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510(k) Data Aggregation
(113 days)
Magnum
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) | 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.
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(90 days)
INTRODUCER, MODEL ADELANTE MAGNUM
The Adelante® Magnum is intended to facilitate the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements, while minimizing blood loss associated with such insertions. Do not use this device for neural placements.
Introducer, Model Adelante® Magnum
This document is a 510(k) clearance letter from the FDA for a medical device called "Introducer, model Adelante Magnum." It declares the device substantially equivalent to a predicate device. However, this document does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.
Therefore, I cannot fulfill your request for that specific information based solely on the provided text. The document primarily focuses on regulatory approval and substantial equivalence, not detailed performance studies.
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(255 days)
ION MAGNUM GENIUS
Ion Magnum Genius is intended for muscle conditioning to stimulate healthy muscles. The Ion Magnum Genius is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Ion Magnum Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Ion Magnum Genius is only offered under prescription given by a physician licensed in the state in which he or she practices.
Ion Magnum Genius is a muscle stimulator with six ports and one output that is the same for all ports. The unit is designed for healthy men & women to provide muscle conditioning. Ion Magnum Genius stimulator provides selections of different programs through manual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz which are within the same range as the predicate that offer a range from 1-120 Hz. The setting that the frequency button is turned shows which frequency the device is set on. The device delivers a voltage of 50 volts at 500 Ohms load and 100ma just like the predicate. It delivers a voltage of 200 volts at 10K Ohms just like the predicate. The Ion Magnum maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The Ion Magnum has a maximum output current of 200 volts which is equivalent to the maximum output current of the predicate. The device primarily treats abdominal muscles (ABS). LCD shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. The unit is easy and simple to use. Ion Magnum is suitable for use by all healthy adults. However as with other muscle stimulators some care is needed when using the Ion Magnum Genius [see contraindications and warnings in manual]
The provided text describes a 510(k) premarket notification for the "Ion Magnum Genius" muscle stimulator, asserting substantial equivalence to a predicate device, the "Compex Sport" (K01180). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than conducting new clinical trials to prove efficacy from scratch. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial would. Instead, it focuses on demonstrating equivalence to a known device.
However, I can extract the relevant information from the document that functions as acceptance criteria for demonstrating that the device is "substantially equivalent" and the "reported device performance" to meet those criteria.
Here's a breakdown of the information requested, based on the provided document:
Acceptance Criteria and Device Performance (Demonstration of Substantial Equivalence)
Since this is a 510(k) submission, the "acceptance criteria" are effectively the characteristics of the predicate device, and the "reported device performance" is how the Ion Magnum Genius compares to these characteristics to establish substantial equivalence.
1. Table of acceptance criteria and the reported device performance:
| Feature/Criterion (Based on Predicate Device: Compex Sport K01180) | Ion Magnum Genius Performance/Characteristic |
|---|---|
| Indications for Use: Muscle conditioning to stimulate healthy muscles; not for therapy/treatment of medical conditions; not for injured/ailing muscles. | Identical: Muscle conditioning to stimulate healthy muscles; not for therapy/treatment of medical conditions; not for injured/ailing muscles. Prescription use only, administered by a trained physician. |
| Waveform: Biphasic synchronous | Biphasic synchronous |
| Synchronous or alternating channels: Synchronous | Synchronous |
| Max Output Voltage: 50V @ 500 Ω, 200V @ 10k Ω | 50V @ 500 Ω, 200V @ 10k Ω |
| Max Output Current: 100 mA at 500 Ohms | 100 mA at 500 Ohms |
| Frequency (Hz) for Muscle Conditioning: 1-120 Hz | 90 Hz, 100 Hz, 120 Hz (within range) |
| Pulse Duration: 200 to 400 µsec | 416 - 500 µsec |
| Pulse Width: 200 to 400 µsec | 416 - 500 µsec |
| Maximum Phase Charge: 40 µC | 50 µC @ 500 Ω (90/100 Hz); 40 µC @ 500 Ω (120 Hz) |
| Maximum Current Density: 4 mA/cm2 | 4 mA/cm2 |
| Maximum Power Density: 0.038 W/cm^2 | 0.0012 W/cm^2 |
