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510(k) Data Aggregation
(24 days)
The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.
The VAPORMAX is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.
The VAPORMAX is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.
Due to the nature of the provided document, which is a 510(k) premarket notification summary for a medical device (VAPORMAX™ Side Firing Fiber), the information requested about acceptance criteria and a study proving the device meets those criteria is not present in the document.
Here's why and what can be extracted based on your request:
- No Acceptance Criteria or Performance Study: This document states explicitly in sections "VII. Nonclinical Data" and "VIII. Clinical Data" that "No nonclinical data were submitted in this Premarket Notification" and "No clinical tests were submitted in this Premarket Notification."
- Predicate Device Equivalence: The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than submitting extensive de novo acceptance criteria and performance data for a new technology. The VAPORMAX™'s submission focuses on its technological characteristics (increased power handling) compared to existing Trimedyne side firing fibers and the Lumenis DUOTOME SIDELITE™.
- Intended Use Statement: The "Conclusions Drawn From Testing" (Section IX) simply states, "The VAPORMAX performs as intended and has acceptable mechanical properties when used in accordance with its labeling." This is a general statement, not a detailed report of specific performance metrics against defined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, experts, or ground truth as this information was not part of this 510(k) submission.
Summary based on available information:
| Aspect | Information from Document |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not provided. The document states, "No nonclinical data were submitted" and "No clinical tests were submitted." Conclusions are general: "The VAPORMAX performs as intended and has acceptable mechanical properties." |
| 2. Sample size for test set and data provenance | Not applicable/Not provided. No nonclinical or clinical test data was submitted. The device was cleared based on substantial equivalence to predicate devices, not on new performance data against specific acceptance criteria. |
| 3. Number of experts used to establish ground truth for the test set and their qualifications | Not applicable/Not provided. No test set with ground truth was presented in this submission. |
| 4. Adjudication method for the test set | Not applicable/Not provided. No test set was presented. |
| 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size of human readers improvement | Not applicable/Not provided. No clinical studies, and therefore no MRMC studies, were submitted or discussed. |
| 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done | Not applicable/Not provided. This is a physical laser fiber, not an algorithm. |
| 7. The type of ground truth used | Not applicable/Not provided. No test data requiring ground truth was provided. |
| 8. The sample size for the training set | Not applicable/Not provided. There is no mention of machine learning or algorithms that would require a training set. This is a physical medical device. |
| 9. How the ground truth for the training set was established | Not applicable/Not provided. There is no mention of machine learning or algorithms. |
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(90 days)
The Optical Integrity General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, cystoscopes, cystoscopes, gastroscopes, and colonoscopes, or for contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Optical Integrity GS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT, General and Vascular Surgery, Lithotripsy, Arthroscopy, Podiatry, Orthopedics and Neurosurgery.
The Optical Integrity General Shaped (GS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the GS fiber may be used for a wide variety of surgical procedures.
The provided text for K022338 describes a medical device, the Optical Integrity General Shaped (GS) Fiber, and its intended use. However, it does not contain detailed information regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive clinical study report with detailed performance metrics against predefined acceptance criteria.
Based only on the provided text, I can infer the following about how the device meets its claims:
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Acceptance Criteria and Reported Device Performance: This information is not
explicitly stated in the provided document. The document states "Bench testing was performed to demonstrate that the device will perform as intended," but it does not specify what those "intentions" (i.e., acceptance criteria) were, nor does it list specific performance results like accuracy, sensitivity, specificity, etc., that would typically be found in a performance table. The focus of the 510(k) is on the technological characteristics and comparison to predicate devices, not on quantitative performance metrics against specific criteria. -
Sample Size and Data Provenance for Test Set: This information is not provided in the document. The text mentions "Bench testing," which implies laboratory-based tests, but no details on the number of samples used or if any human-derived data was involved. Given it's "bench testing," it's likely physical or engineering tests on the fiber itself, not a clinical test set with patient data.
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Number of Experts and Qualifications: This information is not provided. Bench testing typically involves engineers or technicians, not medical experts in the way clinical studies do for ground truth establishment.
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Adjudication Method: This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are used in clinical trials involving human readers/interpreters to establish ground truth from discrepancies. Bench testing does not involve this type of adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: An MRMC comparative effectiveness study was not mentioned in the document. This type of study would be relevant for evaluating the impact of AI on human reader performance, which is not the focus of this 510(k) for a laser delivery fiber.
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Standalone Performance Study (Algorithm Only): A standalone performance study was not mentioned. This device is a physical fiber optic laser delivery system, not an algorithm.
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Type of Ground Truth Used: For "bench testing," the "ground truth" would be engineering specifications, physical measurements, and performance benchmarks relevant to the fiber's function (e.g., optical power transmission, durability, beam profile, heat dissipation). The document does not specify the exact type of ground truth used for these bench tests.
