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Found 5 results
510(k) Data Aggregation
(231 days)
Summit Medical Ltd.
Assistance in the delivery of local anaesthetic after hamstring ligament reconstruction procedures
GRAFTSITE is 28.25 cm in length with an inner diameter of 2.6 mm and an outer diameter of 4.0 mm, sized to fit down the hamstring harvest site. It is rounded and blocked at the patient end and has a 6% female luer at the user end. There are lateral eyes over a length at the patient end of the catheter. A buttoned stylet consisting of a rigid stainless steel rod of diameter slightly less than the bore of the catheter, functions to stiffen the device. GRAFTSITE can be used to directly administer a bolus of the users chosen local anesthetic, via injection down the lumen of the catheter, into the terminus of the gutter at the site of comorbidity.
The provided text describes the GRAFTSITE Local Anesthetic Delivery Assistance Device. It details the device's characteristics and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
1. Table of acceptance criteria and the reported device performance
Since this is a non-clinical submission, the "acceptance criteria" are the ability to perform equally well as the predicate device in specific non-clinical tests. The "reported device performance" refers to the successful completion of these tests.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Pressure testing of the catheter/hub for resistance to liquid leakage (EN 1618 and ISO 594-2) | GRAFTSITE performed equally well to the predicate. |
| Tensile bond performance of the catheter/hub and stylet/button (BS 6196 and EN 1618) | GRAFTSITE performed equally well to the predicate. |
| Corrosion resistance of the stylet (EN 1618) | GRAFTSITE performed equally well to the predicate. |
| Flow rate of the catheter (EN 1618) | GRAFTSITE performed equally well to the predicate. |
| Radio-opacity of the catheter (ASTM F640-12) | GRAFTSITE performed equally well to the predicate. |
| Human factors/usability validation | GRAFTSITE was proven to be usable in a cadaveric usability investigation and did not raise different questions of safety and effectiveness when compared to the predicate. |
| Biocompatibility (ISO 10993-1 and FDA guidance) | Biocompatibility testing on the fully finished device demonstrated that GRAFTSITE is biocompatible in relation to its intended use. This included cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, particulate analysis, hemolysis, and endotoxin testing. |
| Gamma irradiation validation (ISO 11137-1 and ISO 11137-2) | Validation using the VDmax25 method was successful in eliciting no growth for a routine processing dose of 25-40kGy and giving a SAL of 10-6 (in accordance with EN 556). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide specific numerical sample sizes for each test set (e.g., number of devices tested for flow rate). However, it states that "GRAFTSITE was directly compared to the predicate in comparative performance tests" and that "comparative in vitro testing was performed, with the results for GRAFTSITE compared to the predicate."
The data provenance is not explicitly stated in terms of country of origin but is implicitly from the manufacturer, Summit Medical Ltd. in the United Kingdom. The tests performed are non-clinical (in vitro and cadaveric usability), not human clinical studies, so the terms "retrospective" or "prospective" are not applicable in the same way they would be for patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are physical and mechanical performance evaluations against established standards, and a cadaveric usability study. While the cadaveric study would involve experts (e.g., surgeons/clinicians), the document does not specify their number or qualifications as ground truth experts for a diagnostic algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the studies described are non-clinical, mechanical, and biocompatibility tests, and a cadaveric usability study. There's no "ground truth" to be adjudicated in the sense of medical image interpretation or diagnosis.
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 MRMC comparative effectiveness study was done. This device is a local anesthetic delivery assistance device, not an AI-powered diagnostic or interpretive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests were established engineering and medical device performance standards (e.g., EN 1618, ISO 594-2, BS 6196, ASTM F640-12, ISO 10993-1, ISO 11137-1, ISO 11137-2). For the usability study, the ground truth was the ability to perform the intended function in a cadaveric model.
8. The sample size for the training set
This is not applicable since the device does not employ machine learning or AI models, and therefore does not have a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
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(167 days)
Summit Medical Ltd.
Tibial fixation of biological ligament during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction
ANCHORMAN is a PEEK cortical tibial suspensory fixation device, and functions via the looping of a biological or artificial tendon graft through the loop component of the device. The tendon graft is then pulled through the tibial and femoral tunnels. The wing components of the device rest on the tibial cortex, facilitating tensioning on the femoral side (if required). The device then provides tibial suspensory fixation, supporting the graft until aperture healing occurs and the graft integrates with the bone, at which point the device does not bear load and is redundant.