| Current or Voltage Driven: Current Driven / Voltage | Current Driven / Voltage |
| Symmetrical Phases of Waveform: Yes | Yes |
| Regulated Current/Voltage: Constant Current Regulator / Regulated Current | Regulated Voltage and Regulated Current |
| Method of Channel Isolation: Channels isolated by separated transformers | Channels isolated by separated transformers |
| Self-Adhesive Electrodes: Identical | Identical (Axelgaard type, K970426) |
| Current Leakage: >100 microamps (implied predicate limit) | 0.07 µA (demonstrates improved safety here) |
| Software/Microcomputer Control: Yes | No (different, but argued not to affect safety/effectiveness) |
| Number of Channels: 4 | 6 (different, but argued equally safe via risk assessment) |
| Safety Features: Automatic overload trip, automatic shut-off, patient override control, wire insulation/gap design. | Automatic overload trip, automatic shut-off, patient override control, increased wire insulation/gap (9mm). |
| ISO Certification for Manufacturing: Not explicitly stated for predicate in comparison table. | ISO 13485:2003 for muscle stimulators (2011-2014) |
| Bench Tests prior to release: Not explicitly stated for predicate. | Extensive bench tests prior to each unit release. |
Missing Information (Not provided in the document for this type of submission):
The following information is typically associated with clinical trials or specific performance studies, which are generally not required for a 510(k) submission when substantial equivalence is established through comparison to a predicate device. The document does not describe such studies.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no clinical test set is described. The comparison is primarily based on technical specifications and claims of physical characteristics.
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. Ground truth, in the context of clinical studies, is not established for this 510(k) submission.
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, as this device is a muscle stimulator, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this device is a physical muscle stimulator and does not involve "algorithm only" performance separate from its physical application. The entire device performance is akin to "standalone" in that it performs its function. Some technical bench tests are mentioned (e.g., current leakage, electrical outputs) but these are for device specification verification, not a clinical efficacy trial.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the clinical sense. The "ground truth" here is the technical specifications and established safety/efficacy profile of the predicate device. The Ion Magnum Genius demonstrates "truth" by having equivalent (or improved, i.e., current leakage, safety design changes) technical specifications.
8. The sample size for the training set
- Not applicable, as no machine learning/AI training set is described.
9. How the ground truth for the training set was established
- Not applicable.
Summary of "Proof" in a 510(k) Context:
The "study that proves the device meets the acceptance criteria" in this 510(k) submission is the comprehensive comparison table and discussion of technological characteristics and intended use against the predicate legally marketed device. The manufacturer (Ion Genius, Inc.) asserts and demonstrates through specification comparison, and in some cases, risk assessment (e.g., for 6 channels vs. 4), that the Ion Magnum Genius is substantially equivalent to the Compex Sport, which is legally marketed and presumed safe and effective for its intended use. The FDA's issuance of the 510(k) clearance (K123158) confirms this finding of substantial equivalence based on the provided information.
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(446 days)
LUCENT OR LUCENT MAGNUM
Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
This product is an intervertebral body fusion device, manufactured from titanium (Ti-6Al-4V) or PEEK-Optima®, for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. This modification seeks clearance for the addition of PEEK devices coated with a plasma-sprayed titanium coating.
The provided text describes a 510(k) premarket notification for a medical device, specifically an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and ground truth establishment, which are typical for studies validating AI/ML models or novel devices requiring extensive clinical data, is not directly applicable in the context of this 510(k) submission.
Here's an explanation based on the provided document and why most of your requested fields cannot be filled:
-
Nature of the Device: The Lucent® and Lucent Magnum® are physical intervertebral body fusion devices, not AI/ML systems or diagnostic tools. Their performance is assessed through mechanical testing against established ASTM standards and comparison to predicate devices, not through clinical studies with "test sets," "ground truth experts," or "AI assistance effect sizes."