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Sample Size for Training Set: This information is not applicable or provided. The device is a physical product, not an AI/ML algorithm that requires a training set.
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How Ground Truth for Training Set was Established: This information is not applicable or provided for the reasons mentioned above.
Summary based on available information:
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Acceptance Criteria & Performance Table | Not explicitly stated in the document. The general intent is that the device "will perform as intended" based on bench testing. | "Bench testing was performed to demonstrate that the device will perform as intended." No specific quantitative results are provided. |
| Sample Size (Test Set) & Data Provenance | Not specified. Bench testing implies laboratory/engineering samples, not clinical data. | Not specified. |
| Number & Qualifications of Experts (Ground Truth) | Not applicable in the context of device bench testing. | Not applicable. |
| Adjudication Method (Test Set) | Not applicable. | Not applicable. |
| MRMC Comparative Effectiveness Study | No MRMC study was mentioned. | Not mentioned. |
| Standalone Performance Study (Algorithm Only) | Not applicable; this is a physical device, not an algorithm. | Not applicable. |
| Type of Ground Truth Used | Engineering specifications, physical properties, and performance benchmarks for fiber optic laser delivery systems (inferred). | Not explicitly stated. |
| Sample Size (Training Set) | Not applicable; this is a physical device, not an AI/ML algorithm. | Not applicable. |
| Ground Truth Establishment (Training Set) | Not applicable. | Not applicable. |
The 510(k) summary (K022338) for the Optical Integrity General Shaped Fiber primarily focuses on establishing substantial equivalence to existing predicate devices through technological characteristic comparison and general bench testing, rather than presenting detailed clinical performance data against specific acceptance criteria.
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(80 days)
The ArthroCare Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures may include the following: General Surgery: cholecystectomy, lysis of adhesions, upper GI, GI (other), splenectomy, thyroidectomy, herniorrhaphy, breast biopsy, bowel resection, pelvic adhesiolysis, removal of lesions, removal of polyps, tumor biopsy. Gynecological Surgery: lysis of adhesions, hysterectomy, salpingo-oophorectomy, burch colposuspension, myomectomy, endometriosis, ovariohysterectomy, removal of tumors.
The ArthroCarc Electrosurgery Wands are single use, disposable bipolar electrosurgical devices designed to be used in conjunction with the ArthroCare Electrosurgery System (System 2000).
Please note that the provided text is a 510(k) Summary for a medical device (ArthroCare Electrosurgery Wands) seeking substantial equivalence to existing predicate devices. It is not a research paper detailing a study designed to establish acceptance criteria for an AI/ML device and demonstrate its performance against those criteria. Therefore, many of the requested points, particularly those related to AI/ML specific studies, expert ground truth, sample sizes for training/test sets, and comparative effectiveness studies, are not applicable or cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence to predicate devices through a comparison of indications for use, materials, technology, product specifications, energy requirements, and performance testing.
Here's an attempt to answer your questions based solely on the provided text, while acknowledging the limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance in the way an AI/ML study would. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices, and the "reported device performance" is summarized as being safe and effective for its intended use.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use | Equivalent to predicate devices (K001302, K981361, K990947). Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. |
| Materials | Equivalent to predicate devices. |
| Technology | Equivalent to predicate devices. |
| Product Specifications | Equivalent to predicate devices. |
| Energy Requirements | Equivalent to predicate devices. |
| Safe and Effective Use | Demonstrated through performance testing for resection and ablation of soft tissue. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance testing," but does not provide any details about sample size (number of cases/patients), data provenance (country of origin), or whether the data was retrospective or prospective. It simply states "Performance testing has been completed to demonstrate the safe and effective use of the Electrosurgery Wands in the resection and ablation of soft tissue."
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)
This information is not provided in the document. The type of "ground truth" for a medical device like an electrosurgery wand usually involves established safety and performance benchmarks and clinical observable outcomes (e.g., successful tissue resection, coagulation, hemostasis) rather than expert labelling of data like in AI/ML.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to the type of performance testing described for an electrosurgical device.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant to AI-assisted diagnostic or interpretative devices, which is not what the ArthroCare Electrosurgery Wands are. They are surgical tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The ArthroCare Electrosurgery Wands are manual surgical tools, not AI/ML algorithms, and therefore do not have a standalone algorithm-only performance. They are used by a human surgeon.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document does not explicitly state the "type of ground truth" in the way an AI/ML study would. However, for an electrosurgical device, the "ground truth" for proving safe and effective use would likely involve:
- Direct observable outcomes: Successful tissue resection, ablation, and coagulation; effective hemostasis.
- Pathology/Histology: Confirmation of tissue effects.
- Physiological measurements: E.g., temperature, current, power delivery.
- Adverse events: Absence of unintended tissue damage or complications.
The document refers to "performance testing" to demonstrate "safe and effective use," implying these types of objective measures were used.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm that requires a training set or ground truth for training.
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