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510(k) Data Aggregation
(87 days)
The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
The product has 2 sizes: 50mm(L)×50mm(W)×5mm(T) and 50mm(L)×25mm(W)× 5mm(T). The product is composed by a small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel' with a polyurethane foam base and pressure sensitive adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.
The provided FDA 510(k) summary (K241022) for the Sterile single use tip cleaner (WK800-S10, WK800-S20) does not contain information on how the acceptance criteria were established or details of a study that proves the device meets specific performance criteria related to clinical efficacy.
The document focuses on non-clinical performance testing for physical characteristics and manufacturing-related residuals, primarily to establish substantial equivalence to a predicate device. There is no mention of clinical studies, human reader performance, AI assistance, or related metrics.
Here's an analysis based on the information provided, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Requirement) | Reported Device Performance (Result) |
|---|---|---|
| Appearance | 1.1 The surface of the product should be clean, free from damage, cracking, or other undesirable phenomena. | PASS |
| 1.2 The product sandpaper surface, sponge base layer, pressure-sensitive adhesive, X-ray ray, and release paper should be tightly bonded, no curling/falling off. | PASS | |
| Product Performance | 2.1 The double-sided adhesive has good adhesion, smoothness, and no warping. | PASS |
| 2.2 There is no sand falling off on the polishing abrasive (sandpaper) surface. | PASS | |
| 2.3 The peel strength of the double-sided adhesive should be ≥ 2N/CM. | PASS | |
| Residual Testing | 3. FTO Residual ≤ 4mg/pcs; ECH ≤ 9mg/pcs. | PASS |
Note: These acceptance criteria are for non-clinical, physical, and manufacturing characteristics, not for clinical performance or diagnostic accuracy.
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 specifies "Non-clinical Performance Testing" but does not provide details on the sample size for these tests (e.g., how many units were tested for peel strength or appearance). It also does not mention the data provenance beyond it being conducted by the manufacturer, WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. in China. Given the nature of these tests, they would be prospective manufacturing quality and material property tests.
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. The tests performed are non-clinical, evaluating physical properties and chemical residuals, not requiring expert clinical interpretation or ground truth establishment in the way a diagnostic imaging device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication. The results are from physical measurements and observations against defined specifications.
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 device is a sterile single-use tip cleaner, an accessory for electrosurgical cauterization. It is a physical medical device, not an AI or software-driven diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. As explained above, this device is not an AI algorithm. The performance tests are for its physical properties and sterility.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" or reference is the predefined technical specifications and standards (e.g., "free from damage, cracking," "peel strength ≥ 2N/CM," "FTO Residual ≤ 4mg/pcs"). These are established engineering and quality control criteria.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable, for the same reasons above.
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(114 days)
The Trocar, Model: Auto-Locking Trocar, Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Trocar Models: Auto-Locking Trocar, Bladeless Trocar and Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three kinds of diameter sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. Auto-Locking Trocar 10 mm can accept 4 mm to 11 mm sized instruments with its built-in universal seal without the use of a converter. Auto-Locking Trocar 12 mm can accept 4 mm to 13 mm sized instruments with its built-in universal seal without the use of a converter.
The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock.
The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip,, which is designed for open Laparoscopy. The visible trocar is available in three sizes: 5mm, 10mm and 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock.
The provided document is a 510(k) summary for a medical device (Trocar), not a study proving an AI device meets acceptance criteria. It focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and non-clinical performance testing. Therefore, it does not contain the information requested about acceptance criteria, test sets, expert involvement, and statistical analyses typical for AI/ML device validation studies.
Specifically, the document does not provide information on:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes for a test set (it mentions in-house non-clinical tests, but not a large-scale clinical test set for AI).
- Data provenance for a test set.
- Number of experts or their qualifications for establishing ground truth for a test set.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size of human readers improving with AI assistance.
- Standalone performance of an algorithm (as it's a physical device).
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set (not an AI/ML device).
- How ground truth for a training set was established.
Instead, the document states:
Acceptance Criteria & Device Performance (for the physical Trocar device):
-
Acceptance Criteria (Implied): The device is expected to meet various performance requirements related to its function, biocompatibility, and sterilization. Specifically, the document mentions:
- Biocompatibility as per ISO 10993 standards (e.g., Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-Mediated Pyrogenicity).
- Sterilization validation per ISO 11135:2014.
- Specific performance aspects: Obturator Compatibility, Insertion & Cannula Stability, Air Leakage, Trocar Insertion/Removal force.
-
Reported Device Performance: The document states, "All the test results demonstrate Trocar meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide specific numerical or qualitative results for each criterion; rather, it makes a general statement of compliance.
Study Proving Device Meets Acceptance Criteria:
- Type of Study: Non-clinical testing (bench testing, biocompatibility testing, sterilization validation). This is conducted by the manufacturer, WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
- Sample Size Used for Test Set: Not specified. The document only mentions that "a series of tests were performed" and "The performance testing conducted on subject device is listed below." No quantitative sample sizes for these tests are provided.
- Data Provenance: Implied to be in-house testing conducted by the manufacturer in China, as per their address. It's non-clinical, so "retrospective or prospective" is not directly applicable in the same way it would be for patient data.
- Number of Experts/Qualifications & Adjudication Methods: Not applicable, as this is a physical medical device undergoing bench and biocompatibility testing, not an AI/ML assessment involving human interpretation of data.
- MRMC Comparative Effectiveness Study/Standalone Performance: Not applicable for a physical surgical instrument.
- Type of Ground Truth: The ground truth for this device's performance is objective measurements against established engineering specifications, biocompatibility standards (e.g., ISO 10993), and sterilization standards (e.g., ISO 11135).
- Training Set/Ground Truth for Training Set: Not applicable, as this is not an AI/ML device.
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(63 days)
The Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
The Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
This document is a 510(k) summary for the WickiMed Veress Needle and provides information on its substantial equivalence to a predicate device. It does not describe an AI/ML powered device, therefore no information about acceptance criteria and studies proving the device meets these criteria as would be relevant for an AI/ML system is available.
The document discusses the following types of non-clinical testing for the Veress Needle:
- Biocompatibility tests: Conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, and ISO 10993-12:2012. These included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, and Material-Mediated Pyrogenicity.
- Sterilization validation: Performed per ISO 11135:2014.
- Performance tests:
- Tip Pull Test
- Switch Operation
- Spring Obturator Operation
- Needle Puncture Force Test
The document states that "All the test results demonstrate the performance of Veress Needle meets the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide the specific numerical acceptance criteria for these tests, nor the reported device performance values. It also does not discuss any of the other specific items from your request (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) as these are not relevant to a traditional medical device submission like a Veress Needle.
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