This document describes a premarket notification (510(k)) for the ANCHORMAN Tibial Ligament Fixation Device. The submission focuses on demonstrating substantial equivalence to a predicate device, the Arthrex Inc., Retrobutton.
Here's an analysis of the provided information regarding acceptance criteria and the study:
Key Takeaway: The device discussed is a medical implant (Tibial Ligament Fixation Device), not an AI/software as a medical device (SaMD). Therefore, the provided text does not contain information related to AI/SaMD testing methods such as test sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance. Instead, it focuses on mechanical, chemical, and physical performance of a physical medical device.
Therefore, the requested information regarding AI/SaMD specific testing (points 2, 3, 4, 5, 6, 7, 8, 9) is not applicable to this document. I will answer based on the information that is present for this physical device.
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device in terms of mechanical, chemical, physical, and handling characteristics. The reported device performance is presented in terms of comparative in-vitro testing.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported ANCHORMAN Device Performance |
|---|---|
| Mechanical Characteristics | Comparative in-vitro testing on human cadaveric tibiae was performed. The results for ANCHORMAN were compared to that of the predicate (Retrobutton). The results showed that ANCHORMAN possesses mechanical characteristics necessary to demonstrate substantial equivalence. Specifically, for relevant performance/clinical characteristics which may be affected by size (UTS, initial and cyclic displacement, and stiffness), ANCHORMAN's performance was confirmed to be equivalent with reference to clinically identified failure levels. |
| Chemical Characteristics | Although ANCHORMAN (made of PEEK) and the predicate (made of UHMWPE and Titanium Ti6Al4V) are composed of different materials and thus have chemical differences, both materials are long-established implant materials. Confirmatory biocompatibility testing verified their suitability. Comparative in-vitro testing further showed that the chemical differences do not raise any new questions of safety and effectiveness. |
| Physical Characteristics | Although ANCHORMAN and the predicate have different designs and materials, direct comparative performance testing in cadaveric tibiae confirmed that, when considering relevant performance/clinical characteristics affected by size (UTS, initial and cyclic displacement, and stiffness), ANCHORMAN's performance is equivalent with reference to the clinically identified failure levels. |
| Handling Characteristics | Direct comparative performance testing in human cadaveric tibiae confirmed that, when implanted properly, the relevant performance/clinical characteristics affected by size (UTS, initial and cyclic displacement, and stiffness) are equivalent with reference to the clinically identified failure levels. A cadaveric usability study for ANCHORMAN demonstrated the appropriateness of this technique for users, even in worst-case insertion and removal circumstances. These differences do not raise any new questions of safety and effectiveness. |
Regarding AI/SaMD specific questions (Not Applicable to this device):
- Sample size used for the test set and the data provenance: Not applicable. (No AI test set).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (No expert ground truth for an AI test set).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. (No AI test set adjudication).
- 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. (No human readers or AI involved with this physical device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. (No algorithm).
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. (The "ground truth" for this device's performance is based on direct mechanical and physical testing against pre-defined clinical failure levels and comparison to a predicate device).
- The sample size for the training set: Not applicable. (No AI training set).
- How the ground truth for the training set was established: Not applicable. (No AI training set ground truth).
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(64 days)
SUMMIT MEDICAL LTD.
The Summit Medical CellTrans™ Postoperative Autotransfusion Set is intended for the collection, filtration and reinfusion of blood lost postoperatively following surgery, particularly orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
The CellTrans™ Postoperative Autotransfusion Set consists of two individually sterilized packages, containing the Summit Medical CellTrans™ Postoperative Autotransfusion System (K022489) and the Summit Medical Transfusion Filter (K022477) respectively, presented for ease of handling and reordering in a non-sterile. polvethylene slide lock transit bag. Inside the transit bag the CellTrans™ device is double-wrapped, whilst the Transfusion Filter is single wrapped, both using Tyvek & Film packaging. The transit bag also contains an additional copy of the CellTrans™ Instructions For Use to facilitate use of the Transfusion Filter.
The provided text describes a 510(k) premarket notification for the CellTrans™ Postoperative Autotransfusion Set. This is a medical device for blood collection and reinfusion, and the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices. Therefore, the information typically found in a study proving a device meets acceptance criteria for an AI/ML product (such as performance metrics, sample sizes, expert involvement, and ground truth establishment) is not present in this document.
