Search Results
Found 7 results
510(k) Data Aggregation
(113 days)
When properly worn, the surgical face masks are intent and healthcare workers from transfer of microorganisms, body fluids and particulate material. The face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.
Magnum is a surgical face mask identified by Regulation 21 CFR 878.4040 under FDA product code, FXX. This medical device is offered in a single color – blue.
The inner and outer layers are made of spun-bond polypropylene non-woven fabric, and the middle layer is made of melt blown filter media. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PVC coated aluminum wire.
The model 2200 is level 2 surgical face mask and the model 2300 is level 3 surgical face mask. Both these models are provided with ear loops to hold and fit the face mask in place over the user's mouth and nose. The ear loops are made of knitted elastic.
The model 1200 is level 2 surgical face mask and the model 1300 is level 3 surgical face mask. Both these models are provided with tie back to hold and fit the face mask in place over the user's mouth and nose. The tie back string is made of spun-bond polypropylene non-woven fabric.
The dimensions of the test item are: length- 172 ± 3 mm and width- 95 ± 3 mm.
The surgical masks are single-use, disposable devices, provided non-sterile.
The provided text describes the acceptance criteria and performance data for Magnum surgical masks in their 510(k) submission to the FDA. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document provides two tables (Table 2 and what is labeled as "Table 2" but is actually a third table, both on page 9) summarizing the performance testing for different models (Level 3 models 1300 and 2300, and Level 2 models 1200 and 2200). I will combine these into a single table for clarity, indicating the specific level for the criteria.
| Test Performed | Acceptance Criteria (Level 3 Models) | Reported Performance (Model 1300) | Reported Performance (Model 2300) | Acceptance Criteria (Level 2 Models) | Reported Performance (Model 1200) | Reported Performance (Model 2200) | Overall Result |
|---|---|---|---|---|---|---|---|
| Fluid resistance (ASTM F1862/F1862M-17) | Pass at 160 mmHg | Pass at 160 mmHg | Pass at 160 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03(2017)) | ≥ 98% | > 98% | > 98% | ≥ 98% | > 98% | > 98% | Pass |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥ 98% | > 98% | > 98% | ≥ 98% | > 98% | > 98% | Pass |
| Differential pressure (ΔP) (EN 14683 Annex C: 2019) | < 6.0 mmH2O/cm² | < 3.0 mmH2O/cm² | < 3.0 mmH2O/cm² | < 6.0 mmH2O/cm² | < 3.0 mmH2O/cm² | < 3.0 mmH2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 | Pass |
Biocompatibility Acceptance Criteria and Performance:
| Test Performed | Standard | Acceptance Criteria/Expected Outcome | Reported Performance (Proposed Device) | Overall Result |
|---|---|---|---|---|
| In-vitro Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Non-cytotoxic | Pass |
| Skin Irritation | ISO 10993-23:2021 | Non-irritating | Non-irritating | Pass |
| Skin Sensitization | ISO 10993-10:2021 | Non-sensitizer | Non-sensitizing | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for the non-clinical performance tests (fluid resistance, PFE, BFE, differential pressure, flammability) or the biocompatibility tests (cytotoxicity, skin irritation, skin sensitization). However, these are standard laboratory tests typically performed on a limited number of samples to demonstrate compliance with the specified ASTM, EN, ISO, and CFR standards.
The data provenance is described as "Non-Clinical Data" and "Performance Tests" performed on the "proposed device" (Magnum surgical masks). The tests were conducted according to established international and US standards. The document does not explicitly state the country of origin for the testing itself, but the manufacturer is based in India. This is retrospective testing performed on manufactured devices to demonstrate compliance.
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 a physical medical device (surgical masks) and relies on objective, standardized non-clinical performance and biocompatibility testing, not expert interpretation of data or images. Therefore, there is no concept of "ground truth" established by experts in the context of this device's testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the testing involves objective measurement against industry standards, not subjective interpretations requiring adjudication.