-
510(k) Process: A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predecessor. The primary method for proving this "substantial equivalence" is through comparison of material specifications, design features, intended use, and performance data (often mechanical testing for implants) against predicate devices. Clinical efficacy studies as you've described for AI models are generally not required for 510(k)s unless the device raises new safety or effectiveness questions not addressed by predicates.
Therefore, many of your specific questions are not addressed in this type of regulatory document. I will fill in what can be inferred or directly stated from the text.
Acceptance Criteria and Device Performance (for a physical medical device)
The "acceptance criteria" for this device are implicitly tied to demonstrating performance at least as good as the predicate devices, as measured by standard mechanical tests. The "reported device performance" is a statement that the device did meet these criteria.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical performance at least as good as previously cleared Lucent system devices (K071724 and K073348) according to ASTM F2077, ASTM F2267, ASTM F1877, ASTM F2025-06. | "A comparison of the data to mechanical testing performance results of the previously cleared Lucent system devices indicates that the additional Lucent devices have the capability to perform at least as well the Lucent device." |
| Coating characteristics meeting standards set by ASTM F1044 and ASTM F1147. | "Coating Characterization testing was performed using coupons... All data indicates that the device will perform as intended." |
Study Details and Ground Truth Establishment
Given the nature of a 510(k) for a physical implant, the following information is not applicable or not provided in the document as it would be for an AI/ML diagnostic device study:
- Sample size for the test set: Not applicable. Performance was assessed through mechanical testing of the device itself and components, not a "test set" of clinical cases.
- Data provenance: Not applicable. Mechanical test results do not have "provenance" in the sense of clinical data (country or retrospective/prospective).
- Number of experts used to establish the ground truth for the test set & qualifications: Not applicable. There is no "ground truth" to be established by experts for a mechanical device in this context.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This device is not an AI algorithm assisting human readers.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used: Not applicable in the sense of clinical ground truth (e.g., pathology). The "ground truth" for mechanical performance is defined by the ASTM standards and the performance of the predicate device.
- Sample size for the training set: Not applicable. This is a physical device, not an AI model.
- How the ground truth for the training set was established: Not applicable.
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(106 days)
TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT
TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant is a male condom consisting of a sheath of natural rubber latex which covers the penis with a fitted membrane, coated with a lubricant consisting of low levels of sensory ingredients to create a perception of warming and tingling. The condom is a taper-walled, non-textured, nipple-end condom with an integral formed ring at the open end.
This 510(k) notification is for a condom, not an AI/ML powered device. Therefore, many of the requested fields are not applicable. I will provide the information that is available in the document.
Acceptance Criteria and Device Performance for TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety | Biocompatibility with human tissues | TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant is considered safe for consumer use under normal and reasonably foreseeable misuse conditions, based on: in vitro cytotoxicity extract test, vaginal irritation test, acute systemic toxicity, sensitive toxitization test, and bacterial reverse mutation assay. |
| Physical Properties | Meets specifications of ASTM D 3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) | Three (3) lots of condoms with the FIRE & ICE™ lubricant were tested and met the specifications of ASTM D 3492-08. |
| Shelf-life / Stability | Maintains safety and effectiveness over time, chemical compatibility with lubricant | Established through physical testing data using a protocol guided by 21 CFR §801.435. Initial expiration date set at 36 months, to be verified through real-time stability for five (5) years in compliance with 21 CFR §801.435. Chemical compatibility between latex condom and lubricant was also established. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Safety Studies: Not explicitly stated in terms of number of samples, but "studies" were performed.
- Sample Size for Physical Testing: Three (3) lots of condoms were tested.
- Data Provenance: Not specified, but generally, such testing is conducted in a controlled laboratory setting. The document does not indicate country of origin for the data or whether it was retrospective or prospective in the context of a clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical product (condom), and its performance is evaluated against established physical and biocompatibility standards, not against expert interpretation of data like in medical imaging.