The document states that "No safety or effectiveness issues are raised when the Summit Medical CellTrans™ Postoperative Autotransfusion Set is compared to the predicate products and therefore the CellTrans™ Postoperative Autotransfusion Set is substantially equivalent to the Summit Medical CellTrans™ Postoperative Autotransfusion System and the Summit Medical Transfusion Filter." This indicates that the primary "acceptance criterion" for this 510(k) submission was demonstrated substantial equivalence to existing predicate devices, rather than meeting specific performance metrics from a new clinical study.
Therefore, I cannot fulfill your request for the following sections based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study information
- Standalone performance information
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
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(88 days)
SUMMIT MEDICAL LTD.
The Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surgical site or post-operative wound drainage.
The Transfusion Filter device consists of a sterile, single wrapped package, containing a filter assembly, with or without an administration set. The administration set is fitted with a drip chamber and roller clamp. The filter unit is connected to a flexible bag containing the blood to be reinfused via a spike port in the bag. The filter is primed by holding the bag inverted, with the filter above the bag, then squeezing the bag to force blood through the filter medium and to the desired level within the drip chamber. The roller clamp is then closed, and the system hung on a drip stand ready for use. The administration line can then be primed and connected to the patient according to clinical practice, and the rate of blood flow to the patient requlated by adjusting the roller clamp.
The provided text describes the Summit Medical Transfusion Filter and its substantial equivalence to a predicate device. It outlines performance testing conducted to demonstrate safety and effectiveness, but it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically associated with clinical or AI/software validation studies.
Instead, the document focuses on demonstrating that the device is substantially equivalent to a legally marketed predicate device (Pall Biomedical Products Co. SQ40 Blood Transfusion Filter, K960993) by showing it has the "same design principles, made of the same materials, and have the same indications and contraindications for use."
The performance testing mentioned is primarily related to manufacturing quality, biocompatibility, and sterility, which are standard for medical devices.
Therefore, I cannot populate the requested table and answer many of the questions as the specific details are not present in the provided document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical/Physical | |
| Bubble point test compliance | Achieved |
| Pressure leak test compliance | Achieved |
| Particulate cleanliness | Achieved |
| Mechanical testing of bonded joints | Achieved |
| Hydrostatic testing of bonded joints | Achieved |
| Biocompatibility | |
| Cytotoxicity | Compliant with ISO 10993 |
| Sensitization | Compliant with ISO 10993 |
| Irritation or Intracutaneous Reactivity | Compliant with ISO 10993 |
| Acute Systemic Toxicity | Compliant with ISO 10993 |
| Haemocompatibility | Compliant with ISO 10993 |
| Sterility | |
| Gamma sterilization validation | In accordance with ISO 11137 |
| Microbiological bioburden | Achieved |
| Endotoxin validation | Achieved |
Note: The document states that "The test results achieved demonstrate that the device meets the applicable standards, is biocompatible, and performs in accordance with design specifications." However, it does not provide the specific quantitative acceptance limits or thresholds for each of these tests.
Information Not Found in the Provided Text:
- Sample sizes used for the test set and data provenance: The document mentions "performance testing" and "biocompatibility testing" but does not specify sample sizes for these tests, nor the origin or nature (retrospective/prospective) of any data beyond indicating it was performed on the device itself.
- Number of experts used to establish ground truth for the test set and their qualifications: This type of information is relevant for studies involving human interpretation or clinical endpoints. As this is a physical filter, such an expert panel for "ground truth" establishment in a diagnostic sense is not applicable to the reported tests.
- Adjudication method for the test set: Not applicable based on the type of testing described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable to a physical transfusion filter. MRMC studies are typically for evaluating diagnostic software or imaging modalities where human readers interpret results.
- Standalone (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests described are the established scientific and regulatory standards (e.g., ISO standards) for material properties, sterility, and biocompatibility.
- Sample size for the training set: Not applicable, as this is a physical device, not a machine learning model requiring training data.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence primarily through a comparison of design, materials, and indications for use with a predicate device, supported by standard medical device performance, biocompatibility, and sterility testing. It does not contain evidence of a study designed to validate performance against specific clinical acceptance criteria in a way that would require expert-established ground truth, human reader performance analysis, or AI/algorithm metrics.
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(72 days)
SUMMIT MEDICAL LTD.
The Summit Medical CellTrans™ Postoperative Autotransfusion System is intended for the collection for reinfusion of blood lost by a patient following surgery including but not limited to orthopaedic joint replacement. The device is indicated for autologous blood transfusion.
