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Found 9 results
510(k) Data Aggregation
(224 days)
SHERWOOD MEDICAL CO.
The Mahurkar 13.5 Fr Cuffed Catheter with curved extensions is intended to be used as an acute or chronic central venous access device for hemodialysis, apheresis, and infusion.
The Mahurkar 13.5 Fr Cuffed Silicone catheter is designed for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.
The Mahurkar 13.5 Fr Cuffed Catheter with curved extensions is a radiopaque silicone tube with two D-shaped lumina. The lumina can be distinguished by the color-coded luer-lock adapters on the clear silicone rubber extensions: the red adapter indicates the proximal lumen, and the blue adapter indicates the distal lumen. During hemodialysis and apheresis, the proximal lumen provides "arterial" outflow from the patient and the distal lumen provides "venous" return.
The Mahurkar 13.5 Fr Cuffed Catheter with curved extensions is available in four (4) implantable lengths (36 cm, 40 cm, 45 cm, and 50 cm), and will be packaged in single, catheter kit and catheter tray configurations.
The provided text is a 510(k) summary for a medical device (Mahurkar 13.5 Fr Cuffed Catheter with Curved Extensions) and an FDA clearance letter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and a detailed study report with quantitative performance metrics.
Therefore, much of the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text. The document states that "test results demonstrate that the device is substantially equivalent to the predicate device," but it does not detail those test results or the specific criteria met.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The overarching acceptance criterion is "substantial equivalence" to the predicate device.
- Reported Device Performance: The document generally states that performance data were compared and demonstrate substantial equivalence. No specific performance values (e.g., flow rates, durability, biocompatibility test results) are provided.
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not available.
- Data Provenance: Not available (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable/not available. This type of device relies on engineering/biocompatibility testing rather than expert-derived ground truth for diagnostic accuracy.
- Qualifications: Not applicable/not available.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not available. This is relevant for studies involving human interpretation or clinical endpoints that require consensus, which is not described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is for diagnostic devices where human readers interpret results, often with AI assistance. This device is a catheter, not a diagnostic tool requiring human interpretation in that sense.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.
6. Standalone (Algorithm Only) Performance
- Was a standalone performance study done? Not applicable. This device does not have an "algorithm" in the sense of AI or a diagnostic computing component. Its performance is related to its physical and functional characteristics.
7. Type of Ground Truth Used
- Type of Ground Truth: The document implies that the "ground truth" for proving substantial equivalence was the performance of the predicate device, against which the new device's performance data were compared. The specific parameters of comparison are not detailed. It would likely involve engineering specifications, material properties, and in vitro/in vivo functional tests.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable.
Summary of available information:
- Device Name: Mahurkar 13.5 Fr Cuffed Catheter with Curved Extensions
- Intended Use: Acute or chronic central venous access for hemodialysis, apheresis, and infusion.
- Predicate Device: PermCath Dual Lumen Catheters (Quinton Instrument Co.)
- Performance Data: Performance data for the Mahurkar 13.5 Fr Cuffed Catheter with curved extensions were compared to that of the predicate device and were deemed to "demonstrate that the device is substantially equivalent."
- Unique Characteristic: Curved extensions (compared to the predicate).
In conclusion, the provided text serves as a regulatory summary for substantial equivalence rather than a detailed technical report of performance against specific, quantifiable acceptance criteria.
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(287 days)
SHERWOOD MEDICAL CO.
The Monoject™ Blunt I.V. Access Cannula is a sterile, lubricated plastic cannula with a female luer hub. It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials.
The Monoject™ Blunt I.V. Access Cannula is a sterile, lubricated plastic cannula with a female luer hub. It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials. The Monoject™ Blunt I.V. Access Cannula will be available in the following configurations: Individual Blunt Cannula; Blunt I.V. Access Cannula attached to piston syringe of 3 ml, 6ml and 12 ml sizes.
The provided document (K960982) is a 510(k) summary for the Monoject™ Blunt I.V. Access Cannula, submitted to the FDA in 1996. It outlines the device's classification, intended use, and substantial equivalence to other marketed devices.
This document describes comparative testing to demonstrate substantial equivalence, but it does not contain the information requested regarding detailed acceptance criteria, a specific study proving those criteria were met, sample sizes for test or training sets, data provenance, expert ground truth establishment, or specific performance metrics in the format of a typical AI/ML device study.