4. Adjudication Method
Not applicable for this type of device and testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-powered diagnostic or assistive device.
6. Standalone (Algorithm Only) Performance
Not applicable. This is not an AI/ML algorithm.
7. Type of Ground Truth Used
- Safety: Established through standard biocompatibility tests (e.g., in vitro cytotoxicity, irritation tests) which have defined endpoints for safety.
- Physical Properties: Established by the specifications defined in ASTM D 3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms).
- Shelf-life: Established by physical testing data and compliance with 21 CFR §801.435, which guides expiration date labeling requirements.
8. Sample Size for the Training Set
Not applicable. There is no "training set" as this is a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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(105 days)
TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT
TROJAN® MAGNUM® Condom with WARMING™ Lubricant is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The TROJAN® MAGNUM® Condom with WARMING™ Lubricant is a male condom consisting of a sheath of natural rubber latex with a lubricated coating consisting of a glycol-type base to create a perception of warming. The condom is a taper-walled, non-textured, nipple-end condom as described in K 895640. The 510(k)-subject condom's physical specifications are substantially equivalent to the predicate device, the lubricant has been modified.
The provided text describes a 510(k) submission for the "TROJAN® MAGNUM® Condom with WARMING™ Lubricant." This is a medical device submission seeking clearance for a new product, not a study evaluating an AI algorithm's performance or a diagnostic device. Therefore, many of the requested fields related to AI, ground truth, experts, and comparative effectiveness studies are not applicable.
Below is an analysis of the available information based on the provided text, focusing on the device itself and its acceptance criteria as a traditional medical device (condom).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Reference Standard) | Reported Device Performance (TROJAN® MAGNUM® Condom with WARMING™ Lubricant) |
|---|---|---|
| Safety | Biocompatibility (cytotoxicity, irritation, acute systemic toxicity, sensitization, bacterial reverse mutation, mouse lymphoma assay) | Considered safe for consumer use under normal and reasonably foreseeable misuse conditions. |
| Physical Properties | ASTM D 3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) | Met the specifications of ASTM D 3492-08. |
| Shelf-life / Stability | 21 CFR §801.435 (evaluation of physical testing data) | Initial expiration date set at 36 months, to be verified through real-time stability up to five (5) years. Chemical compatibility between latex and lubricant established. |
| Intended Use | Contraception and prophylactic purposes (prevent pregnancy and STIs) | Remains the same as the predicate device. |
| Technological Characteristics | No significant changes in intended use, method of operations, materials, or design compared to predicate. Similar base lubricant formulation to secondary predicates, consistent with Special Controls of 21 CFR §884.5300. | Substantially equivalent to predicate MAGNUM condom in design and material. Glycol-based lubricant (different from predicate's silicone-based) but similar to secondary predicates (K073016, K000748). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Biocompatibility Studies: Not explicitly stated how many condoms or batches were used for the in vitro and in vivo biocompatibility tests.
- Sample Size for Physical Testing Data: "Three (3) lots of condoms with the WARMING™ lubricant were tested."
- Sample Size for Shelf-life: Not explicitly stated beyond "results of physical testing data."
- Data Provenance: The studies were performed on the 510(k)-subject device, indicating prospective testing by the manufacturer (Church & Dwight Co., Inc.). Country of origin of data is not specified but implied to be related to the manufacturer's testing facilities or contract labs. The submission is to the US FDA, so standards relevant to the US market were followed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a medical device clearance, not an AI algorithm study requiring human expert ground truth for classification or diagnosis. The "ground truth" for condom performance is established by adherence to recognized national and international standards (e.g., ASTM D 3492-08) and regulatory requirements related to safety and effectiveness.
4. Adjudication Method for the Test Set
Not applicable. This is a medical device clearance, not an AI algorithm study requiring adjudication of expert opinions. Performance is assessed against predefined quantitative and qualitative standards.