The CellTrans 10 device consists of a sterile, double wrapped package, containing two needle and drain assemblies, a blood collection assembly with patient drain connection line and a compressible bellows collection vessel with twin outlet ports, and two blood Transfer bags. The patient and transfer bag lines are fitted with pinch clamps, and in addition the transfer bag connection luers are fitted with sealing caps, for use after a filled bag is removed from the collection vessel. The collection bellows and transfer bags are fitted with non-return valves to prevent backflow of exudate to the patient.
The drains are placed in the patient, and connected to the collection system via the twin drain Y-connector. The transfer bags are fitted to the collection vessel outlet ports. Blood collection is initiated by compressing the bellows to apply a low vacuum to the wound, the collected blood then transferring into one of the transfer bags, via the gross filter. When the baq is full, or in accordance with the American Association of Blood Banks Guidelines for Blood Recovery and Reinfusion in Surgery (AABB), the bag can be removed from the collection system, and transferred for reinfusion to the patient. Blood collection can continue with the second transfer bag.
Following use of the second bag, the device can be used as a wound drainage device if this is clinically desirable, by draining into a standard wound drainage bag.
This document describes the Summit Medical CellTrans™ Postoperative Autotransfusion System, a device for collecting and reinfusing a patient's own blood following surgery. The information provided outlines the safety and effectiveness testing conducted to demonstrate its substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Functional Performance | Vacuum testing | Device meets criteria; specific values not provided. |
| Pressure leak decay tests | Device meets criteria; specific values not provided. | |
| Functional testing (water and time-expired blood) | Performs in accordance with design specifications. | |
| Mechanical Integrity | Mechanical testing of bonded joints | Device meets criteria; specific values not provided. |
| Sterilization | Microbiological bioburden validation | Validated. |
| Endotoxin validation | Validated. | |
| Gamma sterilization (ISO 11137, EN552) | Validated. | |
| Biocompatibility | Cytotoxicity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. |
| Sensitization (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Irritation or Intracutaneous Reactivity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Acute Systemic Toxicity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Subchronic Toxicity (ISO 10993, FDA Blue Book Memo G95-1) | Biocompatible. | |
| Hemocompatibility | Hemocompatibility testing (ISO 10993-4) | Detailed evaluation of blood cell parameters demonstrated device meets applicable standards. |
2. Sample Size for Test Set and Data Provenance:
The provided document describes performance testing, sterilization validation, and biocompatibility testing, not a clinical study involving a "test set" of patient data in the typical sense for an AI/diagnostic device. For the hemocompatibility testing (ISO 10993-4), which involved comparing blood passed through the CellTrans™ system with homologous (banked) blood, the sample size for the blood cell parameter evaluation is not specified.
The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is based in the UK (Summit Medical Ltd, Gloucestershire, UK). The nature of the testing suggests laboratory-based evaluations rather than retrospective or prospective clinical data collection from a patient population.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
Not applicable. The "test set" here refers to laboratory samples (e.g., blood cell parameters, materials for biocompatibility) and engineering tests, not a set of clinical cases requiring expert consensus or ground truth establishment by clinical experts.
4. Adjudication Method (Test Set):
Not applicable. This was not a clinical study requiring adjudication of expert interpretations. The results were likely evaluated against pre-defined engineering and biological specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This device is an autotransfusion system, not a diagnostic imaging or AI-assisted diagnostic device, and therefore this type of study is not relevant to its evaluation.
6. Standalone Performance Study:
Yes, the studies described are essentially standalone performance studies of the device itself. The performance testing (vacuum, pressure, functional, mechanical) evaluates the device's intrinsic capabilities. The sterilization validation ensures the device's sterility. The biocompatibility and hemocompatibility testing assesses the device's interaction with biological systems in a standalone manner, without human intervention as part of the primary performance metric.
7. Type of Ground Truth Used:
For the performance and validation tests, the "ground truth" was established by predetermined engineering specifications, international standards (e.g., ISO 11137, EN552, ISO 10993, ISO 10993-4), and regulatory guidance (FDA Blue Book Memo G95-1). For example, for hemocompatibility, the "ground truth" was the characteristics of homologous (banked) blood, against which the blood processed by the device was compared.
8. Sample Size for Training Set:
Not applicable. This device is not an AI/machine learning device that requires a "training set" for model development.
9. How Ground Truth for Training Set Was Established:
Not applicable, as no training set was used.
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