The document predates the widespread use of AI/ML in medical devices and therefore does not include the type of studies and data typically associated with AI/ML performance evaluation (e.g., standalone performance, MRMC studies, specific metrics like sensitivity, specificity, AUC).
Instead, the document focuses on mechanical and biological safety testing against existing devices.
Therefore, I cannot populate the requested table and answer the specific questions about AI/ML device performance from the provided text.
Summary of available information vs. requested information:
- Acceptance Criteria & Reported Performance: The document lists types of comparative testing (Insertion Force Test, Bend Test, Break Resistance and Resilience Test, Cytotoxicity, etc.) and states the results "will indicate that the Monoject™ Pointless Blunt l.V. Access Cannula perform equivalently to or better than the B-D Interlink Cannula product." However, it does not provide specific quantitative acceptance criteria or reported performance values for these tests (e.g., "Insertion force
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(138 days)
SHERWOOD MEDICAL CO.
The Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System will include all components commonly required to perform both a spinal and epidural procedure in a sterile, single use procedure-ready package. This procedure tray will be available in several configurations of tray components. This device is a Class II device per 21 CFR 868.5140, Procode: 73CAZ.
The combo tray is intended for Surgical or OB regional anesthesia blocks.
The Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System will include all components commonly required to perform both a spinal and epidural procedure in a sterile, single use procedure-ready package. This procedure tray will be available in several configurations of tray components. This device is a Class II device per 21 CFR 868.5140, Procode: 73CAZ.
The combo tray is intended for Surgical or OB regional anesthesia blocks. The rational for combining the epidural and spinal needles into one kit is as follows; an epidural block takes approximately 25 minutes for onset of the anesthetic, whereas, a spinal block takes approximately 5 min. for onset of Therefore, the patient benefits from both quick pain anesthetic. relief associated with a spinal and long-term pain relief associated with an epidural.
The procedure is as follows, the clinician will first place the epidural needle in the patient's epidural space. The spinal needle is then inserted through the epidural needle into the spinal cavity. The anesthetic is then administered through the spinal needle for quick pain relief. The spinal needle is then removed and an epidural catheter is inserted through the epidural needle into the epidural space. The catheter provides a conduit for the administration and re-administration of anesthetic into the epidural space to provide long term pain relief.
This document is a 510(k) summary for a medical device called the "Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System." It is a premarket notification to the FDA to demonstrate substantial equivalence to previously cleared devices, not a study evaluating the performance or acceptance criteria of a novel diagnostic or AI device.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and study types (MRMC, standalone) is not applicable to this document.
This 510(k) summary focuses on establishing substantial equivalence based on:
- Intended Use: Surgical or OB regional anesthesia blocks.
- Components: Combining a Tuohy Epidural Needle and a Whitacre Spinal Needle in a single tray.
- Comparison to Predicate Devices:
The 510(k) process is about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. It does not typically involve the type of performance studies, acceptance criteria, and ground truth establishment that would be performed for a novel diagnostic device or AI algorithm for the purposes of evaluating its accuracy, sensitivity, or specificity against defined metrics.
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(175 days)
SHERWOOD MEDICAL CO.
The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity.
The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray will include all components commonly required to perform a chest drainage procedure in a single procedure-ready package. This procedure tray will be available in several configurations of tray components. The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter will be available in 8, 10 and 12 fr sizes. The device incorporates a blunt, multi-sideholed, springloaded inner cannula coaxially housed within a conventional sharp-beveled hollow needle. This entire assembly is housed within polyurethane tapered catheter, which is used as a standard small bore percutaneously placed thoracic catheter. The tapered catheter incorporates four distal side-holes to facilitate drainage.
This document is a 510(k) summary for a medical device (Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray), which focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain the kind of information requested in your prompt (acceptance criteria, device performance metrics, study design, expert evaluation, etc.).
The information you are looking for is typically found in clinical studies, validation reports, or performance testing summaries, which are distinct from a 510(k) summary. A 510(k) summary primarily addresses the device's intended use, technological characteristics, and comparison to a predicate device to establish that it is as safe and effective.
Therefore, I cannot fulfill your request using the provided input because it does not contain the necessary details about acceptance criteria or a study proving device performance.
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(87 days)
SHERWOOD MEDICAL CO.
The Kangaroo® EntriStar Jejunal Feeding System is substantially equivalent to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube (K900590), and the BioSearch Dobbhoff GastroTrac Jejunal Feeding System, (K900624), both currently manufactured by BioSearch and distributed by Sherwood Medical. Sherwood Medical Company will manufacture this product line.