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. Magnum surgical masks are a physical product intended to protect against exposure to microorganisms, body fluids, and particulate material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance and biocompatibility tests, the "ground truth" is defined by the established and published criteria within the referenced standards (e.g., ASTM F2100-19, ASTM F1862/F1862M-17, ISO 10993 series, etc.). These standards set objective thresholds for performance (e.g., >98% filtration efficiency, pass at 160 mmHg fluid resistance) and safety (e.g., non-cytotoxic, non-sensitizing). Compliance with these numerical or qualitative thresholds constitutes meeting the acceptance criteria.
8. The sample size for the training set
Not applicable. This is a physical product, not a machine learning 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 device.
Ask a specific question about this device
(57 days)
The M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The M-CORE needle is not intended for use in bone.
The M-CORE disposable core biopsy needle is a sterile, disposable biopsy needle featuring stainless steel cutting cannula and stylet, with sample is a lotenio, disposable biopsy needle leading stames steaturing statiness steat themoplastic removable spacer is provided to allow easy insection of both hubs into a Bard@ Magnum® reusable biopsy instrument. An LDP of the county the neder in both huss in a Barde Magnum® reuseble available in gauges from 14 - 18 and lengths from 10 - 25 centimeters.
The provided 510(k) summary for the M-CORE disposable core biopsy needle does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria are met. The document focuses on demonstrating substantial equivalence to predicate devices based on design and materials, and mentions "Performance testing summary" but does not elaborate on the specific tests or their results within this summary.
Here's a breakdown of what can be extracted and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., biopsy sample quality scores, tensile strength, or cutting efficiency thresholds). Instead, it relies on demonstrating that the device is "substantially equivalent" to predicate devices, implying similar performance.
The summary states: "Performance testing confirms that the quality of the samples obtained with the M-CORE disposable core biopsy needle is substantially equivalent to the predicate device(s)." This is a general statement of performance, not a quantified measurement against an acceptance criterion.
The table provided in the document compares device characteristics, not performance metrics:
| Characteristic | Reported Device (M-CORE Needle) Performance (Implicitly equivalent to predicate) | Acceptance Criteria (Not explicitly stated in this document) |
|---|---|---|
| Cannula and Stylet Material | 304SS | (Implicitly: Same as predicate) |
| Cannula and Stylet Hub Material | Polycarbonate | (Implicitly: Same as predicate) |
| Sheath | LDPE | (Implicitly: Same as predicate) |
| Stylet Sample Notch | 19mm | (Implicitly: Same as predicate) |
| Spacer | Thermoplastic | (Implicitly: Same as predicate) |
| Non-Pyrogenic | Yes, LAL Test | Yes (Implicitly: Demonstrated by LAL Test) |
| Sterile Packaging | Tyvek pouch | (Implicitly: Same as predicate) |
| Sterilization Method | Gamma, 11137, VDMax25, SAL 10-6 Dose: 25 - 40 kGy | (Implicitly: Equivalent or superior to predicate's EO SAL 10-6 or Gamma) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide any information regarding the sample size used for performance testing (e.g., number of biopsies performed, number of needles tested). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth
No information is provided about experts used to establish ground truth. The summary mentions "the quality of the samples obtained," suggesting an evaluation of biopsy specimens, but does not detail how this quality was assessed or by whom.
4. Adjudication Method for the Test Set
No information is provided regarding any adjudication method for performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned or implied. This device is a biopsy needle, not an imaging or diagnostic algorithm that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical instrument, not an algorithm.
7. Type of Ground Truth Used
While not explicitly called "ground truth," the performance testing likely involved assessing the "quality of samples obtained." This would typically be evaluated through:
* Histopathology/Pathology: Examination of the tissue samples by a pathologist to determine adequacy for diagnosis.
* Visual Inspection/Gross Examination: Assessment of the sample size, integrity, and appearance.
The document does not specify which of these, or any other method, was used.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
In summary, the provided 510(k) notification primarily focuses on demonstrating substantial equivalence through a comparison of design and materials with predicate devices, and a general statement about performance testing confirming sample quality. It lacks the specific details about acceptance criteria, study sizes, methodologies, and expert involvement that your detailed questions request. This level of detail is often found in the full test reports referenced (e.g., "See Section 18" for Performance Testing Summary), but not typically within the concise 510(k) summary itself.