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 a medical device clearance for a condom, not an AI-assisted diagnostic or interpretative 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 (condom), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Regulatory Standards: Adherence to specific parts of the Code of Federal Regulations (e.g., 21 CFR §884.5300, 21 CFR §801.435).
- Consensus Standards: Meeting the specifications of industry-recognized standards like ASTM D 3492-08 for physical properties of male condoms.
- Biocompatibility Testing: Results from established in vitro and in vivo tests for toxicity, irritation, and sensitization.
- Predicate Device Performance: The primary ground truth for substantial equivalence is demonstrating that the new device performs "as well, or better, than the predicate MAGNUM condom" and "does not incorporate any significant changes in intended use, method of operations, materials, or design that could affect the safety and effectiveness."
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device clearance, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. (See #8)
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(57 days)
MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY
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.
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(67 days)
5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM
The ArthroCare Spartan PEEK Suture Implant 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 reattachment
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 ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fullythreaded, corkscrew shape anchor available in 5.5mm diameter size. The suture anchor comes preconfigured with MagnumWire® sutures for traditional knot tying and is mounted on a disposable delivery driver. The device is supplied sterile and is available with our without needles. Associated instruments (Punch Tap and Extraction Tool) for implantation and removal of the implant are available separately and altogether are referred to as the ArthroCare Spartan PEEK Suture Implant System.
The provided text describes a 510(k) submission for the ArthroCare Spartan PEEK Suture Implant System, which is a medical device for fixing soft tissue to bone. However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML device evaluations.
The "study" mentioned in the document is a "bench performance testing" to demonstrate substantial equivalence to predicate devices, and it involves "ultimate strength and cyclic loading tests" in a simulated human bone substrate. This is a biomechanical engineering test, not a clinical study or an AI/ML performance evaluation.
Therefore, for aspects related to AI/ML device performance (like specific metrics, test sets, expert adjudication, MRMC studies, and training data information), the provided document does not contain the requested details.
Here's a breakdown of what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for intended use, device design, technology, and components. | Demonstrated through bench performance testing. |
| Performance testing in accordance with FDA Guidance Document Testing for Bone Anchors. | Performed "ultimate strength and cyclic loading tests." |
| Safe and effective for its intended use. | Performance testing and device comparison demonstrate substantial equivalence, and thus, implicitly, safe and effective for intended use. |
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 Test Set: Not specified. The study involved "insertion of the anchors in a simulated human bone substrate," implying a number of implanted anchors and test cycles, but a specific count is not given.
- Data Provenance: Not applicable in the human data sense. The tests were performed in a "simulated human bone substrate," which suggests a lab-based, synthetic or cadaveric bone analog environment, not human patient data. This is a form of prospective bench testing.
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. Ground truth for a biomechanical bench test is typically established by the results of the physical tests (e.g., force at failure, cycles to failure) as measured by calibrated equipment, not by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is relevant for clinical studies or image interpretation, not for biomechanical bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the physical device's mechanical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for this type of device (bone anchor) would be directly measured mechanical properties:
- Ultimate Strength: The maximum force the anchor can withstand before failure or pullout.
- Cyclic Loading Performance: The number of cycles the anchor can endure under specified loads without significant displacement or failure, simulating repetitive physiological stresses.
- These are directly measured physical parameters, not derived from expert opinion or clinical outcomes in the traditional sense.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the AI/ML sense. "Training" for such a device would involve its design, manufacturing processes, and materials science.
9. How the ground truth for the training set was established
- Not applicable for AI/ML training data. For the device itself, "ground truth" (i.e., meeting design specifications and material properties) would be established through material testing, engineering calculations, and quality control during manufacturing.
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(19 days)
5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
The ArthroCare Spartan PEEK Suture Implant 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 reattachment
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 ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fullythreaded, corkscrew shape anchor available in 5.5mm diameter size. The suture anchor mounted on a disposable delivery driver. The device is supplied sterile and is available with our without needles. Associated instruments (Punch Tap and Extraction Tool) for implantation and removal of the implant are available separately and altogether are referred to as the ArthroCare Spartan PEEK Suture Implant System.