The intended uses and components of the of Kangaroo Jejunal Feeding System are identical to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube and System.
The Kangaroo Jejunal Feeding System is comprised of a gastrostomy tube and a jejunal feeding tube. The gastrostomy tube is identical to the BioSearch gastrostomy tube, and is a Foley-type of catheter. It is a dual lumen catheter with a retention balloon and outlet port at the the distal end. The proximal end has a female luer balloon inflation valve and an outlet adapter. The Gastrostomy Tube allows access to the jejunum by the Kangaroo Jejunal Feeding Tube. It is ethylene oxide sterilized to an SAL of 106.
The Jejunal feeding tube is included with the system, and may also be packaged and sold separately. It consists of a polyetherbased polyurethane and will be available in lengths ranging from 18" to 36", and in a range of tube diameters from 6 to 12 French.
This document is a 510(k) summary for a medical device called the "Kangaroo® EntriStar Jejunal Feeding System." It is a submission to the FDA (Food and Drug Administration) for premarket notification.
However, the provided text does not contain any information about acceptance criteria, study data, sample sizes, expert ground truth, or any of the other specific details requested in your prompt.
The document only asserts substantial equivalence to a predicate device (BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube/System) based on:
- Identical intended uses and components.
- Identical technological and performance characteristics.
- The only change being the manufacturing site.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, study details, or ground truth information because that data is not present in the provided text.
This document is a regulatory submission focused on demonstrating equivalence rather than presenting an clinical performance study. For such details, one would typically look for a separate clinical study report, a performance study report, or a section within the 510(k) that explicitly addresses performance testing against defined acceptance criteria.
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(85 days)
SHERWOOD MEDICAL CO.
The function of the stylet is to provide the necessary stiffness to aid the clinician in the placement of a nasointestinal feeding tube.
The Kangaroo® Stylets are comprised of a stainless steel wire that terminates at its distal end welded to an atraumatic stainless steel spring. The proximal end of the stainless stylet wire is mechanically attached to a flow-through male polypropylene luer hub.
I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device (Kangaroo® Pedi-Tube Flow Through Stylet & Kangaroo® Flow-Through Stylet) and its substantial equivalence to other devices, but it does not detail any acceptance criteria, performance studies, or related data such as sample sizes, expert qualifications, or ground truth establishment. This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results like those you've asked for.
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(93 days)
SHERWOOD MEDICAL CO.
The device is intended to be used in critical care units to aspirate secretions from patient airways who have endotracheal or tracheostomy tubes and require mechanical ventilation. The system allow for the insertion and withdrawal of a suction catheter into the artificial airway without disconnecting the patient from the ventilator circuit. The components of this system are sterile, single patient use, and disposable.
The Argyle® ASPR-Care™ Closed Suction System consists of three discreet components: a dual swivel T-piece, a sheathed suction catheter, and a suction control valve. When connected together, these components form a closed system suction catheter similar in form and function to the closed system catheters available from Ballard and Concord/Portex.
This document is a 510(k) summary for the Argyle® ASPR-Care™ Closed Suction System, not a study evaluating acceptance criteria against reported device performance as might be found for AI/ML-driven medical devices. Therefore, much of the requested information (e.g., sample sizes, expert qualifications, MRMC studies, training set details) is not applicable or cannot be extracted directly from this type of regulatory submission.
However, I can extract the general acceptance criteria in terms of "substantial equivalence" and the types of tests performed.