Ask a specific question about this device
(43 days)
The Magnum Nail is intended for use in fixation of stable and unstable fractures of the proximal femur. The types of proximal femoral fractures include pertrochanteric, intertrochanteric, basal neck fractures, high subtrochanteric fractures and combinations of these fractures. The Magnum Nail is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures and revision procedures.
The Magnum Nail consists of nails, distal bone screws, cannulated lag screws, cannulated blades and set screws in a variety of sizes to accommodate differing anatomic requirements.
The provided text {0} discusses substantial equivalence based on basic design, intended use, indications, anatomic sites, and "mechanical performance." However, it does not explicitly define acceptance criteria or detail a specific study proving the device meets these criteria in the context of clinical performance or diagnostic accuracy. The document is a 510(k) summary for a medical device (Magnum Nail) and focuses on demonstrating substantial equivalence to predicate devices, primarily through design, intended use, and mechanical properties, not through a study demonstrating acceptance criteria for an AI/algorithm-driven device.
Therefore, most of the requested information (items 1-9) cannot be extracted directly from this document as it pertains to a different type of device evaluation (mechanical fixation rather than AI/algorithm performance).
However, I can extract the following relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document assesses "mechanical performance" for substantial equivalence of a fixative nail, not diagnostic or algorithmic performance. No specific acceptance criteria or quantitative performance metrics are provided in the context of an AI/algorithm evaluation.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set for an AI/algorithm is mentioned.
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. No ground truth establishment for an AI/algorithm is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set for an AI/algorithm is mentioned.
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. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for an AI/algorithm is mentioned.
8. The sample size for the training set
Not applicable. No training set for an AI/algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/algorithm is mentioned.
Ask a specific question about this device
(27 days)
The Magnum MP bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction. ITB tenodesis: patellar ligament and tendon avulsions
The Magnum MP device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
The provided text is a 510(k) premarket notification for a medical device (Magnum MP Fixation Device) and a clearance letter from the FDA. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about a specific study designed to prove the device meets acceptance criteria or detailed performance metrics.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not available in the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document focuses on substantial equivalence to a predicate device, rather than specific performance metrics against pre-defined acceptance criteria for a new study. | Not provided. The document does not present quantitative performance data for the Magnum MP Fixation Device against specific acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not provided.
- Data provenance: Not applicable, as no specific study data is presented. The submission discusses the device's design and materials in comparison to a predicate device.
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)
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not provided.
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: Not performed or reported. This type of study is typically related to diagnostic AI devices, and the Magnum MP is a fixation device.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This concept is relevant for AI algorithms, not for a physical fixation device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not applicable, as no "ground truth" in the context of diagnostic accuracy is discussed for this physical device. The submission relies on demonstrating substantial equivalence in design, materials, and intended use as evidence of safety and effectiveness.
8. The sample size for the training set
- Sample size for training set: Not applicable, as this device is a physical medical device, not an AI or algorithmic system requiring a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable.
Summary of available information from the provided text:
The provided document is a 510(k) summary, which aims to demonstrate that the new device (Magnum MP Fixation Device) is "substantially equivalent" to an already legally marketed predicate device (Magnum PI Knotless Fixation Device, K070227). The core argument is based on:
- Same intended use: "fixation of soft tissue to bone."
- Similar technical characteristics: The document states, "The Magnum MP design and technology is substantially equivalent to the existing Magnum PI Knotless Fixation Device." It also mentions "The materials are well characterized and have been used in predicate devices with similar indications."
- No new questions of safety or effectiveness: "The differences between the Magnum MP and the predicate device do not raise any questions regarding the safety and effectiveness of the implant."
In essence, the "study" for this 510(k) is the comparison and argument for substantial equivalence to a device already cleared by the FDA, rather than a de novo clinical or performance study with defined acceptance criteria and performance results for the new device.
Ask a specific question about this device
(24 days)
Ask a specific question about this device
(81 days)
Ask a specific question about this device
(90 days)
Ask a specific question about this device
Page 1 of 1