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510(k) Data Aggregation
(54 days)
The O-Mec Laparoscopes 690 Series (Models, 90-331000H, 690-300500H, 690-300500H, are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are rigid endoscopes that are used to view a patient's internal anatomy for examination, diagnosis and therapy during laparoscopic procedures. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are available in two sizes: 5mm or 10mm diameters, with either 0° or 30° directions of view. O-Mec laparoscope provides a high definition image and can correct chromatic aberration in the 400-900nm wavelength range.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are delivered non-sterile and are reusable and fully autoclavable. O-Mec laparoscopes must be cleaned according to the Instructions of Use before each use.
The provided text describes the O-Mec Laparoscopes 690 Series and its substantial equivalence to predicate devices, but it does not contain information related to AI/ML device performance, acceptance criteria for AI/ML, or studies explicitly designed to prove an AI/ML device meets such criteria.
The document is a 510(k) Pre-Market Notification for a traditional medical device (laparoscopes). The "acceptance criteria" discussed are for the physical and functional performance of the laparoscope itself (e.g., optical performance, sterilization validation, electrical safety) in comparison to predicate devices, not for an AI/ML algorithm's diagnostic or predictive capabilities.
Therefore, I cannot extract the requested information, such as:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes used for test sets (for AI/ML), data provenance, etc.
- Number of experts, qualifications, and adjudication methods for AI/ML ground truth.
- MRMC comparative effectiveness study details (AI vs. human).
- Standalone performance of an AI algorithm.
- Type of ground truth used (for AI/ML).
- Sample size for the training set (for AI/ML).
- How ground truth for the training set was established (for AI/ML).
The document explicitly states: "Clinical testing was not performed with this device." and the "Summary of Non-Clinical Testing" focuses on hardware performance, cleaning, and safety. There is no mention of an AI/ML component or any associated performance metrics or studies.
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(47 days)
Laparoscopes are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, gastric bypass, laparoscopic Nissen and examination of the abdominal cavity, appendix, gallbladder and liver.
Bariatric laparoscopes allow surgeons to perform procedures on morbidly obese segments of their patient population.
The Stryker Bariatric Laparoscope is a reusable rigid endoscopc, packaged in the not-sterile state.
The provided text describes a 510(k) submission for a medical device, the Stryker Bariatric Laparoscope, which is a design modification of an existing laparoscope. The primary goal of the submission is to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device rather than defining new, specific performance acceptance criteria for the modified device in isolation. The acceptance criteria essentially revolve around showing that the modified device performs equivalently to the predicate device in key aspects and introduces no new safety or effectiveness concerns.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Sterilizability (10^-6 sterility assurance level) | "demonstrated to be sterilizable with a sterility assurance level (SAL) of 10^-6 under a variety of recommended sterility assurance cycles at health care facilities, including: ethylene oxide, steam autoclave, Sterrad and Steris." |
| Biocompatibility (per ISO 10993 and CDRH G95-1 guidance) | "constructed of materials which are tested for biocompatibility per ISO 10993 and CDRH G95-1 guidance; these material are non-toxic and durable for their intended purposes." |
| Electrical Safety (conformance to IEC 601-2-18) | "conforms to the electrical safety requirements of IEC 601-2-18 as a type BF or type CF applied part of medical electrical equipment." |
| Optical Performance (Equivalent to Predicate) | "The Stryker Bariatric Laparoscope has been evaluated to ensure equivalent optical performance to the predicate device." (No specific metrics provided, but implies testing was done to confirm non-inferiority or equivalence) |
| Mechanical Strength and Rigidity (Equivalent to Predicate) | "The Stryker Bariatric Laparoscope has been evaluated to ensure equivalent mechanical strength and rigidity under loads normally expected in laparoscopic surgery." (No specific metrics provided, but implies testing was done to confirm non-inferiority or equivalence under surgical loads) |
| No new issues compared to predicate device or uses | "The Stryker Bariatric Laparoscope does not introduce new issues when compared to its predicate device or uses. Therefore the Stryker Bariatric Laparoscope is considered to be substantially equivalent to its predicate device and uses." (This is a conclusion drawn from the cumulative evaluation of the above criteria.) |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify a sample size for a test set in the traditional sense of clinical or performance testing with a 'test set' of subjects or cases. The evaluation appears to be primarily focused on bench testing and engineering assessments of the device's technical specifications and material properties against established standards or in comparison to the predicate device.
- Data Provenance: The nature of the tests (sterilization cycles, biocompatibility, electrical safety, optical performance, mechanical strength) suggests that the data would be derived from laboratory testing and engineering analyses performed by the manufacturer, Stryker Endoscopy. It is retrospective in the sense that the testing was performed on the manufactured device models to support the submission (i.e., not a prospective clinical trial). There is no mention of country of origin of the data beyond the manufacturer's location in Santa Clara, CA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable in the traditional sense. For a 510(k) submission showing substantial equivalence for a device like a laparoscope, "ground truth" isn't established by expert consensus on clinical cases. Instead, the "ground truth" or reference points are:
- Established international and national standards (e.g., ISO 10993, IEC 601-2-18).
- The performance characteristics of the predicate device (K910132).
- General understanding of expected performance for endoscopes in laparoscopic surgery.
- The individuals who conducted and interpreted these engineering and material tests would be qualified engineers, material scientists, and regulatory specialists employed by Stryker Endoscopy or their contracted testing facilities. Their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set:
- Not Applicable. Since there isn't a "test set" of patient cases requiring expert review or a "ground truth" established by multiple experts in a clinical context, an adjudication method like 2+1 or 3+1 is not relevant to the information provided. The "adjudication" for this submission would be the FDA's regulatory review process.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is a surgical instrument (laparoscope), not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study evaluating human reader performance with or without AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a rigid endoscope, which is a hardware instrument. It does not contain an algorithm or AI component to be tested in a standalone fashion.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
As explained in point 3, the "ground truth" is not patient-specific clinical ground truth. Instead, it relies on:
- Adherence to recognized standards: ISO 10993 for biocompatibility, IEC 601-2-18 for electrical safety.
- Comparison to predicate device specifications: For optical performance, mechanical strength, and rigidity.
- Demonstrated performance against validated test methods: For sterilization efficacy.
8. The sample size for the training set:
- Not Applicable. This device development did not involve a "training set" in the context of machine learning or AI. It's a hardware modification.
9. How the ground truth for the training set was established:
- Not Applicable. As explained in point 8, there was no training set for this device.
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