1. Table of Acceptance Criteria and Reported Aevice Performance
| Acceptance Criteria (based on 'substantial equivalence' to predicate devices and recognized standards) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Primary Closed Suction System: | |
| - Allow aspiration of patient secretions without loss of mechanical ventilation (PEEP, FiO2) | The Argyle® ASPR-Care™ Closed Suction System is "similar in form and function" to predicate devices (Ballard Trach Care™ and Concord/Portex Steri-Cath™). It "allows for the aspiration of patient secretions without the loss of mechanical ventilation." Clinical objectives are to "reduce the loss of Positive End-Expiratory Pressure (PEEP) and Fraction of Inspired Oxygen (FIO2) while suctioning patient airways" and "reduce the possibility of hypoxia and cardiac irregularities during suctioning." |
| - Enclosed in a clear plastic sleeve to protect clinician from patient secretions | "Each system is enclosed in a clear plastic sleeve to protect the clinician from patient secretions." Clinical objective is "to protect the clinician from patient secretions." |
| - Adapter (connector) to eliminate strain between mechanical ventilator circuit and ET/tracheostomy tube | "Each system comes with an adapter (connector) to eliminate strain between the mechanical ventilator circuit and the endotracheal tube or tracheostomy tube." |
| - Suction control valve for vacuum application | "Each system comes with a suction control valve that allows for the application of vacuum (suction) as necessary to remove secretions from the patient's airway." |
| - Allows introduction of irrigation to clean catheter and lavage patient | "Each system allows for the introduction of irrigation to clean the catheter and lavage the patient." |
| - Catheter contains depth marks | "Each catheter contains depth marks which allows the clinician to determine the depth the catheter has been inserted into the patient's trachea." |
| - Biocompatibility (ISO 10993 Part 1 for surface device, prolonged contact with mucosal membrane) | The device "has passed the following battery of tests; cytotoxicity, sensitization, irritation, systemic toxicity and implantation." |
| - Safe and effective conduit for ventilator gases and efficient tracheal/oral suctioning | "Sherwood Medical has conducted a battery of tests comparing the performance of the Argyle® ASPR-Care™ Closed Suction System and ancillary components with those devices to which we are claiming substantial equivalence. This testing was conducted to ensure Sherwood's device provides a safe and effective conduit for ventilator qases and allows efficient tracheal and oral suctioning capabilities." (Specific results not detailed in summary). A Failure Modes Affect Analysis (FMEA) was conducted to identify preventive and corrective actions for safety during design and manufacturing. |
| Bronchoscope Adapter: | |
| - Allow introduction of bronchoscope into artificial airway without loss of ventilation, facilitating bronchoscopy without disconnecting patient | Substantially equivalent to Portex Fiberoptic Swivel Adapter. "They both allow for the introduction of a bronchoscope to be inserted into the artificial airway without the loss of ventilation to the patient. Which in turn allows the clinician to perform a bronchoscopy without having to disconnect the patient from the ventilator circuit." |
| - Biocompatibility (indirect patient contact) | "Has only undergone and passed cytotoxicity testing." |
| Sputum Trap: | |
| - Collect sputum sample during routine suctioning without disconnecting patient | "Allows for the collection of a sputum sample during the routine suctioning of a patient without having to disconnect the patient from the ventilator incircuit." |
| - Contain a manifold for in-line placement in suction circuit | Substantially equivalent to Argyle® Lukens Specimen Container. "They both contain a manifold that allows the trap to be placed in-line in the suction circuit." |
| - Contain a cap to seal vial after sample collection | "They both contain a cap to seal the vial after a sputum sample has been collected and the manifold has been removed." |
| - Biocompatibility (non-patient contact) | "Has only undergone and passed cytotoxicity testing." |
2. Sample size used for the test set and the data provenance:
- This document does not specify a "test set" in the context of AI/ML performance evaluation. The "testing" referred to is for device performance characteristics and biocompatibility.
- For performance, "Sherwood Medical has conducted a battery of tests comparing the performance of the Argyle® ASPR-Care™ Closed Suction System and ancillary components with those devices to which we are claiming substantial equivalence." No sample sizes or data provenance (country, retrospective/prospective) are mentioned for these tests in this summary.
- For biocompatibility, the tests were conducted according to ISO 10993 Part 1. Specific sample sizes for these biological tests (e.g., number of animals for systemic toxicity, number of cell cultures for cytotoxicity) are not provided in this summary, nor is the provenance of the samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Ground truth is typically based on laboratory assay results (e.g., cell viability for cytotoxicity, skin reaction for irritation, systemic effects in animal models).
- For performance: Ground truth would be based on engineering specifications, physical measurements (e.g., airflow, pressure integrity, suction flow rates), and functional testing against design requirements and comparison to predicate devices. The summary indicates that testing was "conducted to ensure Sherwood's device provides a safe and effective conduit for ventilator qases and allows efficient tracheal and oral suctioning capabilities," implying functional validation.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable.
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(168 days)
SHERWOOD MEDICAL CO.
The Kanqaroo® EntriStar™ Skin-Level Gastrostomy Kit is a sterile, single use device containing a gastrostomy tube and the components needed to insert a low profile qastrostomy tube. The Kangaro® Skin-Level Gastrostomy Kit is a Class II device, Gastrointestinal Tube and Accessories per 21 CFR 876.5980, Procode: 78KNT.
