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510(k) Data Aggregation
(226 days)
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
| Acceptance Criteria (for reprocessed devices) | Reported Device Performance |
|---|---|
| Functional Equivalence | "The design, materials, and intended use of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the predicate devices. The mechanism of action...is identical...in that the same standard mechanical design, materials, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
| "Each individual Cardiac Stabilization and Positioning Device is tested for appropriate function of its components prior to packaging and labeling operations." | |
| "Performance testing demonstrates that Reprocessed Cardiac Stabilization and Positioning Devices perform as originally intended." | |
| Material/Biocompatibility | "Biocompatibility" testing was conducted. (Specific acceptance values for biocompatibility are not detailed in this summary). |
| Reprocessing Effectiveness | "Validation of reprocessing" was conducted, including "removal of adherent visible soil and decontamination." (Specific acceptance values for cleaning and decontamination are not detailed). |
| Sterility Assurance | "Sterilization Validation" was conducted. (Specific acceptance criteria for sterilization are not detailed). |
| Packaging Integrity | "Packaging Validation" was conducted. (Specific acceptance criteria for packaging are not detailed). |
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.
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(226 days)
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
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material & Design Equivalence | The design, materials, and intended use of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the predicate devices. | Demonstrated: "The design, materials, and intended use of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the predicate devices." "The mechanism of action of Reprocessed Cardiac Stabilization and Positioning Devices is identical to the predicate devices in that the same standard mechanical design, materials, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
| Functional Equivalence | The mechanism of action, performance specifications, and method of operation of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the predicate devices. Each individual reprocessed device is tested for appropriate function of its components. | Demonstrated: "The mechanism of action of Reprocessed Cardiac Stabilization and Positioning Devices is identical to the predicate devices in that the same standard mechanical design, materials, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." "Each individual Cardiac Stabilization and Positioning Device is tested for appropriate function of its components prior to packaging and labeling operations." "Performance testing demonstrates that Reprocessed Cardiac Stabilization and Positioning Devices perform as originally intended." |
| Biocompatibility | The reprocessed devices must be biocompatible, ensuring no unacceptable biological response due to reprocessing. | Demonstrated: "Biocompatibility Validation of reprocessing" was conducted. (No specific numerical criteria or results are provided in this summary, but the completion of validation implies meeting internal standards.) |
| Reprocessing Sterility | The reprocessing must render the devices sterile to an acceptable level (e.g., Sterility Assurance Level - SAL). | Demonstrated: "Sterilization Validation" was conducted. (No specific numerical criteria or results are provided in this summary, but the completion of validation implies meeting internal standards.) |
| Packaging Integrity | The packaging for the reprocessed devices must maintain sterility and product integrity. | Demonstrated: "Packaging Validation" was conducted. (No specific numerical criteria or results are provided in this summary, but the completion of validation implies meeting internal standards.) |
| Cleanliness / Decontamination | Reprocessing steps must include removal of adherent visible soil and decontamination. | Demonstrated: "Ascent Healthcare Solutions's reprocessing of Cardiac Stabilization and Positioning Devices includes removal of adherent visible soil and decontamination." |
| Overall Safety & Effectiveness | The reprocessed devices are safe, effective, and substantially equivalent to the predicate devices. | Demonstrated: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Cardiac Stabilization and Positioning Devices." "Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Cardiac Stabilization and Positioning Devices) are safe, effective, and substantially equivalent to the predicate devices as described herein." This conclusion implies that all individual criteria were met. |
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.
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(79 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device must perform its intended function (stabilize, move, lift, and position the heart) as effectively as the predicate device. | "Representative samples of reprocessed heart stabilizers and positioners underwent functional testing to demonstrate appropriate functional characteristics." (No specific metrics or quantitative results provided) |
| Cleaning Procedures Validation: Reprocessing must effectively clean the devices. | "Process validation testing was done to validate the cleaning... procedures." (No specific metrics or validation methods detailed) |
| Sterilization Procedures Validation: Reprocessing must effectively sterilize the devices. | "Process validation testing was done to validate the... sterilization procedures." (No specific metrics or validation methods detailed) |
| Packaging Validation: Reprocessing must ensure proper packaging for sterility and integrity. | "Process validation testing was done to validate the... device packaging." (No specific metrics or validation methods detailed) |
| Visual and Functional Inspection: All reprocessed products must pass visual and functional checks. | "In addition, the manufacturing process includes visual and functional testing of all products produced." (No specific failure rates or inspection criteria provided) |
| Substantial Equivalence: The reprocessed device must be substantially equivalent to the predicate device in functional design, materials, indications for use, and methods of construction. | "The reprocessed heart stabilizers and positioners are substantially equivalent to the Medtronic Octopus Tissue Stabilizer (and Positioner) (K964445)... This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction." |
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.
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