless steel and is similar to standard clip appliers and surgical clamp designs currently on the market. The disposable clip cartridge is made of various plastic and metal materials and will be sold sterile. The clip cartridges will be available in four sizes, small, medium/large, and large and will house six to ten titanium clips depending on the clip size to be used. The cartridges are color coded Yellow, Blue, Green and Orange respectively according to their size. The key difference between the Applied MCAS and the predicate device is the modular design which provides the user with multiple clips inside a cartridge which is loaded onto a reusable applier instead of manually loading individual clips into the applier during surgical procedures.

The provided text is a 510(k) summary for the Applied Medical Modular Clip Applier System (MCAS). It states that the device passed all testing to demonstrate substantial equivalence to the predicate device and introduces no new safety and effectiveness issues when used as instructed.

However, the document does not describe specific acceptance criteria or the details of any studies, including sample sizes, ground truth establishment, or expert involvement. It is a regulatory submission focused on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to populate the table and answer the questions based only on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not specified.

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 device is a surgical instrument (clip applier), not an AI-powered diagnostic or interpretive system, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

• Standalone performance: No. This device is a mechanical surgical instrument. "Standalone performance" in the context of an algorithm or AI is not applicable here.

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

• Type of ground truth: Not specified. The document refers to "testing to demonstrate substantial equivalence," which likely involved mechanical and functional testing against specifications and comparison to the predicate device, rather than a "ground truth" as might be established for diagnostic image analysis.

8. The sample size for the training set

• Sample size for training set: Not applicable/not specified. As a mechanical device, there is no "training set" in the sense of machine learning.

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

• Ground truth for training set: Not applicable/not specified.

Ask a specific question about this device