The Skin-Level Gastrostomy Tube is a replacement gastrostomy tube placed through an existing stoma via the abdomen into the stomach. The tube acts as a conduit to deliver formula to a patient requiring enteral nutrition and as conduit for insertion of enteral access devices such as qastric a decompression catheters or intestinally placed feeding catheters.
The Kanqaroo® EntriStar™ Skin-Level Gastrostomy Kit is a sterile, single use device containing a gastrostomy tube and the components needed to insert a low profile qastrostomy tube. The Kangaro® Skin-Level Gastrostomy Kit is a Class II device, Gastrointestinal Tube and Accessories per 21 CFR 876.5980, Procode: 78KNT.
The Skin-Level Gastrostomy Tube is a replacement gastrostomy tube placed through an existing stoma via the abdomen into the stomach. The tube acts as a conduit to deliver formula to a patient requiring enteral nutrition and as conduit for insertion of enteral access devices such as qastric a decompression catheters or intestinally placed feeding catheters. The stoma tube is designed so that it is a fixed length to correspond to the depth of the stoma. However, a "step-up shim" may be placed between the external retention device and the abdominal wall to customize the fit to the patient.
The Skin-Level Gastrostomy Tube is inserted and removed by inserting the obturator through the inner lumen of the stoma tube. When inserted, the obturator mechanically slenderizes (elongates) the internal retention device, which reduces its diameter to reduce the physical trauma to the stoma inherent in the insertion and removal procedures.
The Skin-Level Gastrostomy Tube is available in various lengths designed to precisely fit the depth of the patient's stoma, which results in a snuq fit between the surface of the external retention device and the patient's abdomen. An insertion/removal accessory is included for use when inserting and removing the gastrostomy tube.
The distal tip of the obturator and the internal retention device are covered in lubricous Hydromer coatinq to reduce the force needed to insert the obturator and qastrostomy tube. Hydromer coating is currently used in several nasoqastric feeding tubes marketed by Sherwood and Biosearch Medical Products which were cleared via the 510(k) process.
This document is a 510(k) summary for a medical device (Kangaroo EntriStar Skin-Level Gastrostomy Feeding Kit) and does not describe a study involving an AI/ML device. Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable to this submission.
However, based on the provided text, I can extract information related to the device's functional specifications and biocompatibility testing, which serve as its acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Specification | Reported Device Performance (Implied by Submission) |
|---|---|---|
| Biocompatibility | Implantation (7 day) | Will be required to pass prior to release for sale. |
| Cytotoxicity | Will be required to pass prior to release for sale. | |
| Sensitization | Will be required to pass prior to release for sale. | |
| Genotoxicity | Will be required to pass prior to release for sale. | |
| Chronic Toxicity | Will be required to pass prior to release for sale. | |
| Functional Specifications | Snug fit between external retention device and patient's abdomen (due to precise length options) | Designed to achieve a snug fit. |
| Reduced physical trauma during insertion/removal (due to obturator slenderizing internal retention device) | Designed to reduce physical trauma. | |
| Reduced force needed for insertion (due to lubricous Hydromer coating) | Designed to reduce insertion force. | |
| Sterility | Sterile, single-use device. | |
| Substantial Equivalence | Modified version of cleared device K923474 (Low-Profile Gastrostomy Device Kit) | Believed to be substantially equivalent to K923474. |
Study Proving Device Meets Acceptance Criteria:
The document describes that the device will be required to pass a battery of biocompatibility tests (Implantation, Cytotoxicity, Sensitization, Genotoxicity, and Chronic Toxicity) prior to its release for sale, in accordance with ISO 10993 Part-1 Biocompatibility Guidance. This indicates that these tests are the studies proving it meets those specific acceptance criteria.
For functional specifications, the document states (implicitly and explicitly) that Sherwood has established functional specifications to ensure the device is safe and effective. The "study" proving these are met is likely in-house testing and design validation, although details are not provided in this summary. The primary "study" for regulatory clearance is the argument for substantial equivalence to a previously cleared device (K923474). The submission states, "the device covered by this submission is simply a modified version of the design disclosed in K923474." The implication is that since the predicate device met its safety and effectiveness criteria, and this new device is a modified version that maintains core design and function, it also meets the criteria.
Information Not Applicable or Not Provided in the Text (for AI/ML studies):
- 2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: For biocompatibility, the ground truth is established by the results of the specific biological tests per ISO 10993. For functional specifications, it's established by engineering and design validation tests. For substantial equivalence, the "ground truth" is the performance and clearance of the predicate device.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
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(112 days)
SHERWOOD MEDICAL CO.
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