The provided text is a 510(k) summary for the ArthroCare Corporation Spartan™ PEEK Suture Implant System, outlining its substantial equivalence to a predicate device. It does not describe a study involving AI, human readers, or a test set with ground truth established by experts.
Therefore, many of the requested categories related to acceptance criteria, AI performance, expert adjudication, and ground truth establishment cannot be extracted from this document as they are not present.
However, I can provide the available information regarding the device's performance based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Performance Test) | Reported Device Performance |
|---|---|
| Ultimate strength testing | Testing completed to demonstrate substantial equivalence to predicate device. |
| Cyclic loading tests | Testing completed to demonstrate substantial equivalence to predicate device. |
Note: The document states "Bench performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture Implant in accordance with FDA Guidance Document Testing for Bone Anchors." It does not provide specific numerical acceptance thresholds or detailed numerical results for the ultimate strength or cyclic loading tests beyond confirming they were performed and supported substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The study described is a bench performance test for a medical device (suture implant), not a study involving a test set of data with human subjects or images.
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. This was a physical bench performance test, not a study 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. This was a physical bench performance test.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This document does not mention any MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not mention any algorithm or AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" equivalent for this device's performance evaluation was its mechanical behavior (ultimate strength and cyclic loading) in a simulated human bone substrate, compared against the predicate device. This is based on physical testing standards and comparisons.
8. The sample size for the training set
Not applicable. This was a physical bench performance test, not a machine learning study.
9. How the ground truth for the training set was established
Not applicable. This was a physical bench performance test, not a machine learning study.
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria was a series of bench performance tests. These tests involved:
- Insertion of anchors in a simulated human bone substrate.
- Ultimate strength testing.
- Cyclic loading tests.
The purpose of these tests was to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture Implant to its predicate device (Arthrocare 5.5mm Spartan PEEK Suture Implant System, K102262) in accordance with the "FDA Guidance Document Testing for Bone Anchors." The summary concludes that "The performance testing and device comparison demonstrate that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use."
The document does not provide specific methodologies, number of samples tested, or detailed quantitative results for these bench tests, but states they were completed and supported the substantial equivalence claim.
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(29 days)
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM
The 44mm E1™ Acetabular Liner with 44mm Biolox® delta Option Ceramic Head or 44mm M2a Magnum™ Modular Head is for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures where other treatment or devices have failed.
Specific indications for compatible components that can be used with the 44mm Biolox® delta Option Ceramic Head include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830. K042774)
Biomet Manufacturing Corp. is addinq a size 44mm liner to their line of E1™ Acetabular Liners to allow the surgeon more options. Additionally, the 44mm Biolox® delta Option Ceramic Head is added to the ceramic option line. The 44mm M²a Magnum™ may be used when a Co-Cr-Mo option is needed. This submission is a line extension of the previously cleared systems.
This document is a 510(k) Summary for a medical device (44mm E1™ Acetabular Liner with ceramic or modular heads) and does NOT contain information about acceptance criteria or a study proving the device meets said criteria.
The purpose of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria in a study format often seen with AI/software devices. For traditional medical devices like hip implants, substantial equivalence is typically shown through demonstrating similar technological characteristics, materials, and intended use as a predicate device, often supported by non-clinical (e.g., mechanical) testing rather than clinical performance studies.
Therefore, I cannot extract the requested information from the provided text because it is not present. The document explicitly states:
- "Non-Clinical Testing: All parameters of the 'Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems' were met for the devices contained in this 510(k)." This indicates that the device met certain standards, but it doesn't provide the specific acceptance criteria or a "study" in the sense of a performance evaluation with reported metrics.
- "Clinical Testing: None provided." This confirms that there was no clinical study performed, which would be the typical place to find performance data, ground truth establishment, and details about sample sizes, experts, etc.
In summary, this document is a regulatory submission focused on demonstrating substantial equivalence, not a performance study report as you've outlined in your request.
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